%0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e60221 %T Personalized mHealth Intervention (StepAdd) for Increasing Physical Activity in Japanese Patients With Type 2 Diabetes: Secondary Analysis of Social Cognitive Theory Measurements of a Single-Arm Pilot Study %A Waki,Kayo %A Enomoto,Syunpei %A Yamauchi,Toshimasa %A Nangaku,Masaomi %A Ohe,Kazuhiko %K social cognitive theory %K mHealth %K mobile health %K behavior change %K diabetes %K diabetic %K type 2 diabetes %K walk %K step %K exercise %K physical activity %K walking %K digital therapeutics %K secondary analysis %K personalization %K coping %K self-efficacy %D 2025 %7 28.3.2025 %9 %J JMIR Form Res %G English %X Background: A 12-week pilot of the StepAdd mobile health (mHealth) behavior change intervention based on social cognitive theory (SCT) saw an 86.7% increase in mean daily step counts among patients with type 2 diabetes. Due to the lack of exploration of theoretical implications in mHealth intervention studies, there is a need to understand the mechanism underlying the behavioral change to inform the future design of digital therapeutics. Objective: This study aimed to examine the SCT drivers underlying the mean increase in exercise among Japanese patients with type 2 diabetes who participated in the StepAdd intervention. Methods: This is a post hoc analysis of data collected in the single-arm pilot study of the 32 patients who completed the StepAdd intervention. The StepAdd app uses self-mastery and coping strategies to increase self-efficacy and thus increase walking. Self-mastery was measured by the goal completion (GC) rate, which is the percentage of days in which patients met these adapting goals. The use of coping strategies was measured by the strategy implementation (SI) rate, which is the percentage of days in which patients applied their selected coping strategies. We assessed correlations between GC, SI, and self-efficacy to increase walking via linear regression and analyzed relationships via structural equation modeling. Results: We found statistically significant support for the SCT approach, including a correlation coefficient (ρ) of 0.649 between step increase and GC rate (P<.001); a ρ of 0.497 between the coping SI rate and self-efficacy increase (P=.004); a ρ of 0.446 between GC rate and self-mastery increase (P=.01); and a ρ of 0.355 between self-regulation increase and step increase (P=.046), giving us insight into why the behavior intervention succeeded. We also found significant correlations between self-efficacy for barriers and self-efficacy for task-specific behavior (ρ=0.358; P=.04), as well as self-regulation and self-efficacy for task-specific behavior (ρ=0.583; P<.001). However, a cross-lagged panel modeling analysis found no significant evidence that changes in self-efficacy preceded behavior changes in line with SCT. Conclusions: Self-mastery and coping strategies contributed to the walking behavior change in StepAdd, supporting the SCT model of behavior change. Future research is needed to better understand the causal pathways proposed by SCT. %R 10.2196/60221 %U https://formative.jmir.org/2025/1/e60221 %U https://doi.org/10.2196/60221 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 10 %N %P e64096 %T School-Partnered Collaborative Care (SPACE) for Pediatric Type 1 Diabetes: Development and Usability Study of a Virtual Intervention With Multisystem Community Partners %A March,Christine A %A Naame,Elissa %A Libman,Ingrid %A Proulx,Chelsea N %A Siminerio,Linda %A Miller,Elizabeth %A Lyon,Aaron R %+ , Pediatric Endocrinology, UPMC Children's Hospital of Pittsburgh, 4401 Penn Avenue, Pittsburgh, PA, 15224, United States, 1 4126929156, christine.eklund@chp.edu %K type 1 diabetes %K user-centered design %K school health %K collaborative care model %K implementation research %K pediatric %K usability testing %K virtual intervention %K multisystem community partners %K children %K youth %K diabetes management support %K health system partners %K psychosocial interventions %K quantitative assessments %K qualitative assessments %D 2025 %7 26.3.2025 %9 Original Paper %J JMIR Diabetes %G English %X Background: School-partnered interventions may improve health outcomes for children with type 1 diabetes, though there is limited evidence to support their effectiveness and sustainability. Family, school, or health system factors may interfere with intervention usability and implementation. Objective: To identify and address potential implementation barriers during intervention development, we combined methods in user-centered design and implementation science to adapt an evidence-based psychosocial intervention, the collaborative care model, to a virtual school-partnered collaborative care (SPACE) model for type 1 diabetes between schools and diabetes medical teams. Methods: We recruited patient, family, school, and health system partners (n=20) to cocreate SPACE through iterative, web-based design sessions using a digital whiteboard (phase 1). User-centered design methods included independent and group activities for idea generation, visual voting, and structured critique of the evolving SPACE prototype. In phase 2, the prototype was evaluated with the usability evaluation for evidence-based psychosocial interventions methods. School nurses reviewed the prototype and tasks in cognitive walkthroughs and completed the Intervention Usability Scale (IUS). Two members of the research team independently identified and prioritized (1-3 rating) discrete usability concerns. We evaluated the relationship between prioritization and the percentage of nurses reporting each usability issue with Spearman correlation. Differences in IUS scores by school nurse characteristics were assessed with ANOVA. Results: In the design phase, the partners generated over 90 unique ideas for SPACE, prioritizing elements pertaining to intervention adaptability, team-based communication, and multidimensional outcome tracking. Following three iterations of prototype development, cognitive walkthroughs were completed with 10 school nurses (n=10, 100% female; mean age 48.5, SD 9.5 years) representing different districts and years of experience. Nurses identified 16 discrete usability issues (each reported by 10%-60% of participants). Two issues receiving the highest priority (3.0): ability to access a virtual platform (n=3, 30% of participants) and data-sharing mechanisms between nurses and providers (n=6, 60% of participants). There was a moderate correlation between priority rating and the percentage of nurses reporting each issue (ρ=0.63; P=.01). Average IUS ratings (77.8, SD 11.1; 100-point scale) indicated appropriate usability. There was no difference in IUS ratings by school nurse experience (P=.54), student caseload (P=.12), number of schools covered (P=.90), or prior experience with type 1 diabetes (P=.83), suggesting that other factors may influence usability. The design team recommended strategies for SPACE implementation to overcome high-priority issues, including training users on videoconferencing applications, establishing secure forms for school data reporting, and sharing glucose data in real-time during SPACE meetings. Conclusions: Cross-sector interventions are complex, and perceived usability is a potential barrier to implementation. Using web-based cocreation methods with community partners promoted high-quality intervention design that is aligned with end-user priorities. Quantitative and qualitative assessments indicated appropriate degree of usability to move forward with pilot-testing. %M 40138695 %R 10.2196/64096 %U https://diabetes.jmir.org/2025/1/e64096 %U https://doi.org/10.2196/64096 %U http://www.ncbi.nlm.nih.gov/pubmed/40138695 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 10 %N %P e60765 %T Patient and Clinician Perspectives on the Effectiveness of Current Telemedicine Approaches in Endocrinology Care for Type 2 Diabetes: Qualitative Study %A Zupa,Margaret %A Hamm,Megan %A Alexander,Lane %A Rosland,Ann-Marie %+ Division of Endocrinology and Metabolism, University of Pittsburgh School of Medicine, 3601 Fifth Ave, Suite 3A, Pittsburgh, PA, 15213, United States, 1 4125869700, zupamf@upmc.edu %K diabetes %K telemedicine %K video visit %K endocrinology %K effectiveness %K type 2 diabetes mellitus %K patient %K perspectives %K qualitative interviews %K clinicians %D 2025 %7 11.3.2025 %9 Original Paper %J JMIR Diabetes %G English %X Background: Since the rapid widespread uptake in 2020, the use of telemedicine to deliver diabetes specialty care has persisted. However, evidence evaluating patient and clinician perspectives on benefits, shortcomings, and approaches to improve telemedicine care for type 2 diabetes is limited. Objective: This study aims to assess clinician and patient perspectives on specific benefits and limitations of current telemedicine care delivery for type 2 diabetes and views on approaches to enhance telemedicine effectiveness for patients who rely on it. Methods: We conducted semistructured qualitative interviews with diabetes specialty clinicians and adults with type 2 diabetes. We used a qualitative description approach to characterize participant perspectives on care delivery for type 2 diabetes via telemedicine. Results: Both clinicians (n=15) and patients (n=13) identify significant benefits of telemedicine in overcoming both physical (geographic and transportation) and scheduling (work commitments and wait times) barriers to specialty care for type 2 diabetes. In addition, telemedicine may enhance communication around diabetes care by improving information sharing between patients and clinicians. However, clinicians identify limited availability of home blood glucose data and vital signs as factors, which impair the optimal management of type 2 diabetes and related comorbid conditions via telemedicine. Previsit preparation, involvement of multidisciplinary providers, and frequent brief check-ins were identified by patients and clinicians as potential strategies to improve the quality of telemedicine care for adults with type 2 diabetes. Conclusions: Patients and clinicians identify key strengths of telemedicine in enhancing access to diabetes specialty care for adults with type 2 diabetes and describe approaches to ensure that telemedicine delivers high-quality diabetes care to patients who rely on it. %M 40068145 %R 10.2196/60765 %U https://diabetes.jmir.org/2025/1/e60765 %U https://doi.org/10.2196/60765 %U http://www.ncbi.nlm.nih.gov/pubmed/40068145 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e59842 %T High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: Protocol for a Proof-of-Concept Randomized Controlled Trial %A Thirunavukkarasu,Sathish %A Ziegler,Thomas R %A Weber,Mary Beth %A Staimez,Lisa %A Lobelo,Felipe %A Millard-Stafford,Mindy L %A Schmidt,Michael D %A Venkatachalam,Aravind %A Bajpai,Ram %A El Fil,Farah %A Prokou,Maria %A Kumar,Siya %A Tapp,Robyn J %A Shaw,Jonathan E %A Pasquel,Francisco J %A Nocera,Joe R %+ Department of Family and Preventive Medicine, School of Medicine, Emory University, 1518 Clifton Rd. NE, Atlanta, GA, 30322, United States, 1 470 357 8308, sathish.thirunavukkarasu@emory.edu %K isolated impaired fasting glucose %K prediabetes %K high-intensity interval training %K fasting hyperglycemia %K diabetes incidence %K fasting glucose %K glucose %K diabetes %K proof of concept %K interval training %K type 2 diabetes %K hyperglycemia %K overweight %K obese %K weight %K insulin %K feasibility %D 2025 %7 20.2.2025 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Standard lifestyle interventions have shown limited efficacy in preventing type 2 diabetes among individuals with isolated impaired fasting glucose (i-IFG). Hence, tailored intervention approaches are necessary for this high-risk group. Objective: This study aims to (1) assess the feasibility of conducting a high-intensity interval training (HIIT) study and the intervention acceptability among individuals with i-IFG, and (2) investigate the preliminary efficacy of HIIT in reducing fasting plasma glucose levels and addressing the underlying pathophysiology of i-IFG. Methods: This study is a 1:1 proof-of-concept randomized controlled trial involving 34 physically inactive individuals (aged 35-65 years) who are overweight or obese and have i-IFG. Individuals will undergo a 3-step screening procedure to determine their eligibility: step 1 involves obtaining clinical information from electronic health records, step 2 consists of completing questionnaires, and step 3 includes blood tests. All participants will be fitted with continuous glucose monitoring devices for approximately 80 days, including 10 days prior to the intervention, the 8-week intervention period, and 10 days following the intervention. Intervention participants will engage in supervised HIIT sessions using stationary “spin” cycle ergometers in groups of 5 or fewer. The intervention will take place 3 times a week for 8 weeks at the Aerobic Exercise Laboratory in the Rehabilitation Hospital at Emory University. Control participants will be instructed to refrain from engaging in intense physical activities during the study period. All participants will receive instructions to maintain a eucaloric diet throughout the study. Baseline and 8-week assessments will include measurements of weight, blood pressure, body composition, waist and hip circumferences, as well as levels of fasting plasma glucose, 2-hour plasma glucose, and fasting insulin. Primary outcomes include feasibility parameters, intervention acceptability, and participants’ experiences, perceptions, and satisfaction with the HIIT intervention, as well as facilitators and barriers to participation. Secondary outcomes comprise between-group differences in changes in clinical measures and continuous glucose monitoring metrics from baseline to 8 weeks. Quantitative data analysis will include descriptive statistics, correlation, and regression analyses. Qualitative data will be analyzed using framework-driven and thematic analyses. Results: Recruitment for the study is scheduled to begin in February 2025, with follow-up expected to be completed by the end of September 2025. We plan to publish the study findings by the end of 2025. Conclusions: The study findings are expected to guide the design and execution of an adequately powered randomized controlled trial for evaluating HIIT efficacy in preventing type 2 diabetes among individuals with i-IFG. Trial Registration: Clinicaltrials.gov NCT06143345; https://clinicaltrials.gov/study/NCT06143345 International Registered Report Identifier (IRRID): PRR1-10.2196/59842 %M 39977858 %R 10.2196/59842 %U https://www.researchprotocols.org/2025/1/e59842 %U https://doi.org/10.2196/59842 %U http://www.ncbi.nlm.nih.gov/pubmed/39977858 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e65026 %T Exploring the Acceptance of Just-in-Time Adaptive Lifestyle Support for People With Type 2 Diabetes: Qualitative Acceptability Study %A Hietbrink,Eclaire A G %A Middelweerd,Anouk %A d’Hollosy,Wendy %A Schrijver,Laura K %A Laverman,Gozewijn D %A Vollenbroek-Hutten,Miriam M R %+ Department of Biomedical Signals and Systems, University of Twente, Drienerlolaan 5, Enschede, 7500 AE, The Netherlands, 31 53 4892760, e.a.g.hietbrink@utwente.nl %K eHealth %K just-in-time adaptive intervention %K ecological momentary assessment %K type 2 diabetes %K behavior change %K physical activity %K nutrition %K acceptability %K formative evaluation %K mobile phone %D 2025 %7 19.2.2025 %9 Original Paper %J JMIR Form Res %G English %X Background: The management of type 2 diabetes (T2D) requires individuals to adopt and maintain a healthy lifestyle. Personalized eHealth interventions can help individuals change their lifestyle behavior. Specifically, just-in-time adaptive interventions (JITAIs) offer a promising approach to provide tailored support to encourage healthy behaviors. Low-effort self-reporting via ecological momentary assessment (EMA) can provide insights into individuals’ experiences and environmental factors and thus improve JITAI support, particularly for conditions that cannot be measured by sensors. We developed an EMA-driven JITAI to offer tailored support for various personal and environmental factors influencing healthy behavior in individuals with T2D. Objective: This study aimed to assess the acceptability of EMA-driven, just-in-time adaptive lifestyle support in individuals with T2D. Methods: In total, 8 individuals with T2D used the JITAI for 2 weeks. Participants completed daily EMAs about their activity, location, mood, overall condition, weather, and cravings and received tailored support via SMS text messaging. The acceptability of the JITAI was assessed through telephone-conducted, semistructured interviews. Interview topics included the acceptability of the EMA content and prompts, the intervention options, and the overall use of the JITAI. Data were analyzed using a hybrid approach of thematic analysis. Results: Participants with a mean age of 70.5 (SD 9) years, BMI of 32.1 (SD 5.3) kg/m², and T2D duration of 15.6 (SD 7.7) years had high self-efficacy scores in physical activity (ie, 32) and nutrition (ie, 29) and were mainly initiating or maintaining behavior changes. The identified themes were related to the intervention design, decision points, tailoring variables, intervention options, and mechanisms underlying adherence and retention. Participants provided positive feedback on several aspects of the JITAI, such as the motivating and enjoyable messages that appeared well tailored to some individuals. However, there were notable differences in individual experiences with the JITAI, particularly regarding intervention intensity and the perceived personalization of the EMA and messages. The EMA was perceived as easy to use and low in burden, but participants felt it provided too much of a snapshot and too little context, reducing the perceived tailoring of the intervention options. Challenges with the timing and frequency of prompts and the relevance of some tailoring variables were also observed. While some participants found the support relevant and motivating, others were less inclined to follow the advice. Participants expressed the need for even more personalized support tailored to their specific characteristics and circumstances. Conclusions: This study showed that an EMA-driven JITAI can provide motivating and tailored support, but more personalization is needed to ensure that the lifestyle support more closely fits each individual’s unique needs. Key areas for improvement include developing more individually tailored interventions, improving assessment methods to balance active and passive data collection, and integrating JITAIs within comprehensive lifestyle interventions. %M 39969969 %R 10.2196/65026 %U https://formative.jmir.org/2025/1/e65026 %U https://doi.org/10.2196/65026 %U http://www.ncbi.nlm.nih.gov/pubmed/39969969 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 10 %N %P e57526 %T Diabetes Medical Group Visits and Type 2 Diabetes Outcomes: Mediation Analysis of Diabetes Distress %A Reichert,Matthew %A De La Cruz,Barbara A %A Gardiner,Paula %A Mitchell,Suzanne %K diabetes %K diabetic %K diabetes mellitus %K DM %K type 1 diabetes %K type 2 diabetes %K diabetes mellitus type 2 %K diabetes outcomes %K diabetes medical group visit %K DMGVs %K psychosocial functioning %K psychosocial %K glycemic control %K glycemic %K shared medical appointments %K self-management %K mediation analysis %K social support %K minority women %K minority %D 2025 %7 6.2.2025 %9 %J JMIR Diabetes %G English %X Background: Group-based diabetes care, both technology-enabled and in-person, can improve diabetes outcomes in low-income minority women, but the mechanism remains unclear. Objective: We tested whether diabetes group medical visits (GMVs) reduced hemoglobin A1c (HbA1c) by mitigating diabetes distress (DD), an emotional response affecting nearly half of adults with type 2 diabetes in community settings. Methods: We conducted a mediation and moderation analysis of data from the Women in Control 2.0 comparative effectiveness study, which showed that both technology-enabled and in-person diabetes GMVs improve HbA1c. We tested whether DD mediated the relationship between diabetes GMV engagement and reductions in HbA1c. We also tested whether this relationship was moderated by depressive symptoms and social support. Participants were 309 low-income and minority women. Diabetes GMV engagement was measured using the Group Climate Questionnaire. The mediator, DD, was measured using the Diabetes Distress Screening Scale. The outcome was the 6-month change in HbA1c. Social support was measured using the Medical Outcomes Study Social Support Survey. Results: DD mediated the relationship between engagement and 6-month HbA1c. Specifically, group engagement affected HbA1c by reducing distress associated with the regimen of diabetes self-management (P=.04), and possibly the emotional burden of diabetes (P=.09). The relationship between engagement and 6-month HbA1c was moderated by depressive symptoms (P=.02), and possibly social support (P=.08). Conclusions: Engagement in diabetes GMVs improved HbA1c because it helped reduce diabetes-related distress, especially related to the regimen of diabetes management and possibly related to its emotional burden, and especially for women without depressive symptoms and possibly for women who lacked social support. Trial Registration: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/study/NCT02726425 %R 10.2196/57526 %U https://diabetes.jmir.org/2025/1/e57526 %U https://doi.org/10.2196/57526 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e63975 %T Effectiveness of Different Intervention Modes in Lifestyle Intervention for the Prevention of Type 2 Diabetes and the Reversion to Normoglycemia in Adults With Prediabetes: Systematic Review and Meta-Analysis of Randomized Controlled Trials %A Wang,Yachen %A Chai,Xin %A Wang,Yueqing %A Yin,Xuejun %A Huang,Xinying %A Gong,Qiuhong %A Zhang,Juan %A Shao,Ruitai %A Li,Guangwei %+ School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, 31 Yard, Beijige Santiao, Dongcheng District, Beijing, China, Beijing, 100730, China, 86 13911644595, shaoruitai@sph.pumc.edu.cn %K mobile phone %K prediabetic state %K digital health intervention %K intervention mode %K lifestyle intervention %K type 2 diabetes mellitus %K meta-analysis %K systematic review %K review %D 2025 %7 29.1.2025 %9 Review %J J Med Internet Res %G English %X Background: Lifestyle interventions have been acknowledged as effective strategies for preventing type 2 diabetes mellitus (T2DM). However, the accessibility of conventional face-to-face interventions is often limited. Digital health intervention has been suggested as a potential solution to overcome the limitation. Despite this, there remains a significant gap in understanding the effectiveness of digital health for individuals with prediabetes, particularly in reducing T2DM incidence and reverting to normoglycemia. Objective: This study aimed to assess the effectiveness of different intervention modes of digital health, face-to-face, and blended interventions, particularly the benefits of digital health intervention, in reducing T2DM incidence and facilitating the reversion to normoglycemia in adults with prediabetes compared to the usual care. Methods: We conducted a comprehensive search in 9 electronic databases, namely MEDLINE, Embase, ACP Journal Club, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Cochrane Clinical Answers, Cochrane Methodology Register, Health Technology Assessment, and NHS Economic Evaluation Database through Ovid, from the inception to October 2024. This review included randomized controlled trials (RCTs) that studied the effectiveness of lifestyle interventions in adults with prediabetes. The overall intervention effect was synthesized using a random-effects model. The I² statistic was used to assess heterogeneity across the RCTs. We performed a subgroup analysis to explore the effectiveness of digital health, face-to-face, and blended interventions compared with the control group, which received usual care. Results: From an initial 7868 records retrieved from 9 databases, we identified 54 articles from 31 RCTs. Our analysis showed that face-to-face interventions demonstrated a significant 46% risk reduction in T2DM incidence (risk ratio [RR] 0.54, 95% CI 0.47-0.63; I²=43%; P<.001), and a 46% increase in the reversion to normoglycemia (RR 1.46, 95% CI 1.11-1.91; I²=82%; P=.006), when compared with the control group. On the other hand, digital health interventions, compared with the control group, were associated with a 12% risk reduction in T2DM incidence (RR 0.88, 95% CI 0.77-1.01; I²=0.6%; P=.06). Moreover, the blended interventions combining digital and face-to-face interventions suggested a 37% risk reduction in T2DM incidence (RR 0.63, 95% CI 0.49-0.81;I²<0.01%; P<.001) and an 87% increase in the reversion to normoglycemia (RR 1.87, 95% CI 1.30-2.69; I²=23%; P=.001). However, no significant effect on the reversal of prediabetes to normoglycemia was observed from the digital health interventions. Conclusions: Face-to-face interventions have consistently demonstrated promising effectiveness in both reductions in T2DM incidence and reversion to normoglycemia in adults with prediabetes. However, the effectiveness of digital health interventions in these areas has not been sufficiently proven. Given these results, further research is required to provide more definitive evidence of digital health and blended interventions in T2DM prevention in the future. Trial Registration: PROSPERO CRD42023414313; https://tinyurl.com/55ac4j4n %M 39879607 %R 10.2196/63975 %U https://www.jmir.org/2025/1/e63975 %U https://doi.org/10.2196/63975 %U http://www.ncbi.nlm.nih.gov/pubmed/39879607 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 10 %N %P e67636 %T “Now I can see it works!” Perspectives on Using a Nutrition-Focused Approach When Initiating Continuous Glucose Monitoring in People with Type 2 Diabetes: Qualitative Interview Study %A Willis,Holly J %A Henderson,Maren S G %A Zibley,Laura J %A JaKa,Meghan M %+ International Diabetes Center, HealthPartners Institute, 3800 Park Nicollet Blvd, Minneapolis, MN, 55416, United States, 1 9529933219, holly.willis@parknicollet.com %K diabetic %K diabetes mellitus %K DM %K type 2 diabetes %K T2D %K endocrinology %K nutrition %K diet %K continuous glucose monitoring %K glucose monitor %K glucose %K glycemic control %K time in range %K self-care %K education %K mHealth %D 2025 %7 10.1.2025 %9 Original Paper %J JMIR Diabetes %G English %X Background: Food choices play a significant role in achieving glycemic goals and optimizing overall health for people with type 2 diabetes (T2D). Continuous glucose monitoring (CGM) can provide a comprehensive look at the impact of foods and other behaviors on glucose in real time and over the course of time. The impact of using a nutrition-focused approach (NFA) when initiating CGM in people with T2D is unknown. Objective: This study aims to understand the perspectives and behaviors of people with T2D who participated in an NFA during CGM initiation. Methods: Semistructured qualitative interviews were conducted with UNITE (Using Nutrition to Improve Time in Range) study participants. UNITE was a 2-session intervention designed to introduce and initiate CGM using an NFA in people with T2D who do not use insulin. The intervention included CGM initiation materials that emphasized the continuous glucose monitor as a tool to guide evidence-based food choices. The materials were designed to support conversation between the CGM user and diabetes care provider conducting the sessions. A rapid matrix analysis approach was designed to answer two main questions: (1) How do people who participate in an NFA during CGM initiation describe this experience? and (2) How do people who participate in an NFA during CGM initiation use CGM data to make food-related decisions, and what food-related changes do they make? Results: Overall, 15 people completed interviews after completion of the UNITE study intervention: 87% (n=13) identified as White, 60% (n=9) identified as male, mean age of 64 (SD 7.4) years, mean T2D duration of 7.5 (SD 3.8) years, and mean hemoglobin A1c level of 7.5% (SD 0.4%). Participants fluently discussed glycemic metrics such as time in range (percent time with glucose 70-180 mg/dL) and reported regularly using real-time and retrospective CGM data. Participants liked the simplicity of the intervention materials (eg, images and messaging), which demonstrated how to use CGM data to learn the glycemic impact of food choices and suggested how to adjust food choices for improved glycemia. Participants reported that CGM data impacted how they thought about food, and most participants made changes because of seeing these data. Many of the reported changes aligned with evidence-based guidance for a healthy lifestyle, including prioritizing nonstarchy vegetables, reducing foods with added sugar, or walking more; however, some people reported behavior changes, such as skipping or delaying meals to stay in the target glucose range. A few participants reported that the CGM amplified negative feelings about food or eating. Conclusions: Participants agreed that pairing nutrition information with CGM initiation instructions was helpful for their diabetes care. In general, the NFA during CGM initiation was well received and led to positive changes in food choices and behaviors during a 2-month intervention. %M 39793006 %R 10.2196/67636 %U https://diabetes.jmir.org/2025/1/e67636 %U https://doi.org/10.2196/67636 %U http://www.ncbi.nlm.nih.gov/pubmed/39793006 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 13 %N %P e58038 %T Skeletal Muscle Mass Loss and Physical Function in Young to Middle-Aged Adult Patients With Diabetes: Cross-Sectional Observational Study %A Naruse,Aki %A Yamada,Yuka %A Miyamoto,Takeshi %+ Division of Medical Technology, Department of Rehabilitation Technology, Kumamoto University Hospital, 1-1-1, Honjo, Chuo-ku, Kumamoto, 8600811, Japan, 81 096 373 7084, aki-naruse@kuh.kumamoto-u.ac.jp %K type 2 diabetes mellitus %K middle-aged adults %K physical function %K skeletal muscle mass %K sarcopenia %D 2024 %7 18.12.2024 %9 Original Paper %J Interact J Med Res %G English %X Background: Recently, it has been reported that older adults with type 2 diabetes mellitus (T2DM) have lower skeletal muscle mass than healthy individuals. Although skeletal muscle mass in older adults with diabetes is occasionally reported, similar reports on young to middle-aged adults are limited. Objective: This study aims to assess the prevalence of skeletal muscle loss in young to middle-aged adults with diabetes, examine the relationship between skeletal muscle loss and physical function in these patients, and examine whether there are differences in these characteristics between men and women. Methods: This cross-sectional, observational study included patients younger than 65 years with T2DM who were admitted to our hospital between 2014 and 2022 for educational admission for glycemic control and requested rehabilitation by the Department of Metabolic Medicine. The control group consisted of patients who received rehabilitation during their hospitalization at our hospital and did not have diabetes. The main parameters included skeletal muscle mass, muscle strength, physical function, and activities of daily living. Results: The prevalence of skeletal muscle mass loss in this study was 18.2% (10/55) in men and 7.7% (4/52) in women. The skeletal muscle mass index (SMI) was 7.7 (SD 0.8) and 8.4 (SD 0.5) for men in the T2DM and control groups, respectively, and 7.0 (SD 0.9) and 6.8 (SD 0.7) for women in the T2DM and control groups, respectively. Therefore, compared with the nondiabetes group, a significant difference was observed in men but not in women (men: P<.001, women: P=.35). Nonetheless, the diabetes group exhibited significantly lower physical functions, such as a walking speed of 1.3 (SD 0.2) m/s and 1.2 (SD 0.43) m/s for men and women in the T2DM group and 1.6 (SD 0.2) m/s and 1.5 (SD 0.1) m/s for men and women in the control group, respectively (men: P<.001, women: P<.001). One-leg standing time was measured as 30.7 (SD 26.9) seconds and 29.4 (SD 25.5) seconds for men and women in the T2DM group, compared with 100.5 (SD 30.6) seconds and 82.5 (SD 39.8) seconds for men and women in the control group, respectively, with the T2DM group’s times being significantly lower (men: P<.001, women: P<.001). Univariate logistic regression analysis showed that SMI was significantly associated with age, BMI, and peripheral neuropathy (all P≤.002). Multiple logistic regression analysis showed that BMI exhibited the strongest association (odds ratio 1.15, 95% CI 1.07-1.23; P<.001), and peripheral neuropathy was also significantly associated with SMI (P=.009). Conclusions: Patients with diabetes, even those who are not older adults, face an elevated rate of skeletal muscle mass loss, muscle weakness, and a decline in physical function; moreover, they are susceptible to dynapenia and presarcopenia. Therefore, early intervention focusing on muscle evaluation and exercise is crucial. %M 39693147 %R 10.2196/58038 %U https://www.i-jmr.org/2024/1/e58038 %U https://doi.org/10.2196/58038 %U http://www.ncbi.nlm.nih.gov/pubmed/39693147 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e64463 %T Improving Self-Efficacy, Quality of Life, and Glycemic Control in Adolescents With Type 1 Diabetes: Randomized Controlled Trial for the Evaluation of the Family-Centered Empowerment Model %A Alzawahreh,Salah %A Ozturk,Candan %+ Ministry of Health, Al-muzdalefah Street, Amman, 11118, Jordan, 962 0772260125, Salahalzwaherh78@yahoo.com %K adolescents %K family-centered empowerment model %K glycemic control %K quality of life %K self-efficacy %K type 1 diabetes mellitus %K T1DM %K family-centered %K teenager %K glycemic %K experimental evaluation %K empowerment %K Jordan %K glycosylated hemoglobin %K HbA1c %K experimental study %K family %K care education %K self-care %K educational program %K mobile phone %D 2024 %7 10.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Poor glycemic management in adolescents with type 1 diabetes mellitus (T1DM) increases complications. Enhanced control is associated with other factors, such as cultural, socioeconomic, and health care system disparities specific to the Middle East, which can greatly influence individuals’ ability to get and use health care services as well as their reaction to treatment approaches. Objective: This study aims to evaluate the impact of the family-centered empowerment model on Jordanian adolescents with T1DM, focusing on their glycosylated hemoglobin levels, self-efficacy, and quality of life (QOL). Methods: A randomized controlled trial involved 68 adolescents with T1DM visiting Jordanian Royal Medical Services’ clinics. Two sets of participant groups were created: control (n=34) and intervention (n=34). Participants were randomly assigned to either the intervention group, receiving the family-centered empowerment model intervention, or the control group, receiving standard care. Data were collected through face-to-face interviews and medical records. Results: From April to October 2023, a total of 68 adolescents with T1DM participated in the study at the Jordanian Royal Medical Services. QOL had significant improvement among 13 (38%) of the 34 participants in the intervention group, and the program significantly improved moderate self-efficacy levels in 12 (35%) patients (P<.001). In addition, the average glycosylated hemoglobin levels dropped from 11.25% to 10.23% (P<.001). Additionally, improvements were seen in stress management, communication, and treatment adherence, with a substantial decrease in treatment obstacles. The intervention was successful in improving both clinical and psychosocial outcomes, as evidenced by the fact that the control group showed no noticeable improvements in these parameters. Conclusions: The study suggests that patients with T1DM should receive continuous care education sessions, including self-care training, to improve their health. Nurses should also incorporate this training into treatment plans and educational programs for adolescents to enhance their QOL. Trial Registration: ClinicalTrials.gov NCT06694467; https://clinicaltrials.gov/study/NCT06694467 %M 39658013 %R 10.2196/64463 %U https://formative.jmir.org/2024/1/e64463 %U https://doi.org/10.2196/64463 %U http://www.ncbi.nlm.nih.gov/pubmed/39658013 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57312 %T A 360° Approach to Personalize Lifestyle Treatment in Primary Care for People With Type 2 Diabetes: Feasibility Study %A Harakeh,Zeena %A de Hoogh,Iris %A Krijger-Dijkema,Anne-Margreeth %A Berbée,Susanne %A Kalkman,Gino %A van Empelen,Pepijn %A Otten,Wilma %+ Department of Child Health, TNO, Netherlands Organization for Applied Scientific Research, Sylviusweg 71, Leiden, 2333 BE, Netherlands, 31 611615907, zeena.harakeh@tno.nl %K type 2 diabetes %K diagnostic tool %K holistic approach %K personalized treatment %K shared decision-making %K health professionals %K intervention %K feasibility study %K primary care %D 2024 %7 4.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Given the multifactorial nature of type 2 diabetes (T2D), health care for this condition would benefit from a holistic approach and multidisciplinary consultation. To address this, we developed the web-based 360-degree (360°) diagnostic tool, which assesses 4 key domains: “body” (physical health parameters), “thinking and feeling” (eg, mental health and stress), “behavior” (lifestyle factors), and “environment” (eg, work and housing conditions). Objective: This work examines the acceptability, implementation, and potential effects of the 360° diagnostic tool and subsequent tailored treatment (360° approach) in a 6-month intervention and feasibility study conducted in standard primary health care settings in the Netherlands. Methods: A single-group design with baseline, 3-month, and 6-month follow-ups was used. A total of 15 people with T2D and their health care providers from 2 practices participated in a 6-month intervention, which included the 360° diagnosis, tailored treatment, and both individual and group consultations. The 360° diagnosis involved clinical measurements for the “body” domain and self-reports for the “thinking and feeling,” “behavior,” and “environment” domains. After multidisciplinary consultations involving the general practitioner, pharmacist, nurse practitioner (NP), and dietitian, the NP and dietitian provided tailored advice, lifestyle treatment, and ongoing support. At the end of the intervention, face-to-face semistructured interviews were conducted with health care professionals (n=6) and participants (n=13) to assess the acceptability and implementation of the 360° approach in primary health care. Additionally, data from 14 participants on the “thinking and feeling” and “behavior” domains at baseline, 3 months, and 6 months were analyzed to assess changes over time. Results: The semistructured interviews revealed that both participants with T2D and health care professionals were generally positive about various aspects of the 360° approach, including onboarding, data collection with the 360° diagnosis, consultations and advice from the NP and dietitian, the visual representation of parameters in the profile wheel, counseling during the intervention (including professional collaboration), and the group meetings. The interviews also identified factors that promoted or hindered the implementation of the 360° approach. Promoting factors included (1) the care, attention, support, and experience of professionals; (2) the multidisciplinary team; (3) social support; and (4) the experience of positive health effects. Hindering factors included (1) too much information, (2) survey-related issues, and (3) time-consuming counseling. In terms of effects over time, improvements were observed at 3 months in mental health, diabetes-related problems, and fast-food consumption. At 6 months, there was a reduction in perceived stress and fast-food consumption. Additionally, fruit intake decreased at both 3 and 6 months. Conclusions: Our findings suggest that the 360° approach is acceptable to both people with T2D and health care professionals, implementable, and potentially effective in fostering positive health changes. Overall, it appears feasible to implement the 360° approach in standard primary health care. Trial Registration: Netherlands Trial Register NL-7509/NL-OMON45788; https://onderzoekmetmensen.nl/nl/trial/45788 %M 39631068 %R 10.2196/57312 %U https://formative.jmir.org/2024/1/e57312 %U https://doi.org/10.2196/57312 %U http://www.ncbi.nlm.nih.gov/pubmed/39631068 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e60190 %T Beyond Hemoglobin A1c—Outcomes That Matter to Individuals With Type 1 Diabetes in Adopting Digital Health Interventions for Self-Management Support: Qualitative Study %A Markowitz,Benjamin %A de Sequeira,Stephanie %A Najam,Adhiyat %A Pritlove,Cheryl %A Greenberg,Dana %A Greenberg,Marley %A Chan,Chee-Mei %A Lakhanpal,Gurpreet %A Jagadeesh,Samyukta %A Mukerji,Geetha %A Shulman,Rayzel %A Witteman,Holly O %A Yu,Catherine H %A Booth,Gillian L %A Parsons,Janet A %A , %+ Unity Health Toronto, 30 Bond St, Toronto, ON, M5B 1C9, Canada, 1 (416) 360 4000, stephanie.desequeira@unityhealth.to %K T1D self-management %K patient reported outcomes %K patient reported outcome measures %K virtual care %K mobile phone %K type 1 diabetes %D 2024 %7 7.11.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Type 1 diabetes is a demanding chronic condition that requires diligent blood glucose monitoring and timely insulin administration by patients who must integrate self-management into their daily lives. Objective: This study aimed to better understand what outcome measures are important to individuals living with type 1 diabetes (T1D) in Ontario, Canada, to help inform the development of type 1 diabetes virtual self-management Education and support (T1ME) trial. Methods: A qualitative approach was used, in which we conducted 6 focus groups with a total of 24 adult participants living with T1D (from age 18 to >65 years) in Ontario. Each focus group was semistructured in nature; participants were encouraged to talk openly about their experiences with T1D self-management and provide their perspectives on more focused topics such as technology and relationships with health care providers. Results: An interpretive analysis helped us devise a framework for our results that centered around 6 main discussion themes: (1) adapting self-management to meet evolving needs, (2) looking “beyond A1c” toward more personalized indicators of glycemic management, (3) the benefits and challenges of adopting new T1D technology, (4) establishing trusting relationships with diabetes care providers, (5) perceived benefits of peer support, and (6) pre– and post–COVID-19 perspectives on virtual care. Conclusions: Our goal is for these findings to help facilitate the development of patient-oriented outcome measures that are in line with the unique needs and preferences of T1D patients in this new, more virtual landscape of clinical care, education, and self-management support. %M 39509700 %R 10.2196/60190 %U https://diabetes.jmir.org/2024/1/e60190 %U https://doi.org/10.2196/60190 %U http://www.ncbi.nlm.nih.gov/pubmed/39509700 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e59142 %T Effectiveness of King’s Theory of Goal Attainment in Blood Glucose Management for Newly Diagnosed Patients With Type 2 Diabetes: Randomized Controlled Trial %A Yan,Man %A Yu,Yingchun %A Li,Shuping %A Zhang,Peiling %A Yu,Jiaxiang %+ Department of Nursing and Rehabilitations, Faculty of Medicine and Health Sciences, University Putra Malaysia, Administrative building, 3rd Fl., Serdang, 43400, Malaysia, 60 0178736091, yuge1185@gmail.com %K King’s Theory of Goal Attainment %K online feedback approach %K newly diagnosed patients with type 2 diabetes mellitus %K blood glucose control %K type 2 diabetes %K diabetes mellitus %K blood glucose %D 2024 %7 31.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Diabetes poses a significant public health challenge in China and globally, with the number of patients expected to reach 592 million by 2035, notably in Asia. In China alone, an estimated 140 million individuals are living with diabetes, and a significant portion is nonadherent to medications, underscoring the urgency of effective management strategies. Recognizing the necessity of early and comprehensive management for newly diagnosed patients with type 2 diabetes, this study leverages an online teach-back method and “Internet + Nursing” platform based on King’s Theory of Goal Attainment. The approach aims to enhance glycemic control and reduce fear and misconceptions about the disease, addressing both the educational and emotional needs of the patients. Objective: The primary aim of this study was to assess the effectiveness of King’s Goal Attainment Theory in the management of newly diagnosed patients with type 2 diabetes. This research sought to develop a collaborative model for blood glucose management, integrating the expertise and roles of physicians, nurses, and patients. The model is designed to enhance the synergy in health care provision, ensuring a comprehensive approach to diabetes management. Methods: In this study conducted at Changzhou Traditional Chinese Medicine Hospital between January 2022 and February 2023, eligible patients were randomized into a control group or an online feedback group. The control group received standard care, while the online feedback group participated in a King’s Theory of Goal Attainment–based online teach-back program, enhanced by “Internet + Nursing” strategies. This included an interactive platform for goal planning, video content sharing, comprehension assessment, misconception correction, and patient-driven recaps of disease information. Health monitoring was facilitated through the “Internet + Nursing” platform. The study focused on comparing changes in glucose metabolism and emotional disorder symptoms between the groups to evaluate the intervention’s effectiveness. Results: Following a 24-week intervention, we observed significant differences in key metrics between the online feedback group and the control group, each comprising 60 participants. The online feedback group demonstrated significant reductions in fasting plasma glucose, 2-hour postprandial glucose, and hemoglobin A1c (P<.05). Additionally, there was a notable decrease in hypoglycemia-related anxiety and alexithymia within this group. Conversely, the control group maintained relatively higher values for these metrics at the same time point (P<.05). These findings underscore the efficacy of online feedback in managing glycemic control and reducing psychological distress associated with hypoglycemia. Conclusions: The online teaching-back method, guided by King’s Theory of Goal Attainment, effectively enhances glycemic control, reducing fasting plasma glucose, 2-hour postprandial glucose, and hemoglobin A1c levels in newly diagnosed patients with type 2 diabetes. Simultaneously, it alleviates hypoglycemia-related anxiety and mitigates alexithymia. This approach merits widespread promotion and implementation in clinical settings. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400079547; https://www.chictr.org.cn/showproj.html?proj=208223 %M 39481094 %R 10.2196/59142 %U https://www.jmir.org/2024/1/e59142 %U https://doi.org/10.2196/59142 %U http://www.ncbi.nlm.nih.gov/pubmed/39481094 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e54370 %T Implementation of a Technology-Enabled Diabetes Self-Management Peer Coaching Intervention for Patients With Poorly Controlled Diabetes: Quasi-Experimental Case Study %A Arévalo Avalos,Marvyn R %A Patel,Ashwin %A Duru,Haci %A Shah,Sanjiv %A Rivera,Madeline %A Sorrentino,Eleanor %A Dy,Marika %A Sarkar,Urmimala %A Nguyen,Kim H %A Lyles,Courtney R %A Aguilera,Adrian %+ School of Social Welfare, University of California Berkeley, 205 Haviland Hall, #7400, Berkeley, CA, 94720, United States, 1 510 642 4341, aguila@berkeley.edu %K type 2 diabetes %K type 1 diabetes %K diabetes experiences %K eHealth %K mHealth %K peer coaching %K peer coach %K peer support %K self-management %K social determinants of health %K behavioral determinants of health %D 2024 %7 15.10.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Patients with diabetes experience worse health outcomes and greater health care expenditure. Improving diabetes outcomes requires involved self-management. Peer coaching programs can help patients engage in self-management while addressing individual and structural barriers. These peer coaching programs can be scaled with digital platforms to efficiently connect patients with peer supporters who can help with diabetes self-management. Objective: This study aimed to evaluate the implementation of a technology-enabled peer coaching intervention to support diabetes self-management among patients with uncontrolled diabetes. Methods: MetroPlusHealth, a predominant Medicaid health maintenance organization based in New York City, partnered with Pyx Health to enroll 300 Medicaid patients with uncontrolled diabetes into its 6-month peer coaching intervention. Pyx Health peer coaches conduct at least 2 evidence-based and goal-oriented coaching sessions per month with their assigned patients. These sessions are focused on addressing both behavioral and social determinants of health (SDoH) with the goal of helping patients increase their diabetes self-management literacy, implement self-management behaviors, and reduce barriers to ongoing self-care. Data analyzed in this study included patient demographic data, clinical data (patient’s hemoglobin A1c [HbA1c]), and program implementation data including types of behavioral determinants of health and SDoH reported by patients and types of interventions used by peer coaches. Results: A total of 330 patients enrolled in the peer mentoring program and 2118 patients were considered to be on a waitlist group and used as a comparator. Patients who enrolled in the peer coaching program were older; more likely to be English speakers, female, and African American; and less likely to be White or Asian American or Pacific Islander than those in the waitlist condition, and had similar HbA1c laboratory results at baseline (intervention group 10.59 vs waitlist condition 10.62) Patients in the enrolled group had on average a –1.37 point reduction in the HbA1c score (n=70; pre: 10.99, post 9.62; P<.001), whereas patients in the waitlist group had a –0.16 reduction in the HbA1c score (n=207; pre 9.75, post 9.49; P<.001). Among a subsample of participants enrolled in the program with at least 2 HbA1c scores, we found that endorsement of emotional health issues (β=1.344; P=.04) and medication issues (β=1.36; P=.04) were significantly related to increases in HbA1c. Conclusions: This analysis of a technology-enabled 1-on-1 peer coaching program showed improved HbA1c levels for program participants relative to nonprogram participants. Results suggested participants with emotional stressors and medication management issues had worse outcomes and many preferred to connect through phone calls versus an app. These findings support the effectiveness of digital programs with multimodal approaches that include human support for improving diabetes self-management in a typically marginalized population with significant SDoH barriers. %M 39405529 %R 10.2196/54370 %U https://diabetes.jmir.org/2024/1/e54370 %U https://doi.org/10.2196/54370 %U http://www.ncbi.nlm.nih.gov/pubmed/39405529 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 7 %N %P e50370 %T Categorization of mHealth Coaching Technologies for Children or Adolescents With Type 1 Diabetes: Systematic Review %A Trnka,Pavel %A Aldaghi,Tahmineh %A Muzik,Jan %K type 1 diabetes %K adolescents %K children %K parents %K mHealth %K information technology %K PRISMA %D 2024 %7 10.10.2024 %9 %J JMIR Pediatr Parent %G English %X Background: Managing type 1 diabetes in children and adolescents can be difficult for parents, health care professionals, and even patients. However, over the last decades, the quality of services provided to patients with diabetes has increased due to advances in IT. Objective: This study aims to comprehensively document the range of IT tools used in the management of diabetes among children and adolescents, with a focus on identifying the technologies most commonly used based on their frequency. In addition, the study aims to explore relevant methodologies for developing diabetes technology and provide valuable information to developers by delineating essential phases of the design process. Methods: The literature search was focused on MEDLINE (PubMed), Web of Science, and Google Scholar for relevant studies. Keywords such as “type 1 diabetes,” “adolescents,” “kids,” “mHealth,” “children,” and “coaching” were combined using Boolean operators. The inclusion criteria were open access, English-language papers published between 2012 and 2023 focusing on patients younger than 18 years and aligned with our research goal. The exclusion criteria included irrelevant topics and papers older than 18 years. By applying the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) method, 2080 studies were recognized, and after selection, 33 papers were agreed upon between the researchers. Results: Four primary categories were defined: types of IT, methodology identification, purpose identification, and feature determination. Among these, mobile health (mHealth) apps emerged as the predominant type of information, garnering 27 mentions. In particular, user-centered design was identified as the most prevalent methodology, cited 22 times. The primary purpose of self-monitoring blood glucose values was mentioned 20 times, while patient education was the highest among common characteristics, with 23 mentions. Conclusions: Based on our research, we advocate for developers to focus on creating an mHealth app that integrates gamification techniques to develop innovative diabetes management solutions. This app should include vital functionalities such as blood glucose monitoring, strategies to improve hemoglobin A1c levels, carbohydrate tracking, and comprehensive educational materials for patients and caregivers. By prioritizing these features, developers can enhance the usability and effectiveness of the technology, thereby better supporting children or adolescents with diabetes in their daily management endeavors. %R 10.2196/50370 %U https://pediatrics.jmir.org/2024/1/e50370 %U https://doi.org/10.2196/50370 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e60023 %T Long-Term Glycemic Control Improvement After the Home and Self-Care Program for Patients With Type 1 Diabetes: Real-World–Based Cohort Study %A Koo,Dae-Jeong %A Moon,Sun-Joon %A Moon,Suhyeon %A Park,Se Eun %A Rhee,Eun-Jung %A Lee,Won-Young %A Park,Cheol-Young %+ Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea, 82 02 2001 1869, cydoctor@skku.edu %K type 1 diabetes %K structured education %K home health care %K glycated hemoglobin %K continuous glucose monitoring %K mobile phone %D 2024 %7 11.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of type 1 diabetes (T1D) is increasing worldwide, with a much higher proportion of adult patients. However, achieving stable glycemic control is difficult in these patients. Objective: After periodic implementation of structured education for patients with T1D through the Home and Self-Care Program, a pilot home health care project promoted by the Korean government, we evaluated the program’s effects on glycemic control. Methods: This study was conducted from April 2020 to March 2023. We analyzed 119 participants with T1D aged >15 years. Nursing and nutrition education were provided separately up to 4 times per year, with physician consultation up to 6 times per year. A distinguishing feature of this study compared with previous ones was the provision of remote support using a general-purpose smartphone communication app offered up to 12 times annually on an as-needed basis to enhance the continuity of in-person education effects. Patients were followed up on at average intervals of 3 months for up to 24 months. The primary end point was the mean difference in glycated hemoglobin (HbA1c) at each follow-up visit from baseline. For continuous glucose monitoring (CGM) users, CGM metrics were also evaluated. Results: The mean HbA1c level of study participants was 8.6% at baseline (mean duration of T1D 10.02, SD 16.10 y). The HbA1c level reduction in participants who received at least 1 structured educational session went from 1.63% (SD 2.03%; P<.001; adjustment model=1.69%, 95% CI 1.24%-2.13% at the first follow-up visit) to 1.23% (SD 1.31%; P=.01; adjustment model=1.28%, 95% CI 0.78%-1.79% at the eighth follow-up visit). In the adjustment model, the actual mean HbA1c values were maintained between a minimum of 7.33% (95% CI 7.20%-7.46% at the first follow-up visit) and a maximum of 7.62% (95% CI 7.41%-7.82% at the sixth follow-up visit). Among CGM users, after at least 1 session, the mean time in the target range was maintained between 61.59% (adjusted model, 95% CI 58.14%-65.03% at the second follow-up visit) and 54.7% (95% CI 50.92%-58.48% at the eighth follow-up visit), consistently staying above 54.7% (corresponding to an HbA1c level of <7.6%). The mean time below the target range (TBR) also gradually improved to the recommended range (≤4% for TBR of <70 mg/dL and ≤1% for TBR of <54 mg/dL). Conclusions: The Home and Self-Care Program protocol for glycemic control in patients with T1D is effective, producing significant improvement immediately and long-term maintenance effects, including on CGM indexes. %M 39259960 %R 10.2196/60023 %U https://www.jmir.org/2024/1/e60023 %U https://doi.org/10.2196/60023 %U http://www.ncbi.nlm.nih.gov/pubmed/39259960 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e45561 %T The Development of a Text Messaging Platform to Enhance a Youth Diabetes Prevention Program: Observational Process Study %A Sapre,Manali %A Elaiho,Cordelia R %A Brar Prayaga,Rena %A Prayaga,Ram %A Constable,Jeremy %A Vangeepuram,Nita %+ Department of General Pediatrics, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place Box 1198, New York, NY, 10029, United States, 1 917 478 2106, nita.vangeepuram@mssm.edu %K community-based participatory research %K youth %K diabetes prevention %K peer education %K mobile health technology %K SMS text messaging %K mobile phone %K artificial intelligence %K AI %D 2024 %7 29.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Approximately 1 in 5 adolescents in the United States has prediabetes, and racially and ethnically minoritized youths are disproportionately impacted. Unfortunately, there are few effective youth diabetes prevention programs, and in-person interventions are challenging because of barriers to access and engagement. Objective: We aimed to develop and assess the preliminary feasibility and acceptability of a youth-informed SMS text messaging platform to provide additional support and motivation to adolescents with prediabetes participating in a diabetes prevention workshop in East Harlem, New York City, New York, United States. We collaborated with our youth action board and a technology partner (mPulse Mobile) to develop and pilot-test the novel interactive platform. Methods: The technology subcommittee of our community action board (comprising youths and young adults) used the results from focus groups that we had previously conducted with youths from our community to develop 5 message types focused on healthy eating and active living: goal setting, behavior tracking, individually tailored guidance, motivational messages, and photo diary. We used an iterative process to develop and pilot the program with our internal study team, including youths from our community action board and mPulse Mobile developers. We then conducted a pilot of the 12-week SMS text messaging program with 13 youths with prediabetes. Results: Participants (aged 15-21 years; 10/13, 77% female; 3/10, 23% Black and 10/13, 77% Hispanic or Latinx) received an average of 2 automated messages per day. The system correctly sent 84% (2231/2656) of the messages at the time intended; the remaining 16% (425/2656) of the messages were either sent at the incorrect time, or the system did not recognize a participant response to provide the appropriate reply. The level of engagement with the program ranged from 1 (little to no response) to 5 (highly responsive) based on how frequently participants responded to the interactive (2-way) messages. Highly responsive participants (6/13, 46%) responded >75% (1154/1538) of the time to interactive messages sent over 12 weeks, and 69% (9/13) of the participants were still engaged with the program at week 12. During a focus group conducted after program completion, the participants remarked that the message frequency was appropriate, and those who had participated in our in-person workshops reflected that the messages were reminiscent of the workshop content. Participants rated goal setting, behavior tracking, and tailored messages most highly and informed planned adaptations to the platform. Participants described the program as: “interactive, informative, enjoyable, very convenient, reliable, motivational, productive, and reflective.” Conclusions: We partnered with youths in the initial content development and pilot testing of a novel SMS text messaging platform to support diabetes prevention. This study is unique in the triple partnership we formed among researchers, technology experts, and diverse youths to develop a mobile health platform to address diabetes-related disparities. %M 38809599 %R 10.2196/45561 %U https://formative.jmir.org/2024/1/e45561 %U https://doi.org/10.2196/45561 %U http://www.ncbi.nlm.nih.gov/pubmed/38809599 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54043 %T Grocery Delivery to Support Individuals With Type 2 Diabetes: Protocol for a Pilot Quality Improvement Program %A Oshman,Lauren %A Waselewski,Marika %A Hisamatsu,Rina %A Kim,Noa %A Young,Larrea %A Hafez Griauzde,Dina %A Chang,Tammy %+ Department of Family Medicine, University of Michigan, 2800 Plymouth Road, Building 14, Room G128, Ann Arbor, MI, 48109, United States, 1 7347304636, tachang@med.umich.edu %K T2D %K type 2 diabetes %K food insecurity %K low carbohydrate %K quality improvement %K healthy eating %K grocery %K delivery program %K diabetes %K T2DM %K type 2 diabetes mellitus %K low-income %K US %K United States %K adults %K adult %K low diet quality %K carbohydrate %K carbohydrates %K glycemic control %K nutrition education %D 2024 %7 15.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: People with low income are disproportionately affected by type 2 diabetes (T2D), and 17.6% of US adults with T2D experience food insecurity and low diet quality. Low-carbohydrate eating plans can improve glycemic control, promote weight loss, and are associated with improved cardiometabolic health and all-cause mortality. Little is known about supporting low-carbohydrate eating for people with T2D, although food-as-medicine interventions paired with nutrition education offer a promising solution. Objective: This program aims to support the initiation of dietary changes by using grocery delivery and low-carbohydrate education to increase the quality of low-carbohydrate nutrition among people with T2D and food insecurity. Methods: This program was a nonrandomized pilot conducted at 21 primary care practices in Michigan. Adults with T2D and food insecurity or low income were eligible to enroll. Patients were referred by primary care clinic staff. All participants received the 3-month program, which included monthly US $80 credits for healthy foods, free grocery delivery from Shipt, and low-carbohydrate nutrition education. Food credits were restricted to the purchase of healthy foods. Education materials, developed in collaboration with providers and patients, included print, digital, interactive web, and video formats. At enrollment, participants completed a survey including demographics, diabetes health, diet and physical activity, and diabetes management and knowledge. After the 3-month program, participants completed a survey with repeat assessments of diabetes health, diet and physical activity, and diabetes management and knowledge. Perspectives on participant experience and perceived program impact, food purchasing behaviors, and use of educational materials were also collected. Diabetes health information was supplemented with data from participant medical records. We plan to perform mixed methods analysis to assess program feasibility, acceptability, and impact. Primary quality improvement (QI) measures are the number of patients referred and enrolled, use of US $80 food credits, analysis of food purchasing behavior, participant experience with the program, and program costs. Secondary QI measures include changes in hemoglobin A1c, weight, medications, self-efficacy, diabetes and carbohydrate knowledge, and activity between baseline and follow-up. Results: This program started in October 2022. Data collection is expected to be concluded in June 2024. A total of 151 patients were referred to the program, and 83 (55%) were enrolled. The average age was 57 (SD 13; range 18-86) years, 72% (57/79) were female, 90% (70/78) were White, and 96% (74/77) were of non-Hispanic ethnicity. All participants successfully ordered grocery delivery during the program. Conclusions: This pilot QI program aimed to improve diet quality among people with T2D and food insecurity by using grocery delivery and low-carbohydrate nutrition education. Our findings may help inform the implementation of future QI programs and research studies on food-as-medicine interventions that include grocery delivery and education for people with T2D. International Registered Report Identifier (IRRID): DERR1-10.2196/54043 %M 38748461 %R 10.2196/54043 %U https://www.researchprotocols.org/2024/1/e54043 %U https://doi.org/10.2196/54043 %U http://www.ncbi.nlm.nih.gov/pubmed/38748461 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e52923 %T A Self-Guided Web-Based App (MyDiaMate) for Enhancing Mental Health in Adults With Type 1 Diabetes: Insights From a Real-World Study in the Netherlands %A Embaye,Jiska %A de Wit,Maartje %A Snoek,Frank %+ Department of Medical Psychology, Amsterdam Public Health, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, Amsterdam, 1081 HZ, Netherlands, 31 2004440190, j.embaye@amsterdamumc.nl %K type 1 diabetes %K e-mental health %K web based %K self-help %K real world %K naturalistic %K uptake %K adoption %K usage %K mental health %K distress %K emotional well-being %K cognitive behavioral therapy %K internet-based cognitive behavioral therapy %K Europe %K Netherlands %K Dutch %D 2024 %7 3.4.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: MyDiaMate is a web-based intervention specifically designed for adults with type 1 diabetes (T1D) that aims to help them improve and maintain their mental health. Prior pilot-testing of MyDiaMate verified its acceptability, feasibility, and usability. Objective: This study aimed to investigate the real-world uptake and usage of MyDiaMate in the Netherlands. Methods: Between March 2021 and December 2022, MyDiaMate was made freely available to Dutch adults with T1D. Usage (participation and completion rates of the modules) was tracked using log data. Users could volunteer to participate in the user profile study, which required filling out a set of baseline questionnaires. The usage of study participants was examined separately for participants scoring above and below the cutoffs of the “Problem Areas in Diabetes” (PAID-11) questionnaire (diabetes distress), the “World Health Organization Well-being Index” (WHO-5) questionnaire (emotional well-being), and the fatigue severity subscale of the “Checklist Individual Strength” (CIS) questionnaire (fatigue). Two months after creating an account, study participants received an evaluation questionnaire to provide us with feedback. Results: In total, 1008 adults created a MyDiaMate account, of whom 343 (34%) participated in the user profile study. The mean age was 43 (SD 14.9; 18-76) years. Most participants were female (n=217, 63.3%) and higher educated (n=198, 57.6%). The majority had been living with T1D for over 5 years (n=241, 73.5%). Of the study participants, 59.1% (n=199) of them reported low emotional well-being (WHO-5 score≤50), 70.9% (n=239) of them reported elevated diabetes distress (PAID-11 score≥18), and 52.4% (n=178) of them reported severe fatigue (CIS score≥35). Participation rates varied between 9.5% (n=19) for social environment to 100% (n=726) for diabetes in balance, which opened by default. Completion rates ranged from 4.3% (n=1) for energy, an extensive cognitive behavioral therapy module, to 68.6% (n=24) for the shorter module on hypos. There were no differences in terms of participation and completion rates of the modules between study participants with a more severe profile, that is, lower emotional well-being, greater diabetes distress, or more fatigue symptoms, and those with a less severe profile. Further, no technical problems were reported, and various suggestions were made by study participants to improve the application, suggesting a need for more personalization. Conclusions: Data from this naturalistic study demonstrated the potential of MyDiaMate as a self-help tool for adults with T1D, supplementary to ongoing diabetes care, to improve healthy coping with diabetes and mental health. Future research is needed to explore engagement strategies and test the efficacy of MyDiaMate in a randomized controlled trial. %M 38568733 %R 10.2196/52923 %U https://diabetes.jmir.org/2024/1/e52923 %U https://doi.org/10.2196/52923 %U http://www.ncbi.nlm.nih.gov/pubmed/38568733 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 12 %N %P e46699 %T The Key Digital Tool Features of Complex Telehealth Interventions Used for Type 2 Diabetes Self-Management and Monitoring With Health Professional Involvement: Scoping Review %A Mannoubi,Choumous %A Kairy,Dahlia %A Menezes,Karla Vanessa %A Desroches,Sophie %A Layani,Geraldine %A Vachon,Brigitte %+ School of Rehabilitation, Université de Montréal, 7077, avenue du Parc, Montreal, QC, H3N 1X7, Canada, 1 5143436111, cmannoubi@gmail.com %K telehealth %K telemedicine %K telenutrition %K telemonitoring %K electronic coaching %K e-coaching %K scoping review %K type 2 diabetes %K prediabetes %K diabetes management %K diabetes self-management %K mobile phone %D 2024 %7 13.3.2024 %9 Review %J JMIR Med Inform %G English %X Background: Therapeutic education and patient self-management are crucial in diabetes prevention and treatment. Improving diabetes self-management requires multidisciplinary team intervention, nutrition education that facilitates self-management, informed decision-making, and the organization and delivery of appropriate health care services. The emergence of telehealth services has provided the public with various tools for educating themselves and for evaluating, monitoring, and improving their health and nutrition-related behaviors. Combining health technologies with clinical expertise, social support, and health professional involvement could help persons living with diabetes improve their disease self-management skills and prevent its long-term consequences. Objective: This scoping review’s primary objective was to identify the key digital tool features of complex telehealth interventions used for type 2 diabetes or prediabetes self-management and monitoring with health professional involvement that help improve health outcomes. A secondary objective was to identify how these key features are developed and combined. Methods: A 5-step scoping review methodology was used to map relevant literature published between January 1, 2010 and March 31, 2022. Electronic searches were performed in the MEDLINE, CINAHL, and Embase databases. The searches were limited to scientific publications in English and French that either described the conceptual development of a complex telehealth intervention that combined self-management and monitoring with health professional involvement or evaluated its effects on the therapeutic management of patients with type 2 diabetes or prediabetes. Three reviewers independently identified the articles and extracted the data. Results: The results of 42 studies on complex telehealth interventions combining diabetes self-management and monitoring with the involvement of at least 1 health professional were synthesized. The health professionals participating in these studies were physicians, dietitians, nurses, and psychologists. The digital tools involved were smartphone apps or web-based interfaces that could be used with medical devices. We classified the features of these technologies into eight categories, depending on the intervention objective: (1) monitoring of glycemia levels, (2) physical activity monitoring, (3) medication monitoring, (4) diet monitoring, (5) therapeutic education, (6) health professional support, (7) other health data monitoring, and (8) health care management. The patient-logged data revealed behavior patterns that should be modified to improve health outcomes. These technologies, used with health professional involvement, patient self-management, and therapeutic education, translate into better control of glycemia levels and the adoption of healthier lifestyles. Likewise, they seem to improve monitoring by health professionals and foster multidisciplinary collaboration through data sharing and the development of more concise automatically generated reports. Conclusions: This scoping review synthesizes multiple studies that describe the development and evaluation of complex telehealth interventions used in combination with health professional support. It suggests that combining different digital tools that incorporate diabetes self-management and monitoring features with a health professional’s advice and interaction results in more effective interventions and outcomes. %M 38477979 %R 10.2196/46699 %U https://medinform.jmir.org/2024/1/e46699 %U https://doi.org/10.2196/46699 %U http://www.ncbi.nlm.nih.gov/pubmed/38477979 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55435 %T Effectiveness of the Pasifika Women’s Diabetes Wellness Program (PWDWP): Protocol for a Pilot Intervention and Feasibility Randomized Controlled Trial %A Akbar,Heena %A Contor,Madison %A Niumata,Winnie %A Anderson,Debra %A Gallegos,Danielle %+ School of Public Health, Faculty of Medicine, The University of Queensland, 288 Herston Rd, Herston, Brisbane, 4006, Australia, 61 423460211, h.akbar@uq.edu.au %K type 2 diabetes %K Māori and Pasifika women %K diabetes self-management %K culturally co-design intervention %K Pasifika diaspora %K talanoa %D 2024 %7 11.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 2 diabetes poses public health challenges for Māori and Pasifika communities in Australia. The women of these communities face a greater burden from type 2 diabetes–related mortality and comorbidities. Lifestyle modification behaviors through previous women’s wellness programs have been shown to reduce the risk of developing complications in established type 2 diabetes. The Pasifika Women’s Diabetes Wellness Program (PWDWP) pilot study, co-designed with Māori and Pasifika communities, was aimed at addressing late hospital presentations from diabetes-related complications. Objective: This study (1) examines the efficacy of women with type 2 diabetes in the intervention group for improved glycated hemoglobin (HbA1c) clinical levels and diabetes self-management compared with the control group from baseline (T0) to week 12 (T1) and week 24 (T2; postintervention) and (2) assesses the cultural adaptability, acceptability, and feasibility of the pilot intervention for future studies. Methods: This study uses a quasiexperimental design that involves a 24-week intervention. We recruited 50 Māori and Pasifika women with type 2 diabetes (25 in the intervention group from the south side of Brisbane and 25 in the control group from the north side of Brisbane) using participatory talanoa methodologies. The intervention group participated in face-to-face and virtual whānau education workshops (5 weeks) and had access to individual coaching and virtual support delivered by trained Māori and Pasifika health professionals and community health workers. The control group received usual care with their identified health provider. Both groups received copies of the PWDWP journal, fact sheets, and a health check passbook with tailored motivational text messages. An advisory committee was set up to oversee the program implementation, including protocols of engagement, health checks, and data collection in community settings. The quantitative data were collected at T0, T1, and T2 with HbA1c as the primary outcome measure. Secondary outcomes measured changes in diabetes self-care and body composition (eg, BMI, waist circumference). Qualitative data will ascertain the program’s feasibility and cultural adaptability using talanoa focus groups. Results: This pilot study was approved by the Queensland University of Technology Human Ethic Research Committee (5609) and began in January 2023 after participant recruitment between July 2022 and December 2022. The final data collection including the health check, focus group, and survey data was completed in November 2023, and data analysis and reporting are expected to conclude in 2024. Conclusions:  This study provides a blueprint for PWDWP. Collaborative partnerships with community organizations and stakeholders are crucial for program success and suggest a potential model for targeting diabetes management for Māori and Pasifika communities, emphasizing the need for culturally relevant interventions. The findings will have significant implications for policymakers and practitioners when developing and implementing public health initiatives, particularly for communities with unique cultural nuances. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622001100785p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384470&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/55435 %M 38286130 %R 10.2196/55435 %U https://www.researchprotocols.org/2024/1/e55435 %U https://doi.org/10.2196/55435 %U http://www.ncbi.nlm.nih.gov/pubmed/38286130 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53514 %T Efficacy of StepAdd, a Personalized mHealth Intervention Based on Social Cognitive Theory to Increase Physical Activity Among Patients With Type 2 Diabetes Mellitus: Protocol for a Randomized Controlled Trial %A Waki,Kayo %A Tsurutani,Yuya %A Waki,Hironori %A Enomoto,Syunpei %A Kashiwabara,Kosuke %A Fujiwara,Akira %A Orime,Kazuki %A Kinguchi,Sho %A Yamauchi,Toshimasa %A Hirawa,Nobuhito %A Tamura,Kouichi %A Terauchi,Yasuo %A Nangaku,Masaomi %A Ohe,Kazuhiko %+ Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, 81 03 5800 9129, kwaki-tky@m.u-tokyo.ac.jp %K digital therapeutics %K behavior change %K social cognitive theory %K exercise %K type 2 diabetes mellitus %K mobile app %K randomized controlled trial %K mobile phone %D 2024 %7 23.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Increasing physical activity improves glycemic control in patients with type 2 diabetes (T2D). Mobile health (mHealth) interventions have been proven to increase exercise, but engagement often fades with time. As the use of health behavior theory in mHealth design can increase effectiveness, we developed StepAdd, an mHealth intervention based on the constructs of social cognitive theory (SCT). StepAdd improves exercise behavior self-efficacy and self-regulation through the use of goal-setting, barrier-identifying, and barrier-coping strategies, as well as automatic feedback functions. A single-arm pilot study of StepAdd among 33 patients with T2D showed a large increase in step count (mean change of 4714, SD 3638 daily steps or +86.7%), along with strong improvements in BMI (mean change of −0.3 kg/m2) and hemoglobin A1c level (mean change of −0.79 percentage points). Objective: In this study, we aim to investigate the efficacy and safety of StepAdd, an mHealth exercise support system for patients with T2D, via a large, long, and controlled follow-up to the pilot study. Methods: This is a randomized, open-label, multicenter study targeting 160 patients with T2D from 5 institutions in Japan with a 24-week intervention. The intervention group will record daily step counts, body weight, and blood pressure using the SCT-based mobile app, StepAdd, and receive feedback about these measurements. In addition, they will set weekly step count goals, identify personal barriers to walking, and define strategies to overcome these barriers. The control group will record daily step counts, body weight, and blood pressure using a non–SCT-based placebo app. Both groups will receive monthly consultations with a physician who will advise patients regarding lifestyle modifications and use of the app. The 24-week intervention period will be followed by a 12-week observational period to investigate the sustainability of the intervention’s effects. The primary outcome is between-group difference in the change in hemoglobin A1c values at 24 weeks. The secondary outcomes include other health measures, measurements of steps, measurements of other behavior changes, and assessments of app use. The trial began in January 2023 and is intended to be completed in December 2025. Results: As of September 5, 2023, we had recruited 44 patients. We expect the trial to be completed by October 8, 2025, with the follow-up observation period being completed by December 31, 2025. Conclusions: This trial will provide important evidence about the efficacy of an SCT-based mHealth intervention in improving physical activities and glycemic control in patients with T2D. If this study proves the intervention to be effective and safe, it could be a key step toward the integration of mHealth as part of the standard treatment received by patients with T2D in Japan. Trial Registration: Japan Registry of Clinical Trials (JRCT) jRCT2032220603; https://rctportal.niph.go.jp/en/detail?trial_id=jRCT2032220603 International Registered Report Identifier (IRRID): DERR1-10.2196/53514 %M 38393770 %R 10.2196/53514 %U https://www.researchprotocols.org/2024/1/e53514 %U https://doi.org/10.2196/53514 %U http://www.ncbi.nlm.nih.gov/pubmed/38393770 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e48313 %T Web-Based Intervention to Act for Weight Loss in Adults With Type 2 Diabetes With Obesity (Chance2Act): Protocol for a Nonrandomized Controlled Trial %A Mohd Saad,Noraini %A Mohamad,Mariam %A Mat Ruzlin,Aimi Nadira %+ Faculty of Medicine, Universiti Teknologi MARA, Sungai Buloh Campus, Jalan Hospital, Sungai Buloh, Selangor, 47000, Malaysia, 60 361267176, mariammd@uitm.edu.my %K readiness to change %K behavior change %K diabetes %K overweight %K weight reduction %K eHealth %K obesity %D 2024 %7 31.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: In adults with type 2 diabetes (T2D), weight loss can improve hemoglobin A1c, blood pressure, and triglycerides, and reduce the frequency of medications needed. Unfortunately, a large proportion of these individuals are not ready to initiate weight efforts, making existing obesity management strategies less effective. Many digital health interventions aim at weight loss, but there is still limited evidence on their effectiveness in changing weight loss behavior, especially in adults with T2D. Objective: This study aims to develop and validate “Chance2Act,” a new web-based intervention, designed specifically to facilitate behavioral change in adults with T2D with obesity who are not ready to act toward weight loss. Then, the effectiveness of the newly developed intervention will be determined from a nonrandomized controlled trial. Methods: A web-based intervention will be developed based on the Transtheoretical Model targeting adults with T2D with obesity who are not ready to change for weight loss. Phase 1 will involve the development and validation of the web-based health intervention module. In phase 2, a nonrandomized controlled trial will be conducted in 2 government health clinics selected by the investigator. This is an unblinded study with a parallel assignment (ie, intervention vs control [usual care] with an allocation ratio of 1:1). A total of 124 study participants will be recruited, of which 62 participants will receive the Chance2Act intervention in addition to the usual care. The primary outcome is the changes in an individual’s readiness from a stage of not being ready to change (precontemplation, contemplation, or preparation stage) to being ready for weight loss (action stage). The secondary outcomes include changes in self-efficacy, decisional balance, family support for weight loss, BMI, waist circumference, and body fat composition. Results: The phase 1 study will reveal the intervention’s validity through the Content Validity Index and Face Validity Index, considering it valid if both indices exceed 0.83. The effectiveness of the intervention will be determined in phase 2, where the differences within and between groups will be analyzed in terms of the improvement of stages of change and all secondary outcomes as defined in the methodology. Data analysis for phase 2 will commence in 2024, with the anticipated publication of results in March 2024. Conclusions: If proven effective, the result of the study may give valuable insights into the effective behavioral modification strategies for a web-based intervention targeting adults with T2D with obesity but not yet ready to change for weight loss. This intervention may be replicated or adopted in different settings, focusing on behavioral modification support that patients need. This study offers a deeper understanding of the application of behavior change techniques for a more holistic approach to obesity care in T2D. Trial Registration: ClinicalTrials.gov NCT05736536; https://clinicaltrials.gov/study/NCT05736536 International Registered Report Identifier (IRRID): DERR1-10.2196/48313 %M 38294848 %R 10.2196/48313 %U https://www.researchprotocols.org/2024/1/e48313 %U https://doi.org/10.2196/48313 %U http://www.ncbi.nlm.nih.gov/pubmed/38294848 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e45659 %T Acceptability of a Self-Led Mindfulness-Based Intervention for Teens with Type 1 Diabetes: Pilot Randomized Controlled Trial %A Humiston,Tori %A Cummings,Caroline %A Suss,Stephen %A Cohen,Laura B %A Hazlett-Stevens,Holly %A Hughes Lansing,Amy %+ Department of Psychological Sciences, University of Vermont, 2 Colchester Ave, Burlington, VT, 05401, United States, 1 8026562670, tori.humiston@uvm.edu %K adolescents %K diabetes distress %K diabetes %K health group intervention %K intervention %K mindfulness %K psychosocial intervention %K self-led mindfulness %K type 1 diabetes %D 2024 %7 30.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Diabetes distress among adolescents with type 1 diabetes has been associated with suboptimal diabetes outcomes, including lower quality of life, increased diabetes self-management challenges, and suboptimal glycemic outcomes. Objective: This study examined the feasibility and acceptability of a scalable self-led mindfulness-based intervention to reduce diabetes distress in adolescents with type 1 diabetes. Methods: Adolescents (N=25) aged between 14 and 18 years diagnosed with type 1 diabetes completed a baseline assessment. Participants were randomized to receive a 10-week self-guided mindfulness-based stress reduction workbook program (e-book or paper option) immediately (n=15) or after a 10-week wait (n=10). During the intervention period, participants completed weekly assignments and feedback surveys. At 10 weeks and 20 weeks, follow-up assessments were completed. Results: Findings indicated that participants did not find the original intervention feasible or acceptable. Adolescents reported barriers to completing the weekly material, such as that they forgot or that the material was not sufficiently related to their diabetes management. Adolescents also reported that a digital format rather than a workbook or e-book may be more acceptable. Results from weekly surveys provided the foundation for recommendations for future iterations of the mindfulness-based intervention for adolescents with type 1 diabetes. Conclusions: Participant feedback informed recommendations for self-led mindfulness programs for youth with type 1 diabetes. Adolescents indicated that a shorter, digital mindfulness-based intervention focused on diabetes-specific behaviors may be more helpful. Trial Registration: ClinicalTrials.gov NCT05115175; https://clinicaltrials.gov/study/NCT05115175 %M 38289663 %R 10.2196/45659 %U https://formative.jmir.org/2024/1/e45659 %U https://doi.org/10.2196/45659 %U http://www.ncbi.nlm.nih.gov/pubmed/38289663 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e46418 %T Examining a Remote Group-Based Type 2 Diabetes Self-Management Education Program in the COVID-19 Era Using the ORBIT Model: Small 6-Week Feasibility Study %A Hiemstra,Madison S %A Reichert,Sonja M %A Mitchell,Marc S %+ School of Kinesiology, Western University, 1151 Richmond Street, Thames Hall, Room TH 3199, London, ON, N6A 3K7, Canada, 1 (519) 661 2111 ext 87936, marc.mitchell@uwo.ca %K activity monitor %K diabetes self-management education %K flash glucose monitor %K glycated hemoglobin %K group education %K HbA1c %K T2D %K type 2 diabetes %K virtual care %K wearables %D 2024 %7 29.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: To date, most group-based diabetes self-management education (DSME) programs for type 2 diabetes (T2D) have been delivered in person. The rapid transition to remote care at the outset of the COVID-19 pandemic presented opportunities to test, evaluate, and iterate a new remote DSME program. Objective: We aim to refine the delivery and evaluation of a multicomponent remote DSME program for adults living with T2D by examining several feasibility outcomes. Methods: We recruited a convenience sample of patients from a London, Canada, outpatient diabetes clinic (serving high-risk, low-income adults) to participate in a 6-week, single cohort feasibility study from November 2020 to March 2021. This small ORBIT phase 1b feasibility study represents the first in a planned series guided by the ORBIT model for developing behavioral interventions for chronic diseases (phase 1: design; phase 2: preliminary testing; phase 3: efficacy; and phase 4: effectiveness). The feasibility of delivering and evaluating a remote DSME program, including (1) live video education classes, (2) individualized physical activity (PA) prescription and counseling, and (3) intermittently scanned continuous glucose and wearable PA monitoring, was assessed. Feasibility outcomes included recruitment and retention rates, program adherence, and acceptability (ie, technology issues and exit survey feedback). PA was assessed with Fitbit Inspire 2 (Fitbit Inc) and estimated glycated hemoglobin (HbA1c) using the FreeStyle Libre (Abbot). Given the small study sample, group- and individual-level data are reported descriptively. Results: A total of 10 adults living with T2D were recruited (female 60%; age 49.9, SD 14.3 years; estimated HbA1c 6.2%, SD 0.5%). Recruitment and retention rates were 29% and 80%, respectively. Participants attended 83% (25/30) and 93% (37/40) of education classes and PA counseling phone calls, respectively. There were 3.2 (SD 2.6) technology issues reported per person, most of which were related to study data transfer. Exit survey responses suggest most participants (8/9, 89%) were “satisfied” with the program. Recognizing the small sample size and the fact that no inferential statistics were conducted, the mean (SD) for the weekly daily step count and estimated HbA1c are provided for illustrative purposes. Participants accumulated 7103 (SD 2900) and 7515 (SD 3169) steps per day at baseline and week 6, respectively. The estimated HbA1c was 6.2% (SD 0.5%) and 6.2% (SD 0.6%) at baseline and week 6, respectively. Conclusions: This ORBIT phase 1b study served to refine the delivery (eg, automatic study data upload process recommended to reduce participant burden) and evaluation (eg, purposeful sampling of participants with baseline HbA1c >8% recommended to address selection bias) of a remote DSME program. Preliminary proof-of-concept testing (ORBIT phase 2) incorporating some of these learnings is now warranted. Trial Registration: ClinicalTrials.gov NCT04498819; https://clinicaltrials.gov/study/NCT04498819 %M 38285502 %R 10.2196/46418 %U https://formative.jmir.org/2024/1/e46418 %U https://doi.org/10.2196/46418 %U http://www.ncbi.nlm.nih.gov/pubmed/38285502 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 9 %N %P e52987 %T The Potential of a Digital Weight Management Program to Support Specialist Weight Management Services in the UK National Health Service: Retrospective Analysis %A Richards,Rebecca %A Wren,Gina %A Whitman,Michael %+ Second Nature, 483 Green Lanes, London, N13 4BS, United Kingdom, 44 020 3488 0769, becky@secondnature.io %K digital health intervention %K smartphone %K diabetes management %K obesity management %K mobile phone %K management %K obesity %K digital health %K diabetes %K weight %K manage %K support %K weight management %K retrospective analysis %K treatment %K type 2 diabetes %K effectiveness %K primary care %K weight loss %K clinical %K primary care service %D 2024 %7 24.1.2024 %9 Original Paper %J JMIR Diabetes %G English %X Background: Digital weight management interventions (DWMIs) have the potential to support existing specialist weight management services (SWMS) in the National Health Service (NHS) to increase access to treatment for people living with obesity and type 2 diabetes. At present, there is limited real-world evidence and long-term outcomes on the potential effectiveness of DWMIs to support such services. Objective: This study aimed to examine real-world data to evaluate the impact of Second Nature’s 12-month DWMI for patients living with obesity with or without type 2 diabetes, referred from NHS primary care services, on sustained weight loss over a 2-year period. Methods: Retrospective data were extracted in August 2023 for participants who participated in the program between January 1, 2017, and January 8, 2021. Eligible participants were adults with a BMI ≥35 kg/m2, with or without type 2 diabetes. The primary outcomes were weight change in kilograms and percentage weight change at 2 years. Secondary outcomes were weight loss at 1 year, program engagement, and the proportion of participants who achieved ≥5% and ≥10% weight loss. Differences in weight loss between baseline and the 1- and 2-year follow-up points were compared using paired 2-tailed t tests. Linear regression models were used to examine whether participants’ ethnicity, indices of multiple deprivation, presence of type 2 diabetes, or program engagement were associated with weight loss at 1 year or 2 years. Results: A total of 1130 participants with a mean baseline BMI of 46.3 (SD 31.6) kg/m2 were included in the analysis. Of these participants, 65% (740/1130) were female (mean age 49.9, SD 12.0 years), 18.1% (205/339) were from Black, Asian, mixed, or other ethnicities, and 78.2% (884/1130) had type 2 diabetes. A total of 281 (24.9%) participants recorded weight readings at 2 years from baseline, with a mean weight loss of 13.8 kg (SD 14.2 kg; P<.001) or 11.8% (SD 10.9%; P<.001). A total of 204 (18.1%) participants achieved ≥5% weight loss, and 130 (11.5%) participants reached ≥10% weight loss. Weight loss did not significantly differ by ethnicity, indices of multiple deprivation, presence of type 2 diabetes, or engagement in the program. Conclusions: The findings suggested that Second Nature’s DWMI has the potential to support people living with obesity and type 2 diabetes remotely to achieve clinically significant and sustained weight loss at 2 years from baseline. Further research is needed to compare the intervention to standard care and assess integration with multidisciplinary clinical teams and pharmacotherapy in order to support this study’s findings. %M 38265852 %R 10.2196/52987 %U https://diabetes.jmir.org/2024/1/e52987 %U https://doi.org/10.2196/52987 %U http://www.ncbi.nlm.nih.gov/pubmed/38265852 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e49097 %T Barriers and Enablers to the Adoption of a Healthier Diet Using an App: Qualitative Interview Study With Patients With Type 2 Diabetes Mellitus %A Montilva-Monsalve,Jonas %A Dimantas,Bruna %A Perski,Olga %A Gutman,Leslie Morrison %+ Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, United Kingdom, 44 020 7679 2000, l.gutman@ucl.ac.uk %K behavior change techniques %K diabetes %K apps %K smartphone %K enablers %K barriers %K mobile phone %D 2023 %7 19.12.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Adopting a healthy diet is one of the cornerstones of type 2 diabetes (T2D) management. Apps are increasingly used in diabetes self-management, but most studies to date have focused on assessing their impact in terms of weight loss or glycemic control, with limited evidence on the behavioral factors that influence app use to change dietary habits. Objective: The main objectives of this study were to assess the enablers and barriers to adopting a healthier diet using the Gro Health app in 2 patient groups with T2D (patients with recently diagnosed and long-standing T2D) and to identify behavior change techniques (BCTs) to enhance enablers and overcome barriers. Methods: Two semistructured qualitative interview studies were conducted; the first study took place between June and July 2021, with a sample of 8 patients with recently diagnosed (<12 mo) T2D, whereas the second study was conducted between May and June 2022 and included 15 patients with long-standing (>18 mo) T2D. In both studies, topic guides were informed by the Capability, Opportunity, Motivation, and Behavior model and the Theoretical Domains Framework. Transcripts were analyzed using a combined deductive framework and inductive thematic analysis approach. The Behavior Change Wheel framework was applied to identify appropriate BCTs that could be used in future iterations of apps for patients with diabetes. Themes were compared between the patient groups. Results: This study identified similarities and differences between patient groups in terms of enablers and barriers to adopting a healthier diet using the app. The main enablers for recently diagnosed patients included the acquired knowledge about T2D diets and skills to implement these, whereas the main barriers were the difficulty in deciding which app features to use and limited cooking skills. By contrast, for patients with long-standing T2D, the main enablers included knowledge validation provided by the app, along with app elements to help self-regulate food intake; the main barriers were the limited interest paid to the content provided or limited skills engaging with apps in general. Both groups reported more enablers than barriers to performing the target behavior when using the app. Consequently, BCTs were selected to address key barriers in both groups, such as simplifying the information hierarchy in the app interface, including tutorials demonstrating how to use the app features, and redesigning the landing page of the app to guide users toward these tutorials. Conclusions: Patients with recently diagnosed and long-standing T2D encountered similar enablers but slightly different barriers when using an app to adopting a healthier diet. Consequently, the development of app-based approaches to adopt a healthier diet should account for these similarities and differences within patient segments to reduce barriers to performing the target behavior. %M 38113087 %R 10.2196/49097 %U https://diabetes.jmir.org/2023/1/e49097 %U https://doi.org/10.2196/49097 %U http://www.ncbi.nlm.nih.gov/pubmed/38113087 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e53874 %T Daily Functioning of Veterans With Type 2 Diabetes: Protocol for an Ambulatory Assessment Study %A Wooldridge,Jennalee S %A Morse,Jessica L %A Delgado,Jorge %A Afari,Niloofar %+ VA San Diego Healthcare System, 3350 La Jolla Village Dr., San Diego, CA, 92161, United States, 1 6194978236, jewooldridge@health.ucsd.edu %K type 2 diabetes mellitus %K ecological momentary assessment %K ambulatory assessment %K intensive longitudinal assessment %K physical activity %K self-management behavior %K functioning %K social support %D 2023 %7 20.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes impacts nearly 25% of veterans. Many veterans do not engage in recommended physical activity and other diabetes self-management behaviors. Type 2 diabetes is generally asymptomatic; as such, the long-term consequences of inadequate self-management and benefits of consistent self-management are not salient in the short term. Furthermore, self-management behaviors typically take place outside of medical visits; however, self-management–related factors are only assessed during medical visits, likely missing large amounts of variability. Thus, ambulatory assessment methods such as ecological momentary assessment (EMA), accelerometry, and continuous glucose monitoring are needed to understand the dynamics of daily self-management and identify potential intervention targets. Objective: The overarching goal of this study is to understand daily, time-varying factors (comorbid affective symptoms and social context) that influence physical activity, diabetes self-management, glycemic management, daily functioning, and quality of life in participants’ natural environments. Methods: We are recruiting veterans with type 2 diabetes (target N=100). Participants are required to complete a battery of baseline assessments related to mental health, psychosocial factors, and self-management behaviors. Participants then receive 5 momentary EMA surveys and 1 daily EMA survey per day, in which veterans report comorbid affective symptoms (mood, stress, and pain), social support, social interactions, physical activity, and other self-management behaviors. Momentary surveys are delivered randomly during daily preprogrammed intervals over a 14-day sampling period. Accelerometry and continuous glucose monitoring are also used to assess physical activity and blood glucose, respectively. The first 6 participants also completed interviews assessing their experience in the study and barriers to participation. These test participants informed modifications to the protocol for the remaining participants. Results: The project received funding in April of 2023. Enrollment began in March of 2023 and is planned to be completed in April 2025. Among the 6 test participants, the overall EMA response rate was 87% (range 74%-95%). The response rate for the EMA survey including daily items (67%, range 21%-93%) was lower than the earlier shorter EMA surveys (89%, range 81%-96%). The mean rate of valid accelerometer wear of at least 20 hours per day was 93% (SD 11%), and continuous glucose monitoring data were available for 91% (SD 17%) of days on average. Participants reported few barriers to completing EMA surveys but noted the random timing of questions made it difficult to plan around, and the end-of-day survey was long. Two participants reported survey items reminded or motivated them to engage in diabetes self-management behaviors. Conclusions: Assessment tools developed from this study can inform clinical decision-making by considering barriers to self-management that occur in daily life. Clinical applications include tailored, adaptive technology–supported interventions to improve self-management that provide the right type and amount of support at the right time by adapting to an individual’s changing internal and contextual state. International Registered Report Identifier (IRRID): DERR1-10.2196/53874 %M 37983070 %R 10.2196/53874 %U https://www.researchprotocols.org/2023/1/e53874 %U https://doi.org/10.2196/53874 %U http://www.ncbi.nlm.nih.gov/pubmed/37983070 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50183 %T Telehealth Diabetes Prevention Program for Adults With Prediabetes in an Academic Medical Center Setting: Protocol for a Hybrid Type III Trial %A Gamble,Abigail %A Khan,Tamkeen %A Hughes,Alejandro %A Guo,Yan %A Vasaitis,Siga %A Bidwell,Josie %A Christman,Brian %+ Department of Preventive Medicine, John D Bower School of Population Health, University of Mississippi Medical Center, 2500 N State Street, Jackson, MS, 39216, United States, 1 601 815 9482, agamble2@umc.edu %K prediabetic state %K prevention %K preventive medicine %K Centers for Disease Control and Prevention %K Medicare %K telemedicine %K telehealth %K behavioral science %K implementation science %K implementation %K research evaluation %K cost-benefit analysis %K diabetes %K diabetic %K cost %K costs %K economic %K prevention %K design %K engagement %K use %K distant learning %D 2023 %7 13.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes is a costly epidemic in the United States associated with both health and economic consequences. These consequences can be mitigated by participation in structured lifestyle change programs such as the National Diabetes Prevention Program (DPP) led by the Centers for Disease Control and Prevention. Mississippi consistently has among the highest rates of diabetes and prediabetes nationally. Implementing the National DPP through large health care systems can increase reach and accessibility for populations at the highest risk for diabetes. Translational research on the National DPP in Mississippi has not been studied. Objective: This study aims to evaluate the implementation and impact of the National DPP delivered using telehealth modalities at the University of Mississippi Medical Center in Jackson, Mississippi. Methods: An effectiveness-implementation hybrid type III research design is proposed. The study design is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and the Practical, Robust Implementation and Sustainability Model. Participants are being recruited via provider referral, and the DPP is being delivered by trained lifestyle coaches. Study participants include adult (≥18 years) patients eligible for the DPP with at least 1 encounter at 1 of 3 ambulatory clinic specialties (lifestyle medicine, family medicine, and internal medicine) between January 2019 and December 2023. The National DPP eligibility criteria include a BMI ≥25 kg/m2 and hemoglobin A1c between 5.7% and 6.4%. The University of Mississippi Medical Center criteria include Medicare or Medicaid beneficiaries. The University of Mississippi Medical Center’s a priori implementation plan was developed using the Consolidated Framework for Implementation Research and includes 23 discrete strategies. The primary aim will use an embedded mixed method process analysis to identify and mitigate challenges to implementation. The secondary aim will use a nonrandomized quasi-experimental design to assess the comparative effectiveness of the DPP on health care expenditures. A propensity score matching method will be implemented to compare case subjects to control subjects. The primary outcomes include patient referrals, participant enrollment, retention, engagement, the incidence of diabetes, and health care resource use and costs. Results: At baseline, of the 26,151 patients across 3 ambulatory clinic specialties, 1010 (3.9%) had prediabetes and were eligible for the National DPP. Of the 1010 patients, more than half (n=562, 55.6%) were aged 65 years or older, 79.5% (n=803) were Medicare beneficiaries, 65.9% (n=666) were female, and 70.8% (n=715) were obese. Conclusions: This is the first translational study of the National DPP in Mississippi. The findings will inform implementation strategies impacting the uptake and sustainability of the National DPP delivered in an academic medical setting using distance learning and telehealth modalities. Trial Registration: ClinicalTrials.gov NCT04822480; https://clinicaltrials.gov/study/NCT03622580 International Registered Report Identifier (IRRID): DERR1-10.2196/50183 %M 37955955 %R 10.2196/50183 %U https://www.researchprotocols.org/2023/1/e50183 %U https://doi.org/10.2196/50183 %U http://www.ncbi.nlm.nih.gov/pubmed/37955955 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45977 %T Optimizing an mHealth Program to Promote Type 2 Diabetes Prevention in High-Risk Individuals: Cross-Sectional Questionnaire Study %A Ross,Edgar %A Al Ozairi,Ebaa %A Al qabandi,Naeema %A Jamison,Robert %+ Atrius Healthcare, Harvard Medical School, 20 Wall Street, Burlington, MA, 01803-4758, United States, 1 617 657 6410, edgarross245@gmail.com %K SMS %K short text message interventions: mHealth %K smartphone %K type 2 diabetes prevention %K social media %K friends and family %K percolation theory %K diabetes %K prevention %K risk %K development %K pilot study %K social network %K theory modeling %K disease control %K initiative %D 2023 %7 16.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: We evaluated the outcomes of a pilot SMS text messaging–based public health campaign that identified social networking nodes and variations of response rates to develop a list of variables that could be used to analyze and develop an outreach strategy that would maximize the impact of future public health campaigns planned for Kuwait. Computational analysis of connections has been used to analyze the spread of infectious diseases, dissemination of new thoughts and ideas, efficiency of logistics networks, and even public health care campaigns. Percolation theory network analysis provides a mathematical alternative to more established heuristic approaches that have been used to optimize network development. We report on a pilot study designed to identify and treat subjects at high risk of developing type 2 diabetes mellitus in Kuwait. Objective: The aim of this study was to identify ways to optimize efficient deployment of resources and improve response rates in a public health campaign by using variables identified in this secondary analysis of our previously published data (Alqabandi et al, 2020). This analysis identified key variables that could be used in a computational analysis to plan for future public health campaigns. Methods: SMS text message screening posts were sent inviting recipients to answer 6 questions to determine their risk of developing type 2 diabetes mellitus. If subjects agreed to participate, a link to the Centers for Disease Control and Prevention prediabetes screening test was automatically transmitted to their mobile devices. The phone numbers used in this campaign were recorded and compared to the responses received through SMS text messaging and social media forwarding. Results: A total of 180,000 SMS text messages through 5 different campaigns were sent to 6% of the adult population in Kuwait. A total of 260 individuals agreed to participate, of which 153 (58.8%) completed the screening. Remarkably, 367 additional surveys were received from individuals who were not invited by the original circulated SMS text messages. These individuals were invited through forwarded surveys from the original recipients after authentication with the study center. The original SMS text messages were found to successfully identify influencers in existing social networks to improve the efficacy of the public health campaign. Conclusions: SMS text messaging–based health care screening campaigns were found to have limited effectiveness alone; however, the increased reach through shared second-party forwarding suggests the potential of exponentially expanding the reach of the study and identifying a higher percentage of eligible candidates through the use of percolation theory. Future research should be directed toward designing SMS text messaging campaigns that support a combination of SMS text message invitations and social networks along with identification of influential nodes and key variables, which are likely unique to the environment and cultural background of the population, using percolation theory modeling and chatbots. %M 37843911 %R 10.2196/45977 %U https://formative.jmir.org/2023/1/e45977 %U https://doi.org/10.2196/45977 %U http://www.ncbi.nlm.nih.gov/pubmed/37843911 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51431 %T A Complex mHealth Coaching Intervention to Prevent Overweight, Obesity, and Diabetes in High-Risk Women in Antenatal Care: Protocol for a Hybrid Type 2 Effectiveness-Implementation Study %A O'Reilly,Sharleen L %A Laws,Rachel %A Maindal,Helle Terkildsen %A Teede,Helena %A Harrison,Cheryce %A McAuliffe,Fionnuala M %A Geraghty,Aisling %A Campoy,Cristina %A Bermúdez,Mercedes G %A Pirhonen,Laura %A Burden,Christy %A Davies,Anna %A Laursen,Ditte Hjorth %A Skinner,Timothy %A , %+ School of Agriculture and Food Science, University College Dublin, School of Agriculture and Food Science, University College Dublin, Belfield, Dublin, D4, Ireland, 353 17162157, sharleen.oreilly@ucd.ie %K hybrid type 2 effectiveness-implementation %K gestational diabetes %K obesity %K mHealth %K mobile health %K health behavior change %K pregnancy %K postpartum %K weight management %K health coaching %K maternal health %D 2023 %7 18.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Women with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period. Objective: We aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes. Methods: IMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant’s needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses. Results: The study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024. Conclusions: This is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/51431 %M 37721798 %R 10.2196/51431 %U https://www.researchprotocols.org/2023/1/e51431 %U https://doi.org/10.2196/51431 %U http://www.ncbi.nlm.nih.gov/pubmed/37721798 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e33810 %T A Culturally Adapted Diet and Physical Activity Text Message Intervention to Prevent Type 2 Diabetes Mellitus for Women of Pakistani Origin Living in Scotland: Formative Study %A Krasuska,Marta %A Davidson,Emma M %A Beune,Erik %A Jenum,Anne Karen %A Gill,Jason MR %A Stronks,Karien %A van Valkengoed,Irene GM %A Diaz,Esperanza %A Sheikh,Aziz %+ Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, United Kingdom, 44 131 650 8102, emma.davidson@ed.ac.uk %K diabetes %K diet %K ethnic minority populations %K Pakistani %K physical activity %K prevention %K South Asian %K text messages %K women %K women’s health %K health intervention %K digital health %K mobile health %K minority %K exercise %K text message %K text messaging %K SMS %K development %K formative %K diabetes mellitus %D 2023 %7 15.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals of South Asian origin are at an increased risk of developing type 2 diabetes mellitus (T2DM) compared with other ethnic minority groups. Therefore, there is a need to develop interventions to address, and reduce, this heightened risk. Objective: We undertook formative work to develop a culturally adapted diet and physical activity text message intervention to prevent T2DM for women of Pakistani origin living in Scotland. Methods: We used a stepwise approach that was informed by the Six Steps in Quality Intervention Development framework, which consisted of gathering evidence through literature review and focus groups (step 1), developing a program theory for the intervention (step 2), and finally developing the content of the text messages and an accompanying delivery plan (step 3). Results: In step 1, we reviewed 12 articles and identified 3 key themes describing factors impacting on diet and physical activity in the context of T2DM prevention: knowledge on ways to prevent T2DM through diet and physical activity; cultural, social, and gender norms; and perceived level of control and sense of inevitability over developing T2DM. The key themes that emerged from the 3 focus groups with a total of 25 women were the need for interventions to provide “friendly encouragement,” “companionship,” and a “focus on the individual” and also for the text messages to “set achievable goals” and include “information on cooking healthy meals.” We combined the findings of the focus groups and literature review to create 13 guiding principles for culturally adapting the text messages. In step 2, we developed a program theory, which specified the main determinants of change that our text messages should aim to enhance: knowledge and skills, sense of control, goal setting and planning behavior, peer support, and norms and beliefs guiding behavior. In step 3, we used both the intervention program theory and guiding principles to develop a set of 73 text messages aimed at supporting a healthy diet and 65 text messages supporting increasing physical activity. Conclusions: We present a theory-based approach to develop a culturally adapted diet and physical activity text message intervention to prevent T2DM for women of Pakistani origin living in Scotland. This study outlines an approach that may also be applicable to the development of interventions for other ethnic minority populations in diverse settings. There is now a need to build on this formative work and undertake a feasibility trial of a text message–based diet and physical activity intervention to prevent T2DM for women of Pakistani origin living in Scotland. %M 37713245 %R 10.2196/33810 %U https://formative.jmir.org/2023/1/e33810 %U https://doi.org/10.2196/33810 %U http://www.ncbi.nlm.nih.gov/pubmed/37713245 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49115 %T Impact on Knowledge, Competence, and Performance of a Faculty-Led Web-Based Educational Activity for Type 2 Diabetes and Obesity: Questionnaire Study Among Health Care Professionals and Analysis of Anonymized Patient Records %A Okemah,Jennifer %A Neunie,Sola %A Noble,Alexander %A Wysham,Carol %+ Rockwood Center for Diabetes and Endocrinology, 400 E 5th Ave #4, Spokane, WA, 99202, United States, 1 509 838 2531, Carol.Wysham@multicare.org %K continuing medical education %K incretin-based therapy %K multidisciplinary care %K obesity %K overweight %K type 2 diabetes %K patient data %K diabetes management %K patient education %K chronic disease %K web-based education %K digital education %K health education %K diabetes %K diabetes mellitus %K survey %K web-based survey %K education %K glycemic %D 2023 %7 13.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Strategies for managing type 2 diabetes (T2D) and obesity are evolving with the introduction of targeted therapies, including incretin-based dual agonists and growing knowledge of the importance of multidisciplinary care. Accessible, effective continuing medical education (CME) activities are required to ensure that health care professionals (HCPs) understand and can implement the most recent data to optimize patient outcomes. Objective: We aimed to measure changes in knowledge, competence, and self-reported performance and quantitatively evaluate changes in performance using anonymized patient data following participation in a web-based educational activity. The faculty-led CME-accredited activity was based on incretin-based dual agonists and patient education on T2D and obesity. The remaining educational gaps in this field were also identified. Methods: A CME-accredited, web-based, multidisciplinary (touchMDT) educational activity titled “The future for glycemic control and weight loss in T2D and obesity: Incretin-based dual-agonists and optimizing patient education” was developed. HCP knowledge, competence, and performance were assessed before and after the activity against Moore’s expanded outcomes framework (levels 1-5), using self-reported questionnaires and by analyzing anonymized patient record data. Results: For evaluating knowledge and competence (50 respondents before and 50 learners after the activity), the mean number of correctly answered questions was significantly higher post activity (median 5.0, IQR 4.0-6.0 to 6.0, IQR 5.0-7.0; mean 4.98, SD 1.22 to 5.78, SD 1.13; P<.001). Modest, nonsignificant improvements in self-reported performance (N=50 respondents preactivity; N=50 learners postactivity) from before to after the activity were observed (median 4.0, IQR 3.25-4.0 to 4.0, IQR 4.0-4.0; mean 3.64, SD 0.69 to 3.76, SD 0.48; P=.32). PPatient data analysis indicated that patients were being treated more intensively postactivity: before the activity, the most commonly used treatment regimens were metformin monotherapy (13/50, 26%) and dual therapy with metformin plus injectable glucagon-like peptide-1 (GLP-1) receptor agonist (RA; 11/50, 22%); post activity, this changed to dual therapy with metformin plus injectable GLP-1 RA (12/50, 24%) and triple therapy with metformin plus injectable GLP-1 RA plus sodium-glucose cotransporter-2 inhibitor (SGLT2i; 10/50, 20%). In addition, there was an increased number of referrals to a combination of specialists (physicians referred 27%, 8/30 of patients to ≥2 specialists before the activity and 36%, 10/28 to ≥2 specialists post activity). The remaining educational gaps included understanding the biology and psychology of obesity, efficacy and safety data for incretin-based dual agonists, and the role of the diabetes educator or diabetes care and education specialist in managing T2D and obesity. Conclusions: This short, web-based CME activity on the management of T2D and obesity led to improvements in HCP knowledge, competence, and performance. Several remaining unmet needs were identified, which can be used to inform the content of future educational activities in this disease area. %M 37703084 %R 10.2196/49115 %U https://formative.jmir.org/2023/1/e49115 %U https://doi.org/10.2196/49115 %U http://www.ncbi.nlm.nih.gov/pubmed/37703084 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46115 %T Understanding Whether and How a Digital Health Intervention Improves Transition Care for Emerging Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Realist Evaluation %A Wang,Ruoxi %A Rouleau,Geneviève %A Booth,Gillian Lynn %A Brazeau,Anne-Sophie %A El-Dassouki,Noor %A Taylor,Madison %A Cafazzo,Joseph A %A Greenberg,Marley %A Nakhla,Meranda %A Shulman,Rayzel %A Desveaux,Laura %+ Institute for Better Health, Trillium Health Partners, 100 Queensway W, Mississauga, ON, L5B 1B8, Canada, 1 437 772 6836, laura.desveaux@thp.ca %K digital health %K emerging adults %K realist evaluation %K self-management %K transition to adult care %K type 1 diabetes %D 2023 %7 13.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to an increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from pediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which groups of individuals. Objective: This study aims to evaluate the design and implementation of a multicomponent SMS text message–based digital health intervention to support emerging adults living with T1D in real-world settings. The objectives are to identify the intervention components and associated mechanisms that support user engagement and T1D health care transition experiences and determine the individual characteristics that influence the implementation process. Methods: We used a realist evaluation embedded alongside a randomized controlled trial, which uses a sequential mixed methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and realist interviews. In step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships among “individual-level contextual factors, intervention components and features, mechanisms, and outcomes,” with special attention paid to user engagement. Among them, intervention components and features depict 10 core characteristics such as transition support information, problem-solving information, and real-time interactivity. The proximal outcomes of interest include user engagement, self-efficacy, and negative emotions, whereas the distal outcomes of interest include transition readiness, self-blood glucose monitoring behaviors, and blood glucose. In step 2, we plan to conduct semistructured realist interviews with the randomized controlled trial’s intervention-arm participants to test the hypothesized “context-intervention-mechanism-outcome” configurations. In step 3, we plan to triangulate all sources of data using a coincidence analysis to identify the necessary combinations of factors that determine whether and how the desired outcomes are achieved and use these insights to consolidate the program theory. Results: For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for this realist evaluation was anticipated to start in July 2023 and continue until we reached thematic saturation or achieved informational power. Conclusions: Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences. International Registered Report Identifier (IRRID): PRR1-10.2196/46115 %M 37703070 %R 10.2196/46115 %U https://www.researchprotocols.org/2023/1/e46115 %U https://doi.org/10.2196/46115 %U http://www.ncbi.nlm.nih.gov/pubmed/37703070 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41502 %T Just-In-Time Adaptive Intervention to Sit Less and Move More in People With Type 2 Diabetes: Protocol for a Microrandomized Trial %A Daryabeygi-Khotbehsara,Reza %A Dunstan,David W %A Islam,Sheikh Mohammed Shariful %A Zhang,Yuxin %A Abdelrazek,Mohamed %A Maddison,Ralph %+ Institute for Physical Activity and Nutrition (IPAN), Deakin University, 221 Burwood Hw, Geelong, 3125, Australia, 61 3 924 459362, reza.d@deakin.edu.au %K diabetes %K just-in-time adaptive intervention %K JITAI %K micro-randomized trial %K MRT %K physical activity %K sedentary behavior %D 2023 %7 6.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Reducing sedentary behavior and increasing physical activity in people with type 2 diabetes (T2D) are associated with various positive health benefits. Just-in-time adaptive interventions offer the potential to target both of these behaviors through more contextually aware, tailored, and personalized support. We have developed a just-in-time adaptive intervention to promote sitting less and moving more in people with T2D. Objective: This paper presents the study protocol for a microrandomized trial to investigate whether motivational messages are effective in reducing time spent sitting in people with T2D and to determine what behavior change techniques are effective and in which context (eg, location, etc). Methods: We will use a 6-week microrandomized trial design. A total of 22 adults with T2D will be recruited. The intervention aims to reduce sitting time and increase time spent standing and walking and comprises a mobile app (iMove), a bespoke activity sensor called Sedentary Behavior Detector (SORD), a messaging system, and a secured database. Depending on the randomization sequence, participants will potentially receive motivational messages 5 times a day. Results: Recruitment was initiated in October 2022. As of now, 6 participants (2 female and 4 male) have consented and enrolled in the study. Their baseline measurements have been completed, and they have started using iMove. The mean age of 6 participants is 56.8 years, and they were diagnosed with T2D for 9.4 years on average. Conclusions: This study will inform the optimization of digital behavior change interventions to support people with T2D Sit Less and Move More to increase daily physical activity. This study will generate new evidence about the immediate effectiveness of sedentary behavior interventions, their active ingredients, and associated factors. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12622000426785; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383664 International Registered Report Identifier (IRRID): DERR1-10.2196/41502 %M 37672323 %R 10.2196/41502 %U https://www.researchprotocols.org/2023/1/e41502 %U https://doi.org/10.2196/41502 %U http://www.ncbi.nlm.nih.gov/pubmed/37672323 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45004 %T Adapting the Diabetes Prevention Program for Older Adults: Descriptive Study %A Beasley,Jeannette M %A Johnston,Emily A %A Costea,Denisa %A Sevick,Mary Ann %A Rogers,Erin S %A Jay,Melanie %A Zhong,Judy %A Chodosh,Joshua %+ Department of Nutrition and Food Studies, New York University Steinhardt School of School of Culture, Education, and Human Development, 411 Lafayette Street, 526, New York, NY, 10003, United States, 1 2129985782, jbeasley@nyu.edu %K aging %K diabetes prevention program %K nutrition %K diet %K physical activity %K weight loss %K weight %K exercise %K diabetes %K prevention %K diabetic %K ageing %K older adult %K online intervention %K digital intervention %K virtual delivery %K lifestyle coach %K group-based intervention %D 2023 %7 29.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Prediabetes affects 26.4 million people aged 65 years or older (48.8%) in the United States. Although older adults respond well to the evidence-based Diabetes Prevention Program, they are a heterogeneous group with differing physiological, biomedical, and psychosocial needs who can benefit from additional support to accommodate age-related changes in sensory and motor function. Objective: The purpose of this paper is to describe adaptations of the Centers for Disease Control and Prevention’s Diabetes Prevention Program aimed at preventing diabetes among older adults (ages ≥65 years) and findings from a pilot of 2 virtual sessions of the adapted program that evaluated the acceptability of the content. Methods: The research team adapted the program by incorporating additional resources necessary for older adults. A certified lifestyle coach delivered 2 sessions of the adapted content via videoconference to 189 older adults. Results: The first session had a 34.9% (38/109) response rate to the survey, and the second had a 34% (30/88) response rate. Over three-quarters (50/59, 85%) of respondents agreed that they liked the virtual program, with 82% (45/55) agreeing that they would recommend it to a family member or a friend. Conclusions: This data will be used to inform intervention delivery in a randomized controlled trial comparing in-person versus virtual delivery of the adapted program. %M 37642989 %R 10.2196/45004 %U https://formative.jmir.org/2023/1/e45004 %U https://doi.org/10.2196/45004 %U http://www.ncbi.nlm.nih.gov/pubmed/37642989 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45294 %T A Digital Coach (E-Supporter 1.0) to Support Physical Activity and a Healthy Diet in People With Type 2 Diabetes: Acceptability and Limited Efficacy Testing %A Hietbrink,Eclaire A G %A Oude Nijeweme-d’Hollosy,Wendy %A Middelweerd,Anouk %A Konijnendijk,Annemieke A J %A Schrijver,Laura K %A ten Voorde,Anouk S %A Fokkema,Elise M S %A Laverman,Gozewijn D %A Vollenbroek-Hutten,Miriam M R %+ Department of Biomedical Signals and Systems, University of Twente, Drienerlolaan 5, Enschede, 7500 AE, Netherlands, 31 53 4892760, e.a.g.hietbrink@utwente.nl %K eHealth %K type 2 diabetes %K physical activity %K nutrition %K lifestyle change %K acceptability %K limited efficacy %K formative evaluation %K mobile phone %D 2023 %7 28.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: A healthy lifestyle, including regular physical activity and a healthy diet, is increasingly part of type 2 diabetes (T2D) management. As many people with T2D have difficulty living and maintaining a healthy lifestyle, there is a need for effective interventions. eHealth interventions that incorporate behavior change theories and tailoring are considered effective tools for supporting a healthy lifestyle. The E-Supporter 1.0 digital coach contains eHealth content for app-based eHealth interventions and offers tailored coaching regarding physical activity and a healthy diet for people with T2D. Objective: This study aimed to assess the acceptability of E-Supporter 1.0 and explore its limited efficacy on physical activity, dietary behavior, the phase of behavior change, and self-efficacy levels. Methods: Over a span of 9 weeks, 20 individuals with T2D received daily motivational messages and weekly feedback derived from behavioral change theories and determinants through E-Supporter 1.0. The acceptability of the intervention was assessed using telephone-conducted, semistructured interviews. The interview transcripts were coded using inductive thematic analysis. The limited efficacy of E-Supporter 1.0 was explored using the Fitbit Charge 2 to monitor step count to assess physical activity and questionnaires to assess dietary behavior (using the Dutch Healthy Diet index), phase of behavior change (using the single-question Self-Assessment Scale Stages of Change), and self-efficacy levels (using the Exercise Self-Efficacy Scale). Results: In total, 5 main themes emerged from the interviews: perceptions regarding remote coaching, perceptions regarding the content, intervention intensity and duration, perceived effectiveness, and overall appreciation. The participants were predominantly positive about E-Supporter 1.0. Overall, they experienced E-Supporter 1.0 as a useful and easy-to-use intervention to support a better lifestyle. Participants expressed a preference for combining E-Supporter with face-to-face guidance from a health care professional. Many participants found the intensity and duration of the intervention to be acceptable, despite the coaching period appearing relatively short to facilitate long-term behavior maintenance. As expected, the degree of tailoring concerning the individual and external factors that influence a healthy lifestyle was perceived as limited. The limited efficacy testing showed a significant improvement in the daily step count (z=−2.040; P=.04) and self-efficacy levels (z=−1.997; P=.046) between baseline and postintervention. Diet was improved through better adherence to Dutch dietary guidelines. No significant improvement was found in the phase of behavior change (P=.17), as most participants were already in the maintenance phase at baseline. Conclusions: On the basis of this explorative feasibility study, we expect E-Supporter 1.0 to be an acceptable and potentially useful intervention to promote physical activity and a healthy diet in people with T2D. Additional work needs to be done to further tailor the E-Supporter content and evaluate its effects more extensively on lifestyle behaviors. %M 37505804 %R 10.2196/45294 %U https://formative.jmir.org/2023/1/e45294 %U https://doi.org/10.2196/45294 %U http://www.ncbi.nlm.nih.gov/pubmed/37505804 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46513 %T Evaluation of Psychological Resources of Young Adults With Type 1 Diabetes Mellitus During the Transition From Pediatric to Adult Diabetes Clinics: Multicenter Cross-sectional Study %A Cyranka,Katarzyna %A Juza,Anna %A Kwiendacz,Hanna %A Nabrdalik,Katarzyna %A Gumprecht,Janusz %A Małecki,Maciej %A Klupa,Tomasz %A Matejko,Bartłomiej %+ Department of Metabolic Diseases, Jagiellonian University Medical College, 2 Jakubowskiego Street, Kraków, 30-688, Poland, 48 48 12 400 29 50, b.matejko@yahoo.com %K young adults %K type 1 diabetes %K transitioning care %K psychological %K diabetes %K cross-sectional study %K anxiety %K socioeconomic %K validation %K anger %K depression %K outpatient %K chronic disease %K pediatric %K adulthood %K coping mechanism %D 2023 %7 29.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The transition period of patients with type 1 diabetes from pediatric to adult-oriented health care is associated with poorer glycemic control and less frequent clinic attendance. Fears and anxiety about the unknown, care approach differences in adult settings, and sadness about leaving the pediatric provider all contribute to a patient’s reluctance to transition. Objective: This study aimed to evaluate the psychological parameters of young patients with type 1 diabetes transitioning to an adult outpatient clinic during the first visit. Methods: We examined 50 consecutive patients (n=28, 56% female) transitioning from March 2, 2021, to November 21, 2022, into adult care (3 diabetes centers from 3 regions in southern Poland: A, n=16; B, n=21; and C, n=13) and their basic demographic information. They completed the following psychological questionnaires: State-Trait Anxiety Inventory (STAI), Generalized Self-Efficacy Scale, Perceived Stress Scale, Satisfaction with Life Scale, Acceptance of Illness Scale, Multidimensional Health Locus of Control Scale Form C, Courtauld Emotional Control Scale, and Quality of Life Questionnaire Diabetes. We compared their data with those for the general healthy population and patients with diabetes from Polish Test Laboratory validation studies. Results: During the first adult outpatient visit, patients’ mean age was 19.2 (SD 1.4) years, with a diabetes duration of 9.8 (SD 4.3) years and BMI of 23.5 (SD 3.1) kg/m2. Patients came from diverse socioeconomic backgrounds: 36% (n=18) live in villages, 26% (n=13) live in towns with ≤100,000 inhabitants, and 38% (n=19) live in bigger cities. Regarding therapy type, 68% (n=34) were treated with insulin pump therapy, whereas 32% (n=16) were treated with multiple daily injections. Patients from center A had a mean glycated hemoglobin level of 7.5% (SD 1.2%). There was no difference regarding the level of life satisfaction, perceived level of stress, and state anxiety between the patients and reference populations. Patients had similar health locus of control and negative emotions control to the general population of patients with diabetes. Most patients (n=31, 62%) believe that control over their health depends on themselves, whereas 52% (n=26) believe that it depends mostly on others. Patients had higher levels of suppression of negative emotions—anger, depression, and anxiety—than the age-matched general population. Additionally, the patients were characterized by a higher acceptance of illness and higher level of self-efficacy compared to the reference populations: 64% (n=32) had a high level of self-efficacy and 26% (n=13) had a high level of life satisfaction. Conclusions: This study indicated that young patients transitioning to adult outpatient clinics have good psychological resources and coping mechanisms, which might result in adequate adaptation and adult life satisfaction including future metabolic control. These result also disprove the stereotypes that young people with chronic disease have worse life perspectives when entering adulthood. %M 37247225 %R 10.2196/46513 %U https://formative.jmir.org/2023/1/e46513 %U https://doi.org/10.2196/46513 %U http://www.ncbi.nlm.nih.gov/pubmed/37247225 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42590 %T Impact of Multimedia Messaging Service Education and Exercise Social Support on Physical Activity Among Patients With Type 2 Diabetes: Quasi-Experimental Study %A Alyahya,Mohammad S %A Al-Sheyab,Nihaya A %A Khader,Yousef S %A Alqudah,Jumana A %+ Health Management and Policy, Faulty of Medicine, Jordan University of Science and Technology (JUST), 22110, Irbid, 3030, Jordan, 962 775582824, msalyahya@just.edu.jo %K diabetes mellitus %K educational interventions %K multimedia messaging service %K physical activity %K social support %D 2023 %7 22.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Social support is one of the interpersonal stimuli that define an individual’s predisposition to engage in health-promoting behaviors and is considered a facilitator in improving health habits. Patients with type 2 diabetes mellitus (T2DM) can benefit from educating supportive families and friends on self-care management including exercise behavior. Multimedia messaging service (MMS) could also be an effective method for delivering targeted educational interventions that focus on physical activity (PA). Objective: This study aimed to assess the effectiveness of MMS educational interventions and perceived social support for exercise on level of PA of patients with T2DM. Methods: A quasi-experimental pretest-posttest design was conducted to recruit 98 patients with T2DM. The intervention group received MMS education aiming to improve exercise social support and PA level for 2 months, and their counterparts in the control group received the usual routine care. We sent 2 to 3 messages daily for 2 weeks from Saturday to Thursday (12 days total). These messages were a combination of videos and texts, and the evidence-based content of these messages was reviewed and approved by the advisory committee. We randomly assigned eligible patients in a 1:1 ratio into the intervention or the control groups. Participants completed a survey in 3 periods. Results: There were no significant differences in friends’ support, family verbal, practical, or emotional support over time in the intervention group (P>.05). Yet, there was a small effect size (Cohen d) in friends’ social support (0.389), family practical support (0.271), and moderate activities (0.386). A medium effect size was found in family verbal (0.463) and emotional (0.468) support. Being married increased the likelihood of friends’ support by 2.3 times after intervention (P=.04), whereas rarely doing exercise decreased the likelihood of friends’ support by 28% (P=.03) and family practical support by 28% (P=.01). Being female and married increased the likelihood of doing moderate activities by 1.6 times (P=.002) and 1.5 times (P=.049) in the intervention group. Being a housewife decreased the likelihood of doing moderate activities by 20% (P=.001). Finally, being a female with a higher educational level decreased the likelihood of doing hard activities by 20% (P=.04) and 15% (P=.002), respectively. Conclusions: A theoretically based MMS health education targeting PA levels and social support of family and friends to perform PA seems promising in promoting family and friends’ social support and improving PA levels among patients with T2DM. Actively involving family and friends in educational interventions that target PA can have an impact on health-promoting behaviors in patients with diabetes. %M 37213171 %R 10.2196/42590 %U https://formative.jmir.org/2023/1/e42590 %U https://doi.org/10.2196/42590 %U http://www.ncbi.nlm.nih.gov/pubmed/37213171 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e44295 %T Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low–Carbohydrate Web-Based Program: Randomized Controlled Trial %A Saslow,Laura R %A Missel,Amanda L %A O’Brien,Alison %A Kim,Sarah %A Hecht,Frederick M %A Moskowitz,Judith T %A Bayandorian,Hovig %A Pietrucha,Martha %A Raymond,Kate %A Richards,Blair %A Liestenfeltz,Bradley %A Mason,Ashley E %A Daubenmier,Jennifer %A Aikens,James E %+ Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Room 2178 400NIB, Ann Arbor, MI, 48109, United States, 1 (734) 764 7836, saslowl@umich.edu %K eHealth %K type 2 diabetes %K T2D %K very low–carbohydrate diet %K weight loss %K glycemic control %K text messages %K self-monitoring %D 2023 %7 11.5.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: A very low–carbohydrate (VLC) nutritional strategy may improve glycemic control and weight loss in adults with type 2 diabetes (T2D). However, the supplementary behavioral strategies that might be able to improve outcomes using this nutritional strategy are uncertain. Objective: This study aims to compare the impact of adding 3 different supplementary behavioral strategies to a web-based VLC diet intervention. To our knowledge, this is the first trial to randomize participants to different frequencies of dietary self-monitoring. Methods: The study included 112 overweight adults with T2D (hemoglobin A1c ≥6.5%) taking no antiglycemic medications or only metformin. They received a remotely delivered 12-month VLC diet intervention. Participants were randomly assigned through a full factorial 2×2×2 design to supplementary strategies: either daily or monthly dietary self-monitoring, either mindful eating training or not, and either positive affect skills training or not. Our research goal was to determine whether 3 different supplemental strategies had at least a medium effect size (Cohen d=0.5). Results: Overall, the VLC intervention led to statistically significant improvements in glycemic control (−0.70%, 95% CI −1.04% to −0.35%; P<.001), weight loss (−6.82%, 95% CI −8.57% to −5.08%; P<.001), and depressive symptom severity (Cohen d −0.67, 95% CI −0.92 to −0.41; P<.001). Furthermore, 30% (25/83) of the participants taking metformin at baseline reduced or discontinued their metformin. Only 1 Cohen d point estimate reached 0.5; daily (vs monthly) dietary self-monitoring had a worse impact on depressive symptoms severity (Cohen d=0.47, 95% CI −0.02 to 0.95; P=.06). None of the strategies had a statistically significant effect on outcomes. For changes in our primary outcome, hemoglobin A1c, the daily (vs monthly) dietary self-monitoring impact was 0.42% (95% CI −0.28% to 1.12%); for mindful eating, it was −0.47% (95% CI −1.15% to 0.22%); and for positive affect, it was 0.12% (95% CI −0.57% to 0.82%). Other results for daily (vs monthly) dietary self-monitoring were mixed, suggesting an increase in weight (0.98%) and depressive symptoms (Cohen d=0.47), less intervention satisfaction (Cohen d=−0.20), more sessions viewed (3.02), and greater dietary adherence (Cohen d=0.24). For mindful eating, the results suggested a benefit for dietary adherence (Cohen d=0.24) and intervention satisfaction (Cohen d=0.30). For positive affect, the results suggested a benefit for depressive symptoms (Cohen d=−0.32), the number of sessions viewed (3.68), dietary adherence (Cohen d=0.16), and intervention satisfaction (Cohen d=0.25). Conclusions: Overall, our results support the use of a VLC diet intervention in adults with T2D. The addition of monthly (not daily) dietary self-monitoring, mindful eating, and positive affect skills training did not show a definitive benefit, but it is worth further testing. Trial Registration: ClinicalTrials.gov NCT03037528; https://clinicaltrials.gov/ct2/show/NCT03037528 %M 37166961 %R 10.2196/44295 %U https://diabetes.jmir.org/2023/1/e44295 %U https://doi.org/10.2196/44295 %U http://www.ncbi.nlm.nih.gov/pubmed/37166961 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e43292 %T Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation %A Joshi,Shilpa %A Verma,Ritika %A Lathia,Tejal %A Selvan,Chitra %A Tanna,Snehal %A Saraf,Amit %A Tiwaskar,Mangesh %A Modi,Alok %A Kalra,Sanjay %A K,Vasudevarao %A Chitale,Manoj %A Malde,Forum %A Abdul Khader,Mohammed %A Singal,Arbinder Kumar %+ Office of Chief Executive Officer, Fitterfly HealthTech Pvt Ltd, Street 503, Akshar BlueChip Corporate Park, Turbhe MIDC, Navi Mumbai, 400705, India, 91 8879698997, arbinder@fitterfly.com %K digital therapeutics %K glycemic control %K continuous glucose monitoring %K monitoring %K glucose %K diabetes %K type 2 diabetes %K decision-making %K model %K glycemic %K effectiveness %K mobile application %K application %K engagement %D 2023 %7 3.5.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Digital therapeutic platforms facilitate health care through patient-centered strategies based on multidisciplinary teams and shared decision-making. Such platforms can be used for developing a dynamic model of diabetes care delivery, which can help in improving glycemic control by promoting long-term behavior changes in people with diabetes. Objective: This study aims to evaluate the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutics program for improving glycemic control in people with type 2 diabetes mellitus (T2DM) after the completion of 90 days in the program. Methods: We analyzed deidentified data of 109 participants in the Fitterfly Diabetes CGM program. This program was delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology. This program consists of 3 phases: the first phase is observation, wherein the patient’s CGM readings are observed for 7 days (week 1); the second phase is the intervention; and the third phase aims at sustaining the lifestyle modification introduced during the second phase. The primary outcome of our study was the change in the participants’ hemoglobin A1c (HbA1c) levels after program completion. We also evaluated the changes in participant weight and BMI after the program, changes in the CGM metrics in the initial 2 weeks of the program, and the effects of participant engagement in the program on improving their clinical outcomes. Results: At the end of the 90 days of the program, the mean HbA1c levels, weight, and BMI of the participants were significantly reduced by 1.2% (SD 1.6%), 2.05 (SD 2.84) kg, and 0.74 (SD 1.02) kg/m2 from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m2 in week 1, respectively (P<.001). The average blood glucose levels and time above range values showed a significant mean reduction by 16.44 (SD 32.05) mg/dL and 8.7% (SD 17.1%) in week 2 from week 1 baseline values of 152.90 (SD 51.63) mg/dL and 36.7% (SD 28.4%), respectively (P<.001 for both). Time in range values significantly improved by 7.1% (SD 16.7%) from a baseline value of 57.5% (SD 25%) in week 1 (P<.001). Of all the participants, 46.9% (50/109) showed HbA1c reduction ≥1% and 38.5% (42/109) showed weight loss ≥4%. The average number of times the mobile app was opened by each participant during the program was 108.80 (SD 127.91) times. Conclusions: Our study shows that participants in the Fitterfly Diabetes CGM program showed a significant improvement in their glycemic control and reduction in weight and BMI. They also showed a high level of engagement with the program. Weight reduction was significantly associated with higher participant engagement with the program. Thus, this digital therapeutic program can be considered as an effective tool for improving glycemic control in people with T2DM. %M 37133922 %R 10.2196/43292 %U https://diabetes.jmir.org/2023/1/e43292 %U https://doi.org/10.2196/43292 %U http://www.ncbi.nlm.nih.gov/pubmed/37133922 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e35682 %T The Influence of Age, Sex, and Socioeconomic Status on Glycemic Control Among People With Type 1 and Type 2 Diabetes in Canada: Patient-Led Longitudinal Retrospective Cross-sectional Study With Multiple Time Points of Measurement %A Mousavi,Seyedmostafa %A Tannenbaum Greenberg,Dana %A Ndjaboué,Ruth %A Greiver,Michelle %A Drescher,Olivia %A Chipenda Dansokho,Selma %A Boutin,Denis %A Chouinard,Jean-Marc %A Dostie,Sylvie %A Fenton,Robert %A Greenberg,Marley %A McGavock,Jonathan %A Najam,Adhiyat %A Rekik,Monia %A Weisz,Tom %A Willison,Donald J %A Durand,Audrey %A Witteman,Holly O %A , %+ Department of Family and Emergency Medicine, Faculty of Medicine, Université Laval, Pavillon Ferdinand Vandry, 1050 Ave. de la Médecine, Québec, QC, G1V 0A6, Canada, 1 418 656 2131 ext 403981, holly.witteman@fmed.ulaval.ca %K adolescent %K adult %K cohort studies %K co-design %K diabetes mellitus %K diabetes mellitus type 1 %K diabetes mellitus type 2 %K glycated hemoglobin %K menopause %K participatory medicine %K patient engagement %K postmenopause %K premenopause %K public and patient involvement %K sex factors %K socioeconomic disparities in health %K user design %K patient engagement %K public and patient involvement %D 2023 %7 27.4.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Clinical guidelines for most adults with diabetes recommend maintaining hemoglobin A1c (HbA1c) levels ≤7% (≤53 mmol/mol) to avoid microvascular and macrovascular complications. People with diabetes of different ages, sexes, and socioeconomic statuses may differ in their ease of attaining this goal. Objective: As a team of people with diabetes, researchers, and health professionals, we aimed to explore patterns in HbA1c results among people with type 1 or type 2 diabetes in Canada. Our research question was identified by people living with diabetes. Methods: In this patient-led retrospective cross-sectional study with multiple time points of measurement, we used generalized estimating equations to analyze the associations of age, sex, and socioeconomic status with 947,543 HbA1c results collected from 2010 to 2019 among 90,770 people living with type 1 or type 2 diabetes in Canada and housed in the Canadian National Diabetes Repository. People living with diabetes reviewed and interpreted the results. Results: HbA1c results ≤7.0% represented 30.5% (male people living with type 1 diabetes), 21% (female people living with type 1 diabetes), 55% (male people living with type 2 diabetes) and 59% (female people living with type 2 diabetes) of results in each subcategory. We observed higher HbA1c values during adolescence, and for people living with type 2 diabetes, among people living in lower income areas. Among those with type 1 diabetes, female people tended to have lower HbA1c levels than male people during childbearing years but higher HbA1c levels than male people during menopausal years. Team members living with diabetes confirmed that the patterns we observed reflected their own life courses and suggested that these results be communicated to health professionals and other stakeholders to improve the treatment for people living with diabetes. Conclusions: A substantial proportion of people with diabetes in Canada may need additional support to reach or maintain the guideline-recommended glycemic control goals. Blood sugar management goals may be particularly challenging for people going through adolescence or menopause or those living with fewer financial resources. Health professionals should be aware of the challenging nature of glycemic management, and policy makers in Canada should provide more support for people with diabetes to live healthy lives. %M 37104030 %R 10.2196/35682 %U https://diabetes.jmir.org/2023/1/e35682 %U https://doi.org/10.2196/35682 %U http://www.ncbi.nlm.nih.gov/pubmed/37104030 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e38680 %T Effectiveness of the Lilly Connected Care Program in Improving Glycemic Management Among Patients With Type 2 Diabetes in China: Retrospective Real-world Study %A Su,Benli %A Chen,Yu %A Shen,Xingping %A Guo,Jianchao %A Ding,Yuchen %A Ma,Xiao %A Yang,Yuxin %A Liu,Dongfang %+ Department of Endocrinology, The Second Affiliated Hospital of Chongqing Medical University, Linjiang Road, No 76, Chongqing, 400010, China, 86 023 63693222, ldf023023@qq.com %K type 2 diabetes mellitus %K T2DM %K diabetes management %K Lilly Connected Care Program %K LCCP %K hemoglobin A1c %K real-word study %D 2023 %7 25.4.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 2 diabetes mellitus (T2DM) is a worldwide public health concern. Mobile health management platforms could be a potential way to achieve effective glycemic control. Objective: This study aimed to evaluate the real-world effectiveness of the Lilly Connected Care Program (LCCP) platform in glycemic control among patients with T2DM in China. Methods: This retrospective study included Chinese patients with T2DM (aged ≥18 years) from April 1, 2017, to January 31, 2020, for the LCCP group and from January 1, 2015, to January 31, 2020, for the non-LCCP group. Propensity score matching was used to match the LCCP and non-LCCP groups to reduce confounding, with covariates including age, sex, the duration of diabetes, baseline hemoglobin A1c (HbA1c), and the number of oral antidiabetic medication classes. HbA1c reduction over 4 months, the proportions of patients achieving an HbA1c reduction of ≥0.5% or ≥1%, and the proportions of patients reaching to target HbA1c level of ≤6.5% or <7% were compared between the LCCP and non-LCCP groups. Multivariate linear regression was used to assess factors associated with HbA1c reduction. Results: A total of 923 patients were included, among whom 303 pairs of patients were well matched after propensity score matching. HbA1c reduction during the 4-month follow-up was significantly larger in the LCCP group than the non-LCCP group (mean 2.21%, SD 2.37% vs mean 1.65%, SD 2.29%; P=.003). The LCCP group had a higher proportion of patients with an HbA1c reduction of ≥1% (209/303, 69% vs 174/303, 57.4%; P=.003) and ≥0.5% (229/303, 75.6% vs 206/303, 68%; P=.04). The proportions of patients reaching the target HbA1c level of ≤6.5% were significantly different between the LCCP and non-LCCP groups (88/303, 29% vs 61/303, 20.1%; P=.01), whereas the difference in the proportions of patients reaching the target HbA1c level of <7% was not statistically significant (LCCP vs non-LCCP: 128/303, 42.2% vs 109/303, 36%; P=.11). LCCP participation and higher baseline HbA1c were associated with a larger HbA1c reduction, whereas older age, longer diabetes duration, and higher baseline dose of premixed insulin analogue were associated with a smaller HbA1c reduction. Conclusions: The LCCP mobile platform was effective in glycemic control among patients with T2DM in China in the real world. %M 37097724 %R 10.2196/38680 %U https://www.jmir.org/2023/1/e38680 %U https://doi.org/10.2196/38680 %U http://www.ncbi.nlm.nih.gov/pubmed/37097724 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45104 %T Real-time Assessment of the Bidirectional Relationship Between Affective States and Glucose: Protocol for a 14-Day Observational Study %A Rethorst,Chad D %A Githinji,Phrashiah %A Seguin-Fowler,Rebecca A %A MacMillan Uribe,Alexandra L %A Szeszulski,Jacob %A Liao,Yue %+ Institute for Advancing Health Through Agriculture, Texas A&M AgriLife Research, 17360 Coit Rd, Dallas, TX, 75252, United States, 1 972 952 9243, chad.rethorst@ag.tamu.edu %K affect %K glucose %K eating behavior %K glucose variability %K glucose excursion %K ecological momentary assessment %K continuous glucose monitoring %K continuous glucose monitor %D 2023 %7 22.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Glucose variability increases cardiometabolic disease risk. While many factors can influence glucose levels, postprandial glucose response is the primary driver of glucose variability. Furthermore, affect may directly and indirectly impact glucose variability through its effect on eating behavior. Continuous glucose monitors (CGMs) facilitate the real-time evaluation of blood glucose, and ecological momentary assessment (EMA) can be used to assess affect in real time. Together, data collected from these sources provide the opportunity to further understand the role of affect in glucose levels. Objective: This paper presents the protocol for a study that aims to (1) evaluate the feasibility and acceptability of using CGMs along with EMA in nondiabetic populations and (2) examine the bidirectional relationship between affect and glucose in nondiabetic adults with overweight or obesity using a CGM and EMA. Methods: Eligibility criteria for the study include participants (1) aged 18 to 65 years old, (2) with a BMI of ≥25 kg/m2, (3) who are able to read and write in English, and (4) who own a smartphone. Individuals will be excluded if they (1) have type 1 or 2 diabetes or have any other condition that requires glucose monitoring, (2) are pregnant, (3) use any medications that have the potential to alter blood glucose levels or interfere with the glucose sensing process, or (4) have a diagnosed gastrointestinal condition or eating disorder. In a 14-day observational study, participants will wear a FreeStyle Libre Pro CGM sensor (Abbott) and will receive mobile phone–based EMA prompts 6 times per day (randomly within six 2-hour windows between 8 AM and 8 PM) to assess positive and negative affect. Participants will also wear a Fitbit Inspire 2 (Fitbit) to continuously monitor physical activity and sleep, which will be included as covariates in the analysis. Multilevel linear regression models will be used to evaluate the acute relationship between glucose level and affect. Results: Recruitment started in October 2022 and is expected to be completed in March 2023. We will aim to recruit 100 participants. As of December 12, 2022, a total of 39 participants have been enrolled. Conclusions: The results of this study will further elucidate the role of affect in glucose variability. By identifying affective states that may lead to glucose excursions, our findings could inform just-in-time behavioral interventions by indicating opportunities for intervention delivery. International Registered Report Identifier (IRRID): DERR1-10.2196/45104 %M 36947140 %R 10.2196/45104 %U https://www.researchprotocols.org/2023/1/e45104 %U https://doi.org/10.2196/45104 %U http://www.ncbi.nlm.nih.gov/pubmed/36947140 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e40490 %T Effects of a Salutogenic Healthy Eating Program in Type 2 Diabetes (the SALUD Study): Protocol for a Randomized Controlled Trial %A Polhuis,Kristel C M M %A Vaandrager,Lenneke %A Koelen,Maria A %A Geleijnse,Johanna M %A Soedamah-Muthu,Sabita S %+ Health & Society, Wageningen University & Research, Hollandseweg 1, Wageningen, 6709KN, Netherlands, 31 317 487305, kristel.polhuis@wur.nl %K salutogenesis %K lifestyle %K nutritional intervention %K diabetes type 2 %K randomized controlled trial %K RCT %K patient centered %K empowerment %K resilience %D 2023 %7 21.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Healthy eating can improve the course of type 2 diabetes mellitus (T2DM) considerably. As changing eating behaviors in everyday is challenging, there is a need for a nutritional strategy with an eye for everyday life of people with T2DM. A theory centered around the everyday life context is salutogenesis. Salutogenic principles have been operationalized in a new nutritional program for T2DM on food literacy and well-being: the Salutogenic Intervention for Type 2 Diabetes (SALUD) program. Objective: This study aims to describe the protocol of the invention study that will examine the quantitative and qualitative effects of the SALUD program. Methods: A semiblinded randomized controlled trial will be performed in the Netherlands. A sample size of 56 (including a 30% dropout rate) people with T2DM has been calculated, of whom half (n=28, 50%) will follow the SALUD program (intervention) and half (n=28, 50%) will receive usual care (control). Recruitment strategies consist of advertisement via local health care professionals, posters, social media, and local newspapers. The SALUD program consists of 12 weekly web-based group sessions under the supervision of a certified lifestyle coach. Fidelity of the delivery is guaranteed by selecting a salutogenic coach, use of an intervention manual, training of the coach, weekly evaluation forms, and recording several sessions. The theoretical salutogenic principle of the intervention is mobilizing 2 important psychosocial resources required for organizing healthy eating in everyday life: self-identity and social support. Measurements will be performed at 3 times: at baseline (T0), after 12 weeks (postintervention; T1), and after 24 weeks (follow-up; T2). The primary outcome is food literacy, measured with the self-perceived food literacy scale questionnaire (expected effect size=0.9). Secondary outcomes are self-efficacy, quality of life, sense of coherence, diet quality, body weight, BMI, and waist-hip ratio. All outcomes will be tested with linear mixed models, following an intention-to-treat approach and standard principles of randomized controlled trials. In addition, a qualitative analysis will be performed. Results: The proposed study will provide useful information on the effects of a salutogenic program on healthy eating and well-being in people with T2DM in everyday life. Recruitment started on October 1, 2021. The intervention participants followed the SALUD program between January and August, 2022. The acquisition of the data was completed on August 1, 2022; publications are expected in 2023. Conclusions: This study will be one of the first salutogenic interventions for T2DM, which will provide valuable information on what salutogenic intervention entail. The SALUD program may serve as a concrete, web-based tool. The combination of quantitative and qualitative measures allows a comprehensive evaluation of effects. These insights can be used for further optimalization of T2DM interventions. Trial Registration: Netherlands Trial Registry, NL8963; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8963 International Registered Report Identifier (IRRID): DERR1-10.2196/40490 %M 36943335 %R 10.2196/40490 %U https://www.researchprotocols.org/2023/1/e40490 %U https://doi.org/10.2196/40490 %U http://www.ncbi.nlm.nih.gov/pubmed/36943335 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e42389 %T The Clinical Impact of Flash Glucose Monitoring—a Digital Health App and Smartwatch Technology in Patients With Type 2 Diabetes: Scoping Review %A Diez Alvarez,Sergio %A Fellas,Antoni %A Santos,Derek %A Sculley,Dean %A Wynne,Katie %A Acharya,Shamasunder %A Navathe,Pooshan %A Girones,Xavier %A Coda,Andrea %+ School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, University Drive Callaghan, Newcastle, 2258, Australia, 61 409916949, sergio.diezalvarez@uon.edu.au %K type 2 diabetes %K flash glucose monitoring %K digital health %K smartwatch %K scoping review %K app %K smartphone %K mobile phone %K mHealth %K digital %K application %K technology %K effective %K management %K glucose %K monitoring %K database %K wearable %K diabetes %K diabetic %K glucose monitoring %D 2023 %7 15.3.2023 %9 Review %J JMIR Diabetes %G English %X Background: Type 2 diabetes has a growing prevalence and confers significant cost burden to the health care system, raising the urgent need for cost-effective and easily accessible solutions. The management of type 2 diabetes requires significant commitment from the patient, caregivers, and the treating team to optimize clinical outcomes and prevent complications. Technology and its implications for the management of type 2 diabetes is a nascent area of research. The impact of some of the more recent technological innovations in this space, such as continuous glucose monitoring, flash glucose monitoring, web-based applications, as well as smartphone- and smart watch–based interactive apps has received limited attention in the research literature. Objective: This scoping review aims to explore the literature available on type 2 diabetes, flash glucose monitoring, and digital health technology to improve diabetic clinical outcomes and inform future research in this area. Methods: A scoping review was undertaken by searching Ovid MEDLINE and CINAHL databases. A second search using all identified keywords and index terms was performed on Ovid MEDLINE (January 1966 to July 2021), EMBASE (January 1980 to July 2021), Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library, latest issue), CINAHL (from 1982), IEEE Xplore, ACM Digital Libraries, and Web of Science databases. Results: There were very few studies that have explored the use of mobile health and flash glucose monitoring in type 2 diabetes. These studies have explored somewhat disparate and limited areas of research, and there is a distinct lack of methodological rigor in this area of research. The 3 studies that met the inclusion criteria have addressed aspects of the proposed research question. Conclusions: This scoping review has highlighted the lack of research in this area, raising the opportunity for further research in this area, focusing on the clinical impact and feasibility of the use of multiple technologies, including flash glucose monitoring in the management of patients with type 2 diabetes. %M 36920464 %R 10.2196/42389 %U https://diabetes.jmir.org/2023/1/e42389 %U https://doi.org/10.2196/42389 %U http://www.ncbi.nlm.nih.gov/pubmed/36920464 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44254 %T Implementing an Activity Tracker to Increase Motivation for Physical Activity in Patients With Diabetes in Primary Care: Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis %A Pelletier,Cynthia %A Chabot,Christian %A Gagnon,Marie-Pierre %A Rhéaume,Caroline %+ Department of Family Medicine and Emergency Medicine, Faculty of Medicine, Université Laval, Local 4617, 1050 avenue de la Médecine, Pavillon Ferdinand-Vandry, Québec, QC, G1V 0A6, Canada, 1 418 656 8711 ext 5172, caroline.rheaume@fmed.ulaval.ca %K activity tracker %K type 2 diabetes %K family medicine research %K SWOT analysis %K physical activity %K physical activity motivation %K diabetes %K implementation %K chronic disease %K intervention %K questionnaire %K tool %D 2023 %7 10.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Many projects related to technology implementation in the context of chronic diseases have been developed over the years to better manage lifestyle medicine interventions and improve patient care. However, technology implementation in primary care settings remains challenging. Objective: The aim is to carry out a strengths, weaknesses, opportunities, and threats (SWOT) analysis (1) to assess satisfaction among patients with type 2 diabetes using an activity tracker to increase motivation for physical activity (PA) and (2) to explore the research and health care team’s perceptions of this technology’s implementation in a primary care setting. Methods: A 3-month hybrid type 1 study, which included 2 stages, was conducted in an academic primary health center in Quebec City, Quebec, Canada. In stage 1, a total of 30 patients with type 2 diabetes were randomized to the intervention (activity tracker) group or the control group. In stage 2, a SWOT analysis was performed on both patients and health care professionals to determine the components of successful technology implementation. Two questionnaires were used to gather feedback: a satisfaction and acceptability questionnaire concerning an activity tracker (15 patients in the intervention group) and a questionnaire based on the SWOT elements (15 patients in the intervention group and 7 health care professionals). Both questionnaires contained quantitative and qualitative questions. Qualitative variables from open questions were synthesized in a matrix and ranked according to apparition frequency and global importance. A thematic analysis was performed by the first author and validated by 2 coauthors separately. The information gathered was triangulated to propose recommendations that were then approved by the team. Both quantitative (randomized controlled trial participants) and qualitative (randomized controlled trial participants and team) results were combined for recommendations. Results: In total, 86% (12/14) of the participants were satisfied with their activity tracker use and 75% (9/12) felt that it incited them to stick to their PA program. The main strengths of the team members’ perspectives were the project initiation and involvement of a patient partner, the study design, the team, and the device. The weaknesses were the budgetary constraints, the turnover, and the technical issues. The opportunities were the primary care setting, the loan of equipment, and common technology. The threats were recruitment issues, administrative challenges, technological difficulties, and a single research site. Conclusions: Patients with type 2 diabetes were satisfied with their activity tracker used to improve motivation for PA. Health care team members agreed that implementation can be done in primary care, but some challenges remain in using this technological tool in clinical practice regularly. Trial Registration: ClinicalTrials.gov NCT03709966; https://clinicaltrials.gov/ct2/show/NCT03709966 %M 36897642 %R 10.2196/44254 %U https://formative.jmir.org/2023/1/e44254 %U https://doi.org/10.2196/44254 %U http://www.ncbi.nlm.nih.gov/pubmed/36897642 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43535 %T Improvement of Selected Psychological Parameters and Quality of Life of Patients With Type 1 Diabetes Mellitus Undergoing Transition From Multiple Daily Injections and Self-Monitoring of Blood Glucose Directly to the MiniMed 780G Advanced Hybrid Closed-Loop System: Post hoc Analysis of a Randomized Control Study %A Cyranka,Katarzyna %A Matejko,Bartłomiej %A Juza,Anna %A Kieć-Wilk,Beata %A Krzyżowska,Sabina %A Cohen,Ohad %A Da Silva,Julien %A Lushchyk,Maxim %A Malecki,Maciej T %A Klupa,Tomasz %+ Department of Metabolic Diseases, Jagiellonian University Medical College, Jakubowskiego 2, Krakow, 30-688, Poland, 48 664680001, katarzyna.cyranka@gmail.com %K type 1 diabetes mellitus %K personal insulin pump %K advanced hybrid closed loop %K quality of life %D 2023 %7 24.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: While introducing new technologies and methods of treatment for type 1 diabetes mellitus (T1DM), it seems essential to monitor whether modern technologies in diabetes treatment may improve the psychological and emotional status of patients. Objective: This study aims to assess the baseline psychological parameters of patients with T1DM during investigation of the direct transition from multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG) to the MiniMed 780G advanced hybrid closed-loop (AHCL) system and to evaluate changes in the psychological well-being and quality of life (QoL) after the transition in these individuals versus the control group. Methods: The trial was a 2-center, randomized controlled, parallel group study. In total, 41 patients with T1DM managed with MDI or SMBG were enrolled and randomized either to the AHCL or the MDI+SMBG group. Of these, 37 (90%) participants (mean age 40.3 years, SD 8.0 years; mean duration of diabetes 17.3, SD 12.1 years; mean hemoglobin A1c [HbA1c] 7.2%, SD 1.0%) completed the study (AHCL: n=20, 54%; MDI+SMBG: n=17, 46%). Psychological parameters (level of stress, coping mechanisms, level of anxiety, self-efficacy level, acceptance of illness, locus of control of illness, life satisfaction, QoL) were measured at baseline and at the end of the study using 10 psychological questionnaires. Results: At baseline, the general level of stress of the examined patients was higher than in the general healthy Polish population (P=.001), but coping strategies used in stressful situations were significantly more effective and the level of self-efficacy (P<.001) was much higher than in the general population. The patients in this study accepted their illness more than patients with diabetes from the general Polish population (P<.001), but they felt that their health does not depend on them compared to the general population (P<.001). The overall life satisfaction was similar to that of the general population (P=.161). After 3 months from transition, the AHCL group reported an increase in 4 scales of the QoL—feeling well (P=.042), working (P=.012), eating as I would like (P=.011), and doing normal things (P=.034)—in comparison to the control group, where no significant change occurred. The level of both state anxiety and trait anxiety decreased in the AHCL group: State-Trait Anxiety Inventory (STAI) X1 scores (P=.009), STAI X1 stens (P=.013), and STAI X2 scores (P=.022). The AHCL group became more emotion oriented in stressful situations (Coping Inventory for Stressful Situations [CISS] E; P=.043) and significantly less self-blaming after 3 months of the study (P=.020). Conclusions: The results indicate that the patients who decided to take part in the transition study were characterized by higher levels of stress than the general healthy population but had better coping strategies and self-efficacy. Furthermore, transitioning from MDI+SMBG treatment to the AHCL in patients naive to technology may significantly improve psychological well-being and QoL within 3 months. The rapidity of these changes suggests that they may be related to the significant improvement in glycemic outcomes but also significantly less burdened diabetes self-management. Trial Registration: ClinicalTrials.gov NCT04616391; https://clinicaltrials.gov/ct2/show/NCT04616391 %M 36692945 %R 10.2196/43535 %U https://formative.jmir.org/2023/1/e43535 %U https://doi.org/10.2196/43535 %U http://www.ncbi.nlm.nih.gov/pubmed/36692945 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e39474 %T Perspectives on Promoting Physical Activity Using eHealth in Primary Care by Health Care Professionals and Individuals With Prediabetes and Type 2 Diabetes: Qualitative Study %A Woldamanuel,Yohannes %A Rossen,Jenny %A Andermo,Susanne %A Bergman,Patrik %A Åberg,Linda %A Hagströmer,Maria %A Johansson,Unn-Britt %+ Department of Health Promoting Science, Sophiahemmet University, Lindstedtsvägen 8, Stockholm, 11486, Sweden, 46 84062037, yohannes@shh.se %K eHealth %K focus groups %K health care professionals %K physical activity %K prediabetes %K primary care %K qualitative research %K self-management %K type 2 diabetes %D 2023 %7 20.1.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: The trend of an exponential increase in prediabetes and type 2 diabetes (T2D) is projected to continue rising worldwide. Physical activity could help prevent T2D and the progression and complications of the disease. Therefore, we need to create opportunities for individuals to acquire the necessary knowledge and skills to self-manage their chronic condition through physical activity. eHealth is a potential resource that could facilitate self-management and thus improve population health. However, there is limited research on users’ perception of eHealth in promoting physical activity in primary care settings. Objective: This study aims to explore the perspectives of health care professionals and individuals with prediabetes and T2D on eHealth to promote physical activity in primary care. Methods: A qualitative approach was applied using focus group discussions among individuals with prediabetes or T2D (14 participants in four groups) and health care professionals (10 participants in two groups). The discussions were audio-recorded and transcribed verbatim. Qualitative content analysis was used inductively to code the data. Results: Three main categories emerged: utility, adoption process, and accountability. The utility of eHealth was described as a motivational, entertaining, and stimulating tool. Registration of daily medical measurements and lifestyle parameters in a cohesive digital platform was recognized as a potential resource for strengthening self-management skills. The adoption process includes eHealth to increase the accessibility of care and personalize the support of physical activity. However, participants stated that digital technology might only suit some and could increase health care providers’ administrative burden. Accountability refers to the knowledge and skills to optimize eHealth and ensure data integrity and security. Conclusions: People with prediabetes and T2D and health care professionals positively viewed an integration of eHealth technology in primary care to promote physical activity. A cohesive platform using personal metrics, goal-setting, and social support to promote physical activity was suggested. This study identified eHealth illiteracy, inequality, privacy, confidentiality, and an increased workload on health care professionals as factors of concern when integrating eHealth into primary care. Continuous development of eHealth competence was reported as necessary to optimize the implementation of eHealth technology in primary care. %M 36662555 %R 10.2196/39474 %U https://diabetes.jmir.org/2023/1/e39474 %U https://doi.org/10.2196/39474 %U http://www.ncbi.nlm.nih.gov/pubmed/36662555 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e39724 %T Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study %A Vojtila,Lenka %A Sherifali,Diana %A Dragonetti,Rosa %A Ashfaq,Iqra %A Veldhuizen,Scott %A Naeem,Farooq %A Agarwal,Sri Mahavir %A Melamed,Osnat C %A Crawford,Allison %A Gerretsen,Philip %A Hahn,Margaret %A Hill,Sean %A Kidd,Sean %A Mulsant,Benoit %A Serhal,Eva %A Tackaberry-Giddens,Leah %A Whitmore,Carly %A Marttila,Jennifer %A Tang,Frank %A Ramdass,Seeta %A Lourido,Gloria %A Sockalingam,Sanjeev %A Selby,Peter %+ Nicotine Dependence Service, Addictions Program, Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6J 1H1, Canada, 1 416 535 8501 ext 36859, peter.selby@camh.ca %K collaborative care %K type 2 diabetes mellitus %K technology %K mental health %K diabetes %K diabetic %K feasibility %K coaching %K patient education %K satisfaction %K qualitative %K nursing %K nurse %K virtual care %K eHealth %K digital health %K health outcome %K substance use %D 2023 %7 17.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The COVID-19 pandemic disrupted the delivery of diabetes care and worsened mental health among many patients with type 2 diabetes (T2D). This disruption puts patients with T2D at risk for poor diabetes outcomes, especially those who experience social disadvantage due to socioeconomic class, rurality, or ethnicity. The appropriate use of communication technology could reduce these gaps in diabetes care created by the pandemic and also provide support for psychological distress. Objective: The purpose of this study is to test the feasibility of an innovative co-designed Technology-Enabled Collaborative Care (TECC) model for diabetes management and mental health support among adults with T2D. Methods: We will recruit 30 adults with T2D residing in Ontario, Canada, to participate in our sequential explanatory mixed methods study. They will participate in 8 weekly web-based health coaching sessions with a registered nurse, who is a certified diabetes educator, who will be supported by a digital care team (ie, a peer mentor, an addictions specialist, a dietitian, a psychiatrist, and a psychotherapist). Assessments will be completed at baseline, 4 weeks, and 8 weeks, with a 12-week follow-up. Our primary outcome is the feasibility and acceptability of the intervention, as evident by the participant recruitment and retention rates. Key secondary outcomes include assessment completion and delivery of the intervention. Exploratory outcomes consist of changes in mental health, substance use, and physical health behaviors. Stakeholder experience and satisfaction will be explored through a qualitative descriptive study using one-on-one interviews. Results: This paper describes the protocol of the study. The recruitment commenced in June 2021. This study was registered on October 29, 2020, on ClinicalTrials.gov (Registry ID: NCT04607915). As of June 2022, all participants have been recruited. It is anticipated that data analysis will be complete by the end of 2022, with study findings available by the end of 2023. Conclusions: The development of an innovative, technology-enabled model will provide necessary support for individuals living with T2D and mental health challenges. This TECC program will determine the feasibility of TECC for patients with T2D and mental health issues. Trial Registration: ClinicalTrials.gov NCT04607915; https://clinicaltrials.gov/ct2/show/NCT04607915 International Registered Report Identifier (IRRID): DERR1-10.2196/39724 %M 36649068 %R 10.2196/39724 %U https://www.researchprotocols.org/2023/1/e39724 %U https://doi.org/10.2196/39724 %U http://www.ncbi.nlm.nih.gov/pubmed/36649068 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 10 %N %P e40017 %T A Digital Lifestyle Coach (E-Supporter 1.0) to Support People With Type 2 Diabetes: Participatory Development Study %A Hietbrink,Eclaire A G %A Middelweerd,Anouk %A van Empelen,Pepijn %A Preuhs,Katharina %A Konijnendijk,Annemieke A J %A Oude Nijeweme-d’Hollosy,Wendy %A Schrijver,Laura K %A Laverman,Gozewijn D %A Vollenbroek-Hutten,Miriam M R %+ Department of Biomedical Signals and Systems, University of Twente, Drienerlolaan 5, Enschede, 7500 AE Enschede, Netherlands, 31 53 4892760, e.a.g.hietbrink@utwente.nl %K eHealth %K mHealth %K diet %K nutrition %K physical activity %K lifestyle change %K coaching %K dynamic tailoring %K behavior change %K blended care %K type 2 diabetes %K design %K treatment %K chronic disease %K behavioral %K theory %K intervention %K acceptability %K usability %K cost %D 2023 %7 12.1.2023 %9 Original Paper %J JMIR Hum Factors %G English %X Background: A healthy lifestyle, including regular physical activity and a healthy diet, is becoming increasingly important in the treatment of chronic diseases. eHealth interventions that incorporate behavior change techniques (BCTs) and dynamic tailoring strategies could effectively support a healthy lifestyle. E-Supporter 1.0 is an eCoach designed to support physical activity and a healthy diet in people with type 2 diabetes (T2D). Objective: This paper aimed to describe the systematic development of E-Supporter 1.0. Methods: Our systematic design process consisted of 3 phases. The definition phase included the selection of the target group and formulation of intervention objectives, and the identification of behavioral determinants based on which BCTs were selected to apply in the intervention. In the development phase, intervention content was developed by specifying tailoring variables, intervention options, and decision rules. In the last phase, E-Supporter 1.0 integrated in the Diameter app was evaluated using a usability test in 9 people with T2D to assess intervention usage and acceptability. Results: The main intervention objectives were to stimulate light to moderate-vigorous physical activities or adherence to the Dutch dietary guidelines in people with T2D. The selection of behavioral determinants was informed by the health action process approach and theories explaining behavior maintenance. BCTs were included to address relevant behavioral determinants (eg, action control, self-efficacy, and coping planning). Development of the intervention resulted in 3 types of intervention options, consisting of motivational messages, behavioral feedback, and tailor-made supportive exercises. On the basis of IF-THEN rules, intervention options could be tailored to, among others, type of behavioral goal and (barriers to) goal achievement. Data on these variables could be collected using app data, activity tracker data, and daily ecological momentary assessments. Usability testing revealed that user experiences were predominantly positive, despite some problems in the fixed delivery of content. Conclusions: The systematic development approach resulted in a theory-based and dynamically tailored eCoach. Future work should focus on expanding intervention content to other chronic diseases and lifestyle behaviors, enhancing the degree of tailoring and evaluating intervention effects on acceptability, use, and cost-effectiveness. %M 36633898 %R 10.2196/40017 %U https://humanfactors.jmir.org/2023/1/e40017 %U https://doi.org/10.2196/40017 %U http://www.ncbi.nlm.nih.gov/pubmed/36633898 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 8 %N %P e39750 %T Glycemic Variability and Fluctuations in Cognitive Status in Adults With Type 1 Diabetes (GluCog): Observational Study Using Ecological Momentary Assessment of Cognition %A Mascarenhas Fonseca,Luciana %A Strong,Roger W %A Singh,Shifali %A Bulger,Jane D %A Cleveland,Michael %A Grinspoon,Elizabeth %A Janess,Kamille %A Jung,Lanee %A Miller,Kellee %A Passell,Eliza %A Ressler,Kerry %A Sliwinski,Martin John %A Verdejo,Alandra %A Weinstock,Ruth S %A Germine,Laura %A Chaytor,Naomi S %+ Department of Community and Behavioral Health, Elson S Floyd College of Medicine, Washington State University, Office 453, 665 N Riverpoint Blvd, Spokane, WA, 99202, United States, 1 509 368 6948, luciana.fonseca@wsu.edu %K ecological momentary assessment %K type 1 diabetes %K cognitive variability %K digital neuropsychology %K digital technology %K remote assessment %K continuous glucose monitoring %K cognition %K diabetes %K physiological %K behavioral %K psychological %K cognitive %K adults %K glucose %K data %K study design %K assessment %K sample %K hypoglycemia %D 2023 %7 5.1.2023 %9 Original Paper %J JMIR Diabetes %G English %X Background: Individuals with type 1 diabetes represent a population with important vulnerabilities to dynamic physiological, behavioral, and psychological interactions, as well as cognitive processes. Ecological momentary assessment (EMA), a methodological approach used to study intraindividual variation over time, has only recently been used to deliver cognitive assessments in daily life, and many methodological questions remain. The Glycemic Variability and Fluctuations in Cognitive Status in Adults with Type 1 Diabetes (GluCog) study uses EMA to deliver cognitive and self-report measures while simultaneously collecting passive interstitial glucose in adults with type 1 diabetes. Objective: We aimed to report the results of an EMA optimization pilot and how these data were used to refine the study design of the GluCog study. An optimization pilot was designed to determine whether low-frequency EMA (3 EMAs per day) over more days or high-frequency EMA (6 EMAs per day) for fewer days would result in a better EMA completion rate and capture more hypoglycemia episodes. The secondary aim was to reduce the number of cognitive EMA tasks from 6 to 3. Methods: Baseline cognitive tasks and psychological questionnaires were completed by all the participants (N=20), followed by EMA delivery of brief cognitive and self-report measures for 15 days while wearing a blinded continuous glucose monitor. These data were coded for the presence of hypoglycemia (<70 mg/dL) within 60 minutes of each EMA. The participants were randomized into group A (n=10 for group A and B; starting with 3 EMAs per day for 10 days and then switching to 6 EMAs per day for an additional 5 days) or group B (N=10; starting with 6 EMAs per day for 5 days and then switching to 3 EMAs per day for an additional 10 days). Results: A paired samples 2-tailed t test found no significant difference in the completion rate between the 2 schedules (t17=1.16; P=.26; Cohen dz=0.27), with both schedules producing >80% EMA completion. However, more hypoglycemia episodes were captured during the schedule with the 3 EMAs per day than during the schedule with 6 EMAs per day. Conclusions: The results from this EMA optimization pilot guided key design decisions regarding the EMA frequency and study duration for the main GluCog study. The present report responds to the urgent need for systematic and detailed information on EMA study designs, particularly those using cognitive assessments coupled with physiological measures. Given the complexity of EMA studies, choosing the right instruments and assessment schedules is an important aspect of study design and subsequent data interpretation. %M 36602848 %R 10.2196/39750 %U https://diabetes.jmir.org/2023/1/e39750 %U https://doi.org/10.2196/39750 %U http://www.ncbi.nlm.nih.gov/pubmed/36602848 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e37429 %T Participants’ and Health Care Providers’ Insights Regarding a Web-Based and Mobile-Delivered Healthy Eating Program for Disadvantaged People With Type 2 Diabetes: Descriptive Qualitative Study %A Karimi,Nazgol %A Opie,Rachelle %A Crawford,David %A O’Connell,Stella %A Hamblin,Peter Shane %A Steele,Cheryl %A Ball,Kylie %+ Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Building J, SENS, 221 Burwood Highway, Burwood, Melbourne, VIC 3125, Australia, 61 392517310, karimin@deakin.edu.au %K type 2 diabetes %K healthy eating %K diet %K dietary intervention %K low socioeconomic position %K digitally delivered %K mobile health %K mHealth %K website %K mobile phone %K SMS text message %K qualitative descriptive %D 2023 %7 4.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Healthy eating is a key element of type 2 diabetes (T2D) self-management. Digital interventions offer new avenues to reach broad audiences to promote healthy eating behaviors. However, acceptance of these interventions by socioeconomically disadvantaged people (eg, those with lower levels of education and income or from ethnic minority groups) has not yet been fully evaluated. Objective: This study aimed to investigate the acceptability and usability of EatSmart, a 12-week web-based and mobile-delivered healthy eating behavior change support program, from the perspective of intervention participants living with T2D and health care providers (HCPs) involved in diabetes care. Methods: This study used a qualitative descriptive design. Overall, 60 disadvantaged adults with T2D, as determined by receipt of either a HealthCare Card or a pension or benefit as the main source of income, were recruited. Data from participants regarding their experiences with and perceptions of the program and longer-term maintenance of any behavior or attitudinal changes were collected through a web-based self-report survey with open-ended questions administered 12 weeks after baseline (54/60, 90%) and semistructured telephone interviews administered 36 weeks after baseline (16/60, 27%). Supplementary semistructured interviews with 6 HCPs involved in diabetes care (endocrinologists, accredited practicing dietitians, and diabetes nurse educators) were also conducted 36 weeks after baseline. These interviews aimed to understand HCPs’ views on successful and unsuccessful elements of EatSmart as a technology-delivered intervention; any concerns or barriers regarding the use of these types of interventions; and feedback from their interactions with patients on the intervention’s content, impact, or observed benefits. All data from the surveys and interviews were pooled and thematically analyzed. Results: In total, 5 key themes emerged from the data: program impact on food-related behaviors and routines, satisfaction with the program, reasons for low engagement and suggestions for future programs, benefits and challenges of digital interventions, and cultural considerations. Results showed that EatSmart was acceptable to participants and contributed positively to improving food-related behaviors. Most participants (27/43, 63%) mentioned that they enjoyed their experience with EatSmart and expressed high satisfaction with its content and delivery. The educational and motivational content was considered the most useful part of the program. Benefits discussed by intervention participants included gaining health knowledge and skills, positive changes in their food purchasing and cooking, and eating greater quantities and varieties of fruits and vegetables. HCPs also described the intervention as beneficial and persuasive for the target audience and had specific suggestions for future tailoring of such programs. Conclusions: The findings suggested that this digitally delivered intervention with supportive educational modules and SMS text messages was generally appealing for both participants and HCPs. This intervention medium shows promise and could feasibly be rolled out on a broader scale to augment usual diabetes care. International Registered Report Identifier (IRRID): RR2-10.2196/19488 %M 36598815 %R 10.2196/37429 %U https://formative.jmir.org/2023/1/e37429 %U https://doi.org/10.2196/37429 %U http://www.ncbi.nlm.nih.gov/pubmed/36598815 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e38479 %T Using Continuous Glucose Monitoring to Detect and Intervene on Dietary Restriction in Individuals With Binge Eating: The SenseSupport Withdrawal Design Study %A Juarascio,Adrienne S %A Srivastava,Paakhi %A Presseller,Emily K %A Lin,Mandy %A Patarinski,Anna G G %A Manasse,Stephanie M %A Forman,Evan M %+ Center for Weight, Eating, and Lifestyle Science, Drexel University, 3201 Chestnut St., Philadelphia, PA, 19104, United States, 1 215 553 7154, asj32@drexel.edu %K binge eating %K loss-of-control eating %K continuous glucose monitoring %K mobile phone %D 2022 %7 14.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Dietary restraint is a key factor for maintaining engagement in binge eating among individuals with binge eating disorder (BED) and bulimia nervosa (BN). Reducing dietary restraint is a mechanism of change in cognitive behavioral therapy (CBT) for individuals with BN and BED. However, many individuals who undergo CBT fail to adequately reduce dietary restraint during treatment, perhaps owing to difficulty in using treatment skills (eg, regular eating) to reduce dietary restraint during their daily lives. The SenseSupport system, a novel just-in-time, adaptive intervention (JITAI) system that uses continuous glucose monitoring to detect periods of dietary restraint, may improve CBT to reduce dietary restraint during treatment by providing real-time interventions. Objective: This study aimed to describe the feasibility, acceptability, and initial evaluation of SenseSupport. We presented feasibility, acceptability, target engagement, and initial treatment outcome data from a small trial using an ABAB (A=continuous glucose monitoring data sharing and JITAIs-Off, B=continuous glucose monitoring data sharing and JITAIs-On) design (in which JITAIs were turned on for 2 weeks and then turned off for 2 weeks throughout the treatment). Methods: Participants (N=30) were individuals with BED or BN engaging in ≥3 episodes of ≥5 hours without eating per week at baseline. Participants received 12 sessions of CBT and wore continuous glucose monitors to detect eating behaviors and inform the delivery of JITAIs. Participants completed 4 assessments and reported eating disorder behaviors, dietary restraint, and barriers to app use weekly throughout treatment. Results: Retention was high (25/30, 83% after treatment). However, the rates of continuous glucose monitoring data collection were low (67.4% of expected glucose data were collected), and therapists and participants reported frequent app-related issues. Participants reported that the SenseSupport system was comfortable, minimally disruptive, and easy to use. The only form of dietary restraint that decreased significantly more rapidly during JITAIs-On periods relative to JITAIs-Off periods was the desire for an empty stomach (t43=1.69; P=.049; Cohen d=0.25). There was also a trend toward greater decrease in overall restraint during JITAs-On periods compared with JITAIs-Off periods, but these results were not statistically significant (t43=1.60; P=.06; Cohen d=0.24). There was no significant difference in change in the frequency of binge eating during JITAIs-On periods compared with JITAIs-Off periods (P=.23). Participants demonstrated clinically significant, large decreases in binge eating (t24=10.36; P<.001; Cohen d=2.07), compensatory behaviors (t24=3.40; P=.001; Cohen d=0.68), and global eating pathology (t24=6.25; P<.001; Cohen d=1.25) from pre- to posttreatment. Conclusions: This study describes the successful development and implementation of the first intervention system combining passive continuous glucose monitors and JITAIs to augment CBT for binge-spectrum eating disorders. Despite the lower-than-anticipated collection of glucose data, the high acceptability and promising treatment outcomes suggest that the SenseSupport system warrants additional investigation via future, fully powered clinical trials. Trial Registration: ClinicalTrials.gov NCT04126694; https://clinicaltrials.gov/ct2/show/NCT04126694 %M 36515992 %R 10.2196/38479 %U https://formative.jmir.org/2022/12/e38479 %U https://doi.org/10.2196/38479 %U http://www.ncbi.nlm.nih.gov/pubmed/36515992 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 4 %P e37715 %T Implementation Plan for a High-Frequency, Low-Touch Care Model at Specialized Type 1 Diabetes Clinics: Model Development %A de Sequeira,Stephanie %A Presseau,Justin %A Booth,Gillian L %A Lipscombe,Lorraine L %A Perkins,Isabelle %A Perkins,Bruce A %A Shulman,Rayzel %A Lakhanpal,Gurpreet %A Ivers,Noah %+ Unity Health Toronto, 250 Yonge St. 6th floor, Toronto, ON, M5G 1B1, Canada, 1 416 864 6060 ext 77095, stephanie.desequeira@unityhealth.to %K type 1 diabetes %K virtual care %K high-frequency care %K implementation science %K diabetes %K support %K incentives %K clinics %K intervention %K behavior change %K education %K glycemic control %K self-management %D 2022 %7 8.12.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Individuals with type 1 diabetes (T1D) are more likely to achieve optimal glycemic management when they have frequent visits with their health care team. There is a potential benefit of frequent, telemedicine interventions as an effective strategy to lower hemoglobin A1c (HbA1c). Objective: The objective is this study was to understand the provider- and system-level factors affecting the successful implementation of a virtual care intervention in type 1 diabetes (T1D) clinics. Methods: Semistructured interviews were conducted with managers and certified diabetes educators (CDEs) at diabetes clinics across Southern Ontario before the COVID-19 pandemic. Deductive analysis was carried out using the Theoretical Domains Framework, followed by mapping to behavior change techniques to inform potential implementation strategies for high-frequency virtual care for T1D. Results: There was considerable intention to deliver high-frequency virtual care to patients with T1D. Participants believed that this model of care could lead to improved patient outcomes and engagement but would likely increase the workload of CDEs. Some felt there were insufficient resources at their site to enable them to participate in the program. Member checking conducted during the pandemic revealed that clinics and staff had already developed strategies to overcome resource barriers to the adoption of virtual care during the pandemic. Conclusions: Existing enablers for high-frequency virtual care for T1D can be leveraged, and barriers can be overcome with targeted clinical incentives and support. %M 36480257 %R 10.2196/37715 %U https://diabetes.jmir.org/2022/4/e37715 %U https://doi.org/10.2196/37715 %U http://www.ncbi.nlm.nih.gov/pubmed/36480257 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e40278 %T Changes in Glycemic Control Following Use of a Spanish-Language, Culturally Adapted Diabetes Program: Retrospective Study %A Edwards,Caitlyn %A Orellana,Elisa %A Rawlings,Kelly %A Rodriguez-Pla,Mirta %A Venkatesan,Aarathi %+ Vida Health, 100 Montgomery St, Ste 750, San Francisco, CA, 94104, United States, 1 415 989 1017, caitlyn.edwards@vida.com %K type 2 diabetes %K digital health %K diabetes intervention %K diabetes %K mobile health %K mhealth %K app-based %K health coaching %K HbA1c %K glycemic improvements %K localization %K Spanish %K health application %K health education %K patient education %K nutrition %K digital health intervention %K health management %D 2022 %7 7.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Several barriers to diabetes treatment and care exist, particularly in underserved medical communities. Objective: This study aimed to evaluate a novel, culturally adapted, Spanish-language mHealth diabetes program for glycemic control. Methods: Professional Spanish translators, linguists, and providers localized the entirety of the Vida Health Diabetes Management Program into a culturally relevant Spanish-language version. The Spanish-language Vida Health Diabetes Management Program was used by 182 (n=119 women) Spanish-speaking adults with diabetes. This app-based program provided access to culturally adapted educational content on diabetes self-management, one-on-one remote counseling and coaching sessions, and on-demand in-app messaging with bilingual (Spanish and English) certified health coaches, registered dietitian nutritionists, and certified diabetes care and education specialists. Hemoglobin A1c (HbA1c) was the primary outcome measure, and a 2-tailed, paired t test was used to evaluate changes in HbA1c before and after program use. To determine the relationship between program engagement and changes in glycemic control, a cluster-robust multiple regression analysis was employed. Results: We observed a significant decrease in HbA1c of –1.23 points between baseline (mean 9.65%, SD 1.56%) and follow-up (mean 8.42%, SD 1.44%; P<.001). Additionally, we observed a greater decrease in HbA1c among participants with high program engagement (high engagement: –1.59%, SD 1.97%; low engagement: –0.84%, SD 1.64%; P<.001). Conclusions: This work highlights improvements in glycemic control that were clinically as well as statistically significant among Spanish-preferring adults enrolled in the Vida Health Spanish Diabetes Management Program. Greater improvements in glycemic control were observed among participants with higher program engagement. These results provide needed support for the use of digital health interventions to promote meaningful improvements in glycemic control in a medically underserved community. %M 36476397 %R 10.2196/40278 %U https://formative.jmir.org/2022/12/e40278 %U https://doi.org/10.2196/40278 %U http://www.ncbi.nlm.nih.gov/pubmed/36476397 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 12 %P e43208 %T Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam %A Chan,Hiu Nam %A Lim,Hong Shen %A Chong,Pui Lin %A Yung,Chee Kwang %A Abd Mulok,Musjarena %A Wei,Yuan %A Yong,Alice Moi Ling %+ EVYD Research Pte Ltd, 55 Tras Street, #03-01, Singapore, 078994, Singapore, 65 92300660, candy.chan@evydtech.com %K DEsireD %K type 2 diabetes mellitus %K digital intervention %K mHealth %K health coaching %K chronic disease management %K EMR %K value-based care %D 2022 %7 7.12.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Digital interventions that incorporate the use of mobile phones and wearables have been getting popular. A combination of a digital intervention with support from professional management can enhance users’ self-efficacy better than a digital intervention alone and provide better accessibility to a lifestyle intervention. However, there are limited studies exploring the feasibility and efficacy of applying a digital intervention in Muslim-majority countries, and none have been conducted in Brunei Darussalam. Objective: The study aims to determine the effectiveness and feasibility of a proposed 16-week digital intervention program for T2DM self-management and to guide the rollout of a mobile app as part of a population health solution for adults with T2DM in Brunei. The primary outcome of this study is to measure the proportion of participants with a hemoglobin A1c (HbA1c) reduction of at least 0.6% from baseline, and the secondary outcomes include a change in HbA1c, BMI, lipid profile, and EQ-5D-5L score. Methods: This single-arm nonrandomized pilot study will recruit participants using web-based (with the national health care app [BruHealth] and official social media platforms being used for outreach) and offline (in-person recruitment at health centers) approaches. A target of 180 individuals with T2DM aged between 20 and 70 years that meet the inclusion criteria will be enrolled in a 16-week digital intervention program. Baseline and postintervention markers will be evaluated. Results: The study received approval from the Medical and Health Research & Ethics Committee of the Brunei Darussalam Ministry of Health (MHREC/MOH/2022/4(1)). The recruitment process is ongoing, and we anticipate that the study will conclude by April 2023. This will be followed by data analysis and the reporting of outcomes with the intention to publish. The results of this study will be disseminated through scientific publications and conferences. This study will serve as a guide to launch T2DM digital therapeutic programs and extend to other noncommunicable diseases (NCDs) if proven as an effective and feasible approach in Brunei. Conclusions: The Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD) study will be the first study to investigate the clinical effectiveness and feasibility of the proposed 16-week T2DM digital intervention program tailored for Brunei, a Muslim-majority country. The findings of this study can potentially scale up the proposed model of care to other NCDs as a national approach for health management solutions. Trial Registration: ClinicalTrials.gov NCT05364476; https://clinicaltrials.gov/ct2/show/NCT05364476 International Registered Report Identifier (IRRID): DERR1-10.2196/43208 %M 36477014 %R 10.2196/43208 %U https://www.researchprotocols.org/2022/12/e43208 %U https://doi.org/10.2196/43208 %U http://www.ncbi.nlm.nih.gov/pubmed/36477014 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 4 %P e38660 %T Modified e-Delphi Process for the Selection of Patient-Reported Outcome Measures for Children and Families With Type 1 Diabetes Using Continuous Glucose Monitors: Delphi Study %A Shah,Payal %A Raymond,Jennifer K %A Espinoza,Juan %+ Children's Hospital Los Angeles, 4650 Sunset Blvd, Los Angeles, CA, 90027, United States, 1 323 361 2721, jespinoza@chla.usc.edu %K type 1 diabetes %K diabetes %K diabetic %K juvenile %K pediatrics %K paediatrics %K child %K youth %K continuous glucose monitor %K glucose %K monitoring %K patient reported %K outcome measure %K PROM %K Delphi %K disease management %K self-management %K measurement %K instrument %D 2022 %7 30.11.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Type 1 diabetes (T1D) management is complex and associated with significant psychosocial burden. Continuous glucose monitors (CGM) can improve disease management and outcomes and introduce new or exacerbate existing psychosocial concerns. Patient-reported outcome measures (PROMs) can be used to capture this information, but there is no consensus on which PROMs should be used in pediatric CGM research. Objective: Here we describe the process to (1) identify PROMs that could be used to assess the impact of CGMs on pediatric patients with T1D, (2) implement a modified electronic Delphi (e-Delphi) methodology to arrive at an expert consensus on which PROMs are most suitable for clinical and research applications, and (3) establish a periodicity table for the administration of PROMs over time in a real-world evidence study. Methods: To identify appropriate PROMs for pediatric patients and families with T1D and CGMs, we conducted an asynchronous, e-Delphi process with a multidisciplinary group of experts from around the country. We identified candidate instruments through a literature review. The 3-round e-Delphi process was conducted via a study website, email, and web-based forms. Participants provided opinions on the usefulness of instruments, age validation, feasibility, time, and frequency of administration. Results: In total, 16 experts participated in the e-Delphi process; 4 of whom consistently participated in all 3 rounds. We identified 62 candidate instruments, which were narrowed down to 12 final PROMs across 5 domains: diabetes distress and burden (n=4), autonomy (n=2), quality of life (n=1), psychosocial (n=3), and technology acceptance (n=2). A quarterly administration schedule was developed to reduce burden on participants. Conclusions: PROMs can provide critical insights into the psychosocial well-being of patients. The specific measures identified in the paper are particularly well suited for pediatric patients with T1D using CGMs. Clinical implementation could help health care providers, patients, and families to engage in more comprehensive disease management. %M 36265838 %R 10.2196/38660 %U https://diabetes.jmir.org/2022/4/e38660 %U https://doi.org/10.2196/38660 %U http://www.ncbi.nlm.nih.gov/pubmed/36265838 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 4 %P e40366 %T The Use of Information and Communication Technology–Based Self-management System DialBeticsLite in Treating Abdominal Obesity in Japanese Office Workers: Prospective Single-Arm Pilot Intervention Study %A Kawai,Yuki %A Waki,Kayo %A Yamaguchi,Satoko %A Shibuta,Tomomi %A Miyake,Kana %A Kimura,Shigeko %A Toyooka,Tsuguyoshi %A Nakajima,Ryo %A Uneda,Kazushi %A Wakui,Hiromichi %A Tamura,Kouichi %A Nangaku,Masaomi %A Ohe,Kazuhiko %+ Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8654, Japan, 81 70857985897, kwaki-tky@m.u-tokyo.ac.jp %K abdominal obesity %K self-management %K telemedicine %K mobile phone %D 2022 %7 28.11.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Making lifestyle changes is an essential element of abdominal obesity (AO) reduction. To support lifestyle modification and self-management, we developed an information and communication technology–based self-management system—DialBeticsLite—with a fully automated dietary evaluation function for the treatment of AO. Objective: The objective of this study was to evaluate the preliminary efficacy and feasibility of DialBeticsLite among Japanese office workers with AO. Methods: A 2- to 3-month prospective single-arm pilot intervention study was designed to assess the effects of the intervention using DialBeticsLite. The information and communication technology system was composed of 4 modules: data transmission (body weight, blood pressure, blood glucose, and pedometer count); data evaluation; exercise input; and food recording and dietary evaluation. Eligible participants were workers who were aged ≥20 years and with AO (waist circumference ≥85 cm for men and ≥90 cm for women). Physical parameters, blood tests, nutritional intake, and self-care behavior were compared at baseline and after the intervention. Results: A total of 48 participants provided completed data for analysis, which yielded a study retention rate of 100%. The average age was 46.8 (SD 6.8) years, and 92% (44/48) of participants were male. The overall average measurement rate of DialBeticsLite, calculated by dividing the number of days with at least one measurement by the number of days of the intervention, was 98.6% (SD 3.4%). In total, 85% (41/48) of the participants reported that their participation in the study helped them to improve their lifestyle. BMI, waist circumference, and visceral fat area decreased significantly after the intervention (P<.001). In addition, the daily calorie intake reduced significantly (P=.02). There was a significant improvement in self-care behavior in terms of exercise and diet (P=.001). Conclusions: Using DialBeticsLite was shown to be a feasible and potentially effective method for reducing AO by providing users with a motivational framework to evaluate their lifestyle behaviors. %M 36441577 %R 10.2196/40366 %U https://diabetes.jmir.org/2022/4/e40366 %U https://doi.org/10.2196/40366 %U http://www.ncbi.nlm.nih.gov/pubmed/36441577 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 10 %P e39689 %T Barriers to and Facilitators of Using eHealth to Support Gestational Diabetes Mellitus Self-management: Systematic Literature Review of Perceptions of Health Care Professionals and Women With Gestational Diabetes Mellitus %A Safiee,Ladan %A Rough,Daniel John %A Whitford,Heather %+ School of Science and Engineering, University of Dundee, Queen Mother Building, Dundee, DD1 4HN, United Kingdom, 44 01382 383000, drough001@dundee.ac.uk %K gestational diabetes mellitus %K GDM %K gestational diabetes %K self-management %K eHealth %D 2022 %7 27.10.2022 %9 Review %J J Med Internet Res %G English %X Background: Gestational diabetes mellitus (GDM) is one of the most common medical complications during pregnancy. eHealth technologies are proving to be successful in supporting the self-management of medical conditions. Digital technologies have the potential to improve GDM self-management. Objective: The primary objective of this systematic literature review was to identify the views of health professionals (HPs) and women with GDM regarding the use of eHealth for GDM self-management. The secondary objective was to investigate the usability and user satisfaction levels when using these technologies. Methods: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) approach, the search included primary papers in English on the evaluation of technology to support self-management of GDM from January 2008 to September 2021 using MEDLINE, CINAHL, Embase, ACM, and IEEE databases. The lists of references from previous systematic literature reviews, which were related to technology and GDM, were also examined for primary studies. Papers with qualitative, quantitative, and mixed methodologies were included and evaluated. The selected papers were assessed for quality using the Cochrane Collaboration tool, National Institute for Health and Care Excellence clinical guidelines, Critical Appraisal Skills Programme Qualitative Checklist, and McGill University Mixed Methods Appraisal Tool. NVivo (QSR International) was used to extract qualitative data, which were subjected to thematic analysis. Narrative synthesis was used to analyze the quantitative data. Results: A total of 26 papers were included in the review. Of these, 19% (5/26) of studies used quantitative research methodologies, 19% (5/26) used qualitative methods, and 62% (16/26) used mixed methods. In all, 4 themes were identified from the qualitative data: the benefits of using technology, engagement with people via technology, the usability of technology, and discouragement factors for the use of technology. The thematic analysis revealed a vast scope of challenges and facilitators in the use of GDM self-management systems. The challenges included usability aspects of the system, technical problems, data privacy, lack of emotional support, the accuracy of reported data, and adoption of the system by HPs. Convenience, improved GDM self-management, peer support, increased motivation, increased independence, and consistent monitoring were facilitators to use these technologies. Quantitative data showed that there is potential for improving the usability of the GDM self-management systems. It also showed that convenience, usefulness, increasing motivation for GDM self-management, helping with GDM self-management, and being monitored by HPs were facilitators to use the GDM self-management systems. Conclusions: This novel systematic literature review shows that HPs and women with GDM encountered some challenges in using GDM self-management systems. The usability of GDM systems was the primary challenge derived from qualitative and quantitative results, with convenience, consistent monitoring, and optimization of GDM self-management emerging as important facilitators. %M 36301613 %R 10.2196/39689 %U https://www.jmir.org/2022/10/e39689 %U https://doi.org/10.2196/39689 %U http://www.ncbi.nlm.nih.gov/pubmed/36301613 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 4 %P e40326 %T Improved Glycemia and Quality of Life Among Loop Users: Analysis of Real-world Data From a Single Center %A Morrison,Amy E %A Chong,Kimberley %A Lai,Valerie %A Farnsworth,Kate %A Senior,Peter A %A Lam,Anna %+ Department of Endocrinology and Metabolism, Department of Medicine, University of Alberta, Walter C. Mackenzie Health Sciences Centre, 111st NW, Edmonton, AB, T6G 2R3, Canada, 1 780 492 6621, amymorrison15@doctors.org.uk %K type 1 diabetes %K closed loop %K automated insulin delivery %K do-it-yourself %D 2022 %7 24.10.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Despite do-it-yourself automated insulin delivery being an unapproved method of insulin delivery, an increasing number of people with type 1 diabetes (T1D) worldwide are choosing to use Loop, a do-it-yourself automated insulin delivery system. Objective: In this study, we aimed to assess glycemic outcomes, safety, and the perceived impact on quality of life (QOL) in a local Edmonton cohort of known Loop users. Methods: An observational study of adults with T1D who used Loop was performed. An assessment of glycemic and safety outcomes, HbA1c, time in range, hospital admissions, and time below range compared users most recent 6 months of Loop use, with their prior regulatory approved insulin delivery method. QOL outcomes were assessed using Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations, diabetes impact, and device satisfaction measures (with maximum scores of 100, 10, and 10, respectively) and semistructured interviews. Results: The 24 adults with T1D who took part in this study 16 (67%) were female, with a median age of 33 (IQR 28-45) years, median duration of diabetes of 22 (IQR 17-32) years, median pre-Loop HbA1c of 7.9% (IQR 7.6%-8.3%), and a median duration of Loop use of 18 (IQR 12-25) months. During Loop use, the participants had median (IQR) values of 7.1% (6.5%-7.5%), 54 mmol (48-58) for HbA1c and 76.5% (64.6%-81.9%) for time in range, which were a significant improvement from prior therapy (P=.001 and P=.005), with a nonsignificant reduction in time below range; 3.0 to 3.9 mmol/L (P=.17) and <3 mmol/L (P=.53). Overall, 2 episodes of diabetic ketoacidosis occurred in a total of 470 months of Loop use, and no severe hypoglycemia occurred. The positive impact of Loop use on QOL was explored in qualitative analysis and additionally demonstrated through a median Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations score of 86 (IQR 79-95), a median diabetes impact score of 2.8 (IQR 2.1-3.9), and a median device satisfaction score of 9 (IQR 8.2-9.4). Conclusions: This local cohort of people with T1D demonstrated a beneficial effect of Loop use on both glycemic control and QOL, with no safety concerns being highlighted. %M 36279156 %R 10.2196/40326 %U https://diabetes.jmir.org/2022/4/e40326 %U https://doi.org/10.2196/40326 %U http://www.ncbi.nlm.nih.gov/pubmed/36279156 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e39193 %T Medication Adherence and Cardiometabolic Control Indicators Among American Indian Adults Receiving Tribal Health Services: Protocol for a Longitudinal Electronic Health Records Study %A Scarton,Lisa %A Nelson,Tarah %A Yao,Yingwei %A Segal,Richard %A Donahoo,William T %A Goins,R Turner %A DeVaughan-Circles,Ashley %A Manson,Spero M %A Wilkie,Diana J %+ College of Nursing, University of Florida, 1225 Center Dr, Gainesville, FL, 32607, United States, 1 352 274 6417, lscarton@ufl.edu %K medication adherence %K American Indian %K type 2 diabetes %D 2022 %7 24.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: American Indian adults have the highest prevalence of type 2 diabetes (T2D) in any racial or ethnic group and experience high rates of comorbidities. Uncontrolled cardiometabolic risk factors—insulin resistance, resulting in impaired glucose tolerance, dyslipidemia, and hypertension—increase the risk of mortality. Mortality is significantly reduced by glucose- and lipid-lowering and antihypertensive medication adherence. Medication adherence is low among American Indian adults living in non–Indian Health Service health care settings. Virtually nothing is known about the nature and extent of medication adherence among reservation-dwelling American Indian adults who primarily receive their medications without cost from Indian Health Service or tribal facilities. Electronic health records (EHRs) offer a rich but underused data source regarding medication adherence and its potential to predict cardiometabolic control indicators (C-MCIs). With the support of the Choctaw Nation of Oklahoma (CNO), we address this oversight by using EHR data generated by this large, state-of-the-art tribal health care system to investigate C-MCIs. Objective: Our specific aims are to determine, using 2018 EHR data, the bivariate relationships between medication adherence and C-MCIs, demographics, and comorbidities and each C-MCI and demographics and comorbidities; develop machine learning models for predicting future C-MCIs from the previous year’s medication adherence, demographics, comorbidities, and common laboratory tests; and identify facilitators of and barriers to medication adherence within the context of social determinants of health (SDOH), EHR-derived medication adherence, and C-MCIs. Methods: Drawing on the tribe’s EHR (2018-2021) data for CNO patients with T2D, we will characterize the relationships among medication adherence (to glucose- and lipid-lowering and antihypertensive drugs) and C-MCIs (hemoglobin A1c ≤7%, low-density lipoprotein cholesterol <100 mg/dL, and systolic blood pressure <130 mm Hg); patient demographics (eg, age, sex, SDOH, and residence location); and comorbidities (eg, BMI ≥30, cardiovascular disease, and chronic kidney disease). We will also characterize the association of each C-MCI with demographics and comorbidities. Prescription and pharmacy refill data will be used to calculate the proportion of days covered with medications, a typical measure of medication adherence. Using machine learning techniques, we will develop prediction models for future (2019-2021) C-MCIs based on medication adherence, patient demographics, comorbidities, and common laboratory tests (eg, lipid panel) from the previous year. Finally, key informant interviews (N=90) will explore facilitators of and barriers to medication adherence within the context of local SDOH. Results: Funding was obtained in early 2022. The University of Florida and CNO approved the institutional review board protocols and executed the data use agreements. Data extraction is in process. We expect to obtain results from aims 1 and 2 in 2024. Conclusions: Our findings will yield insights into improving medication adherence and C-MCIs among American Indian adults, consistent with CNO’s State of the Nation’s Health Report 2017 goal of reducing T2D and its complications. International Registered Report Identifier (IRRID): PRR1-10.2196/39193 %M 36279173 %R 10.2196/39193 %U https://www.researchprotocols.org/2022/10/e39193 %U https://doi.org/10.2196/39193 %U http://www.ncbi.nlm.nih.gov/pubmed/36279173 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e40164 %T Social Determinants of Health and Diabetes-Related Distress in Patients With Insulin-Dependent Type 2 Diabetes: Cross-sectional, Mixed Methods Approach %A Levy,Natalie K %A Park,Agnes %A Solis,Daniela %A Hu,Lu %A Langford,Aisha T %A Wang,Binhuan %A Rogers,Erin S %+ Department of Medicine, New York University Grossman School of Medicine, 462 First Ave, New York, NY, 10016, United States, 1 212 263 8924, natalie.levy@nyulangone.org %K social determinants of health %K income %K socioeconomic %K cross sectional %K insulin %K diabetic %K HbA1c %K barrier %K diabetes-related distress %K type 2 diabetes %K ambulatory care %K healthcare %K health care %K distress %K epidemiology %K T2DM %K diabetes %D 2022 %7 12.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Social determinants of health (SDOH) refer to the social, economic, and psychosocial conditions that influence health. Lower levels of SDOH factors including income, education, and employment are associated with a higher prevalence of diabetes, poorer glycemic control, and increased diabetes-related mortality. Few studies have conducted a comprehensive evaluation of multiple SDOH factors in a population with type 2 diabetes mellitus (T2DM). Objective: This study aimed to identify the range of SDOH challenges—including diabetes-related distress—that impact patients with insulin-dependent diabetes at an urban safety-net clinic using the 5-domain SDOH framework developed by the Healthy People 2020 initiative. Methods: The pilot study used a cross-sectional, mixed methods approach. Participants were recruited from 3 programs within a general internal medicine clinic that provides ambulatory care for patients with uncontrolled T2DM. We administered an investigator-developed SDOH survey based on the Healthy People 2020 framework and the validated Diabetes Distress Scale (DDS), which assesses 4 domains of diabetes-related distress. One-on-one interviews were conducted to gain in-depth information about challenges. Results: In total, 57 participants had an average hemoglobin A1c level of 11.0% (SD 2.6%). Overall, 92% (52/57) of participants had a barrier in at least one SDOH domain. SDOH challenges were most commonly reported in the domain of Health and Health Care (84%, 48/57), followed by Economic Stability (54%, n=31), Neighborhood and Built Environment (53%, n=30), Education and Health Literacy (47%, n=27), and Social and Community context (37%, n=21). The mean overall DDS score was 2.09 (SD 0.84), where scores of ≥2 indicate distress. Further, 79% (45/57) of participants had at least moderate diabetes-related distress in one of the 4 DDS domains. General themes that emerged from participant interviews included job interference with healthy behaviors, concerns about burdening others, challenges communicating with providers, and difficulty getting appointments in a timely manner. Conclusions: We found high levels of SDOH barriers across all 5 domains of the Center for Disease Control and Prevention’s Healthy People 2020 framework, including significant levels of diabetes-related distress. Future programs to address SDOH barriers in patients with uncontrolled insulin-dependent diabetes should consider screening for and focusing on a wide range of challenges. %M 36222807 %R 10.2196/40164 %U https://formative.jmir.org/2022/10/e40164 %U https://doi.org/10.2196/40164 %U http://www.ncbi.nlm.nih.gov/pubmed/36222807 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 9 %P e30602 %T The Effects of a Lifestyle Intervention Supported by the InterWalk Smartphone App on Increasing Physical Activity Among Persons With Type 2 Diabetes: Parallel-Group, Randomized Trial %A Thorsen,Ida Kær %A Yang,Yanxiang %A Valentiner,Laura Staun %A Glümer,Charlotte %A Karstoft,Kristian %A Brønd,Jan Christian %A Nielsen,Rasmus Oestergaard %A Brøns,Charlotte %A Christensen,Robin %A Nielsen,Jens Steen %A Vaag,Allan Arthur %A Pedersen,Bente Klarlund %A Langberg,Henning %A Ried-Larsen,Mathias %+ Center of Inflammation and Metabolism and Centre for Physical Activity Research, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen, 2100, Denmark, 45 28700785, ida.kaer.thorsen@regionh.dk %K type 2 diabetes mellitus %K exercise %K telemedicine %K primary health care %K accelerometry %K quality of life %K waist circumference %K mHealth %K mobile app %D 2022 %7 28.9.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Effective and sustainable implementation of physical activity (PA) in type 2 diabetes (T2D) health care has in general not been successful. Efficacious and contemporary approaches to support PA adherence and adoption are required. Objective: The primary objective of this study was to investigate the effectiveness of including an app-based (InterWalk) approach in municipality-based rehabilitation to increase moderate-and-vigorous PA (MVPA) across 52 weeks compared with standard care among individuals with T2D. Methods: The study was designed as a parallel-group, randomized trial with 52 weeks’ intervention and subsequent follow-up for effectiveness (52 weeks from baseline). Participants were recruited between January 2015 and December 2016 and randomly allocated (2:1) into 12 weeks of (1) standard care + InterWalk app–based interval walking training (IWT; IWT group; n=140), or (2) standard care + the standard exercise program (StC group; n=74). Following 12 weeks, the IWT group was encouraged to maintain InterWalk app–based IWT (3 times per week for 30-60 minutes) and the StC group was encouraged to maintain exercise without structured support. Moreover, half of the IWT group (IWTsupport group, n=54) received additional motivational support following the 12-week program until 52-week follow-up. The primary outcome was change in objectively measured MVPA time (minutes/day) from baseline to 52-week follow-up. Key secondary outcomes included changes in self-rated physical and mental health–related quality of life (HRQoL), physical fitness, weight, and waist circumference. Results: Participants had a mean age of 59.6 (SD 10.6) years and 128/214 (59.8%) were men. No changes in MVPA time were observed from baseline to 52-week follow-up in the StC and IWT groups (least squares means [95% CI] 0.6 [–4.6 to 5.8] and –0.2 [–3.8 to 3.3], respectively) and no differences were observed between the groups (mean difference [95% CI] –0.8 [–8.1 to 6.4] minutes/day; P=.82). Physical HRQoL increased by a mean of 4.3 (95% CI 1.8 to 6.9) 12-item Short-Form Health Survey (SF-12) points more in the IWT group compared with the StC group (Benjamini-Hochberg adjusted P=.007) and waist circumference apparently decreased a mean of –2.3 (95% CI –4.1 to –0.4) cm more in the IWT group compared with the StC group but with a Benjamini-Hochberg adjusted P=.06. No between-group differences were observed among the remaining key secondary outcomes. Conclusions: Among individuals with T2D referred to municipality-based lifestyle programs, randomization to InterWalk app–based IWT did not increase objectively measured MVPA time over 52 weeks compared with standard health care, although apparent benefits were observed for physical HRQoL. Trial Registration: ClinicalTrials.gov NCT02341690; https://clinicaltrials.gov/ct2/show/NCT02341690 %M 36170002 %R 10.2196/30602 %U https://mhealth.jmir.org/2022/9/e30602 %U https://doi.org/10.2196/30602 %U http://www.ncbi.nlm.nih.gov/pubmed/36170002 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 9 %P e39800 %T A Web-Delivered, Clinician-Led Group Exercise Intervention for Older Adults With Type 2 Diabetes: Single-Arm Pre-Post Intervention %A Kirwan,Morwenna %A Chiu,Christine L %A Laing,Thomas %A Chowdhury,Noureen %A Gwynne,Kylie %+ Faculty of Medicine, Health and Human Sciences, Macquarie University, 75 Talavera Road, Macquarie Park, Australia, 61 0428999072, morwenna.kirwan@mq.edu.au %K exercise %K fitness %K diabetic %K physical activity %K diabetes %K functional fitness %K community-based %K older adult %K videoconference %K online %K web-based %K elder %K geriatric %K gerontology %K balance %K movement %K internet-based %K eHealth %K digital health %K weight %K patient education %K translational %D 2022 %7 23.9.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: The COVID-19 pandemic created unprecedented shifts in the way health programs and services are delivered. A national lockdown to prevent the spread of COVID-19 in Australia was introduced in March 2020. This lockdown included the closure of exercise clinics, fitness centers, and other community spaces, which, before the pandemic, were used to deliver Beat It. Beat It is an 8-week in-person, community-based, and clinician-led group exercise and education program for adults self-managing diabetes. To continue offering Beat It, it was adapted from an in-person program to a fully web-based supervised group exercise program for adults with type 2 diabetes (T2DM). Objective: This study aims to assess whether the Beat It Online program produced comparable health outcomes to the Beat It in-person program in terms of improving physical fitness (muscular strength and power, aerobic endurance, balance, and flexibility) and waist circumference in older adults with T2DM. Methods: Australians with T2DM who were aged ≥60 years were included. They were enrolled in Beat It Online, a twice-weekly supervised group exercise and education program conducted via videoconference over 8 weeks. Anthropometric measurements and physical fitness parameters were assessed at baseline and completion. The adaptations to Beat It are reported using the Model for Adaptation, Design, and Impact, including the type of changes (what, where, when, and for whom), the criteria for making those changes (why and how), and the intended and unintended outcomes. The intended outcomes were comparable functional fitness as well as physical and mental health improvements across demographics and socioeconomic status. Results: A total of 171 adults (mean 71, SD 5.6 years; n=54, 31.6% male) with T2DM were included in the study, with 40.4% (n=69) residing in lower socioeconomic areas. On the completion of the 8-week program, significant improvements in waist circumference, aerobic capacity, muscular strength, flexibility, and balance were observed in both male and female participants (all P<.001). The Model for Adaptation, Design, and Impact reports on 9 clinical, practical, and technical aspects of Beat It that were adapted for web-based delivery. Conclusions: This study found that Beat It Online was just as effective as the in-person program. This adapted program produced comparable health benefits across demographics and socioeconomic status. This study offers important findings for practitioners and policy makers seeking to maintain independence of older people with T2DM, reversing frailty and maximizing functional and physical fitness, while improving overall quality of life. Beat It Online offers a flexible and inclusive solution with significant physical and mental health benefits to individuals. Further evaluation of Beat It (both in-person and Online) adapted for culturally and linguistically diverse communities will provide greater insights into the efficacy of this promising program. %M 36149745 %R 10.2196/39800 %U https://www.jmir.org/2022/9/e39800 %U https://doi.org/10.2196/39800 %U http://www.ncbi.nlm.nih.gov/pubmed/36149745 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e40739 %T Agreement Between Clinically Measured Weight and Self-reported Weight Among Patients With Type 2 Diabetes Through an mHealth Lifestyle Coaching Program in Denmark: Secondary Analysis of a Randomized Controlled Trial %A Imeraj,Albi %A Olesen,Thomas Bastholm %A Laursen,Ditte Hjorth %A Søndergaard,Jens %A Brandt,Carl Joakim %+ Research Unit for General Practice, Department of Public Health, University of Southern Denmark, J B Winsløws Vej 9A, Odense, 5000, Denmark, 45 31390187, aimeraj@health.sdu.dk %K telemedicine %K digital behavioral coaching %K lifestyle change %K mobile intervention %K obesity %K diabetes %K patient engagement %K validation %K self-report %K body weight %D 2022 %7 14.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital health interventions are increasingly used to handle and promote positive health behaviors. Clinical measures are often used, and a certain precision is essential for digital health interventions to have an effect. Only few studies have compared clinically measured weights with self-reported weights. No study has examined the validity of self-reported weight from a mobile app used in a tailored weight loss intervention. Objective: The aim of this study was to analyze the agreement between clinically measured weight and self-reported weight collected from a mobile health lifestyle coaching program during a 12-month weight loss intervention for obese patients with and without type 2 diabetes. The secondary aim was to investigate the determinants for possible discrepancies between clinically measured and self-reported weights of these patients with different demographic and lifestyle characteristics and achievements of weight loss goals. Methods: Weight registrations were collected from participants (N=104) in a Danish randomized controlled trial examining the effect of a digital lifestyle intervention on weight loss among obese patients with and without type 2 diabetes. Data were collected at baseline and after 6 and 12 months. Self-reported weight was measured at home and registered in the app. Results: Self-reported body weight was lower than the weight measured in the clinic after 6 months by 1.03 kg (95% CI 1.01-1.05; P<.001) and after 12 months also by 1.03 kg (95% CI 0.99-1.04; P<.001). After 6 months, baseline weight and BMI were associated with a discrepancy of 0.03 kg (95% CI 0.01-0.04; P=.01) and 0.09 kg (95% CI 0.02-0.17; P=.02) per increment of 1 kg and 1 kg/m2, respectively, between clinically measured weight and self-reported weight. Weight change during the first 6 months was also associated with a difference of 0.1 kg (95% CI 0.04-0.01; P<.001) per kilogram of difference in weight between clinically measured weight and self-reported weight. Participants who did not achieve the 5% weight loss goal underestimated their weight by 0.79 kg (95% CI 0.34-1.23) at 6 months. After 12 months, only baseline weight was associated with a discrepancy of 0.03 kg (95% CI 0.01-0.05; P=.02) per increment of kilogram between clinically measured weight and self-reported weight. None of the other factors showed any significant discrepancy after 12 months. Conclusions: Self-reported weight obtained from mobile health is a valid method for collecting anthropometric measurements. Trial Registration: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915 %M 36047606 %R 10.2196/40739 %U https://formative.jmir.org/2022/9/e40739 %U https://doi.org/10.2196/40739 %U http://www.ncbi.nlm.nih.gov/pubmed/36047606 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 11 %N 2 %P e34433 %T The Physical Activity Assessment of Adults With Type 2 Diabetes Using Accelerometer-Based Cut Points: Scoping Review %A Moldovan,Ioana A %A Bragg,Alexa %A Nidhiry,Anna S %A De La Cruz,Barbara A %A Mitchell,Suzanne E %+ Department of Family Medicine and Community Health, University of Massachusetts Chan Medical School, 55 Lake Avenue, Worcester, MA, 01655, United States, 1 9789856033, Suzanne.Mitchell2@umassmed.edu %K accelerometer %K cut points %K type 2 diabetes %K physical activity %D 2022 %7 6.9.2022 %9 Original Paper %J Interact J Med Res %G English %X Background: Incorporating physical activity into lifestyle routines is recommended for individuals with type 2 diabetes. Accelerometers offer a promising method for objectively measuring physical activity and for assessing interventions. However, the existing literature for accelerometer-measured physical activity among middle-aged and older adults with type 2 diabetes is lacking. Objective: This study aims to identify research studies in which accelerometer-based cut points were used to classify the physical activity intensity of middle-aged to older adults with type 2 diabetes as sedentary, light, moderate, vigorous, and very vigorous, and to determine if validated accelerometer cut points specifically for this population exist. Methods: We followed the Joanna Briggs Institute methodology for scoping reviews. Between June 23 and July 12, 2020, two reviewers independently screened records from four databases (PubMed, Web of Science, Embase, Engineering Village) and the ActiGraph Corp web site for eligible studies that included patients with type 2 diabetes with a sample mean age ≥50 years, used research-grade accelerometers, applied cut points to categorize objectively measured physical activity, and were available in English. We excluded studies reporting exclusively steps or step counts measured by accelerometers or pedometers and conference abstracts or other sources that did not have a full text available. Data extraction was completed using Microsoft Excel. Data for the following variables were tabulated based on frequency distributions: study design, accelerometer type, device placement, epoch length, total wear time, and cut points used. Study aims and participant demographic data were summarized. Results: A total of 748 records were screened at the abstract level, and 88 full-text articles were assessed for eligibility. Ultimately, 46 articles were retained and analyzed. Participants’ mean ages ranged from 50 to 79.9 years. The ActiGraph accelerometer and the Freedson et al and Troiano et al counts-per-minute cut points were the most frequently used across the literature. Freedson et al and Troiano et al counts-per-minute cut points for light, moderate, and vigorous activity correspond to <1952, 1952-5724, and ≥5725, and 100-2019, 2020-5998, and ≥5999, respectively. The Lopes et al cut points were developed by calibrating the ActiGraph in middle-aged and older adults with overweight/obesity and type 2 diabetes. These counts-per-minute thresholds are ≥200 (light), ≥1240 (moderate), and ≥2400 (vigorous), and were applied in 1 interventional study. Conclusions: An assortment of accelerometer cut points have been used by researchers to categorize physical activity intensity for middle-aged and older adults with diabetes. Only one set of cut points was validated and calibrated in our population of interest. Additional research is warranted to address the need for diabetes-specific cut points to inform public health recommendations. This includes confirmation that the Lopes et al cut points reflect clinically meaningful changes in physical activity for adults with diabetes who have comorbidities other than overweight/obesity and the development of relative intensity cut points that may be more suitable for those with suboptimal physical functioning. %M 36066937 %R 10.2196/34433 %U https://www.i-jmr.org/2022/2/e34433 %U https://doi.org/10.2196/34433 %U http://www.ncbi.nlm.nih.gov/pubmed/36066937 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e37528 %T Exploring the Experiences and Needs of Patients With Type 2 Diabetes Mellitus in Sleman Regency, Yogyakarta, Indonesia: Protocol for a Qualitative Study %A Linawati,Yunita %A Kristin,Erna %A Prabandari,Yayi Suryo %A Kristina,Susi Ari %+ Department of Health Behavior, Environment Health & Social Medicine, Faculty of Medicine, Public Health and Nursing, Gadjah Mada University, Jl. Farmako, Sekip Utara, Yogyakarta, 55281, Indonesia, 62 0274 545458, yayisuryo@ugm.ac.id %K type 2 diabetes mellitus %K social cognitive theory %K personal factors %K environment %K behavior %K knowledge %K attitude %K adherence %K HbA1c %K hemoglobin A1c %D 2022 %7 6.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 2 diabetes mellitus (T2DM) is a chronic disease that can cause adverse effects if not managed effectively. The prevalence of T2DM will continue to rise every year, and data from the International Diabetes Federation show that the number of patients diagnosed with T2DM in Indonesia is predicted to increase from 10.3 million in 2017 to 16.7 million in 2045. Managing T2DM properly is a challenge for the patients because they need to implement lifestyle changes that involve the self-monitoring of blood glucose, consuming prescribed medication properly, maintaining a healthy diet, getting sufficient physical training, keeping a healthy sleeping pattern, managing stress properly, and consulting medical professionals regularly. The worldwide intervention for T2DM focuses on self-management education. The varied results in studies about interventions show that no particular intervention method can be regarded as the most effective. In Indonesia, there are limited studies on educational interventions to improve the quality of life and health of patients with T2DM. Objective: This study aims to explore the experiences and needs of patients with T2DM in Sleman Regency, Yogyakarta, Indonesia, to develop effective self-management education. Methods: The study will use the phenomenology method with purposive sampling to collect data. The inclusion criteria are patients in the Chronic Disease Self-Management Program at the Sleman Regency Public Health Center who are aged ≥18 years, diagnosed with T2DM for more than a year, with hemoglobin A1c levels ≤7.5% and >7.5%, capable of communicating verbally and literate in the Indonesian language, not deaf, and willing to participate. The data collection is based on the Social Cognitive Theory, which involves selecting assessment targets and analyzing personal factors, environment, and behavior that determine the knowledge, attitude, and adherence of persons with T2DM. Researchers will collect the data through in-depth, face-to-face interviews to learn about knowledge, self-efficacy, outcome expectancy, outcome experience, worry, illness belief, treatment belief, diet, physical activity, medicine intake, treatment pattern, support system, as well as ethnic and cultural influences. The results will be taken from unstructured and open-ended questions written in Indonesian according to the interview guidelines. The data analysis process will go through several stages: reading the data thoroughly; coding; sorting the categories; creating the themes; making general descriptions; and presenting the data in charts, narratives, and recorded quotations from the interviews. Results: This study received a grant in May 2021 and gained permission from the Medical and Health Research Ethics Committee of Universitas Gadjah Mada, Indonesia, on July 1, 2021. Data collection started on August 12, 2021, and the results are expected to be published in 2022. Conclusions: The results of this study will be used to design an educational intervention model to improve the knowledge, attitude, and adherence of patients with T2DM. International Registered Report Identifier (IRRID): DERR1-10.2196/37528 %M 36066966 %R 10.2196/37528 %U https://www.researchprotocols.org/2022/9/e37528 %U https://doi.org/10.2196/37528 %U http://www.ncbi.nlm.nih.gov/pubmed/36066966 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e35079 %T Utility and Acceptability of a Brief Type 2 Diabetes Visual Animation: Mixed Methods Feasibility Study %A Alyami,Mohsen %A Serlachius,Anna %A Law,Mikaela %A Murphy,Rinki %A Almigbal,Turky H %A Lyndon,Mataroria %A Batais,Mohammed A %A Algaw,Rawabi K %A Broadbent,Elizabeth %+ Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92109, Auckland, 1142, New Zealand, 64 9 923 0003, e.broadbent@auckland.ac.nz %K illness perception %K visualization %K animation %K intervention %K mobile phone %K type 2 diabetes mellitus %D 2022 %7 9.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Visualizations of illness and treatment processes are promising interventions for changing unhelpful perceptions and improving health outcomes. However, these are yet to be tested in patients with type 2 diabetes mellitus (T2DM). Objective: This study assesses the cross-cultural acceptability and potential effectiveness of a brief visual animation of T2DM at changing unhelpful illness and treatment perceptions and self-efficacy among patients and family members in 2 countries, New Zealand and Saudi Arabia. Health care professionals’ views on visualization are also explored. Methods: A total of 52 participants (n=39, 75% patients and family members and n=13, 25% health care professionals) were shown a 7-minute T2DM visual animation. Patients and family members completed a questionnaire on illness and treatment perceptions and self-efficacy before and immediately after the intervention and completed semistructured interviews. Health care professionals completed written open-ended questions. Means and 95% CIs are reported to estimate potential effectiveness. Inductive thematic analysis was conducted on qualitative data. Results: All participants rated the visual animation as acceptable and engaging. Four main themes were identified: animation-related factors, impact of the animation, animation as an effective format for delivering information, and management-related factors. Effect sizes (ranged from 0.10 to 0.56) suggested potential effectiveness for changing illness and treatment perceptions and self-efficacy among patients and family members. Conclusions: Visualizations are acceptable and may improve the perceptions of patients’ with diabetes in a short time frame. This brief visual animation has the potential to improve current T2DM education. A subsequent randomized controlled trial to investigate the effects on illness and treatment perceptions, adherence, glycemic control, and unplanned hospital admission is being prepared. %M 35943787 %R 10.2196/35079 %U https://formative.jmir.org/2022/8/e35079 %U https://doi.org/10.2196/35079 %U http://www.ncbi.nlm.nih.gov/pubmed/35943787 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e32950 %T Online Guided Self-help Cognitive Behavioral Therapy With Exposure to Anxiety and Problem Solving in Type 1 Diabetes Mellitus: Case Study %A Kern,Dorian %A Ljótsson,Brjánn %A Bonnert,Marianne %A Lindefors,Nils %A Kraepelien,Martin %+ Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Healthcare Services, Norra Stationsgatan 69, Stockholm, 11364, Sweden, 46 723243235, dorian.kern@ki.se %K fear of hypoglycemia %K problem solving %K cognitive behavioral therapy %K psychology %K self-help %K diabetes %K type 1 diabetes mellitus %K high blood glucose %D 2022 %7 13.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Type 1 diabetes mellitus (T1DM) is dependent on self-care to avoid short- and long-term complications. There are several problem areas in diabetes that could be addressed by psychological interventions, such as suboptimal problem-solving strategies and fear of hypoglycemia. There is empirical support for a few psychological interventions, most often cognitive behavioral therapy, with various treatment aims. However, these interventions are largely unavailable in regular diabetes health care. Online guided self-help cognitive behavioral therapy could help achieve greater outreach. Objective: We tested a manualized treatment in the early stage for further development, with the long-term aim to increase access to care. The purpose of this report was to show the potential of this newly developed online intervention by describing 2 illustrative cases. Methods: An online guided self-help cognitive behavioral therapy protocol featuring problem solving and exposure was developed. The treatment was administered from a secure online platform and lasted for 8 weeks. Case 1 was a male participant. He had a number of diabetes-related complications and was worried about his future. He reported that he had a general idea that he needed to change his lifestyle but found it difficult to get started. Case 2 was a female participant. She had fear of hypoglycemia and unhelpful avoidance behaviors. She kept her blood glucose levels unhealthily high in order to prevent hypoglycemic episodes. Furthermore, she avoided contact with diabetes health care. Results: The 2 participants showed clinically significant improvements in their most relevant problem areas. In case 1, the participant’s blood glucose levels reduced, and he was able to establish healthy routines, such as increase physical exercise and decrease overeating. In case 2, the participant’s fear of hypoglycemia greatly decreased, and she was able to confront many of her avoided situations and increase necessary visits to her diabetes clinic. Treatment satisfaction was high, and no adverse events were reported. Conclusions: It is possible to deliver a cognitive behavioral therapy intervention aimed at problem areas in diabetes online. Problem solving appears to help with problems in everyday routines and lifestyle choices. Exposure to aversive stimuli appears to be a plausible intervention specifically aimed at the fear of hypoglycemia. Larger and controlled studies are needed. %M 35830220 %R 10.2196/32950 %U https://formative.jmir.org/2022/7/e32950 %U https://doi.org/10.2196/32950 %U http://www.ncbi.nlm.nih.gov/pubmed/35830220 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 2 %P e37534 %T Community Health Worker-Led mHealth-Enabled Diabetes Self-management Education and Support Intervention in Rural Latino Adults: Single-Arm Feasibility Trial %A Li,Shiyu %A Yin,Zenong %A Lesser,Janna %A Li,Chengdong %A Choi,Byeong Yeob %A Parra-Medina,Deborah %A Flores,Belinda %A Dennis,Brittany %A Wang,Jing %+ College of Nursing, Florida State University, 98 Varsity Way, Suite 472B, Tallahassee, FL, 32306, United States, 1 8506446844, jingwang@nursing.fsu.edu %K health disparity %K rural health %K rural %K community health worker %K health education %K digital health %K diabetes %K diabetes management %K mHealth %K community health %K self management %K mobile health %K technology feasibility %K underserved %K Latino %D 2022 %7 30.5.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Latinos living in rural South Texas have a higher prevalence of diabetes, but their access to diabetes self-management education and support (DSMES) is limited. Objective: We aimed to test the feasibility of a community health worker-led, mobile health (mHealth)-based DSMES intervention to reduce disparities in accessing DSMES in underserved rural Latino residents in South Texas. Methods: This 12-week, single-arm, pre-post trial was delivered by trained community health workers to 15 adults with type 2 diabetes. The intervention consisted of digital diabetes education, self-monitoring, a cloud-based connected platform, and community health worker support. Feasibility was evaluated as retention, actual intervention use, program satisfaction, and barriers to implementation. We also explored the intervention’s effect on weight loss and hemoglobin A1c (HbA1c). Results: All 15 participants were Latino (mean age 61.87 years, SD 10.67; 9/15 female, 60%). The retention rate at posttest was 14 of 15 (93%). On average, the participants completed 37 of 42 (88%) digital diabetes education lessons with 8 participants completing all lessons. Participants spent 81/91 days (89%) step tracking, 71/91 days (78%) food logging, 43/91 days (47%) blood glucose self-monitoring, and 74/91 days (81%) weight self-monitoring. The level of program satisfaction was high. On average, participants lost 3.5 (SD 3.2) kg of body weight (P=.001), while HbA1c level remained unchanged from baseline (6.91%, SD 1.28%) to posttest (7.04%, SD 1.66%; P=.668). Conclusions: A community health worker-led mHealth-based intervention was feasible and acceptable to improve access to DSMES services for Latino adults living in rural communities. Future randomized controlled trials are needed to test intervention efficacy on weight loss and glycemic control. %M 35635752 %R 10.2196/37534 %U https://diabetes.jmir.org/2022/2/e37534 %U https://doi.org/10.2196/37534 %U http://www.ncbi.nlm.nih.gov/pubmed/35635752 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e28091 %T Quantitative User Data From a Chatbot Developed for Women With Gestational Diabetes Mellitus: Observational Study %A Sagstad,Mari Haaland %A Morken,Nils-Halvdan %A Lund,Agnethe %A Dingsør,Linn Jannike %A Nilsen,Anne Britt Vika %A Sorbye,Linn Marie %+ Department of Health and Caring Sciences, Faculty of Health and Social Sciences, Western Norway University of Applied Sciences, 28 Inndalsveien, Bergen, 5063, Norway, 47 920 18489, mari_haaland@yahoo.no %K chatbot %K gestational diabetes mellitus %K user data %K log review %K eHealth %K diabetes %K pregnancy %K dialogue %D 2022 %7 18.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The rising prevalence of gestational diabetes mellitus (GDM) calls for the use of innovative methods to inform and empower these pregnant women. An information chatbot, Dina, was developed for women with GDM and is Norway’s first health chatbot, integrated into the national digital health platform. Objective: The aim of this study is to investigate what kind of information users seek in a health chatbot providing support on GDM. Furthermore, we sought to explore when and how the chatbot is used by time of day and the number of questions in each dialogue and to categorize the questions the chatbot was unable to answer (fallback). The overall goal is to explore quantitative user data in the chatbot’s log, thereby contributing to further development of the chatbot. Methods: An observational study was designed. We used quantitative anonymous data (dialogues) from the chatbot’s log and platform during an 8-week period in 2018 and a 12-week period in 2019 and 2020. Dialogues between the user and the chatbot were the unit of analysis. Questions from the users were categorized by theme. The time of day the dialogue occurred and the number of questions in each dialogue were registered, and questions resulting in a fallback message were identified. Results are presented using descriptive statistics. Results: We identified 610 dialogues with a total of 2838 questions during the 20 weeks of data collection. Questions regarding blood glucose, GDM, diet, and physical activity represented 58.81% (1669/2838) of all questions. In total, 58.0% (354/610) of dialogues occurred during daytime (8 AM to 3:59 PM), Monday through Friday. Most dialogues were short, containing 1-3 questions (340/610, 55.7%), and there was a decrease in dialogues containing 4-6 questions in the second period (P=.013). The chatbot was able to answer 88.51% (2512/2838) of all posed questions. The mean number of dialogues per week was 36 in the first period and 26.83 in the second period. Conclusions: Frequently asked questions seem to mirror the cornerstones of GDM treatment and may indicate that the chatbot is used to quickly access information already provided for them by the health care service but providing a low-threshold way to access that information. Our results underline the need to actively promote and integrate the chatbot into antenatal care as well as the importance of continuous content improvement in order to provide relevant information. %M 35436213 %R 10.2196/28091 %U https://formative.jmir.org/2022/4/e28091 %U https://doi.org/10.2196/28091 %U http://www.ncbi.nlm.nih.gov/pubmed/35436213 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 2 %P e33082 %T Text Messages and Financial Incentives to Increase Physical Activity in Adolescents With Prediabetes and Type 2 Diabetes: Web-Based Group Interviews to Inform Intervention Design %A Vajravelu,Mary Ellen %A Hitt,Talia Alyssa %A Mak,NaDea %A Edwards,Aliya %A Mitchell,Jonathan %A Schwartz,Lisa %A Kelly,Andrea %A Amaral,Sandra %+ Division of Pediatric Endocrinology, Diabetes, and Metabolism, Department of Pediatrics, University of Pittsburgh School of Medicine, 4401 Penn Ave, Faculty Pavilion 6th Floor, Pittsburgh, PA, 15224, United States, 1 412 692 6533, MaryEllen.Vajravelu@pitt.edu %K diabetes mellitus type 2 %K adolescent %K young adult %K text messaging %K physical activity %K motivation %K mobile phone %D 2022 %7 6.4.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Physical activity is a major component of treatment for adolescents with obesity and prediabetes or type 2 diabetes; however, sedentary behavior remains pervasive. An SMS text message–based intervention paired with financial incentives may be an effective way to promote physical activity in this population. Objective: This study aims to obtain end-user feedback on SMS text message content and assess the acceptability of a planned SMS text messaging intervention with financial incentives to motivate youth with prediabetes or type 2 diabetes to increase physical activity. Methods: Adolescents with overweight or obesity and prediabetes or type 2 diabetes who attended a large academic pediatric endocrinology clinic were recruited to participate in group interviews (2-4/group) via videoconferencing. Participants were asked to share their thoughts on the use of SMS text messages and financial incentives to remind and motivate them to be more physically active. They rated and provided feedback on specific messages to be used in clinical trials. Participants were also asked about their personal experience with rewards to motivate behavior change and their anticipated reactions to rewards provided for goal attainment (gain-framing) versus those provided and then taken away if a goal was not met (loss-framing). The interviews were conducted by 2 trained interviewers and a note-taker. Content analysis was used to explore themes. Results: Group interviews were completed with 20 participants (11/20, 55% women; 15/20, 75% with type 2 diabetes; 5/20, 25% with prediabetes) with a mean age of 15 (SD 1; range 12-18) years and a mean BMI of 41 (SD 5) kg/m2 (all >95th percentile for age and sex). Most participants were non-Hispanic Black (14/20, 70%) and 10% (2/20) were Hispanics. Participants frequently cited near-continuous smartphone use and agreed that SMS text messages would serve as good reminders to be physically active, but the consensus about the need for short messages was strong. Favorable content included references to what they were likely to be doing when messages were sent (eg, homework or watching television) and messages that were upbeat or informative. Specific physical activity suggestions were rated favorably. Attitudes toward financial incentives varied, with differing opinions about whether loss-framed incentives would be motivating or discouraging. Many participants highlighted the role of intrinsic, rather than extrinsic, motivation in achieving and sustaining behavior change. Conclusions: The engagement of adolescents with obesity and diabetes or prediabetes allowed for the refinement of SMS text messages for our planned intervention, with an emphasis on short, upbeat, relatable, and informative messages. Although an SMS text messaging intervention using financial incentives to motivate youth with prediabetes or type 2 diabetes to be more physically active is theoretically acceptable, the impact on actual activity levels in this population requires prospective evaluation in a clinical trial. %M 35384850 %R 10.2196/33082 %U https://diabetes.jmir.org/2022/2/e33082 %U https://doi.org/10.2196/33082 %U http://www.ncbi.nlm.nih.gov/pubmed/35384850 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e31629 %T Medication Optimization Among People With Type 2 Diabetes Participating in a Continuous Glucose Monitoring–Driven Virtual Care Program: Prospective Study %A Majithia,Amit R %A Erani,David M %A Kusiak,Coco M %A Layne,Jennifer E %A Lee,Amy Armento %A Colangelo,Francis R %A Romanelli,Robert J %A Robertson,Scott %A Brown,Shayla M %A Dixon,Ronald F %A Zisser,Howard %+ Department of Medicine, University of California San Diego School of Medicine, Biomedical Research Facility II (3A19), 9500 Gilman Drive, La Jolla, CA, 92093, United States, 1 858 822 0727, amajithia@ucsd.edu %K continuous glucose monitoring %K digital health %K GLP-1 receptor agonist %K HbA1c %K telemedicine %K type 2 diabetes %K monitoring %K diabetes %K optimization %K medication %K virtual care %K prospective %K app %K lifestyle %K coaching %K self-management %D 2022 %7 5.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The Onduo virtual care program for people with type 2 diabetes (T2D) includes a mobile app, remote lifestyle coaching, connected devices, and telemedicine consultations with endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices. In a previously described 4-month prospective study of this program, adults with T2D and baseline glycated hemoglobin (HbA1c) ≥8.0% to ≤12.0% experienced a mean HbA1c decrease of 1.6% with no significant increase in hypoglycemia. Objective: The objective of this analysis was to evaluate medication optimization and management in the 4-month prospective T2D study. Methods: Study participants received at least 1 telemedicine consultation with an Onduo endocrinologist for diabetes medication management and used RT-CGM intermittently to guide therapy and dosing. Medication changes were analyzed. Results: Of 55 participants, 48 (87%) had a medication change consisting of a dose change, addition, or discontinuation. Of these, 15 (31%) participants had a net increase in number of diabetes medication classes from baseline. Mean time to first medication change for these participants was 36 days. The percentage of participants taking a glucagon-like peptide-1 receptor agonist increased from 25% (12/48) to 56% (n=27), while the percentages of participants taking a sulfonylurea or dipeptidyl peptidase 4 inhibitor decreased from 56% (n=27) to 33% (n=16) and 17% (n=8) to 6% (n=3), respectively. Prescriptions of other antidiabetic medication classes including insulin did not change significantly. Conclusions: The Onduo virtual care program can play an important role in providing timely access to guideline-based diabetes management medications and technologies for people with T2D. Trial Registration: ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381 %M 35147501 %R 10.2196/31629 %U https://formative.jmir.org/2022/4/e31629 %U https://doi.org/10.2196/31629 %U http://www.ncbi.nlm.nih.gov/pubmed/35147501 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e23535 %T Exploring the Discursive Emphasis on Patients and Coaches Who Participated in Technology-Assisted Diabetes Self-management Education: Clinical Implementation Study of Health360x %A Idris,Muhammed Y %A Alema-Mensah,Ernest %A Olorundare,Elizabeth %A Mohammad,Mohammad %A Brown,Michelle %A Ofili,Elizabeth %A Pemu,Priscilla %+ Department of Medicine and Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive SW, Atlanta, GA, 30310, United States, 1 4047566684, pipemu@msm.edu %K self-management %K structural topic modeling %K coaching %K diabetes %K minority populations %K mobile phone %D 2022 %7 18.3.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: A critical unmet need for underserved patients with diabetes is regular access to sufficient support for diabetes self-management. Although advances in digital technologies have made way for eHealth applications that provide a scalable path for tailored interventions for self-management of chronic conditions, health and digital literacy has remained an obstacle to leveraging these technologies for effective diabetes self-management education. Studies have shown that the availability of coaches helps to maintain engagement in internet-based studies and improves self-efficacy for behavior change. However, little is known about the substances involved in these interactions. Objective: This study aims to compare the content of conversations between patient–coach pairs that achieved their self-management goals and those that did not. The context is a clinical implementation study of diabetes self-management behavior change using Health360x within the practices of the Morehouse Choice Accountable Care Organization in the Atlanta metro area. Health360x is a coach-assisted consumer health information technology designed to support self-management skills acquisition and behavior among underserved, high-risk patients with diabetes. Methods: We provide a novel analysis of the discursive emphasis on patients and coaches. We examined transcripts of visits using a structural topic model to estimate topic content and prevalence as a function of patient and coach characteristics. We compared topics between patient–coach pairs that achieved diabetes-related self-management goals and those who did not. We also estimated a regression in which utterances are the units, the dependent variable is the proportion of an utterance that is about a given topic, and the independent variables are speaker types and explored other themes. Results: Transcripts from 50 patients who were recruited and consented, starting in February 2015, were analyzed. A total of 44 topics were estimated for patient–coach pairs that achieved their intended health goals and 50 topics for those who did not. Analysis of the structural topic model results indicated that coaches in patient–coach pairs that were able to achieve self-management goals provided more contextual feedback and probed into patients’ experience with technology and trust in consumer information technologies. We also found that discussions around problem areas and stress, support (βCoach=.015; P<.001), initial visits (βCoach=.02; P<.001), problems with technology (βCoach=.01; P<.001), health eating goals (βCoach=.01; P=.04), diabetes knowledge (βCoach=.02; P<.001), managing blood sugar (βCoach=.03; P<.001), and using Health360x (βCoach=.003; P=.03) were dominated by coaches. Conclusions: Coach-facilitated, technology-based diabetes self-management education can help underserved patients with diabetes. Our use of topic modeling in this application sheds light on the actual dynamics in conversations between patients and coaches. Knowledge of the key elements for successful coach–patient interactions based on the analysis of transcripts could be applied to understanding everyday patient–provider encounters, given the recent paradigm shift around the use of telehealth. %M 35302506 %R 10.2196/23535 %U https://www.jmir.org/2022/3/e23535 %U https://doi.org/10.2196/23535 %U http://www.ncbi.nlm.nih.gov/pubmed/35302506 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e34029 %T A Lifestyle Intervention to Delay Early Chronic Kidney Disease in African Americans With Diabetic Kidney Disease: Pre-Post Pilot Study %A Ozieh,Mukoso N %A Egede,Leonard E %+ Department of Medicine, Division of Nephrology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, 53226, United States, 1 4149558839, mozieh@mcw.edu %K type 2 diabetes mellitus %K chronic kidney insufficiency %K healthy lifestyle %K outcomes research %K African Americans %K quasiexperimental study %D 2022 %7 15.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Behavioral factors, such as lifestyle, have been shown to explain approximately 24% of the excess risk of chronic kidney disease (CKD) among African Americans. However, there are limited intervention studies culturally tailored to African Americans with type 2 diabetes mellitus and CKD. Objective: The main objective of this study was to examine the feasibility and preliminary efficacy of a culturally tailored lifestyle intervention among African Americans with type 2 diabetes mellitus and CKD. Methods: A pre-post design was used to test the feasibility of a lifestyle intervention in 30 African American adults recruited from the Medical University of South Carolina between January 2017 and February 2017. A research nurse delivered the manualized study intervention weekly for 6 weeks. Clinical outcomes (hemoglobin A1c, blood pressure, and estimated glomerular filtration rate [eGFR]) were measured at baseline and postintervention. Disease knowledge, self-care, and behavior outcomes were also measured using validated structured questionnaires at baseline and postintervention. Descriptive statistics and effect sizes were calculated to determine clinically important changes from baseline. Results: Significant pre-post mean differences and decreases were observed for hemoglobin A1c (mean 0.75%, 95% CI 0.16-1.34; P=.01), total cholesterol (mean 16.38 mg/dL, 95% CI 5.82-26.94; P=.004), low-density lipoprotein (mean 13.73 mg/dL, 95% CI 3.91-23.54; P=.008), and eGFR (mean 6.73 mL/min/1.73m2, 95% CI 0.97-12.48; P=.02). Significant pre-post mean differences and increases were observed for CKD self-efficacy (mean −11.15, 95% CI −21.55 to −0.75; P=.03), CKD knowledge (mean −2.62, 95% CI −3.98 to −1.25; P<.001), exercise behavior (mean −1.21, 95% CI −1.96 to −0.46; P=.003), and blood sugar testing (mean −2.15, 95% CI −3.47 to −0.83; P=.003). Conclusions: This study provides preliminary data for a large-scale appropriately powered randomized controlled trial to examine a culturally tailored lifestyle intervention in African Americans with type 2 diabetes mellitus and CKD in order to improve clinical, knowledge, self-care, and behavior outcomes in this population. %M 35289751 %R 10.2196/34029 %U https://formative.jmir.org/2022/3/e34029 %U https://doi.org/10.2196/34029 %U http://www.ncbi.nlm.nih.gov/pubmed/35289751 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e31530 %T Digitally Supported Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Secondary Analysis of Long-Term User Engagement Trajectories in a Randomized Controlled Trial %A Lavikainen,Piia %A Mattila,Elina %A Absetz,Pilvikki %A Harjumaa,Marja %A Lindström,Jaana %A Järvelä-Reijonen,Elina %A Aittola,Kirsikka %A Männikkö,Reija %A Tilles-Tirkkonen,Tanja %A Lintu,Niina %A Lakka,Timo %A van Gils,Mark %A Pihlajamäki,Jussi %A Martikainen,Janne %+ School of Pharmacy, University of Eastern Finland, P.O. Box 1627, Kuopio, 70211, Finland, 358 407024682, piia.lavikainen@uef.fi %K type 2 diabetes %K user engagement %K digital behavior change intervention %K trajectories %K habit formation %K mobile health %D 2022 %7 24.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Digital health interventions may offer a scalable way to prevent type 2 diabetes (T2D) with minimal burden on health care systems by providing early support for healthy behaviors among adults at increased risk for T2D. However, ensuring continued engagement with digital solutions is a challenge impacting the expected effectiveness. Objective: We aimed to investigate the longitudinal usage patterns of a digital healthy habit formation intervention, BitHabit, and the associations with changes in T2D risk factors. Methods: This is a secondary analysis of the StopDia (Stop Diabetes) study, an unblinded parallel 1-year randomized controlled trial evaluating the effectiveness of the BitHabit app alone or together with face-to-face group coaching in comparison with routine care in Finland in 2017-2019 among community-dwelling adults (aged 18 to 74 years) at an increased risk of T2D. We used longitudinal data on usage from 1926 participants randomized to the digital intervention arms. Latent class growth models were applied to identify user engagement trajectories with the app during the study. Predictors for trajectory membership were examined with multinomial logistic regression models. Analysis of covariance was used to investigate the association between trajectories and 12-month changes in T2D risk factors. Results: More than half (1022/1926, 53.1%) of the participants continued to use the app throughout the 12-month intervention. The following 4 user engagement trajectories were identified: terminated usage (904/1926, 46.9%), weekly usage (731/1926, 38.0%), twice weekly usage (208/1926, 10.8%), and daily usage (83/1926, 4.3%). Active app use during the first month, higher net promoter score after the first 1 to 2 months of use, older age, and better quality of diet at baseline increased the odds of belonging to the continued usage trajectories. Compared with other trajectories, daily usage was associated with a higher increase in diet quality and a more pronounced decrease in BMI and waist circumference at 12 months. Conclusions: Distinct long-term usage trajectories of the BitHabit app were identified, and individual predictors for belonging to different trajectory groups were found. These findings highlight the need for being able to identify individuals likely to disengage from interventions early on, and could be used to inform the development of future adaptive interventions. Trial Registration: ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-019-6574-y %M 35200147 %R 10.2196/31530 %U https://www.jmir.org/2022/2/e31530 %U https://doi.org/10.2196/31530 %U http://www.ncbi.nlm.nih.gov/pubmed/35200147 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 1 %P e34465 %T An Innovative, Paradigm-Shifting Lifestyle Intervention to Reduce Glucose Excursions With the Use of Continuous Glucose Monitoring to Educate, Motivate, and Activate Adults With Newly Diagnosed Type 2 Diabetes: Pilot Feasibility Study %A Oser,Tamara K %A Cucuzzella,Mark %A Stasinopoulos,Marilyn %A Moncrief,Matthew %A McCall,Anthony %A Cox,Daniel J %+ Department of Family Medicine, University of Colorado School of Medicine, 12631 East 17th Avenue F496, Academic Office One, Aurora, CO, 80045, United States, 1 303 724 2060, tamara.oser@cuanschutz.edu %K type 2 diabetes %K continuous glucose monitoring %K glycemic excursion minimization %K initial treatment %K diabetes distress %K diabetes %K monitoring %K treatment %K distress %K pilot study %K lifestyle %K intervention %K motivation. %D 2022 %7 23.2.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: Type 2 diabetes (T2D) is a growing epidemic in the United States, and metabolic control has not been improved over the last 10 years. Glycemic excursion minimization (GEM) is an alternative lifestyle treatment option focused on reducing postnutrient glucose excursions rather than reducing weight. GEM has been proven to be superior to routine care when delivered face to face, and equivalent or superior to conventional weight loss therapy, but it has not been evaluated among patients newly diagnosed with T2D or in a self-administered format. Objective: This pilot study evaluated the feasibility of a self-administered version of GEM, augmented with continuous glucose monitoring (CGM), to improve metabolic control (hemoglobin A1c [HbA1c]) while diminishing or delaying the need for diabetes medications in adults recently diagnosed with T2D. These primary objectives were hypothesized to be achieved by reducing carbohydrate intake and increasing physical activity to diminish CGM glucose excursions, leading to the secondary benefits of an increase in diabetes empowerment and reduced diabetes distress, depressive symptoms, and BMI. Methods: GEM was self-administered by 17 adults recently diagnosed with T2D (mean age 52 years, SD 11.6 years; mean T2D duration 3.9 months, SD 2.5 months; mean HbA1c levels 8.0%, SD 1.6%; 40% female; 33.3% non-White), with the aid of a 4-chapter pocket guide and diary, automated motivational text messaging, and feedback from an activity monitor, along with CGM and supplies for the 6-week intervention and the 3-month follow-up. Treatment was initiated with one telephone call reviewing the use of the technology and 3 days later with a second call reviewing the use of the GEM pocket guide and intervention. Results: At 3-month follow-up, 67% of the participants’ diabetes was in remission (HbA1c levels <6.5%), and only one participant started taking diabetes medication. Participants demonstrated a significant reduction in HbA1c levels (–1.8%; P<.001). Participants also experienced significant reductions in high-glycemic-load carbohydrates routinely consumed, CGM readings that were >140 mg/dL, diabetes distress, depressive symptoms, and BMI. Participants felt that use of the CGM was the most significant single element of the intervention. Conclusions: GEM augmented with CGM feedback may be an effective initial intervention for adults newly diagnosed with T2D. A self-administered version of GEM may provide primary care physicians and patients with a new tool to help people recently diagnosed with T2D achieve remission independent of medication and without weight loss as the primary focus. Future research is needed with a larger and more diverse sample. %M 35050857 %R 10.2196/34465 %U https://diabetes.jmir.org/2022/1/e34465 %U https://doi.org/10.2196/34465 %U http://www.ncbi.nlm.nih.gov/pubmed/35050857 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e32815 %T Development and Usability of a Text Messaging Program for Women With Gestational Diabetes: Mixed Methods Study %A Blair,Rachel A %A Horn,Christine E %A Dias,Jennifer M %A McDonnell,Marie E %A Seely,Ellen W %+ Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Avenue, Boston, MA, 02115, United States, 1 6177329479, rblair4@bwh.harvard.edu %K gestational diabetes mellitus %K SMS text messaging %K mobile phone %K mobile health %K pregnancy %K blood glucose self-monitoring %D 2022 %7 22.2.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Gestational diabetes mellitus (GDM) affects 5%-10% of pregnancies and can lead to serious fetal and maternal complications. SMS text messaging is an effective way to improve diabetes management outside of pregnancy, but has not been well studied in GDM. Objective: This study aimed to perform user experience testing and assess usability and acceptability of an SMS text messaging program (Text 4 Success) for women with GDM. Methods: An automated 2-way texting program was developed. It included (1) reminders to check blood glucose levels, (2) positive feedback to user-reported glucose levels, (3) weekly educational messages, and (4) weekly motivational messages. For the user experience testing, women received simulated messages. For the usability study, women were enrolled in the program and received messages for 2 weeks. All women participated in semistructured interviews. For women in the usability study, data from glucose measuring devices were downloaded to assess adherence to self-monitoring of blood glucose (SMBG), measured as the percentage of recommended SMBG checks performed (a secondary outcome). Results: Ten women participated in user experience testing. Suggestions for optimization included further customization of message timing and minimization of jargon, which were incorporated. Ten women participated in the usability study. All 10 would recommend the program to other women with GDM. Participants liked the immediate feedback to glucose values. Suggestions included further flexibility of messages related to mealtimes and the ability to aggregate blood glucose data into a table or graph. Overall, adherence to SMBG testing was high at baseline (222/238 recommended checks, 93%). In comparing the week prior to the trial with the 2 weeks during the trial, there was a small but statistically insignificant difference (P=.48) in the percentage of recommended SMBG performed (median 93% [25th-75th IQR 89%-100%] vs median 97% [25th-75th IQR 92%-100%]). Conclusions: Overall, women with GDM would recommend the Text 4 Success in GDM program and think it is helpful for GDM self-management. The program was usable and acceptable. The program may be better suited to those who have low levels of adherence to SMBG at baseline or to women at time of their diagnosis of GDM. Adaptations to the program will be made based on user suggestions. Further study of SMS text messaging to improve SMBG in GDM is needed. %M 35191851 %R 10.2196/32815 %U https://humanfactors.jmir.org/2022/1/e32815 %U https://doi.org/10.2196/32815 %U http://www.ncbi.nlm.nih.gov/pubmed/35191851 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e27500 %T Early Development of a Virtual Coach for Healthy Coping Interventions in Type 2 Diabetes Mellitus: Validation Study %A Bassi,Giulia %A Donadello,Ivan %A Gabrielli,Silvia %A Salcuni,Silvia %A Giuliano,Claudio %A Forti,Stefano %+ Department of Developmental and Socialization Psychology, University of Padova, Via Venezia 8, Padova, 35131, Italy, 39 3477334405, giulia.bassi@phd.unipd.it %K virtual coach %K early development %K type 2 diabetes mellitus %K healthy coping %K Wizard of Oz %K ORBIT model %K pilot study %K mobile phone %D 2022 %7 11.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health solutions aimed at monitoring tasks among people with diabetes mellitus (DM) have been broadly applied. However, virtual coaches (VCs), embedded or not in mobile health, are considered valuable means of improving patients’ health-related quality of life and ensuring adherence to self-care recommendations in diabetes management. Despite the growing need for effective, healthy coping digital interventions to support patients’ self-care and self-management, the design of psychological digital interventions that are acceptable, usable, and engaging for the target users still represents the main challenge, especially from a psychosocial perspective. Objective: This study primarily aims to test VC interventions based on psychoeducational and counseling approaches to support and promote healthy coping behaviors in adults with DM. As a preliminary study, university students have participated in it and have played the standardized patients’ (SPs) role with the aim of improving the quality of the intervention protocol in terms of user acceptability, experience, and engagement. The accuracy of users’ role-playing is further analyzed. Methods: This preliminary study is based on the Obesity-Related Behavioral Intervention Trial model, with a specific focus on its early phases. The healthy coping intervention protocol was initially designed together with a team of psychologists following the main guidelines and recommendations for psychoeducational interventions for healthy coping in the context of DM. The protocol was refined with the support of 3 experts in the design of behavioral intervention technologies for mental health and well-being, who role-played 3 SPs’ profiles receiving the virtual coaching intervention in a Wizard of Oz setting via WhatsApp. A refined version of the healthy coping protocol was then iteratively tested with a sample of 18 university students (mean age 23.61, SD 1.975 years) in a slightly different Wizard of Oz evaluation setting. Participants provided quantitative and qualitative postintervention feedback by reporting their experiences with the VC. Clustering techniques on the logged interactions and dialogs between the VC and users were collected and analyzed to identify additional refinements for future VC development. Results: Both quantitative and qualitative analyses showed that the digital healthy coping intervention was perceived as supportive, motivating, and able to trigger self-reflection on coping strategies. Analyses of the logged dialogs showed that most of the participants accurately played the SPs’ profile assigned, confirming the validity and usefulness of this testing approach in preliminary assessments of behavioral digital interventions and protocols. Conclusions: This study outlined an original approach to the early development and iterative testing of digital healthy coping interventions for type 2 DM. Indeed, the intervention was well-accepted and proved its effectiveness in the definition and refinement of the initial protocol and of the user experience with a VC before directly involving real patients in its subsequent use and testing. %M 35147505 %R 10.2196/27500 %U https://formative.jmir.org/2022/2/e27500 %U https://doi.org/10.2196/27500 %U http://www.ncbi.nlm.nih.gov/pubmed/35147505 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 8 %N 2 %P e25890 %T Effectiveness of Mobile Phone and Web-Based Interventions for Diabetes and Obesity Among African American and Hispanic Adults in the United States: Systematic Review %A Enyioha,Chineme %A Hall,Matthew %A Voisin,Christiane %A Jonas,Daniel %+ Department of Family Medicine, University of North Carolina at Chapel Hill, 590 Manning Drive, Chapel Hill, NC, 27514, United States, 1 9849744888, chineme_enyioha@med.unc.edu %K mHealth %K mobile health %K technology %K diabetes %K obesity %K African American %K Hispanic %D 2022 %7 4.2.2022 %9 Review %J JMIR Public Health Surveill %G English %X Background: Mobile health (mHealth) and web-based technological advances allow for new approaches to deliver behavioral interventions for chronic diseases such as obesity and diabetes. African American and Hispanic adults experience a disproportionate burden of major chronic diseases. Objective: This paper reviews the evidence for mHealth and web-based interventions for diabetes and obesity in African American and Hispanic adults. Methods: Literature searches of PubMed/Medline, The Cochrane Library, EMBASE, CINAHL Plus, Global Health, Scopus, and Library & Information Science Source were conducted for relevant English-language articles. Articles identified through searches were reviewed by 2 investigators and, if they met the inclusion criteria, were extracted and assessed for risk of bias. Findings were summarized in tabular and narrative format. The overall strength of the evidence was assessed as high, moderate, low, or insufficient on the basis of risk of bias, consistency of findings, directness, precision, and other limitations. Results: Searches yielded 2358 electronic publications, 196 reports were found to be eligible for inclusion, and 7 studies met the eligibility criteria. All 7 included studies were randomized control trials. Five studies evaluated the effectiveness of an mHealth intervention for weight loss, including one that evaluated the effectiveness for diabetes and two studies focused on diabetes. Of all the studies that focused on weight loss, 3 reported significant differences in weight loss in participants in the intervention group compared with those in the usual care group. Although all studies on diabetes control showed greater improvement in glycemic control for the intervention group compared to that in the control group, only one study showed a significant difference between the 2 groups. Conclusions: This analysis indicates that there are few published studies that assessed mHealth interventions among minority populations and focused on weight or diabetes. Although the overall strength of evidence was low for diabetes control, it was moderate for weight loss, and our findings suggest that mHealth and web-based interventions may provide a promising approach for interventions among African American and Hispanic adults who have obesity or diabetes. %M 35119368 %R 10.2196/25890 %U https://publichealth.jmir.org/2022/2/e25890 %U https://doi.org/10.2196/25890 %U http://www.ncbi.nlm.nih.gov/pubmed/35119368 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 2 %P e31184 %T Continuous Glucose Monitoring With Low-Carbohydrate Nutritional Coaching to Improve Type 2 Diabetes Control: Randomized Quality Improvement Program %A Griauzde,Dina H %A Ling,Grace %A Wray,Daniel %A DeJonckheere,Melissa %A Mizokami Stout,Kara %A Saslow,Laura R %A Fenske,Jill %A Serlin,David %A Stonebraker,Spring %A Nisha,Tabassum %A Barry,Colton %A Pop-Busui,Rodica %A Sen,Ananda %A Richardson,Caroline R %+ VA Ann Arbor Healthcare System, 2215 Fuller Rd, Ann Arbor, MI, 48105, United States, 1 603 860 1066, dhafez@med.umich.edu %K type 2 diabetes mellitus %K continuous glucose monitoring %K low-carbohydrate counseling %D 2022 %7 2.2.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 2 diabetes mellitus (T2DM) is a leading cause of morbidity and mortality globally, with adverse health consequences largely related to hyperglycemia. Despite clinical practice guideline recommendations, effective pharmacotherapy, and interventions to support patients and providers, up to 60% of patients diagnosed with T2DM are estimated to have hemoglobin A1c (HbA1c) levels above the recommended targets owing to multilevel barriers hindering optimal glycemic control. Objective: The aim of this study is to compare changes in HbA1c levels among patients with suboptimally controlled T2DM who were offered the opportunity to use an intermittently viewed continuous glucose monitor and receive personalized low-carbohydrate nutrition counseling (<100 g/day) versus those who received usual care (UC). Methods: This was a 12-month, pragmatic, randomized quality improvement program. All adult patients with T2DM who received primary care at a university-affiliated primary care clinic (N=1584) were randomized to either the UC or the enhanced care (EC) group. Within each program arm, we identified individuals with HbA1c >7.5% (58 mmol/mol) who were medically eligible for tighter glycemic control, and we defined these subgroups as UC–high risk (UC-HR) or EC-HR. UC-HR participants (n=197) received routine primary care. EC-HR participants (n=185) were invited to use an intermittently viewed continuous glucose monitor and receive low-carbohydrate nutrition counseling. The primary outcome was mean change in HbA1c levels from baseline to 12 months using an intention-to-treat difference-in-differences analysis comparing EC-HR with UC-HR groups. We conducted follow-up semistructured interviews to understand EC-HR participant experiences with the intervention. Results: HbA1c decreased by 0.41% (4.5 mmol/mol; P=.04) more from baseline to 12 months among participants in the EC-HR group than among those in UC-HR; however, only 61 (32.9%) of 185 EC-HR participants engaged in the program. Among the EC-HR participants who wore continuous glucose monitors (61/185, 32.9%), HbA1c was 1.1% lower at 12 months compared with baseline (P<.001). Interviews revealed themes related to EC-HR participants’ program engagement and continuous glucose monitor use. Conclusions: Among patients with suboptimally controlled T2DM, a combined approach that includes continuous glucose monitoring and low-carbohydrate nutrition counseling can improve glycemic control compared with the standard of care. %M 35107429 %R 10.2196/31184 %U https://www.jmir.org/2022/2/e31184 %U https://doi.org/10.2196/31184 %U http://www.ncbi.nlm.nih.gov/pubmed/35107429 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e32211 %T A Virtual Coach (Motibot) for Supporting Healthy Coping Strategies Among Adults With Diabetes: Proof-of-Concept Study %A Bassi,Giulia %A Giuliano,Claudio %A Perinelli,Alessio %A Forti,Stefano %A Gabrielli,Silvia %A Salcuni,Silvia %+ Department of Developmental and Socialization Psychology, University of Padova, Via Venezia 8, Padova, 35131, Italy, 39 3477334405, giulia.bassi@phd.unipd.it %K virtual coach %K diabetes mellitus %K adults %K psychosocial factors %K mindfulness %K proof-of-concept study %K mobile phone %D 2022 %7 21.1.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Motivation is a core component of diabetes self-management because it allows adults with diabetes mellitus (DM) to adhere to clinical recommendations. In this context, virtual coaches (VCs) have assumed a central role in supporting and treating common barriers related to adherence. However, most of them are mainly focused on medical and physical purposes, such as the monitoring of blood glucose levels or following a healthy diet. Objective: This proof-of-concept study aims to evaluate the preliminary efficacy of a VC intervention for psychosocial support before and after the intervention and at follow-up. The intent of this VC is to motivate adults with type 1 DM and type 2 DM to adopt and cultivate healthy coping strategies to reduce symptoms of depression, anxiety, perceived stress, and diabetes-related emotional distress, while also improving their well-being. Methods: A total of 13 Italian adults with DM (18-51 years) interacted with a VC, called Motibot (motivational bot) using the Telegram messaging app. The interaction covered 12 sessions, each lasting 10 to 20 minutes, during which the user could dialogue with the VC by inputting text or tapping an option on their smartphone screen. Motibot is developed within the transtheoretical model of change to deliver the most appropriate psychoeducational intervention based on the user’s motivation to change. Results: Results showed that over the 12 sessions, there were no significant changes before and after the intervention and at follow-up regarding psychosocial factors. However, most users showed a downward trend over the 3 time periods in depression and anxiety symptoms, thereby presenting good psychological well-being and no diabetes-related emotional distress. In addition, users felt motivated, involved, encouraged, emotionally understood, and stimulated by Motibot during the interaction. Indeed, the analyses of semistructured interviews, using a text mining approach, showed that most users reported a perceived reduction in anxiety, depression, and/or stress symptoms. Moreover, users indicated the usefulness of Motibot in supporting and motivating them to find a mindful moment for themselves and to reflect on their own emotions. Conclusions: Motibot was well accepted by users, particularly because of the inclusion of mindfulness practices, which motivated them to adopt healthy coping skills. To this extent, Motibot provided psychosocial support for adults with DM, particularly for those with mild and moderate symptoms, whereas those with severe symptoms may benefit more from face-to-face psychotherapy. %M 35060918 %R 10.2196/32211 %U https://humanfactors.jmir.org/2022/1/e32211 %U https://doi.org/10.2196/32211 %U http://www.ncbi.nlm.nih.gov/pubmed/35060918 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e31567 %T Web-Based Structured Education for Type 2 Diabetes: Interdisciplinary User-Centered Design Approach %A Poduval,Shoba %A Ross,Jamie %A Pal,Kingshuk %A Newhouse,Nikki %A Hamilton,Fiona %A Murray,Elizabeth %+ Research Department of Primary Care & Population Health, University College London, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, United Kingdom, 44 020 3108 1207, s.poduval@ucl.ac.uk %K type 2 diabetes %K patient self-management %K diabetes education %K primary care %K digital health %D 2022 %7 14.1.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Digital health research encompasses methods from human-computer interaction and health research. Objective: This paper aims to describe how these methods were combined to develop HeLP-Diabetes: Starting Out, a web-based structured education program for people newly diagnosed with type 2 diabetes. Methods: The development process consisted of three phases: initial design for effectiveness, optimization for usability, and in the wild testing in the National Health Service with people newly diagnosed with type 2 diabetes, and further revisions. We adopted an iterative user-centered approach and followed steps from the human-computer interaction design life cycle and the Medical Research Council guidelines on developing and evaluating complex interventions. Results: The initial design process resulted in an 8-session program containing information and behavior change techniques targeting weight loss, being more active, and taking medication. The usability testing was highlighted at an early stage, where changes needed to be made to the language and layout of the program. The in the wild testing provided data on uptake of and barriers to use. The study suggested low uptake and completion of the program, but those who used it seemed to benefit from it. The qualitative findings suggested that barriers to use included an expectation that the program would take too long. This informed refinements to the program. Conclusions: The use of interdisciplinary methods resulted in an iterative development process and refinements to the program that were based on user needs and data on uptake. The final intervention was more suitable for a definitive evaluation than the initial version. The description of our approach informs other digital health researchers on how to make interventions more sensitive to user needs. %M 35029531 %R 10.2196/31567 %U https://humanfactors.jmir.org/2022/1/e31567 %U https://doi.org/10.2196/31567 %U http://www.ncbi.nlm.nih.gov/pubmed/35029531 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 7 %N 1 %P e23243 %T A 12-Month Follow-Up of the Effects of a Digital Diabetes Prevention Program (VP Transform for Prediabetes) on Weight and Physical Activity Among Adults With Prediabetes: Secondary Analysis %A Batten,Ryan %A Alwashmi,Meshari F %A Mugford,Gerald %A Nuccio,Misa %A Besner,Angele %A Gao,Zhiwei %+ Memorial University of Newfoundland, 300 Prince Philip Drive, St John's, NL, A1B 3V6, Canada, 1 7096910728, mfa720@mun.ca %K mHealth %K mobile health %K diabetes %K DPP %K diabetes prevention program %K digital health %K longitudinal study %K prevention %K weight loss %K physical activity %D 2022 %7 14.1.2022 %9 Original Paper %J JMIR Diabetes %G English %X Background: The prevalence of diabetes is increasing rapidly. Previous research has demonstrated the efficacy of a diabetes prevention program (DPP) in lifestyle modifications that can prevent or delay the onset of type 2 diabetes among individuals at risk. Digital DPPs have the potential to use technology, in conjunction with behavior change science, to prevent prediabetes on a national and global scale. Objective: The aim of this study is to investigate the effects of a digital DPP (Virgin Pulse [VP] Transform for Prediabetes) on weight and physical activity among participants who had completed 12 months of the program. Methods: This study was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in VP Transform for Prediabetes for 12 months of the program. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes. Results: The sample (N=1095) was comprised of people with prediabetes who completed at least 9 months of the VP Transform for Prediabetes program. Participants were 67.7% (n=741) female, with a mean age of 53.6 (SD 9.75) years. After 12 months, participants decreased their weight by an average of 10.9 lbs (5.5%; P<.001) and increased their physical activity by 91.2 (P<.001) minutes. Conclusions: These results suggest that VP Transform for Prediabetes is effective at preventing type 2 diabetes through a significant reduction in body weight and increase of physical activity. Furthermore, these results suggest that the DPP remains effective 12 months after beginning the program. A prospective randomized controlled clinical study is warranted to validate these findings. %M 35029532 %R 10.2196/23243 %U https://diabetes.jmir.org/2022/1/e23243 %U https://doi.org/10.2196/23243 %U http://www.ncbi.nlm.nih.gov/pubmed/35029532 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e33348 %T Digital Behavior Change Interventions for the Prevention and Management of Type 2 Diabetes: Systematic Market Analysis %A Keller,Roman %A Hartmann,Sven %A Teepe,Gisbert Wilhelm %A Lohse,Kim-Morgaine %A Alattas,Aishah %A Tudor Car,Lorainne %A Müller-Riemenschneider,Falk %A von Wangenheim,Florian %A Mair,Jacqueline Louise %A Kowatsch,Tobias %+ Future Health Technologies Programme, Campus for Research Excellence and Technological Enterprise, Singapore-ETH Centre, 1 Create Way, CREATE Tower, #06-01, Singapore, 138602, Singapore, 65 82645302, roman.keller@sec.ethz.ch %K digital health companies %K health care %K type 2 diabetes %K prevention %K management %K conversational agent %K digital behavior change intervention %K investment %K just-in-time adaptive intervention %K digital health %K diabetes %K agent %K behavior %D 2022 %7 7.1.2022 %9 Review %J J Med Internet Res %G English %X Background: Advancements in technology offer new opportunities for the prevention and management of type 2 diabetes. Venture capital companies have been investing in digital diabetes companies that offer digital behavior change interventions (DBCIs). However, little is known about the scientific evidence underpinning such interventions or the degree to which these interventions leverage novel technology-driven automated developments such as conversational agents (CAs) or just-in-time adaptive intervention (JITAI) approaches. Objective: Our objectives were to identify the top-funded companies offering DBCIs for type 2 diabetes management and prevention, review the level of scientific evidence underpinning the DBCIs, identify which DBCIs are recognized as evidence-based programs by quality assurance authorities, and examine the degree to which these DBCIs include novel automated approaches such as CAs and JITAI mechanisms. Methods: A systematic search was conducted using 2 venture capital databases (Crunchbase Pro and Pitchbook) to identify the top-funded companies offering interventions for type 2 diabetes prevention and management. Scientific publications relating to the identified DBCIs were identified via PubMed, Google Scholar, and the DBCIs’ websites, and data regarding intervention effectiveness were extracted. The Diabetes Prevention Recognition Program (DPRP) of the Center for Disease Control and Prevention in the United States was used to identify the recognition status. The DBCIs’ publications, websites, and mobile apps were reviewed with regard to the intervention characteristics. Results: The 16 top-funded companies offering DBCIs for type 2 diabetes received a total funding of US $2.4 billion as of June 15, 2021. Only 4 out of the 50 identified publications associated with these DBCIs were fully powered randomized controlled trials (RCTs). Further, 1 of those 4 RCTs showed a significant difference in glycated hemoglobin A1c (HbA1c) outcomes between the intervention and control groups. However, all the studies reported HbA1c improvements ranging from 0.2% to 1.9% over the course of 12 months. In addition, 6 interventions were fully recognized by the DPRP to deliver evidence-based programs, and 2 interventions had a pending recognition status. Health professionals were included in the majority of DBCIs (13/16, 81%,), whereas only 10% (1/10) of accessible apps involved a CA as part of the intervention delivery. Self-reports represented most of the data sources (74/119, 62%) that could be used to tailor JITAIs. Conclusions: Our findings suggest that the level of funding received by companies offering DBCIs for type 2 diabetes prevention and management does not coincide with the level of evidence on the intervention effectiveness. There is considerable variation in the level of evidence underpinning the different DBCIs and an overall need for more rigorous effectiveness trials and transparent reporting by quality assurance authorities. Currently, very few DBCIs use automated approaches such as CAs and JITAIs, limiting the scalability and reach of these solutions. %M 34994693 %R 10.2196/33348 %U https://www.jmir.org/2022/1/e33348 %U https://doi.org/10.2196/33348 %U http://www.ncbi.nlm.nih.gov/pubmed/34994693 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 4 %P e32320 %T Differences in Secure Messaging, Self-management, and Glycemic Control Between Rural and Urban Patients: Secondary Data Analysis %A Robinson,Stephanie A %A Netherton,Dane %A Zocchi,Mark %A Purington,Carolyn %A Ash,Arlene S %A Shimada,Stephanie L %+ Center for Healthcare Organization and Implementation Research, VA Bedford Healthcare System, Bldg 70, 200 Springs Rd, Bedford, MA, 01730, United States, 1 5712767178, stephanie.robinson5@va.gov %K diabetes %K secure messaging %K rural %K self-management %K patient portal %K urban %K data %K access %K risk %K portal %K eHealth %K digital health %K messaging %K support %K accessible %K cross-sectional %K veteran %D 2021 %7 19.11.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Rural patients with diabetes have difficulty accessing care and are at higher risk for poor diabetes management. Sustained use of patient portal features such as secure messaging (SM) can provide accessible support for diabetes self-management. Objective: This study explored whether rural patients’ self-management and glycemic control was associated with the use of SM. Methods: This secondary, cross-sectional, mixed methods analysis of 448 veterans with diabetes used stratified random sampling to recruit a diverse sample from the United States (rural vs urban and good vs poor glycemic control). Administrative, clinical, survey, and interview data were used to determine patients’ rurality, use of SM, diabetes self-management behaviors, and glycemic control. Moderated mediation analyses assessed these relationships. Results: The sample was 51% (n=229) rural and 49% (n=219) urban. Mean participant age was 66.4 years (SD 7.7 years). More frequent SM use was associated with better diabetes self-management (P=.007), which was associated with better glycemic control (P<.001). Among rural patients, SM use was indirectly associated with better glycemic control through improved diabetes self-management (95% CI 0.004-0.927). These effects were not observed among urban veterans with diabetes (95% CI –1.039 to 0.056). Rural patients were significantly more likely than urban patients to have diabetes-related content in their secure messages (P=.01). Conclusions: More frequent SM use is associated with engaging in diabetes self-management, which, in turn, is associated with better diabetes control. Among rural patients with diabetes, SM use is indirectly associated with better diabetes control. Frequent patient-team communication through SM about diabetes-related content may help rural patients with diabetes self-management, resulting in better glycemic control. %M 34807834 %R 10.2196/32320 %U https://diabetes.jmir.org/2021/4/e32320 %U https://doi.org/10.2196/32320 %U http://www.ncbi.nlm.nih.gov/pubmed/34807834 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e30435 %T Public Perceptions of Diabetes, Healthy Living, and Conversational Agents in Singapore: Needs Assessment %A Dhinagaran,Dhakshenya Ardhithy %A Sathish,Thirunavukkarasu %A Kowatsch,Tobias %A Griva,Konstadina %A Best,James Donovan %A Tudor Car,Lorainne %+ Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Clinical Sciences Building, 11 Mandalay Road, Singapore, 308232, Singapore, 65 69041258, lorainne.tudor.car@ntu.edu.sg %K conversational agents %K chatbots %K diabetes %K prediabetes %K healthy lifestyle change %K mobile phone %D 2021 %7 11.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The incidence of chronic diseases such as type 2 diabetes is increasing in countries worldwide, including Singapore. Health professional–delivered healthy lifestyle interventions have been shown to prevent type 2 diabetes. However, ongoing personalized guidance from health professionals is not feasible or affordable at the population level. Novel digital interventions delivered using mobile technology, such as conversational agents, are a potential alternative for the delivery of healthy lifestyle change behavioral interventions to the public. Objective: We explored perceptions and experiences of Singaporeans on healthy living, diabetes, and mobile health (mHealth) interventions (apps and conversational agents). This study was conducted to help inform the design and development of a conversational agent focusing on healthy lifestyle changes. Methods: This qualitative study was conducted in August and September 2019. A total of 20 participants were recruited from relevant healthy living Facebook pages and groups. Semistructured interviews were conducted in person or over the telephone using an interview guide. Interviews were transcribed and analyzed in parallel by 2 researchers using Burnard’s method, a structured approach for thematic content analysis. Results: The collected data were organized into 4 main themes: use of conversational agents, ubiquity of smartphone apps, understanding of diabetes, and barriers and facilitators to a healthy living in Singapore. Most participants used health-related mobile apps as well as conversational agents unrelated to health care. They provided diverse suggestions for future conversational agent-delivered interventions. Participants also highlighted several knowledge gaps in relation to diabetes and healthy living. Regarding barriers to healthy living, participants mentioned frequent dining out, high stress levels, lack of work-life balance, and lack of free time to engage in physical activity. In contrast, discipline, preplanning, and sticking to a routine were important for enabling a healthy lifestyle. Conclusions: Participants in this study commonly used mHealth interventions and provided important insights into their knowledge gaps and needs in relation to changes in healthy lifestyle behaviors. Future digital interventions such as conversational agents focusing on healthy lifestyle and diabetes prevention should aim to address the barriers highlighted in our study and motivate individuals to adopt healthy lifestyle behavior. %M 34762053 %R 10.2196/30435 %U https://formative.jmir.org/2021/11/e30435 %U https://doi.org/10.2196/30435 %U http://www.ncbi.nlm.nih.gov/pubmed/34762053 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e28554 %T Effectiveness of a Walking Football Program for Middle-Aged and Older Men With Type 2 Diabetes: Protocol for a Randomized Controlled Trial %A Barbosa,Ana %A Brito,João %A Figueiredo,Pedro %A Seabra,André %A Mendes,Romeu %+ EPIUnit – Instituto de Saúde Pública, Universidade do Porto, Rua das Taipas, 135, Porto, 4050-600, Portugal, 351 222061820, romeuduartemendes@gmail.com %K type 2 diabetes %K cardiovascular risk factors %K physical activity %K exercise %K football %K soccer %K walking %K randomized controlled trial %D 2021 %7 3.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Studies on walking football have found positive effects on health; however, there are still several research gaps when applying walking football programs for patients with type 2 diabetes. Objective: This study aims to test the effectiveness of a walking football exercise program on glycemic control and cardiovascular risk factors in middle-aged and older men with type 2 diabetes. Methods: The study will be run as a randomized controlled trial with a 6-month duration in Portugal. Eligible participants will be randomized using a 1:1 ratio for intervention or control groups and compared using an intention-to-treat analysis. The intervention will consist of a walking football exercise program. The control group will continue with usual care in primary health care units. The primary outcome will be the mean difference in glycated hemoglobin between intervention and control groups after 6 months. Secondary outcomes include the mean differences in fasting blood glucose, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, systolic and diastolic blood pressure, body mass index, waist circumference, fat-free mass, and fat mass. Additionally, secondary outcomes include the incidence of exercise-related injuries and adverse events and the walking football exercise program’s cost-utility. Results: The study protocol is being prepared to be submitted to the Health Ethics Committee of the Northern Regional Health Administration, Portugal. After approval, participant recruitment will start in primary health care units in Porto's metropolitan area by family medicine doctors. Conclusions: Walking football might have the potential to be effective in improving glycemic control and cardiovascular risk factors, with a low rate of exercise-related injuries and adverse events and a good cost-utility ratio. Therefore, walking football may be a sustainable intervention strategy for type 2 diabetes management. International Registered Report Identifier (IRRID): PRR1-10.2196/28554 %M 34730549 %R 10.2196/28554 %U https://www.researchprotocols.org/2021/11/e28554 %U https://doi.org/10.2196/28554 %U http://www.ncbi.nlm.nih.gov/pubmed/34730549 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 4 %P e23646 %T Telemedicine via Continuous Remote Care: A Proactive, Patient-Centered Approach to Improve Clinical Outcomes %A Hallberg,Sarah %A Harrison,David %+ Virta Health, 733 Warrick St, West Lafayette, IN, 47906, United States, 1 765 775 6550, sarah@virtahealth.com %K telemedicine %K continuous remote care %K diabetes %K COVID-19 %K pandemic %D 2021 %7 2.11.2021 %9 Viewpoint %J JMIR Diabetes %G English %X The COVID-19 pandemic has revolutionized health care for patients and providers alike. Telemedicine has moved from the periphery of our health care system to center stage more rapidly than anyone could have envisioned. Currently, virtual care has quite effectively replicated the traditional health system’s care delivery model and reimbursement structure—a patient makes an appointment, then sees a physician (except with video or phone replacing in-office visits) who makes a care plan, and the patient and physician meet again at a later timepoint to assess progress. Replicating this episodic care paradigm virtually has been invaluable for delivering care swiftly during the COVID-19 pandemic; however, we can and should do more with the connectedness and convenience that telemedicine technology enables. Continuous remote care, with a data-driven, proactive outreach to patients, represents a decisive step forward in contrast to the currently available episodic, reactive, patient-initiated care. In the context of continuous remote care, patient biometric and symptom data (patient entered and connected data) are assimilated in real time by artificial intelligence–enabled clinical platforms to bring physicians' and other health care team members’ attention to those patients who need intervention, whether this is via medication adjustments, acute care management, or lifestyle coaching. In this paper, we discuss how an innovative continuous remote care approach has improved outcomes in another deadly pandemic—type 2 diabetes mellitus. %M 34505578 %R 10.2196/23646 %U https://diabetes.jmir.org/2021/4/e23646 %U https://doi.org/10.2196/23646 %U http://www.ncbi.nlm.nih.gov/pubmed/34505578 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e27263 %T An Enhanced SMS Text Message–Based Support and Reminder Program for Young Adults With Type 2 Diabetes (TEXT2U): Randomized Controlled Trial %A Middleton,Timothy %A Constantino,Maria %A McGill,Margaret %A D'Souza,Mario %A Twigg,Stephen M %A Wu,Ted %A Thiagalingam,Aravinda %A Chow,Clara %A Wong,Jencia %+ Diabetes Centre, Royal Prince Alfred Hospital, Missenden Road, Camperdown, 2050, Australia, 61 295155888, timothy.middleton@health.nsw.gov.au %K young-onset type 2 diabetes %K SMS %K clinic attendance %K engagement %K diabetes %K digital health %K mobile health %K adolescents %D 2021 %7 21.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Clinic attendance, metabolic control, engagement in self-management, and psychological health are suboptimal in young-onset (age of onset <40 years) type 2 diabetes. Objective: We examined the effectiveness of an enhanced SMS text message–based support and reminder program in improving clinic attendance, metabolic control, engagement in self-management, and psychological health in young-onset type 2 diabetes. Methods: A 12-month, parallel-arm, randomized controlled trial comparing an enhanced, semipersonalized SMS text message–based intervention (incorporating 1-8 supportive and/or informative text messages per month) against standard care was conducted in a specialized clinic for young adult type 2 diabetes. The primary outcome was maintenance of 100% attendance at scheduled quarterly clinical appointments. Secondary outcomes included (1) metabolic indices, (2) pathology and self-monitored blood glucose (SMBG) data availability, and (3) psychosocial well-being. Results: A total of 40 participants were randomized, and 32 completed their 12-month study visit. The average participant age was 32.7 (SD 5.1) years, 50% (20/40) were male, and baseline glycated hemoglobin A1c (HbA1c) was 7.3% (SD 1.9%) (56 mmol/mol, SD 20). A higher proportion of the intervention group achieved 100% attendance (12/21, 57%, vs 5/19, 26%, for the control group); Kaplan-Meier analysis demonstrated significantly greater cumulative attendance in the intervention group (P=.04). There were no between-group differences in HbA1c, BMI, lipids, or availability of pathology and SMBG data. Odds of recording an improvement in the Diabetes Empowerment Scale–Short Form score were higher in the intervention group at 6 months (odds ratio [OR] 4.3, 95% CI 1.1-17), with attenuation of this effect at study end (OR 3.1, 95% CI 0.9-11). Program acceptability was high; >90% of participants would recommend the program to new patients. Conclusions: An enhanced SMS text message–based support and reminder program doubled scheduled clinic attendance rates for patients with young-onset type 2 diabetes. The program was highly acceptable and provided early support for patient empowerment but had no significant effect on measures of metabolic control or self-management. Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN12618000479202); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373579 %M 34524102 %R 10.2196/27263 %U https://www.jmir.org/2021/10/e27263 %U https://doi.org/10.2196/27263 %U http://www.ncbi.nlm.nih.gov/pubmed/34524102 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 4 %P e32298 %T Changes in Glycemic Control Among Individuals With Diabetes Who Used a Personalized Digital Nutrition Platform: Longitudinal Study %A Shea,Benjamin %A Bakre,Shivani %A Carano,Keaton %A Scharen,Jared %A Langheier,Jason %A Hu,Emily A %+ Foodsmart, 595 Pacific Ave, 4th Fl., San Francisco, CA, 94133, United States, 1 7818669200, emily.hu@foodsmart.com %K diabetes %K hyperglycemia %K hemoglobin A1c %K HbA1c %K blood glucose %K digital health %K nutrition %K meal planning %K food environment %K food ordering %K food purchasing %K platform %K longitudinal %K characteristic %K diet %K education %D 2021 %7 18.10.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Diabetes-related costs are the highest across all chronic conditions in the United States, with type 2 diabetes accounting for up to 95% of all cases of diabetes. A healthy diet is strongly associated with lowering glycated hemoglobin A1c (HbA1c) levels among individuals with diabetes, which can help curtail other health complications. Digital health platforms can offer critical support for improving diet and glycemic control among individuals with diabetes. Less is known about the characteristics of people with diabetes who use digital health platforms (specifically, a platform that integrates personalized healthy meal plans and food ordering) and changes in their HbA1c levels. Objective: The aim of this study is to characterize Foodsmart users with diabetes and evaluate the longitudinal impact of Foodsmart—a personalized digital nutrition platform with meal planning, food ordering, and nutrition education features—on changes in HbA1c levels. Methods: We retrospectively analyzed data collected from 643 adults with at least two self-reported HbA1c entries in the Foodsmart platform between January 2016 and June 2021. Participants self-reported their HbA1c levels, height, weight, health conditions, and diet in a 53-item food frequency questionnaire. Diabetes was defined as HbA1c ≥6.5%. We analyzed distributions of characteristics by baseline diabetes status and examined the association of characteristics with the likelihood of having diabetes at baseline. To evaluate the change in HbA1c levels among Foodsmart users, we calculated mean changes (absolute and percent) in HbA1c among participants with diabetes and by length of follow-up. We also compared changes in HbA1c and weight between participants with diabetes at baseline who achieved a normal HbA1c level and those who did not. Results: We found that 43.5% (280/643) of the participants with at least two HbA1c level entries had diabetes at baseline. Participants with diabetes at baseline were more likely to be male, have a higher weight and BMI, report high blood pressure, and have a poorer diet in comparison to participants without diabetes. Using a multivariable logistic regression model, we found that being male and obese were statistically significantly associated with baseline diabetes. Among participants with diabetes at baseline, HbA1c was reduced, on average, by 0.46%. In addition, 21.4% (60/280) of participants with diabetes achieved a normal HbA1c level (<6.5%) in their last HbA1c level entry; this percentage increased with longer follow-up time (39% [7/18] at >24 months). In a sensitivity analysis, users with an HbA1c ≥7.0% at baseline had an average absolute change of –0.62% and 31.2% (62/199) of these participants achieved HbA1c levels of less than 7.0%. Conclusions: This study assessed characteristics of individuals enrolled on the Foodsmart platform with HbA1c levels and found that users with diabetes had lower HbA1c levels over time and a sizable percentage of participants were successful in achieving normal levels. %M 34661545 %R 10.2196/32298 %U https://diabetes.jmir.org/2021/4/e32298 %U https://doi.org/10.2196/32298 %U http://www.ncbi.nlm.nih.gov/pubmed/34661545 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 4 %P e29739 %T A Novel Mobile Health App to Educate and Empower Young People With Type 1 Diabetes to Exercise Safely: Prospective Single-Arm Mixed Methods Pilot Study %A Shetty,Vinutha B %A Soon,Wayne H K %A Roberts,Alison G %A Fried,Leanne %A Roby,Heather C %A Smith,Grant J %A Fournier,Paul A %A Jones,Timothy W %A Davis,Elizabeth A %+ Department of Endocrinology and Diabetes, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, Perth, 6009, Australia, 61 864562222, vinutha.shetty@health.wa.gov.au %K mobile health app %K exercise %K acT1ve %K type 1 diabetes %K young people %K blood glucose level %D 2021 %7 14.10.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Empowering young people with type 1 diabetes (T1D) to manage their blood glucose levels during exercise is a complex challenge faced by health care professionals due to the unpredictable nature of exercise and its effect on blood glucose levels. Mobile health (mHealth) apps would be useful as a decision-support aid to effectively contextualize a blood glucose result and take appropriate action to optimize glucose levels during and after exercise. A novel mHealth app acT1ve was recently developed, based on expert consensus exercise guidelines, to provide real-time support for young people with T1D during exercise. Objective: Our aim was to pilot acT1ve in a free-living setting to assess its acceptability and functionality, and gather feedback on the user experience before testing it in a larger clinical trial. Methods: A prospective single-arm mixed method design was used. Ten participants with T1D (mean age 17.7 years, SD 4.2 years; mean HbA1c, 54 mmol/mol, SD 5.5 mmol/mol [7.1%, SD 0.5%]) had acT1ve installed on their phones, and were asked to use the app to guide their exercise management for 6 weeks. At the end of 6 weeks, participants completed both a semistructured interview and the user Mobile Application Rating Scale (uMARS). All semistructured interviews were transcribed. Thematic analysis was conducted whereby interview transcripts were independently analyzed by 2 researchers to uncover important and relevant themes. The uMARS was scored for 4 quality subscales (engagement, functionality, esthetics, and information), and a total quality score was obtained from the weighted average of the 4 subscales. Scores for the 4 objective subscales were determined by the mean score of each of its individual questions. The perceived impact and subjective quality of acT1ve for each participant were calculated by averaging the scores of their related questions, but were not considered in the total quality score. All scores have a maximal possible value of 5, and they are presented as medians, IQRs, and ranges. Results: The main themes arising from the interview analysis were “increased knowledge,” “increased confidence to exercise,” and “suitability” for people who were less engaged in exercise. The uMARS scores for acT1ve were high (out of 5) for its total quality (median 4.3, IQR 4.2-4.6), engagement (median 3.9, IQR 3.6-4.2), functionality (median 4.8, IQR 4.5-4.8), information (median 4.6, IQR 4.5-4.8), esthetics (median 4.3, IQR 4.0-4.7), subjective quality (median 4.0, IQR 3.8-4.2), and perceived impact (median 4.3, IQR 3.6-4.5). Conclusions: The acT1ve app is functional and acceptable, with a high user satisfaction. The efficacy and safety of this app will be tested in a randomized controlled trial in the next phase of this study. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001414101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378373 %M 34647896 %R 10.2196/29739 %U https://diabetes.jmir.org/2021/4/e29739 %U https://doi.org/10.2196/29739 %U http://www.ncbi.nlm.nih.gov/pubmed/34647896 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e31695 %T Telehealth Behavioral Intervention for Diabetes Management in Adults With Physical Disabilities: Intervention Fidelity Protocol for a Randomized Controlled Trial %A Zengul,Ayse %A Evans,Eric %A Hall,Allyson %A Qu,Haiyan %A Willig,Amanda %A Cherrington,Andrea %A Thirumalai,Mohanraj %+ Department of Health Services Administration, University of Alabama at Birmingham, 1716 9th Avenue South, Birmingham, AL, 35294, United States, 1 205 934 7189, mohanraj@uab.edu %K telehealth %K health coaching %K artificial intelligence %K diabetes mellitus %K intervention fidelity %K mobile phone %D 2021 %7 10.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature. Objective: The aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention—artificial intelligence for diabetes management (AI4DM)—which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research. Methods: We have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC—focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior. Results: Enrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022. Conclusions: Developing and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research. Trial Registration: ClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377. International Registered Report Identifier (IRRID): PRR1-10.2196/31695 %M 34505835 %R 10.2196/31695 %U https://www.researchprotocols.org/2021/9/e31695 %U https://doi.org/10.2196/31695 %U http://www.ncbi.nlm.nih.gov/pubmed/34505835 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e31689 %T Disability-Inclusive Diabetes Self-management Telehealth Program: Protocol for a Pilot and Feasibility Study %A Evans,Eric %A Zengul,Ayse %A Hall,Allyson %A Qu,Haiyan %A Willig,Amanda %A Cherrington,Andrea %A Thirumalai,Mohanraj %+ Department of Health Services Administration, University of Alabama at Birmingham, 1716 9th Avenue South, Birmingham, AL, 35294, United States, 1 205 934 7189, mohanraj@uab.edu %K telehealth %K health coaching %K artificial intelligence %K diabetes mellitus %K mobile phone %D 2021 %7 10.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals with disabilities and type 2 diabetes require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching has been shown to be an effective approach for improving behavioral changes in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of and access to health services. Objective: This protocol outlines the study design for implementing the Artificial Intelligence for Diabetes Management (AI4DM) intervention. The protocol will assess the feasibility, acceptability, and preliminary efficacy of the AI4DM telehealth platform for people with disabilities. Methods: The AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes educational content, and technology access, to 90 individuals with diabetes and physical disabilities. The hypothesis is that this pilot project is feasible and acceptable for adults with permanently impaired mobility and type 2 diabetes. We also hypothesize that adults in the AI4DM intervention groups will have significantly better glycemic control (glycated hemoglobin) and psychosocial and psychological measures than the attention control group at the 3-, 6-, and 12-month follow-ups. Results: The AI4DM study was approved by the university’s institutional review board, and recruitment and enrollment will begin in October 2021. Conclusions: The AI4DM study will improve our understanding of the feasibility and efficacy of a web-based diabetes self-management program for people with disabilities. The AI4DM intervention has the potential to become a scalable and novel method for successfully managing type 2 diabetes in people with disabilities. Trial Registration: ClinicalTrials.gov NCT04927377; https://clinicaltrials.gov/ct2/show/NCT04927377 International Registered Report Identifier (IRRID): PRR1-10.2196/31689 %M 34505831 %R 10.2196/31689 %U https://www.researchprotocols.org/2021/9/e31689 %U https://doi.org/10.2196/31689 %U http://www.ncbi.nlm.nih.gov/pubmed/34505831 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 3 %P e25751 %T Evaluation of the Low Carb Program Digital Intervention for the Self-Management of Type 2 Diabetes and Prediabetes in an NHS England General Practice: Single-Arm Prospective Study %A Summers,Charlotte %A Tobin,Simon %A Unwin,David %+ DDM Health, Technology House, Science Park, University of Warwick, Coventry, CV4 7EZ, United Kingdom, 44 7969091134, Charlotte@ddm.health %K Low Carb Program %K low carbohydrate %K diabetes %K type 2 diabetes intervention %K diabetes prevention %K self-management %K behavior change %K prediabetes %D 2021 %7 9.9.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Type 2 diabetes mellitus has serious health consequences, including blindness, amputation, and stroke. Researchers and clinicians are increasingly in agreement that type 2 diabetes may be effectively treated with a carbohydrate-reduced diet. Digital apps are increasingly used as an adjunct to traditional health care provisions to support remote self-management of long-term health conditions. Objective: Our objective was to evaluate the real-world 12-month outcomes of patients prescribed the Low Carb Program digital health intervention at a primary care National Health Service (NHS) site. The Low Carb Program is a nutritionally focused, 12-session, digitally delivered, educational behavior change intervention for glycemic control and weight loss for adults with prediabetes and type 2 diabetes. The program educates and supports sustainable dietary changes focused on carbohydrate restriction by utilizing behavior change techniques, including goal setting, peer support, and behavioral self-monitoring, as well as personalized downloadable resources, including recipes and meal plans tailored to ethnicity, weekly shopping budget, and dietary preferences. Methods: This study evaluated the real-world outcomes of patients recruited to the Low Carb Program at an NHS general practice in Southport, United Kingdom. All of the NHS patients recruited to the program were diagnosed with type 2 diabetes or prediabetes and were given access to the program at no cost. A total of 45 participants, with a mean age of 54.8 years (SD 13.2), were included in the study. Women made up 42% (19/45) of the sample. The mean hemoglobin A1c (HbA1c) of the sample was 56.7 mmol/mol (SD 16.95) and the mean body weight was 89.4 kg (SD 13.8). Results: Of the 45 study participants recruited to the program, all of them (100%) activated their accounts and 37 (82%) individuals reported outcomes at 12 months. All 45 (100%) patients completed at least 40% of the lessons and 32 (71%) individuals completed more than nine out of 12 core lessons of the program. Glycemic control and weight loss improved, particularly for participants who completed more than nine core lessons in the program over 12 months. The mean HbA1c went from 58.8 mmol/mol at baseline to 54.0 mmol/mol, representing a mean reduction of 4.78 mmol/mol (SD 4.60; t31=5.87; P<.001). Results showed an average total body weight reduction of 4.17%, with an average weight reduction of 3.85 kg (SD 2.49; t31=9.27; P<.001) at the 12-month follow-up point. Conclusions: A digital app prescribed to adults with type 2 diabetes and prediabetes in a primary care setting supporting a transition to a low-carbohydrate diet has been shown to be effective in improving glycemic control and enabling weight loss. Further research to understand more about factors affecting engagement with the app and further positive health implications would be valuable. %M 34499035 %R 10.2196/25751 %U https://diabetes.jmir.org/2021/3/e25751 %U https://doi.org/10.2196/25751 %U http://www.ncbi.nlm.nih.gov/pubmed/34499035 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e27454 %T Dietary Intake and Health Status of Elderly Patients With Type 2 Diabetes Mellitus: Cross-sectional Study Using a Mobile App in Primary Care %A Coleone,Joane Diomara %A Bellei,Ericles Andrei %A Roman,Mateus Klein %A Kirsten,Vanessa Ramos %A De Marchi,Ana Carolina Bertoletti %+ Institute of Exact Sciences and Geosciences, University of Passo Fundo, B5 Building, São José, Highway BR285, Km 292, Passo Fundo, RS, 99052-900, Brazil, 55 5433168354, 168729@upf.br %K eating %K mobile applications %K primary health care %K aged %K type 2 diabetes mellitus %D 2021 %7 27.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Healthy dietary intake reduces the risk of complications of diabetes mellitus. Using assessment methods helps to understand these circumstances, and an electronic application may optimize this practice. Objective: In this study, we aimed to (1) assess the dietary intake and health status of elderly patients with type 2 diabetes mellitus (T2DM) in primary care, (2) use a mobile app as a tool for data collection and analysis in the context of primary care, and (3) verify the perceptions of multidisciplinary health professionals regarding app use. Methods: First, we developed a mobile app comprised of the questions of the Food and Nutrition Surveillance System (SISVAN) of Brazil, which includes a food frequency questionnaire of food categories with a recall of the previous 7 days. Thereafter, we used the app to collect data on the health status and dietary intake of 154 participants, aged 60-96 years, diagnosed with T2DM, and under treatment in primary care centers in the northern region of Rio Grande do Sul, Brazil. We also collected participants’ demographic, anthropometric, biochemical, and lifestyle variables. The associations between dietary intake and other variables were tested using chi-square tests with a 5% significance level. Regarding the app, we assessed usability and acceptance with 20 health professionals. Results: Between August 2018 and December 2018, participants had an intake in line with recommended guidelines for raw salads (57.1%), fruits (76.6%), milk products (68.2%), fried foods (72.7%), savory biscuits (60.4%), cookies or sweets (72.1%), and sugary drinks (92.9%) Meanwhile, the consumption of beans (59.7%), pulses and cooked vegetables (73.4%), and processed meat products (59.7%) was not in line with the guidelines. There were statistically significant differences in meeting the recommended guidelines among participants of different genders (P=.006 and P=.035 for the intake of fried foods and sugary drinks, respectively), place of residence (P=.034 for the intake of cookies and sweets), family history of diabetes (P<.001 for the intake of beans), physical activity engagement (P=.003 for the intake fresh fruits), history of smoking (P=.001 for the intake of raw salads), and presence of coronary disease (P=.050 for the intake of pulses and cooked vegetables). The assessment of usability resulted in a mean score of 71.75 points. Similarly, the assessment of the 15 acceptance questions revealed high scores, and the qualitative questions revealed positive perceptions. Conclusions: We identified that most participants complied with recommended intake guidelines for 7 of 10 categories in the SISVAN guidelines. However, most participants were overweight and had nutritional and clinical disorders, which justifies further investigations in this population. The app was well-rated by health professionals and considered a useful and promising tool for collecting and analyzing data in primary care settings. %M 34448711 %R 10.2196/27454 %U https://formative.jmir.org/2021/8/e27454 %U https://doi.org/10.2196/27454 %U http://www.ncbi.nlm.nih.gov/pubmed/34448711 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 3 %P e26941 %T Challenges and Lessons Learned From a Telehealth Community Paramedicine Program for the Prevention of Hypoglycemia: Pre-Post Pilot Feasibility Study %A Thirumalai,Mohanraj %A Zengul,Ayse G %A Evans,Eric %+ Department of Health Services Administration, University of Alabama at Birmingham, 1716 9th Avenue South, Birmingham, AL, 35294, United States, 1 2059347189, mohanraj@uab.edu %K hypoglycemia %K telehealth %K community paramedicine %K diabetes %K self-efficacy %D 2021 %7 3.8.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Prevention through Intervention is a community paramedicine program developed by Birmingham Fire and Rescue Services in Alabama. This program aims to reduce dependency on emergency medical services (EMS) for nonemergency-related events through education and to lower the frequency of emergency calls in underserved populations. A telehealth intervention with an emphasis on hypoglycemia was implemented to (1) tailor the intervention to meet the educational needs of participants and (2) facilitate follow-ups. A pre-post pilot feasibility evaluation of the telehealth intervention was conducted. Objective: This paper describes the results of the feasibility evaluation, implementation challenges, and the lessons learned about the deployment of a hypoglycemia prevention program in an underserved area and its evaluation. Methods: This single-arm pretest-posttest intervention included (1) an initial in-person visit (week 1), (2) 3 weekly telecoaching calls (weeks 2-4), (3) 1 biweekly call (week 6), and (4) a final in-person visit (week 8) for collecting posttest data from individuals who called EMS due to hypoglycemic events. In-person visits included educational sessions conducted by EMS personnel. Participants’ education included tailored content related to hypoglycemia. Weekly telecoaching calls focused on hypoglycemia symptom monitoring and education reinforcement via a telehealth dashboard. The primary measures focused on feasibility measures, and exploratory measures focused on the fear of hypoglycemia, self-efficacy, and a knowledge of diabetes. Results: A total of 40 participants participated in the intervention. However, the study was marred with high attrition. The various factors behind the low retention rate were discussed. There was a decreasing trend in all three subdomains of the fear of hypoglycemia from pretest to posttest. There was also a significant increase in participants’ self-efficacy in hypoglycemia self-management (P=.03). Conclusions: This study shows preliminary and promising results for a community-based intervention specifically for hypoglycemia. However, the socioeconomic setting in which the intervention was delivered may have resulted in high dropout rates and low attendance during the intervention, which are considerations for future telehealth studies. Trial Registration: ClinicalTrials.gov NCT03665870; https://clinicaltrials.gov/ct2/show/NCT03665870 %M 34342593 %R 10.2196/26941 %U https://diabetes.jmir.org/2021/3/e26941 %U https://doi.org/10.2196/26941 %U http://www.ncbi.nlm.nih.gov/pubmed/34342593 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 3 %P e25820 %T A Personalized Mobile Health Program for Type 2 Diabetes During the COVID-19 Pandemic: Single-Group Pre–Post Study %A Ang,Ian Yi Han %A Tan,Kyle Xin Quan %A Tan,Clive %A Tan,Chiew Hoon %A Kwek,James Wei Ming %A Tay,Joanne %A Toh,Sue Anne %+ Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Tahir Foundation Building, 10th Floor, 12 Science Drive 2, Singapore, Singapore, 65 67791489, yha2103@columbia.edu %K type 2 diabetes %K prediabetic state %K text messaging %K mobile applications %K glycated hemoglobin A %K HbA1c %K blood glucose %K body mass index %K mHealth %K COVID-19 %K diabetes %K intervention %K self-management %K chronic disease %K outcome %D 2021 %7 9.7.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: With increasing type 2 diabetes prevalence, there is a need for effective programs that support diabetes management and improve type 2 diabetes outcomes. Mobile health (mHealth) interventions have shown promising results. With advances in wearable sensors and improved integration, mHealth programs could become more accessible and personalized. Objective: The study aimed to evaluate the feasibility, acceptability, and effectiveness of a personalized mHealth-anchored intervention program in improving glycemic control and enhancing care experience in diabetes management. The program was coincidentally implemented during the national-level lockdown for COVID-19 in Singapore, allowing for a timely study of the use of mHealth for chronic disease management. Methods: Patients with type 2 diabetes or prediabetes were enrolled from the Singapore Armed Forces and offered a 3-month intervention program in addition to the usual care they received. The program was standardized to include (1) in-person initial consultation with a clinical dietitian; (2) in-person review with a diabetes specialist doctor; (3) 1 continuous glucose monitoring device; (4) access to the mobile app for dietary intake and physical activity tracking, and communication via messaging with the dietitian and doctor; and (5) context-sensitive digital health coaching over the mobile app. Medical support was rendered to the patients on an as-needed basis when they required advice on adjustment of medications. Measurements of weight, height, and glycated hemoglobin A1c (HbA1c) were conducted at 2 in-person visits at the start and end of the program. At the end of the program, patients were asked to complete a short acceptability feedback survey to understand the motivation for joining the program, their satisfaction, and suggestions for improvement. Results: Over a 4-week recruitment period, 130 individuals were screened, the enrollment target of 30 patients was met, and 21 patients completed the program and were included in the final analyses; 9 patients were lost to follow-up (full data were not available for the final analyses). There were no differences in the baseline characteristics between patients who were included and excluded from the final analyses (age category: P=.23; gender: P=.21; ethnicity: P>.99; diabetes status category: P=.52, medication adjustment category: P=.65; HbA1c category: P=.69; BMI: P>.99). The 21 patients who completed the study rated a mean of 9.0 out of 10 on the Likert scale for both satisfaction questions. For the Yes-No question on benefit of the program, all of the patients selected “Yes.” Mean HbA1c decreased from 7.6% to 7.0% (P=.004). There were no severe hypoglycemia events (glucose level <3.0 mmol/L) reported. Mean weight decreased from 76.8 kg to 73.9 kg (P<.001), a mean decrease of 3.5% from baseline weight. Mean BMI decreased from 27.8 kg/m2 to 26.7 kg/m2 (P<.001). Conclusions: The personalized mHealth program was feasible, acceptable, and produced significant reductions in HbA1c (P=.004) and body weight (P<.001) in individuals with type 2 diabetes. Such mHealth programs could overcome challenges posed to chronic disease management by COVID-19, including disruptions to in-person health care access. %M 34111018 %R 10.2196/25820 %U https://diabetes.jmir.org/2021/3/e25820 %U https://doi.org/10.2196/25820 %U http://www.ncbi.nlm.nih.gov/pubmed/34111018 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 3 %P e28309 %T Evaluation of Web-Based and In-Person Methods to Recruit Adults With Type 1 Diabetes for a Mobile Exercise Intervention: Prospective Observational Study %A Ash,Garrett I %A Griggs,Stephanie %A Nally,Laura M %A Stults-Kolehmainen,Matthew %A Jeon,Sangchoon %A Brandt,Cynthia %A Gulanski,Barbara I %A Spanakis,Elias K %A Baker,Julien S %A Whittemore,Robin %A Weinzimer,Stuart A %A Fucito,Lisa M %+ Pain, Research, Informatics, Medical Comorbidities and Education Center, Veterans Affairs Connecticut Healthcare System, 11-ACSLG, Building 35A, Rm 235, 950 Campbell Ave, West Haven, CT, 06516, United States, 1 2034443079, garrett.ash@yale.edu %K type 1 diabetes mellitus %K exercise %K behavior and behavior mechanisms %K mobile phone %D 2021 %7 8.7.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Our clinical trial of a mobile exercise intervention for adults 18 to 65 years old with type 1 diabetes (T1D) occurred during COVID-19 social distancing restrictions, prompting us to test web-based recruitment methods previously underexplored for this demographic. Objective: Our objectives for this study were to (1) evaluate the effectiveness and cost of using social media news feed advertisements, a clinic-based approach method, and web-based snowball sampling to reach inadequately active adults with T1D and (2) compare characteristics of enrollees against normative data. Methods: Participants were recruited between November 2019 and August 2020. In method #1, Facebook and Instagram news feed advertisements ran for five 1-to-8-day windows targeting adults (18 to 64 years old) in the greater New Haven and Hartford, Connecticut, areas with one or more diabetes-related profile interest. If interested, participants completed a webform so that the research team could contact them for eligibility screening. In method #2, patients 18 to 24 years old with T1D were approached in person at clinical visits in November and December 2019. Those who were interested immediately completed eligibility screening. Older patients could not be approached due to clinic restrictions. In method #3, snowball sampling was conducted by physically active individuals with T1D contacting their peers on Facebook and via email for 48 days, with details to contact the research staff to express interest and complete eligibility screening. Other methods referred participants to the study similarly to snowball sampling. Results: In method #1, advertisements were displayed to 11,738 unique viewers and attracted 274 clickers (2.33%); 20 participants from this group (7.3%) volunteered, of whom 8 (40%) were eligible. Costs averaged US $1.20 per click and US $95.88 per eligible volunteer. Men had lower click rates than women (1.71% vs 3.17%; P<.001), but their responsiveness and eligibility rates did not differ. In method #2, we approached 40 patients; 32 of these patients (80%) inquired about the study, of whom 20 (63%) volunteered, and 2 of these volunteers (10%) were eligible. Costs including personnel for in-person approaches averaged US $21.01 per inquirer and US $479.79 per eligible volunteer. In method #3, snowball sampling generated 13 inquirers; 12 of these inquirers (92%) volunteered, of whom 8 (67%) were eligible. Incremental costs to attract inquirers were negligible, and total costs averaged US $20.59 per eligible volunteer. Other methods yielded 7 inquirers; 5 of these inquirers (71%) volunteered, of whom 2 (40%) were eligible. Incremental costs to attract inquirers were negligible, and total costs averaged US $34.94 per eligible volunteer. Demographic overrepresentations emerged in the overall cohort (ie, optimal glycemic control, obesity, and low exercise), among those recruited by news feed advertisements (ie, obesity and older age), and among those recruited by snowball sampling (ie, optimal glycemic control and low exercise). Conclusions: Web-based advertising and recruitment strategies are a promising means to attract adults with T1D to clinical trials and exercise interventions, with costs comparing favorably to prior trials despite targeting an uncommon condition (ie, T1D) and commitment to an intervention. These strategies should be tailored in future studies to increase access to higher-risk participants. Trial Registration: ClinicalTrials.gov NCT04204733; https://clinicaltrials.gov/ct2/show/NCT04204733 %M 34047700 %R 10.2196/28309 %U https://diabetes.jmir.org/2021/3/e28309 %U https://doi.org/10.2196/28309 %U http://www.ncbi.nlm.nih.gov/pubmed/34047700 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 2 %P e24981 %T The Influence of Baseline Hemoglobin A1c on Digital Health Coaching Outcomes in Adults With Type 2 Diabetes: Real-World Retrospective Cohort Study %A Martin,Megan %A Patterson,Jonathan %A Allison,Matt %A O’Connor,Blakely B %A Patel,Dhiren %+ Medical Affairs, Pack Health, LLC, 110 12th Street North, Birmingham, AL, 35201, United States, 1 703 400 6513, megan.martin@packhealth.com %K type 2 diabetes %K mobile health %K digital health coaching %K digital therapy %K diabetes support program %K hemoglobin A1c %K body mass index %K diabetes distress %D 2021 %7 16.6.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Digital health coaching is an increasingly common diabetes self-management support strategy for individuals with type 2 diabetes and has been linked to positive mental and physical health outcomes. However, the relationship between baseline risk and outcomes is yet to be evaluated in a real-world setting. Objective: The purpose of this real-world study was to evaluate trends in digital health coaching outcomes by baseline hemoglobin A1c (HbA1c) to better understand which populations may experience the greatest clinical and psychosocial benefit. Methods: A retrospective cohort study design was used to evaluate program effect in a convenience sample of participants in a 12-week digital health coaching program administered by Pack Health. Participants were referred through their health care provider, payer, or employer. The program included patient-centered lifestyle counseling and psychosocial support delivered via telephone, text, and/or email. Self-reported HbA1c and weight were collected at baseline and completion. Physical and mental health were assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form and the Diabetes Distress Scale-2. Changes in HbA1c, weight, BMI, and physical and mental health were analyzed within three participant cohorts stratified by baseline HbA1c level. Results: Participants with complete HbA1c data sets (n=226) were included in the analysis. The sample population was 71.7% (162/226) female, with 61.5% (139/226) identifying as white and 34.1% (77/226) as black. Most participants (184/226, 81.4%) reported a baseline HbA1c ≥7%, and 20.3% (46/226) were classified as high risk (HbA1c >9%). Across HbA1c cohorts, the mean baseline BMI was 35.83 (SD 7.79), and the moderate-risk cohort (7% ≤ HbA1c ≤ 9%) reported the highest mean value (36.6, SD 7.79). At 12 weeks, patients reported a significant decrease in HbAlc, and high-risk participants reduced their levels by the greatest margin (2.28 points; P<.001). Across cohorts, BMI improved by 0.82 (P<.001), with the moderate-risk cohort showing the greatest reduction (−0.88; P<.001). Overall, participants reported significant improvements for PROMIS scores, with the greatest change occurring in the high-risk cohort for whom physical health improved 3.84 points (P<.001) and mental health improved 3.3 points (P<.001). However, the lowest-risk cohort showed the greatest improvements in diabetes distress (−0.76; P=.005). Conclusions: Acknowledging the limitations in this real-world study design, the results reported here suggest that adults with type 2 diabetes with a high baseline HbA1c or high BMI may benefit the most from patient-centered digital health coaching programs when compared to their lower risk counterparts. While all participants improved in physical and mental health categories, participants with high HbA1c experienced the greatest HbA1c reduction and individuals with the highest baseline BMI lost the most weight. These results may be used to inform referrals for patients who are more likely to benefit from digital health coaching. %M 34010804 %R 10.2196/24981 %U https://diabetes.jmir.org/2021/2/e24981 %U https://doi.org/10.2196/24981 %U http://www.ncbi.nlm.nih.gov/pubmed/34010804 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e28884 %T Motivation and Problem Solving Versus Mobile 360° Videos to Promote Enrollment in the National Diabetes Prevention Program’s Lifestyle Change Program Among People With Prediabetes: Protocol for a Randomized Trial %A Gibson,Bryan %A Simonsen,Sara %A Barton,Jonathan %A Zhang,Yue %A Altizer,Roger %A Lundberg,Kelly %A Wetter,David W %+ Department of Biomedical Informatics, University of Utah, 421 Wakara Way, Salt Lake City, UT, 84148, United States, 1 801 585 0929, Bryan.Gibson@utah.edu %K diabetes prevention program %K mobile video %K motivation and problem solving %K program enrollment %K participant engagement %K prediabetes %D 2021 %7 14.6.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: More than 88 million Americans are at risk of developing type 2 diabetes mellitus (T2DM). The National Diabetes Prevention Program’s Lifestyle Change Program (DPP LCP) has been shown to be effective in reducing the risk of progressing from prediabetes to T2DM. However, most individuals who could benefit from the program do not enroll. Objective: The aim of this trial is to test the real-world efficacy of 3 mobile phone–based approaches to increasing enrollment in the DPP LCP including a best-practice condition and 2 novel approaches. Methods: We will conduct a 3-armed randomized clinical trial comparing enrollment and 1-month engagement in the DPP LCP among adults with prediabetes from 2 health care settings. Participants in the best-practice condition will receive SMS-based notifications that they have prediabetes and a link to a website that explains prediabetes, T2DM, and the DPP LCP. This will be followed by a single question survey, “Would you like the DPP LCP to call you to enroll?” Participants in the 2 intervention arms will receive the same best-practice intervention plus either 2 mobile 360° videos or up to 5 brief phone calls from a health coach trained in a motivational coaching approach known as Motivation and Problem Solving (MAPS). We will collect measures of diabetes-related knowledge, beliefs in the controllability of risk for T2DM, risk perceptions for T2DM, and self-efficacy for lifestyle change pre-intervention and 4 weeks later. The primary outcomes of the study are enrollment in the DPP LCP and 4-week engagement in the DPP LCP. In addition, data on the person-hours needed to deliver the interventions as well as participant feedback about the interventions and their acceptability will be collected. Our primary hypotheses are that the 2 novel interventions will lead to higher enrollment and engagement in the DPP LCP than the best-practice intervention. Secondary hypotheses concern the mechanisms of action of the 2 intervention arms: (1) whether changes in risk perception are associated with program enrollment among participants in the mobile 360° video group and (2) whether changes in self-efficacy for lifestyle change are associated with program enrollment among participants in the MAPS coaching group. Finally, exploratory analyses will examine the cost effectiveness and acceptability of the interventions. Results: The project was funded in September 2020; enrollment began in February 2021 and is expected to continue through July 2022. Conclusions: We are conducting a test of 2 novel, scalable, mobile phone–based interventions to increase enrollment in the DPP LCP. If effective, they have tremendous potential to be scaled up to help prevent T2DM nationwide. Trial Registration: ClinicalTrials.gov NCT04746781; https://clinicaltrials.gov/ct2/show/NCT04746781 International Registered Report Identifier (IRRID): DERR1-10.2196/28884 %M 34125075 %R 10.2196/28884 %U https://www.researchprotocols.org/2021/6/e28884 %U https://doi.org/10.2196/28884 %U http://www.ncbi.nlm.nih.gov/pubmed/34125075 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 2 %P e27453 %T Change in Glycemic Control for Patients Enrolled in a Membership-Based Primary Care Program: Longitudinal Observational Study %A Lesser,Lenard I %A Behal,Raj %+ One Medical, 1 Embarcadero Center, Suite 1900, San Francisco, CA, 94111, United States, 1 888 663 6331, LLesser@onemedical.com %K diabetes mellitus %K primary care %K chronic care model %K diabetes %K self-management %K patient %K observational %K digital health %K decision support %K decision-making %K clinical information system %D 2021 %7 11.6.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Both primary care practices based on the chronic care model (CCM) and digital therapeutics have been shown to improve the care of patients with diabetes. Objective: The aim of this observational study was to examine the change in diabetes control for patients enrolled in a membership-based primary care service that is based on the CCM. Methods: Using a diabetes registry, we analyzed the change in glycated hemoglobin (HbA1c) for patients with uncontrolled diabetes mellitus (initial HbA1c≥9%). All patients had access to a technology-enhanced primary care practice built on the CCM. Results: The registry included 621 patients diagnosed with uncontrolled diabetes. All patients had at least two HbA1c measurements, with the average time between the first and last measurement of 1.2 years (SD 0.4). The average starting value of HbA1c was 10.7, which decreased to 8.7, corresponding to a reduction of 2.03 (P<.001). Secondary analyses showed statistically significant reductions in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides. Conclusions: Patients with initially uncontrolled diabetes who undergo care in a technology-enhanced primary care practice based on the CCM have long-term clinically meaningful reductions in HbA1c. %M 33999830 %R 10.2196/27453 %U https://diabetes.jmir.org/2021/2/e27453 %U https://doi.org/10.2196/27453 %U http://www.ncbi.nlm.nih.gov/pubmed/33999830 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 2 %P e24687 %T Improving Management of Type 2 Diabetes Using Home-Based Telemonitoring: Cohort Study %A Milani,Richard %A Chava,Pavan %A Wilt,Jonathan %A Entwisle,Jonathan %A Karam,Susan %A Burton,Jeffrey %A Blonde,Lawrence %+ Center for Health Innovation, Ochsner Health, 1514 Jefferson Highway, New Orleans, LA, 70121, United States, 1 504 842 5874, rmilani@ochsner.org %K diabetes %K digital health %K ehealth %K digital medicine %K connected devices %D 2021 %7 10.6.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Diabetes is present in 10.5% of the US population and accounts for 14.3% of all office-based physician visits made by adults. Despite this established office-based approach, the disease and its adverse outcomes including glycemic control and clinical events tend to worsen over time. Available home technology now provides accurate, reliable data that can be transmitted directly to the electronic medical record. Objective: This study aims to evaluate the impact of a virtual, home-based diabetes management program on clinical measures of diabetes control compared to usual care. Methods: We evaluated glycemic control and other diabetes-related measures after 1 year in 763 patients with type 2 diabetes enrolled into a home-based digital medicine diabetes program and compared them to 794 patients matched for age, sex, race, BMI, hemoglobin A1c (HbA1c), creatinine, estimated glomerular filtration rate, and insulin use in a usual care group after 1 year. Digital medicine patients completed questionnaires online, received medication management and lifestyle recommendations from a clinical pharmacist or advanced practice provider and a health coach, and were asked to submit blood glucose readings using a commercially available Bluetooth-enabled glucose meter that transmitted data directly to the electronic medical record. Results: After 1 year, usual care patients demonstrated no significant changes in HbA1c (mean 7.3, SE 1.7 to mean 7.3, SE 1.6; P=.41) or changes in the proportion of patients with HbA1c≥9.0 (n=117, 15% to n=113, 14%; P=.51). Digital medicine patients demonstrated improvements in HbA1c (mean 7.3, SE 1.5 to mean 6.9, SE 1.2; P<.001) and significant changes in the proportion of patients with HbA1c≥9.0 (n=107, 14% to n=49, 6%; P<.001), diabetes distress (n=198, 26% to n=122, 16%; P<.001), and hypoglycemic episodes (n=313, 41.1% to n=91, 11.9%; P<.001). Conclusions: A digital diabetes program is associated with significant improvement in glycemic control and other diabetes measures. The use of a virtual health intervention using connected devices was widely accepted across a broad range of ethnic diversity, ages, and levels of health literacy. %M 34110298 %R 10.2196/24687 %U https://diabetes.jmir.org/2021/2/e24687 %U https://doi.org/10.2196/24687 %U http://www.ncbi.nlm.nih.gov/pubmed/34110298 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 2 %P e28033 %T Improved Glycemic Control With a Digital Health Intervention in Adults With Type 2 Diabetes: Retrospective Study %A Zimmermann,Gretchen %A Venkatesan,Aarathi %A Rawlings,Kelly %A Scahill,Michael D %+ Vida Health, 100 Montgomery Street, Suite 750, San Francisco, CA, 94104, United States, 1 415 989 1017, aarathi.venkatesan@vida.com %K type 2 diabetes %K digital health %K diabetes intervention %K diabetes %K mobile health %K mHealth %K app-based %K health coaching %K HbA1c %K glycemic improvements %D 2021 %7 2.6.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Traditional lifestyle interventions have shown limited success in improving diabetes-related outcomes. Digital interventions with continuously available support and personalized educational content may offer unique advantages for self-management and glycemic control. Objective: In this study, we evaluated changes in glycemic control among participants with type 2 diabetes who enrolled in a digital diabetes management program. Methods: The study employed a single-arm, retrospective design. A total of 950 participants with a hemoglobin A1c (HbA1c) baseline value of at least 7.0% enrolled in the Vida Health Diabetes Management Program. The intervention included one-to-one remote sessions with a Vida provider and structured lessons and tools related to diabetes management. HbA1c was the primary outcome measure. Of the 950 participants, 258 (27.2%) had a follow-up HbA1c completed at least 90 days from program start. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up. Additionally, a cluster-robust multiple regression analysis was employed to evaluate the relationship between high and low program usage and HbA1c change. A repeated measures analysis of variance was used to evaluate the difference in HbA1c as a function of the measurement period (ie, pre-Vida enrollment, baseline, and postenrollment follow-up). Results: We observed a significant reduction in HbA1c of –0.81 points between baseline (mean 8.68, SD 1.7) and follow-up (mean 7.88, SD 1.46; t257=7.71; P<.001). Among participants considered high risk (baseline HbA1c≥8), there was an average reduction of –1.44 points between baseline (mean 9.73, SD 1.68) and follow-up (mean 8.29, SD 1.64; t139=9.14; P<.001). Additionally, average follow-up HbA1c (mean 7.82, SD 1.41) was significantly lower than pre-enrollment HbA1c (mean 8.12, SD 1.46; F2, 210=22.90; P<.001) There was also significant effect of program usage on HbA1c change (β=–.60; P<.001) such that high usage was associated with a greater decrease in HbA1c (mean –1.02, SD 1.60) compared to low usage (mean –.61, SD 1.72). Conclusions: The present study revealed clinically meaningful improvements in glycemic control among participants enrolled in a digital diabetes management intervention. Higher program usage was associated with greater improvements in HbA1c. The findings of the present study suggest that a digital health intervention may represent an accessible, scalable, and effective solution to diabetes management and improved HbA1c. The study was limited by a nonrandomized, observational design and limited postenrollment follow-up data. %M 34075880 %R 10.2196/28033 %U https://diabetes.jmir.org/2021/2/e28033 %U https://doi.org/10.2196/28033 %U http://www.ncbi.nlm.nih.gov/pubmed/34075880 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 1 %P e26621 %T Diabetes Engagement and Activation Platform for Implementation and Effectiveness of Automated Virtual Type 2 Diabetes Self-Management Education: Randomized Controlled Trial %A Sabo,Roy %A Robins,Jo %A Lutz,Stacy %A Kashiri,Paulette %A Day,Teresa %A Webel,Benjamin %A Krist,Alex %+ Virginia Commonwealth University, 830 East Main Street, Richmond, VA, United States, 1 804 828 3047, roy.sabo@vcuhealth.org %K type 2 diabetes mellitus %K self-management education %K patient engagement %K informatics %D 2021 %7 29.3.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Patients with type 2 diabetes require recommendations for self-management education and support. Objective: In this study, we aim to design the Diabetes Engagement and Activation Platform (DEAP)—an automated patient education tool integrated into primary care workflow—and examine its implementation and effectiveness. Methods: We invited patients aged 18-85 years with a hemoglobin A1c (HbA1c) level ≥8 to participate in a randomized controlled trial comparing DEAP with usual care. DEAP modules addressing type 2 diabetes self-management education and support domains were programmed into patient portals, each with self-guided educational readings, videos, and questions. Care teams received patient summaries and were alerted to patients with low confidence or requesting additional help. HbA1c, BMI, and systolic and diastolic blood pressure (DBP) were measured. Results: Out of the 680 patients invited to participate, 337 (49.5%) agreed and were randomized. All of the 189 intervention patients accessed the first module, and 140 patients (74.1%) accessed all 9 modules. Postmodule knowledge and confidence scores were high. Only 18 patients requested additional help from the care team. BMI was lower for intervention patients than controls at 3 months (31.7 kg/m2 vs 32.1 kg/m2; P=.04) and 6 months (32.5 kg/m2 vs 33.0 kg/m2; P=.003); improvements were even greater for intervention patients completing at least one module. There were no differences in 3- or 6-month HbA1c or blood pressure levels in the intent-to-treat analysis. However, intervention patients completing at least one module compared with controls had a better HbA1c level (7.6% vs 8.2%; P=.03) and DBP (72.3 mm Hg vs 75.9 mm Hg; P=.01) at 3 months. Conclusions: The findings of this study concluded that a significant proportion of patients will participate in an automated virtual diabetes self-management program embedded into patient portals and health systems show promise in helping patients manage their diabetes, weight, and blood pressure. Trial Registration: ClinicalTrials.gov NCT02957721; https://clinicaltrials.gov/ct2/show/NCT02957721 %M 33779567 %R 10.2196/26621 %U https://diabetes.jmir.org/2021/1/e26621 %U https://doi.org/10.2196/26621 %U http://www.ncbi.nlm.nih.gov/pubmed/33779567 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e25085 %T Association Between a Low Carbohydrate Diet, Quality of Life, and Glycemic Control in Australian Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Pilot Study %A Paul,Janine %A Jani,Rati %A Davoren,Peter %A Knight-Agarwal,Catherine %+ Diabetes and Endocrinology, Gold Coast University Hospital and Health Service, 1 Hospital Boulevard, Southport, 4215, Australia, 61 7 5687 4779 ext 74779, u3189207@uni.canberra.edu.au %K type 1 diabetes %K diet %K low carbohydrate %K HbA1c %K adults %K quality of life %D 2021 %7 26.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Globally, the prevalence of type 1 diabetes mellitus (T1DM) is rising. In 2020, a total of 124,652 Australians had T1DM. Maintaining optimal glycemic control (hemoglobin A1c ≤7.0%, ≤53 mmol/mol) on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that a reduced quality of life due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and optimal glycemic control, to our knowledge, no research has examined an association between a low carbohydrate diet, quality of life, and glycemic control, making this study unique in its approach. Objective: The study aims to develop a validated diabetes-specific quality of life questionnaire for use in Australian adults with T1DM and to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in Australian adults living with T1DM. Methods: This cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of 3 phases: phase 1, online Australian diabetes-specific quality of life questionnaire development and piloting (25-30 adults with T1DM); phase 2, questionnaire validation (364 adults with T1DM); and phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in adults with T1DM (16-23 adults with T1DM). The validation of the study-developed Australian diabetes-specific quality of life questionnaire, and changes in hemoglobin A1c and quality of life in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study. Results: Phase 1 of the study is currently open for recruitment and has recruited 12 participants to date. It is anticipated that the first results will be submitted for publication in November 2021. Presently, no results are available. Conclusions: This study is the first of its kind in that it will be the first to generate a new validated instrument, which could be used in evidence-based practice and research to understand the quality of life of Australian adults with T1DM. Second, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM adults in improving their quality of life and glycemic control. Finally, this study could warrant the development of an evidence-based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population. Trial Registration: ClinicalTrials.gov NCT04213300; https://clinicaltrials.gov/ct2/show/NCT04213300 International Registered Report Identifier (IRRID): PRR1-10.2196/25085 %M 33769300 %R 10.2196/25085 %U https://www.researchprotocols.org/2021/3/e25085 %U https://doi.org/10.2196/25085 %U http://www.ncbi.nlm.nih.gov/pubmed/33769300 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 3 %P e23533 %T Human Coaching Methodologies for Automatic Electronic Coaching (eCoaching) as Behavioral Interventions With Information and Communication Technology: Systematic Review %A Chatterjee,Ayan %A Gerdes,Martin %A Prinz,Andreas %A Martinez,Santiago %+ Department for Information and Communication Technologies, Centre for e-Health, University of Agder, Jon Lilletuns Vei 9, Grimstad, 4879, Norway, 47 38141000, ayan.chatterjee@uia.no %K coaching %K electronic coaching %K human behavior %K healthy lifestyle %K persuasive technology %D 2021 %7 24.3.2021 %9 Review %J J Med Internet Res %G English %X Background: We systematically reviewed the literature on human coaching to identify different coaching processes as behavioral interventions and methods within those processes. We then reviewed how those identified coaching processes and the used methods can be utilized to improve an electronic coaching (eCoaching) process for the promotion of a healthy lifestyle with the support of information and communication technology (ICT). Objective: This study aimed to identify coaching and eCoaching processes as behavioral interventions and the methods behind these processes. Here, we mainly looked at processes (and corresponding models that describe coaching as certain processes) and the methods that were used within the different processes. Several methods will be part of multiple processes. Certain processes (or the corresponding models) will be applicable for both human coaching and eCoaching. Methods: We performed a systematic literature review to search the scientific databases EBSCOhost, Scopus, ACM, Nature, SpringerLink, IEEE Xplore, MDPI, Google Scholar, and PubMed for publications that included personal coaching (from 2000 to 2019) and persuasive eCoaching as behavioral interventions for a healthy lifestyle (from 2014 to 2019). The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) framework was used for the evidence-based systematic review and meta-analysis. Results: The systematic search resulted in 79 publications, including 72 papers and seven books. Of these, 53 were related to behavioral interventions by eCoaching and the remaining 26 were related to human coaching. The most utilized persuasive eCoaching methods were personalization (n=19), interaction and cocreation (n=17), technology adoption for behavior change (n= 17), goal setting and evaluation (n=16), persuasion (n=15), automation (n=14), and lifestyle change (n=14). The most relevant methods for human coaching were behavior (n=23), methodology (n=10), psychology (n=9), and mentoring (n=6). Here, “n” signifies the total number of articles where the respective method was identified. In this study, we focused on different coaching methods to understand the psychology, behavioral science, coaching philosophy, and essential coaching processes for effective coaching. We have discussed how we can integrate the obtained knowledge into the eCoaching process for healthy lifestyle management using ICT. We identified that knowledge, coaching skills, observation, interaction, ethics, trust, efficacy study, coaching experience, pragmatism, intervention, goal setting, and evaluation of coaching processes are relevant for eCoaching. Conclusions: This systematic literature review selected processes, associated methods, strengths, and limitations for behavioral interventions from established coaching models. The identified methods of coaching point toward integrating human psychology in eCoaching to develop effective intervention plans for healthy lifestyle management and overcome the existing limitations of human coaching. %M 33759793 %R 10.2196/23533 %U https://www.jmir.org/2021/3/e23533 %U https://doi.org/10.2196/23533 %U http://www.ncbi.nlm.nih.gov/pubmed/33759793 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e25966 %T Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS) %A Bandiera,Carole %A Dotta-Celio,Jennifer %A Locatelli,Isabella %A Nobre,Dina %A Wuerzner,Grégoire %A Pruijm,Menno %A Lamine,Faiza %A Burnier,Michel %A Zanchi,Anne %A Schneider,Marie Paule %+ School of Pharmaceutical Sciences, University of Geneva, Rue Michel Servet 1, Geneva, 1211, Switzerland, 41 22 379 53 16, Marie.Schneider@unige.ch %K medication adherence %K patient compliance %K diabetes mellitus %K diabetes complications %K diabetic nephropathies %K chronic kidney disease %K kidney failure %K renal insufficiency %K electronic monitoring %K interprofessional program %D 2021 %7 19.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite effective treatments, more than 30% of patients with diabetes will present with diabetic kidney disease (DKD) at some point. Patients with DKD are among the most complex as their care is multifactorial and involves different groups of health care providers. Suboptimal adherence to polypharmacy is frequent and contributes to poor outcomes. As self-management is one of the keys to clinical success, structured medication adherence programs are crucial. The PANDIA-IRIS (patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l’adhésion thérapeutique) study is based on a routine medication adherence program led by pharmacists. Objective: The aim of this study is to define the impact of the duration of this medication adherence program on long-term adherence and clinical outcomes in patients with DKD. Methods: This monocentric adherence program consists of short, repeated motivational interviews focused on patients’ medication behaviors combined with the use of electronic monitors containing patients’ medications. When patients open the electronic monitor cap to take their medication, the date and hour at each opening are registered. In total, 73 patients are randomized as 1:1 in 2 parallel groups; the adherence program will last 6 months in the first group versus 12 months in the second group. After the intervention phases, patients continue using their electronic monitors for a total of 24 months but without receiving feedback. Electronic monitors and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation multimodeling, respectively. Longitudinal adherence will be presented as the product of persistence and implementation and modelized by generalized estimating equation multimodeling. The evolution of the ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified-Release Controlled Evaluation) and UKPDS (United Kingdom Prospective Diabetes Study) clinical scores based on medication adherence will be analyzed with generalized estimating equation multimodeling. Patients’ satisfaction with this study will be assessed through qualitative interviews, which will be transcribed verbatim, coded, and analyzed for the main themes. Results: This study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, 2 amendments to the protocol have been approved in June 2017 and October 2019. Patients’ recruitment began in April 2016 and ended in October 2020. This study was introduced to all consecutive eligible patients (n=275). Among them, 73 accepted to participate (26.5%) and 202 (73.5%) refused. Data collection is ongoing and data analysis is planned for 2022. Conclusions: The PANDIA-IRIS study will provide crucial information about the impact of the medication adherence program on the adherence and clinical outcomes of patients with DKD. Monitoring medication adherence during the postintervention phase is innovative and will shed light on the duration of the intervention on medication adherence. Trial Registration: Clinicaltrials.gov NCT04190251_PANDIA IRIS; https://clinicaltrials.gov/ct2/show/NCT04190251 International Registered Report Identifier (IRRID): DERR1-10.2196/25966 %M 33739292 %R 10.2196/25966 %U https://www.researchprotocols.org/2021/3/e25966 %U https://doi.org/10.2196/25966 %U http://www.ncbi.nlm.nih.gov/pubmed/33739292 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e21116 %T Intermittent Versus Continuous Low-Energy Diet in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial %A McDiarmid,Sarah %A Harvie,Michelle %A Johnson,Rhona %A Vyas,Avni %A Aglan,Azza %A Moran,Jacqui %A Ruane,Helen %A Hulme,Amanda %A Sellers,Katharine %A Issa,Basil %+ The Prevent Breast Cancer Research Unit, Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe Hospital, Manchester, M23 9LT, United Kingdom, 44 1612914412, sarah.mcdiarmid@mft.nhs.uk %K type 2 diabetes %K diabetes %K diabetic diet %K low-energy diet %K low calorie diet %K intermittent energy restriction %K intermittent fasting %K diabetes remission %K smartphone %K mobile phone %K mHealth %K mobile health %D 2021 %7 19.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Intensive face-to-face weight loss programs using continuous low-energy diets (CLEDs) providing approximately 800 kcal per day (3347 kJ per day) can produce significant weight loss and remission from type 2 diabetes (T2D). Intermittent low-energy diets (ILEDs) and remotely delivered programs could be viable alternatives that may support patient choice and adherence. Objective: This paper describes the protocol of a pilot randomized controlled trial to test the feasibility and potential efficacy of remotely supported isocaloric ILED and CLED programs among patients with overweight and obesity and T2D. Methods: A total of 79 participants were recruited from primary care, two National Health Service hospital trusts, and a voluntary T2D research register in the United Kingdom. The participants were randomized to a remotely delivered ILED (n=39) or CLED (n=40). The active weight loss phase of CLED involved 8 weeks of Optifast 820 kcal/3430 kJ formula diet, followed by 4 weeks of food reintroduction. The active weight loss phase of ILED (n=39) comprised 2 days of Optifast 820 kcal/3430 kJ diet and 5 days of a portion-controlled Mediterranean diet for 28 weeks. Both groups were asked to complete 56 Optifast 820 kcal/3430 kJ days during their active weight loss phase with an equivalent energy deficit. The diets were isocaloric for the remainder of the 12 months. CLED participants were asked to follow a portion-controlled Mediterranean diet 7 days per week. ILED followed 1-2 days per week of a food-based 820 kcal/3430 kJ diet and a portion-controlled Mediterranean diet for 5-6 days per week. Participants received high-frequency (weekly, fortnightly, or monthly depending on the stage of the trial) multidisciplinary remote support from a dietitian, nurse, exercise specialist, and psychologist via telephone or the Oviva smartphone app. The primary outcomes of the study were uptake, weight loss, and changes in glycated hemoglobin at 12 months. An outcome assessment of trial retention was retrospectively added. Secondary outcomes included an assessment of adherence and adverse events. A qualitative evaluation was undertaken via interviews with participants and health care professionals who delivered the intervention. Results: A total of 79 overweight or obese participants aged 18-75 years and diagnosed with T2D in the last 8 years were recruited to the Manchester Intermittent and Daily Diet Diabetes App Study (MIDDAS). Recruitment began in February 2018, and data collection was completed in February 2020. Data analysis began in June 2020, and the first results are expected to be submitted for publication in 2021. Conclusions: The outcomes of the MIDDAS study will inform the feasibility of remotely delivered ILED and CLED programs in clinical practice and the requirement for a larger-scale randomized controlled trial. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 15394285; http://www.isrctn.com/ISRCTN15394285 International Registered Report Identifier (IRRID): DERR1-10.2196/21116 %M 33739297 %R 10.2196/21116 %U https://www.researchprotocols.org/2021/3/e21116 %U https://doi.org/10.2196/21116 %U http://www.ncbi.nlm.nih.gov/pubmed/33739297 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 2 %P e18224 %T Perspectives From Underserved African Americans and Their Health Care Providers on the Development of a Diabetes Self-Management Smartphone App: Qualitative Exploratory Study %A Barber-Gumbs,Tai %A Trolle Lagerros,Ylva %A Sena,Laura M %A Gittelsohn,Joel %A Chang,Larry W %A Zachary,Wayne W %A Surkan,Pamela J %+ Social and Behavioral Interventions Program, Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe St, Room E5523, Baltimore, MD, 21205-2179, United States, 1 410 502 7396, psurkan@jhu.edu %K diabetes %K mHealth %K type 2 diabetes mellitus %K diabetes self-management %K mobile app %K mobile phone %D 2021 %7 26.2.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Type 2 diabetes mellitus (T2DM) affects approximately 10% of the US population, disproportionately afflicting African Americans. Smartphone apps have emerged as promising tools to improve diabetes self-management, yet little is known about the use of this approach in low-income minority communities. Objective: The goal of the study was to explore which features of an app were prioritized for people with T2DM in a low-income African American community. Methods: Between February 2016 and May 2018, we conducted formative qualitative research with 78 participants to explore how a smartphone app could be used to improve diabetes self-management. Information was gathered on desired features, and app mock-ups were presented to receive comments and suggestions of improvements from smartphone users with prediabetes and T2DM, their friends and family members, and health care providers; data were collected from six interactive forums, one focus group, and 15 in-depth interviews. We carried out thematic data analysis using an inductive approach. Results: All three types of participants reported that difficulty with accessing health care was a main problem and suggested that an app could help address this. Participants also indicated that an app could provide information for diabetes education and self-management. Other suggestions included that the app should allow people with T2DM to log and track diabetes care–related behaviors and receive feedback on their progress in a way that would increase engagement in self-management among persons with T2DM. Conclusions: We identified educational and tracking smartphone features that can guide development of diabetes self-management apps for a low-income African American population. Considering those features in combination gives rise to opportunities for more advanced support, such as determining self-management recommendations based on data in users’ logs. %M 33635279 %R 10.2196/18224 %U https://formative.jmir.org/2021/2/e18224 %U https://doi.org/10.2196/18224 %U http://www.ncbi.nlm.nih.gov/pubmed/33635279 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 2 %P e17573 %T A Novel User Utility Score for Diabetes Management Using Tailored Mobile Coaching: Secondary Analysis of a Randomized Controlled Trial %A Lee,Min-Kyung %A Lee,Da Young %A Ahn,Hong-Yup %A Park,Cheol-Young %+ Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea, 82 2 2001 1869, cydoctor@chol.com %K type 2 diabetes %K mobile applications %K diabetes management %K patient engagement %D 2021 %7 24.2.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile health applications have been developed to support diabetes self-management, but their effectiveness could depend on patient engagement. Therefore, patient engagement must be examined through multifactorial tailored behavioral interventions from an individual perspective. Objective: This study aims to evaluate the usefulness of a novel user utility score (UUS) as a tool to measure patient engagement by using a mobile health application for diabetes management. Methods: We conducted a subanalysis of results from a 12-month randomized controlled trial of a tailored mobile coaching (TMC) system among insurance policyholders with type 2 diabetes. UUS was calculated as the sum of the scores for 4 major core components (range 0-8): frequency of self-monitoring blood glucose testing, dietary and exercise records, and message reading rate. We explored the association between UUS for the first 3 months and glycemic control over 12 months. In addition, we investigated the relationship of UUS with blood pressure, lipid profile, and self-report scales assessing diabetes self-management. Results: We divided 72 participants into 2 groups based on UUS for the first 3 months: UUS:0-4 (n=38) and UUS:5-8 (n=34). There was a significant between-group difference in glycated hemoglobin test (HbA1c) levels for the 12-months study period (P=.011). The HbA1c decrement at 12 months in the UUS:5-8 group was greater than that of the UUS:0-4 group [–0.92 (SD 1.24%) vs –0.33 (SD 0.80%); P=.049]. After adjusting for confounding factors, UUS was significantly associated with changes in HbA1c at 3, 6, and 12 months; the regression coefficients were –0.113 (SD 0.040; P=.006), –0.143 (SD 0.045; P=.002), and –0.136 (SD 0.052; P=.011), respectively. Change differences in other health outcomes between the 2 groups were not observed throughout a 12-month follow-up. Conclusions: UUS as a measure of patient engagement was associated with changes in HbA1c over the study period of the TMC system and could be used to predict improved glycemic control in diabetes self-management through mobile health interventions. Trial Registration: ClinicalTrial.gov NCT03033407; https://clinicaltrials.gov/ct2/show/NCT03033407 %M 33625363 %R 10.2196/17573 %U https://mhealth.jmir.org/2021/2/e17573 %U https://doi.org/10.2196/17573 %U http://www.ncbi.nlm.nih.gov/pubmed/33625363 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 2 %P e18524 %T A Web-Based Computer-Tailored Program to Improve Treatment Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial %A Vluggen,Stan %A Candel,Math %A Hoving,Ciska %A Schaper,Nicolaas C %A de Vries,Hein %+ Department of Health Promotion, Maastricht University, P. Debyeplein 1, Maastricht, 6229 HA, Netherlands, 31 043 3881557, stan.vluggen@maastrichtuniversity.nl %K type 2 diabetes mellitus %K treatment adherence %K eHealth %K computer-tailoring %K randomized controlled trial %D 2021 %7 23.2.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Adherence to core type 2 diabetes mellitus (T2DM) treatment behaviors is suboptimal, and nonadherence is generally not limited to one treatment behavior. The internet holds promise for programs that aim to improve adherence. We developed a computer-tailored eHealth program for patients with T2DM to improve their treatment adherence, that is, adherence to both a healthy lifestyle and medical behaviors. Objective: The objective of this study is to examine the effectiveness of the eHealth program in a randomized controlled trial. Methods: Patients with T2DM were recruited by their health professionals and randomized into either the intervention group, that is, access to the eHealth program for 6 months, or a waiting-list control group. In total, 478 participants completed the baseline questionnaire, of which 234 gained access to the eHealth program. Of the 478 participants, 323 were male and 155 were female, the mean age was 60 years, and the participants had unfavorable BMI and HbA1c levels on average. Outcome data were collected through web-based assessments on physical activity (PA) levels, caloric intake from unhealthy snacks, and adherence to oral hypoglycemic agents (OHAs) and insulin therapy. Changes to separate behaviors were standardized and summed into a composite change score representing changes in the overall treatment adherence. Further standardization of this composite change score yielded the primary outcome, which can be interpreted as Cohen d (effect size). Standardized change scores observed in separate behaviors acted as secondary outcomes. Mixed linear regression analyses were conducted to examine the effectiveness of the intervention on overall and separate treatment behavior adherence, accommodating relevant covariates and patient nesting. Results: After the 6-month follow-up assessment, 47.4% (111/234) of participants in the intervention group and 72.5% (177/244) of participants in the control group were retained. The overall treatment adherence improved significantly in the intervention group compared with the control group, reflected by a small effect size (d=0.27; 95% CI 0.032 to 0.509; P=.03). When considering changes in separate treatment behaviors, a significant decrease was observed only in caloric intake from unhealthy snacks in comparison with the control group (d=0.36; 95% CI 0.136 to 0.584; P=.002). For adherence to PA (d=−0.14; 95% CI −0.388 to 0.109; P=.27), OHAs (d=0.27; 95% CI −0.027 to 0.457; P=.08), and insulin therapy (d=0.35; 95% CI −0.066 to 0.773; P=.10), no significant changes were observed. These results from the unadjusted analyses were comparable with the results of the adjusted analyses, the per-protocol analyses, and the sensitivity analyses. Conclusions: Our multibehavior program significantly improved the overall treatment adherence compared with the control group. To further enhance the impact of the intervention in the personal, societal, and economic areas, a wide-scale implementation of our eHealth intervention is suggested. Trial Registration: Netherlands Trial Register NL664; https://www.trialregister.nl/trial/6664 %M 33620321 %R 10.2196/18524 %U https://www.jmir.org/2021/2/e18524 %U https://doi.org/10.2196/18524 %U http://www.ncbi.nlm.nih.gov/pubmed/33620321 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e27109 %T A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial %A Stanger,Catherine %A Kowatsch,Tobias %A Xie,Haiyi %A Nahum-Shani,Inbal %A Lim-Liberty,Frances %A Anderson,Molly %A Santhanam,Prabhakaran %A Kaden,Sarah %A Rosenberg,Briana %+ Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, 46 Centerra Parkway, Lebanon, NH, , United States, 1 603 646 7023, Catherine.stanger@dartmouth.edu %K type 1 diabetes %K mhealth %K incentives %K health coaching %K young adults %D 2021 %7 23.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Many young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve target range glycemic control. Few interventions, however, have been developed specifically for this age group. Objective: In this randomized trial, we will provide a mobile app (SweetGoals) to all participants as a “core” intervention. The app prompts participants to upload data from their diabetes devices weekly to a device-agnostic uploader (Glooko), automatically retrieves uploaded data, assesses daily and weekly self-management goals, and generates feedback messages about goal attainment. Further, the trial will test two unique intervention components: (1) incentives to promote consistent daily adherence to goals, and (2) web health coaching to teach effective problem solving focused on personalized barriers to self-management. We will use a novel digital direct-to-patient recruitment method and intervention delivery model that transcends the clinic. Methods: A 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A1c ≥ 8.0%. All participants will receive the SweetGoals app that tracks and provides feedback about two adherence targets: (a) daily glucose monitoring; and (b) mealtime behaviors. Participants will be randomized to the factorial combination of incentives and health coaching. The intervention will last 6 months. The primary outcome will be reduction in A1c. Secondary outcomes include self-regulation mechanisms in longitudinal mediation models and engagement metrics as a predictor of outcomes. Participants will complete 6- and 12-month follow-up assessments. We hypothesize greater sustained A1c improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components. Results: Data collection is expected to be complete by February 2025. Analyses of primary and secondary outcomes are expected by December 2025. Conclusions: Successful completion of these aims will support dissemination and effectiveness studies of this intervention that seeks to improve glycemic control in this high-risk and understudied population of young adults with T1D. Trial Registration: ClinicalTrials.gov NCT04646473; https://clinicaltrials.gov/ct2/show/NCT04646473 International Registered Report Identifier (IRRID): PRR1-10.2196/27109 %M 33620330 %R 10.2196/27109 %U https://www.researchprotocols.org/2021/2/e27109 %U https://doi.org/10.2196/27109 %U http://www.ncbi.nlm.nih.gov/pubmed/33620330 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 1 %P e25295 %T Early Insights From a Digitally Enhanced Diabetes Self-Management Education and Support Program: Single-Arm Nonrandomized Trial %A Wilson-Anumudu,Folasade %A Quan,Ryan %A Castro Sweet,Cynthia %A Cerrada,Christian %A Juusola,Jessie %A Turken,Michael %A Bradner Jasik,Carolyn %+ Omada Health, Inc, 500 Sansome Street, Suite 200, San Francisco, CA, 94111, United States, 1 6502696532, folasade.anumudu@omadahealth.com %K diabetes education %K digital health %K remote monitoring %K type 2 diabetes %D 2021 %7 22.2.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: Translation of diabetes self-management education and support (DSMES) into a digital format can improve access, but few digital programs have demonstrated outcomes using rigorous evaluation metrics. Objective: The aim of this study was to evaluate the impact of a digital DSMES program on hemoglobin A1c (HbA1c) for people with type 2 diabetes. Methods: A single-arm, nonrandomized trial was performed to evaluate a digital DSMES program that includes remote monitoring and lifestyle change, in addition to comprehensive diabetes education staffed by a diabetes specialist. A sample of 195 participants were recruited using an online research platform (Achievement Studies, Evidation Health Inc). The primary outcome was change in laboratory-tested HbA1c from baseline to 4 months, and secondary outcomes included change in lipids, diabetes distress, and medication adherence. Results: At baseline, participants had a mean HbA1c of 8.9% (SD 1.9) and mean BMI of 37.5 kg/m2 (SD 8.3). The average age was 45.1 years (SD 8.9), 70% were women, and 67% were White. At 4-month follow up, the HbA1c decreased by 0.8% (P<.001, 95% CI –1.1 to –0.5) for the total population and decreased by 1.4% (P<.001, 95% CI –1.8 to –0.9) for those with an HbA1c of >9.0% at baseline. Diabetes distress and medication adherence were also significantly improved between baseline and follow up. Conclusions: This study provides early evidence that a digitally enhanced DSMES program improves HbA1c and disease self-management outcomes. %M 33616533 %R 10.2196/25295 %U https://diabetes.jmir.org/2021/1/e25295 %U https://doi.org/10.2196/25295 %U http://www.ncbi.nlm.nih.gov/pubmed/33616533 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 1 %P e23796 %T The Use of Telehealth Technology to Support Health Coaching for Older Adults: Literature Review %A Markert,Carl %A Sasangohar,Farzan %A Mortazavi,Bobak J %A Fields,Sherecce %+ Department of Industrial and Systems Engineering, Texas A&M University, 3131 TAMU, College Station, TX, 77843, United States, 1 9794582337, sasangohar@tamu.edu %K telemedicine %K remote sensing technology %K health coaching %K decision support systems %K clinical %K older adults %D 2021 %7 29.1.2021 %9 Review %J JMIR Hum Factors %G English %X Background: Health coaching is an intervention process for driving behavior change through goal-setting, education, encouragement, and feedback on health-related behaviors. Telehealth systems that include health coaching and remote monitoring are making inroads in managing chronic conditions and may be especially suited for older populations. Objective: This literature review aimed to investigate the current status of health coaching interventions incorporating telehealth technology and the associated effectiveness of this intervention to deliver health care with an emphasis on older adults (aged 65 and older). Methods: A literature review was conducted to identify the research conducted on health coaching combined with remote monitoring for delivering health care to older adults. The Ovid MEDLINE and CINAHL databases were queried using a combination of relevant search terms (including middle aged, aged, older adult, elderly, health coaching, and wellness coaching). The search retrieved 196 papers published from January 2010 to September 2019 in English. Following a systematic review process, the titles and abstracts of the papers retrieved were screened for applicability to health coaching for older adults to define a subset for further review. Papers were excluded if the studied population did not include older adults. The full text of the 42 papers in this subset was then reviewed, and 13 papers related to health coaching combined with remote monitoring for older adults were included in this review. Results: Of the 13 studies reviewed, 10 found coaching supported by telehealth technology to provide effective outcomes. Effectiveness outcomes assessed in the studies included hospital admissions/re-admissions, mortality, hemoglobin A1c (HbA1c) level, body weight, blood pressure, physical activity level, fatigue, quality of life, and user acceptance of the coaching program and technology. Conclusions: Telehealth systems that include health coaching have been implemented in older populations as a viable intervention method for managing chronic conditions with mixed results. Health coaching combined with telehealth may be an effective solution for providing health care to older adults. However, health coaching is predominantly performed by human coaches with limited use of technology to augment or replace the human coach. The opportunity exists to expand health coaching to include automated coaching. %M 33512322 %R 10.2196/23796 %U http://humanfactors.jmir.org/2021/1/e23796/ %U https://doi.org/10.2196/23796 %U http://www.ncbi.nlm.nih.gov/pubmed/33512322 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e20322 %T My Diabetes Coach, a Mobile App–Based Interactive Conversational Agent to Support Type 2 Diabetes Self-Management: Randomized Effectiveness-Implementation Trial %A Gong,Enying %A Baptista,Shaira %A Russell,Anthony %A Scuffham,Paul %A Riddell,Michaela %A Speight,Jane %A Bird,Dominique %A Williams,Emily %A Lotfaliany,Mojtaba %A Oldenburg,Brian %+ School of Population and Global Health, The University of Melbourne, 333 Exhibition, Melbourne, Australia, 61 0452389420, egong@student.unimelb.edu.au %K type 2 diabetes mellitus %K self-management %K health-related quality of life %K digital technology %K coaching %K mobile phone %D 2020 %7 5.11.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Delivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health. Objective: This study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months. Methods: This randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA1c) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models. Results: A total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA1c (−0.04%, 95% CI −0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04). Conclusions: The MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users’ HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA1c improvement. Trial Registration: Australia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662 %M 33151154 %R 10.2196/20322 %U https://www.jmir.org/2020/11/e20322 %U https://doi.org/10.2196/20322 %U http://www.ncbi.nlm.nih.gov/pubmed/33151154 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 10 %P e17435 %T Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial %A Cho,So Mi Jemma %A Lee,Jung Hyun %A Shim,Jee-Seon %A Yeom,Hyungseon %A Lee,Su Jin %A Jeon,Yong Woo %A Kim,Hyeon Chang %+ Department of Preventive Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 1873, hckim@yuhs.ac %K metabolic health %K health behavior %K lifestyle modification %K mobile health %D 2020 %7 9.10.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications. Objective: We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting. Methods: In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat. Results: Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean –10.95, SD 2.09 mmHg; app only: mean –7.29, SD 1.83 mmHg; app with personalized coaching: mean –7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean –0.12, SD 0.30 kg; app only: mean –0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean –0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean –0.13, SD 0.34 kg; app only: mean –0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean –0.79, SD 0.38 kg; P=.08). Conclusions: Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention. Trial Registration: ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271 %M 33034564 %R 10.2196/17435 %U https://www.jmir.org/2020/10/e17435 %U https://doi.org/10.2196/17435 %U http://www.ncbi.nlm.nih.gov/pubmed/33034564 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e21195 %T Health Technology Readiness Profiles Among Danish Individuals With Type 2 Diabetes: Cross-Sectional Study %A Thorsen,Ida Kær %A Rossen,Sine %A Glümer,Charlotte %A Midtgaard,Julie %A Ried-Larsen,Mathias %A Kayser,Lars %+ The Centre for Physical Activity Research, University of Copenhagen, Rigshospitalet 7641, Blegdamsvej 9, Copenhagen, DK-2100, Denmark, 45 35 45 76 41, ida.kaer.thorsen@regionh.dk %K readiness for health technology %K telemedicine %K diabetes mellitus, type 2 %K socioeconomic factors %K mental health %K psychological distress %K healthcare disparities %K delivery of healthcare %K exercise %D 2020 %7 15.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Information technologies (IT) are increasingly implemented in type 2 diabetes (T2D) treatment as a resource for remotely supported health care. However, possible pitfalls of introducing IT in health care are generally overlooked. Specifically, the effectiveness of IT to improve health care may depend on the user’s readiness for health technology. Objective: We aim to investigate readiness for health technology in relation to mental well-being, sociodemographic, and disease-related characteristics among individuals with T2D. Methods: Individuals with T2D (aged ≥18 years) who had been referred to self-management education, exercise, diet counseling, smoking cessation, or alcohol counseling completed a questionnaire survey covering (1) background information, (2) the 5-item World Health Organization Well-Being Index (WHO-5), (3) receptiveness to IT use in physical activity, and (4) the Readiness and Enablement Index for Health Technology (READHY), constituted by dimensions related to self-management, social support, and eHealth literacy. Individuals were divided into profiles using cluster analysis based on their READHY scores. Outcomes included differences across profiles in mental well-being, sociodemographic, and disease-related characteristics. Results: Participants in the study were 155 individuals with T2D with a mean age of 60.2 (SD 10.7) years, 55.5% (86/155) of which were men and 44.5% (69/155) of which were women. Participants were stratified into 5 health technology readiness profiles based on the cluster analysis: Profile 1, high health technology readiness; Profile 2, medium health technology readiness; Profile 3, medium health technology readiness and high level of emotional distress; Profile 4, medium health technology readiness and low-to-medium eHealth literacy; Profile 5, low health technology readiness. No differences in sociodemographic and disease-related characteristics were observed across profiles; however, we identified 3 vulnerable subgroups of individuals: Profile 3 (21/155, 13.5%), younger individuals (mean age of 53.4 years, SD 8.9 years) with low mental well-being (mean 42.7, SD 14.7) and emotional distress (mean 1.69, SD 0.38); Profile 4 (20/155, 12.9%), older individuals (mean age 66.3 years, SD 9.0 years) with less IT use (50.0% used IT for communication) and low-to-medium eHealth literacy; and Profile 5 (36/155, 23.2%) with low mental well-being (mean 43.4, SD 20.1) and low readiness for health technology. Conclusions: Implementation of IT in health care of individuals with T2D should be based on comprehensive consideration of mental well-being, emotional distress, and readiness for health technology rather than sociodemographic and disease-related characteristics to identify the individuals in need of social support, self-management education, and extensive IT support. A one-size-fits-all approach to IT implementation in health care will potentially increase the risk of treatment failure among the most vulnerable individuals. %M 32930669 %R 10.2196/21195 %U http://www.jmir.org/2020/9/e21195/ %U https://doi.org/10.2196/21195 %U http://www.ncbi.nlm.nih.gov/pubmed/32930669 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 5 %N 3 %P e15835 %T Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low–Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial %A Saslow,Laura R %A Moskowitz,Judith Tedlie %A Mason,Ashley E %A Daubenmier,Jennifer %A Liestenfeltz,Bradley %A Missel,Amanda L %A Bayandorian,Hovig %A Aikens,James E %A Kim,Sarah %A Hecht,Frederick M %+ Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, 2178 400 North Ingalls Street, Ann Arbor, MI, 48109, United States, 1 7347647836, saslowl@umich.edu %K type 2 diabetes %K diet, ketogenic %K text messages %K self-management %D 2020 %7 9.9.2020 %9 Original Paper %J JMIR Diabetes %G English %X Background: Adults with type 2 diabetes may experience health benefits, including glycemic control and weight loss, from following a very low–carbohydrate, ketogenic (VLC) diet. However, it is unclear which ancillary strategies may enhance these effects. Objective: This pilot study aims to estimate the effect sizes of 3 intervention enhancement strategies (text messages, gifts, and breath vs urine ketone self-monitoring) that may improve outcomes of a 12-month web-based ad libitum VLC diet and lifestyle intervention for adults with type 2 diabetes. The primary intervention also included other components to improve adherence and well-being, including positive affect and mindfulness as well as coaching. Methods: Overweight or obese adults (n=44; BMI 25-45 kg/m2) with type 2 diabetes (glycated hemoglobin [HbA1c] ≥6.5%), who had been prescribed either no glucose-lowering medications or metformin alone, participated in a 12-month web-based intervention. Using a 2×2×2 randomized factorial design, we compared 3 enhancement strategies: (1) near-daily text messages about the intervention’s recommended behaviors (texts n=22 vs no texts n=22), (2) mailed gifts of diet-relevant foods and cookbooks (6 rounds of mailed gifts n=21 vs no gifts n=23), and (3) urine- or breath-based ketone self-monitoring (urine n=21 vs breath n=23). We assessed HbA1c and weight at baseline and at 4, 8, and 12 months. We evaluated whether each strategy exerted a differential impact on HbA1c and weight at 12 months against an a priori threshold of Cohen d of 0.5 or greater. Results: We retained 73% (32/44) of the participants at 12 months. The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up. In intent-to-treat (ITT) analyses, the mean HbA1c reduction was 1.0% (SD 1.6) and the mean weight reduction was 5.3% (SD 6.0), whereas among study completers, these reductions were 1.2% (SD 1.7) and 6.3% (SD 6.4), respectively, all with a P value of less than .001. In ITT analyses, no enhancement strategy met the effect size threshold. Considering only study completers, 2 strategies showed a differential effect size of at least a d value of 0.5 or greater Conclusions: Text messages, gifts of food and cookbooks, and urine-based ketone self-monitoring may potentially enhance the glycemic or weight loss benefits of a web-based VLC diet and lifestyle intervention for individuals with type 2 diabetes. Future research could investigate other enhancement strategies to help create even more effective solutions for the treatment of type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT02676648; http://clinicaltrials.gov/ct2/show/NCT02676648 %M 32902391 %R 10.2196/15835 %U http://diabetes.jmir.org/2020/3/e15835/ %U https://doi.org/10.2196/15835 %U http://www.ncbi.nlm.nih.gov/pubmed/32902391 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 5 %N 3 %P e17794 %T Evaluation of a Text Messaging Intervention to Support Self-Management of Diabetes During Pregnancy Among Low-Income, Minority Women: Qualitative Study %A Yee,Lynn %A Taylor,Shaneah %A Young,Maria %A Williams,Makayla %A Niznik,Charlotte %A Simon,Melissa %+ Northwestern University, 250 E Superior Street, #5-2145, Chicago, IL, 60611, United States, 1 3124724685, lynn.yee@northwestern.edu %K gestational diabetes mellitus %K type 2 diabetes mellitus %K mobile health %K text messaging %K mobile phone %K pregnancy %D 2020 %7 10.8.2020 %9 Original Paper %J JMIR Diabetes %G English %X Background: Given the growing burden of diabetes in underserved communities and the complexity of diabetes self-management during pregnancy, the development of interventions to support low-income pregnant women with diabetes is urgently needed. Objective: This study aims to develop and pilot test a theory-driven curriculum of SMS text messaging for diabetes support and education during pregnancy. Methods: This was a prospective pilot investigation of a novel SMS text messaging intervention offered to pregnant women with pregestational or gestational diabetes mellitus and publicly funded prenatal care. Prior work yielded a conceptual model of diabetes self-management barriers and support factors in this population, which was used to guide curriculum development along with health behavior theories. Participants received three supportive or educational one-way text messages per week during pregnancy. In-depth semistructured interviews were performed at study exit to solicit feedback on the program. Narrative data were analyzed using the constant comparative technique to identify themes and subthemes. Results: Participants (N=31 enrolled and n=26 completed both interviews) consistently reported that SMS text messaging provided enhanced motivation for diabetes self-care, reduced diabetes-related social isolation, increased perceived diabetes-associated knowledge, enhanced comfort with the health care team, and reduced logistical burdens of diabetes during pregnancy. Participants requested enhanced interactive and customizable features in future intervention iterations. Conclusions: Pregnant women with diabetes who were enrolled in this pilot study of an SMS text messaging curriculum for diabetes support described enhanced motivation, knowledge, and comfort with diabetes self-care activities as a result of the health education intervention. The next steps include enriching the interactive features of the intervention and investigating the effect of the intervention on perinatal outcomes. %M 32773367 %R 10.2196/17794 %U http://diabetes.jmir.org/2020/3/e17794/ %U https://doi.org/10.2196/17794 %U http://www.ncbi.nlm.nih.gov/pubmed/32773367 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 5 %N 3 %P e16692 %T User Experiences With a Type 2 Diabetes Coaching App: Qualitative Study %A Baptista,Shaira %A Wadley,Greg %A Bird,Dominique %A Oldenburg,Brian %A Speight,Jane %A , %+ Melbourne School of Population and Global Health, 207 Bouverie Street Carlton, Melbourne, 3051, Australia, 61 3 8344 4037, shaira.baptista@unimelb.edu.au %K type 2 diabetes %K mobile phone %K mobile apps %K mHealth %K smartphone %K self-management %D 2020 %7 17.7.2020 %9 Original Paper %J JMIR Diabetes %G English %X Background: Diabetes self-management apps have the potential to improve self-management in people with type 2 diabetes (T2D). Although efficacy trials provide evidence of health benefits, premature disengagement from apps is common. Therefore, it is important to understand the factors that influence engagement in real-world settings. Objective: This study aims to explore users’ real-world experiences with the My Diabetes Coach (MDC) self-management app. Methods: We conducted telephone-based interviews with participants who had accessed the MDC self-management app via their smartphone for up to 12 months. Interviews focused on user characteristics; the context within which the app was used; barriers and facilitators of app use; and the design, content, and delivery of support within the app. Results: A total of 19 adults with T2D (8/19, 42% women; mean age 60, SD 14 years) were interviewed. Of the 19 interviewees, 8 (42%) had T2D for <5 years, 42% (n=8) had T2D for 5-10 years, and 16% (n=3) had T2D for >10 years. In total, 2 themes were constructed from interview data: (1) the moderating effect of diabetes self-management styles on needs, preferences, and expectations and (2) factors influencing users’ engagement with the app: one size does not fit all. Conclusions: User characteristics, the context of use, and features of the app interact and influence engagement. Promoting engagement is vital if diabetes self-management apps are to become a useful complement to clinical care in supporting optimal self-management. Trial Registration: Australia New Zealand Clinical Trials Registry CTRN126140012296; URL https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366925&isReview=true %M 32706649 %R 10.2196/16692 %U http://diabetes.jmir.org/2020/3/e16692/ %U https://doi.org/10.2196/16692 %U http://www.ncbi.nlm.nih.gov/pubmed/32706649 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e19172 %T Evaluation of the Clinical and Economic Effects of a Primary Care Anchored, Collaborative, Electronic Health Lifestyle Coaching Program in Denmark: Protocol for a Two-Year Randomized Controlled Trial %A Brandt,Carl J %A Christensen,Jeanette Reffstrup %A Lauridsen,Jørgen T %A Nielsen,Jesper Bo %A Søndergaard,Jens %A Sortsø,Camilla %+ Research Unit for General Practice, Department of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9A, Odense, 5000, Denmark, 45 93507088, jrchristensen@health.sdu.dk %K type 2 diabetes management %K digital behavioral coaching %K lifestyle change %K health behavior change %K obesity %K weight loss %K interactive advice %K participant engagement %K quality of life %D 2020 %7 25.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obesity is linked to a number of chronic health conditions, such as type 2 diabetes, heart disease, and cancer, and weight loss interventions are often expensive. Recent systematic reviews concluded that app and web-based interventions can improve lifestyle behaviors and weight loss at a reasonable cost, but long-term sustainability needs to be demonstrated. Objective: This study protocol is for a 2-year randomized controlled trial that aims to evaluate the clinical and economic effects of a primary care, anchored, collaborative, electronic health (eHealth) lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA] 2.0) in obese participants with and without type 2 diabetes. The program’s primary outcome is weight loss. Its secondary outcome is the hemoglobin A1c (HbA1c) level, and its tertiary outcomes are retention rate, quality of life (QOL), and cost effectiveness. Analytically, the focus is on associations of participant characteristics with outcomes and sustainability. Methods: We conduct a multicenter trial with a 1-year intervention and 1-year retention. LIVA 2.0 is implemented in municipalities within administrative regions in Denmark, specifically eight municipalities located within the Region of Southern Denmark and two municipalities located within the Capital Region of Denmark. The participants are assessed at baseline and at 6-, 12-, and 24-month follow-ups. Individual data from the LIVA 2.0 platform are combined with clinical measurements, questionnaires, and participants’ usage of municipality and health care services. The participants have a BMI ≥30 but ≤45 kg/m2, and 50% of the participants have type 2 diabetes. The participants are randomized in an approximately 60:40 manner, and based on sample size calculations on weight loss and intention-to-treat statistics, 200 participants are randomized to an intervention group and 140 are randomized to a control group. The control group is offered the conventional preventive program of the municipality, and it is compared to the intervention group, which follows the LIVA 2.0 in addition to the conventional preventive program. Results: The first baseline assessments have been carried out in March 2018, and the 2-year follow-up will be carried out between March 2020 and April 2021. The hypothesis is that the trial results will demonstrate decreased body weight and that the number of patients who show normalization of their HbA1c levels in the intervention group will be much higher than that in the control group. The participants in the intervention group are also expected to show a greater decrease in their use of glucose-lowering medication and a greater improvement in their QOL when compared with the control group. Operational costs are expected to be lower than standard care, and the intervention is expected to be cost-effective. Conclusions: This is the first time that an app and web-based eHealth lifestyle coaching program implemented in Danish municipalities will be clinically and economically evaluated. If the LIVA 2.0 eHealth lifestyle coaching program is proven to be effective, there is great potential for decreasing the rates of obesity, diabetes, and related chronic diseases. Trial Registration: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915 International Registered Report Identifier (IRRID): DERR1-10.2196/19172 %M 32584260 %R 10.2196/19172 %U http://www.researchprotocols.org/2020/6/e19172/ %U https://doi.org/10.2196/19172 %U http://www.ncbi.nlm.nih.gov/pubmed/32584260 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 6 %P e15478 %T Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial %A Ritchie,Natalie D %A Gutiérrez-Raghunath,Silvia %A Durfee,Michael Josh %A Fischer,Henry %+ Denver Health, 601 Broadway, Denver, CO, 80204, United States, 1 3036022188, natalie.ritchie@dhha.org %K eHealth %K prediabetes %K texting %K weight loss %D 2020 %7 18.6.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: The evidence-based National Diabetes Prevention Program (NDPP) is now widely disseminated, yet strategies to increase its effectiveness are needed, especially for underserved populations. The yearlong program promotes lifestyle changes for weight loss and can be offered in-person, online, via distance learning, or a combination of modalities. Less is known about which delivery features are optimal and may help address disparities in outcomes for subgroups. We previously demonstrated the efficacy of a stand-alone text messaging intervention based on the NDPP (SMS4PreDM) in a randomized controlled trial in a safety net health care system. Upon broader dissemination, we then showed that SMS4PreDM demonstrated high retention and modest weight loss at a relatively low cost, suggesting the potential to improve in-person NDPP delivery. Objective: In this study, we aim to compare the effectiveness of in-person NDPP classes with and without supplementary SMS4PreDM on attendance and weight loss outcomes to determine whether text messaging can enhance in-person NDPP delivery for a safety net patient population. Methods: From 2015 to 2017, patients with diabetes risks were identified primarily from provider referrals and enrolled in NDPP classes, SMS4PreDM, or both per their preference and availability. Participants naturally formed three groups: in-person NDPP with SMS4PreDM (n=236), in-person NDPP alone (n=252), and SMS4PreDM alone (n=285). This analysis compares the first two groups to evaluate whether supplemental text messaging may improve in-person NDPP outcomes. Outcomes for SMS4PreDM-only participants were previously reported. NDPP classes followed standard delivery guidelines, including weekly-to-monthly classes over a year. SMS4PreDM delivery included messages promoting lifestyle change and modest weight loss, sent 6 days per week for 12 months. Differences in characteristics between intervention groups were assessed using chi-square and t tests. Differences in NDPP attendance and weight loss outcomes were analyzed with multivariable linear and logistic regressions. Results: The mean age was 50.4 years (SD 13.9). Out of a total of 488 participants, 76.2% (n=372) were female and 59.0% (n=288) were Hispanic. An additional 17.2% (n=84) were non-Hispanic white and 12.9% (n=63) were non-Hispanic black. A total of 48.4% (n=236) of participants elected to receive supplemental text message support in addition to NDPP classes. Participants who chose supplemental text message support were on average 5.7 (SD 1.2) years younger (P<.001) than the 252 participants who preferred in-person classes alone. Relatively more women and Hispanic individuals enrolled in the NDPP with supplemental text messages than in NDPP classes alone, 83.9% (n=198) vs 69.0% (n=174, P<.001) and 68.6% (n=162) vs 50.0% (n=126, P=.001), respectively. Attendance and weight loss outcomes were comparable between groups. Conclusions: Despite its appeal among priority populations, supplemental text messaging did not significantly increase attendance and weight loss for the in-person NDPP. Further research is needed to identify optimal strategies to improve the effectiveness of the NDPP. %M 32554385 %R 10.2196/15478 %U http://mhealth.jmir.org/2020/6/e15478/ %U https://doi.org/10.2196/15478 %U http://www.ncbi.nlm.nih.gov/pubmed/32554385 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 4 %P e15397 %T Spoken Animated Self-Management Video Messages Aimed at Improving Physical Activity in People With Type 2 Diabetes: Development and Interview Study %A van het Schip,Colette %A Cheung,Kei Long %A Vluggen,Stan %A Hoving,Ciska %A Schaper,Nicolaas C %A de Vries,Hein %+ Caphri School of Public Health and Primary Care, Health Promotion, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433882410, hein.devries@maastrichtuniversity.nl %K diabetes mellitus, type 2 %K internet-based intervention %K telemedicine %K computer tailoring %K self-management %K exercise %K animation %K health literacy %D 2020 %7 23.4.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based tailored interventions are a promising approach to help people with type 2 diabetes successfully adopt regular physical activity. Spoken animation seems to be effective regardless of the characteristics of the user and may be a relevant strategy to communicate complex health information Objective: The objectives of our study were to evaluate (1) pretesting communication elements and user appreciation, and (2) the applied behavior change techniques of the previously designed spoken animated video messages in a tailored self-management program for people with type 2 diabetes. Methods: We conducted semistructured interviews with patients with type 2 diabetes recruited from general practices located in different socioeconomic status urban neighborhoods. Based on the pretesting key communication elements of Salazar’s model, we asked participants about the spoken animated video messages’ attractiveness, comprehensibility, acceptance, believability, involvement, and relevance and to what extent the video messages motivated them to become more physically active. We also assessed participants’ intention to use the spoken animated video messages and to recommend them to others. To evaluate participants’ appreciation of the different applied behavior change techniques, we conducted a post hoc analysis of the qualitative data using the MAXQDA program. Transcripts were coded by 2 coders using iterative qualitative content analysis methods to uncover key health communication issues. Results: Of 23 patients who expressed an interest in participating, 17 met the inclusion criteria and 15 took part in the interviews. The positive appreciation of the comprehensibility, believability, and personalization was supported by participants’ statements on behavior change techniques and other communication elements. Reinforcement of and feedback on participants’ answers were positively evaluated as was the simplicity and concreteness of the spoken animated video messages. Most participants indicated reasons for not feeling motivated to increase their physical activity level, including being already sufficiently physically active and the presence of other impeding health factors. Conclusions: Spoken animated video messages should be simple, short, concrete, and without the use of medical terminology. Providing positive reinforcement, feedback on participants’ answers, examples that match user characteristics, and the possibility to identify with the animation figures will enhance involvement in the health message. To connect more with patients’ needs and thereby increase the perceived relevance of and motivation to use an animated video program, we suggest offering the program soon after diabetes mellitus is diagnosed. We recommend piloting behavior change techniques to identify potential resistance. %M 32324138 %R 10.2196/15397 %U http://www.jmir.org/2020/4/e15397/ %U https://doi.org/10.2196/15397 %U http://www.ncbi.nlm.nih.gov/pubmed/32324138 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 3 %P e15709 %T Impact of Motivational Interviewing on Self-Management in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial %A Wong,Man Kin %A Cheng,Sai Yip Ronald %A Chu,Tsun Kit %A Lam,Fung Yee %A Lai,Shiu Kee %A Wong,Kai Chung %A Liang,Jun %+ Department of Family Medicine and Primary Health Care, Tuen Mun Hospital, New Territories West Cluster, 23 Tsing Chung Koon Road, Tuen Mun,, New Territories, Hong Kong, 852 24685111, man_kin1130@yahoo.com.hk %K motivational interviewing %K diabetes %K nurse %K usual care %K self-management %K self-care %D 2020 %7 31.3.2020 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The nonpharmacological approach to diabetic control in patients with diabetes focuses on a healthy diet, physical activity, and self-management. Therefore, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns and include brief advice and counseling services. Within this context, motivational interviewing (MI) has proven to be effective in changing health behaviors for specific cases. However, stronger evidence is needed on the effectiveness of MI in treating chronic pathologies such as diabetes. Objective: This study will obtain preliminary data on the impact of a nurse-led MI intervention in improving glycemic control, as well as clinical, psychosocial, and self-care outcomes for individuals with type 2 diabetes mellitus when compared with usual care, with the aim of improving diabetic control in patients with diabetes. Methods: An open, two-arm, parallel, randomized controlled, pilot exploratory trial will be performed. Two government outpatient clinics in the New Territories West Cluster in Hong Kong will be involved. In total, 20 to 25 participants will be invited in each arm. Intervention participants will receive face-to-face MI interventions in addition to their usual care from the clinic. Control participants will only receive usual care. Outcomes are assessed at baseline, 6 months, and 12 months. The primary outcome measure is glycated hemoglobin levels. Secondary outcomes include blood pressure, BMI, hip and waist circumference, fasting blood, and psychosocial and self-care measures. Results: This study is currently underway with funding support from the Hong Kong College of Family Physician Research Seed Fund 2017. Conclusions: MI skills constitute the main strategies primary care nurses use on their patients. Having economical, simple, effective, and applicable techniques is essential for primary care professionals to help their patients change their lifestyle and improve their health. This study will provide scientific evidence on the effectiveness of MI. It will be performed with strict control over the data collection, ensuring the maintenance of therapeutic integrity. Trial Registration: Centre for Clinical Research and Biostatistics CUHK_CCRB00614; https://tinyurl.com/v9awzk6 International Registered Report Identifier (IRRID): DERR1-10.2196/15709 %M 32229475 %R 10.2196/15709 %U http://www.researchprotocols.org/2020/3/e15709/ %U https://doi.org/10.2196/15709 %U http://www.ncbi.nlm.nih.gov/pubmed/32229475 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 3 %N 1 %P e15995 %T Actual Use of Multiple Health Monitors Among Older Adults With Diabetes: Pilot Study %A Zheng,Yaguang %A Weinger,Katie %A Greenberg,Jordan %A Burke,Lora E %A Sereika,Susan M %A Patience,Nicole %A Gregas,Matt C %A Li,Zhuoxin %A Qi,Chenfang %A Yamasaki,Joy %A Munshi,Medha N. %+ School of Nursing, University of Pittsburgh, 360D Victoria Building, Pittsburgh, PA, 15261, United States, 1 4126242305, yaz100@pitt.edu %K mobile health %K aged %K lifestyle %K self-management %K diabetes mellitus, type 2 %D 2020 %7 23.3.2020 %9 Original Paper %J JMIR Aging %G English %X Background: Previous studies have reported older adults’ perceptions of using health monitors; however, no studies have examined the actual use of multiple health monitors for lifestyle changes over time among older adults with type 2 diabetes (T2D). Objective: The primary aim of this study was to examine the actual use of multiple health monitors for lifestyle changes over 3 months among older adults with T2D. The secondary aim was to explore changes in caloric intake and physical activity (PA) over 3 months. Methods: This was a single-group study lasting 3 months. The study sample included participants who were aged ≥65 years with a diagnosis of T2D. Participants were recruited through fliers posted at the Joslin Diabetes Center in Boston. Participants attended five 60-min, biweekly group sessions, which focused on self-monitoring, goal setting, self-regulation to achieve healthy eating and PA habits, and the development of problem-solving skills. Participants were provided with the Lose It! app to record daily food intake and devices such as a Fitbit Alta for monitoring PA, a Bluetooth-enabled blood glucose meter, and a Bluetooth-enabled digital scale. Descriptive statistics were used for analysis. Results: Of the enrolled participants (N=9), the sample was white (8/9, 89%) and female (4/9, 44%), with a mean age of 76.4 years (SD 6.0; range 69-89 years), 15.7 years (SD 2.0) of education, 33.3 kg/m2 (SD 3.1) BMI, and 7.4% (SD 0.8) hemoglobin A1c. Over the 84 days of self-monitoring, the mean percentage of days using the Lose It!, Fitbit Alta, blood glucose meter, and scale were 82.7 (SD 17.6), 85.2 (SD 19.7), 65.3 (SD 30.1), and 53.0 (SD 34.5), respectively. From baseline to completion of the study, the mean daily calorie intake was 1459 (SD 661) at week 1, 1245 (SD 554) at week 11, and 1333 (SD 546) at week 12, whereas the mean daily step counts were 5618 (SD 3654) at week 1, 5792 (SD 3814) at week 11, and 4552 (SD 3616) at week 12. The mean percentage of weight loss from baseline was 4.92% (SD 0.25). The dose of oral hypoglycemic agents or insulin was reduced in 55.6% (5/9) of the participants. Conclusions: The results from the pilot study are encouraging and suggest the need for a larger study to confirm the outcomes. In addition, a study design that includes a control group with educational sessions but without the integration of technology would offer additional insight to understand the value of mobile health in behavior changes and the health outcomes observed during this pilot study. %M 32202506 %R 10.2196/15995 %U http://aging.jmir.org/2020/1/e15995/ %U https://doi.org/10.2196/15995 %U http://www.ncbi.nlm.nih.gov/pubmed/32202506 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 5 %N 1 %P e15030 %T Novel Digital Architecture of a “Low Carb Program” for Initiating and Maintaining Long-Term Sustainable Health-Promoting Behavior Change in Patients with Type 2 Diabetes %A Summers,Charlotte %A Curtis,Kristina %+ Diabetes Digital Media, Technology House, Sir William Lyons Road,, University of Warwick Science Park, Coventry, CV4 7EZ, United Kingdom, 44 07969091134, Charlotte@ddm.health %K type 2 diabetes %K behaviour change %K nutrition %K digital intervention %K low carb %K type 2 diabetes remission %K eHealth %D 2020 %7 4.3.2020 %9 Viewpoint %J JMIR Diabetes %G English %X Globally, the burden of noncommunicable diseases such as type 2 diabetes is crippling health care systems. Type 2 diabetes, a disease linked with obesity, affects 1 in every 30 people today and is expected to affect 1 in 10 people by 2030. Current provisions are struggling to manage the trajectory of type 2 diabetes prevalence. Offline, face-to-face education for patients with type 2 diabetes has shown to lack long-term impact or the capacity for widespread democratized adoption. Digitally delivered interventions have been developed for patients with type 2 diabetes, and the evidence shows that some interventions provide the capacity to support hyperpersonalization and real-time continuous support to patients, which can result in significant engagement and health outcomes. However, digital health app engagement is notoriously difficult to achieve. This paper reviews the digital behavior change architecture of the Low Carb Program and the application of health behavioral theory underpinning its development and use in scaling novel methods of engaging the population with type 2 diabetes and supporting long-term behavior change. %M 32130113 %R 10.2196/15030 %U http://diabetes.jmir.org/2020/1/e15030/ %U https://doi.org/10.2196/15030 %U http://www.ncbi.nlm.nih.gov/pubmed/32130113 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 3 %P e16665 %T Nurse Coaching and Mobile Health Compared With Usual Care to Improve Diabetes Self-Efficacy for Persons With Type 2 Diabetes: Randomized Controlled Trial %A Young,Heather M %A Miyamoto,Sheridan %A Dharmar,Madan %A Tang-Feldman,Yajarayma %+ Betty Irene Moore School of Nursing, University of California, Davis, 2570 48th St, Sacramento, CA, 95817, United States, 1 916 734 8558, hmyoung@ucdavis.edu %K mHealth %K electronic health record %K type 2 diabetes %K motivational interviewing %D 2020 %7 2.3.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Type 2 diabetes is a growing public health problem amenable to prevention and health promotion. As healthy behaviors have an impact on disease outcomes, approaches to support and sustain diabetes self-management are vital. Objective: This study aimed to evaluate the effectiveness of a nurse coaching program using motivational interviewing paired with mobile health (mHealth) technology on diabetes self-efficacy and self-management for persons with type 2 diabetes. Methods: This randomized controlled trial compared usual care with an intervention that entailed nurse health coaching and mHealth technology to track patient-generated health data and integrate these data into an electronic health record. The inclusion criteria were as follows: (1) enrolled at 1 of 3 primary care clinics, (2) aged 18 years or above, (3) living with type 2 diabetes, and (4) English-speaking. We collected outcome measures at baseline, 3 months, and 9 months. The primary outcome was diabetes self-efficacy; secondary outcomes were depressive symptoms, perceived stress, physical functioning, and emotional distress and anxiety. Linear regression mixed modeling estimated the population trends and individual differences in change. Results: We enrolled 319 participants; 287 participants completed the study (155 control and 132 intervention). The participants in the intervention group had significant improvements in diabetes self-efficacy (Diabetes Empowerment Scale, 0.34; 95% CI –0.15,0.53; P<.01) and a decrease in depressive symptoms compared with usual care at 3 months (Patient Health Questionnaire-9; 0.89; 95% CI 0.01-1.77; P=.05), with no differences in the other outcomes. The differences in self-efficacy and depression scores between the 2 arms at 9 months were not sustained. The participants in the intervention group demonstrated a significant increase in physical activity (from 23,770 steps per week to 39,167 steps per week at 3 months and 32,601 per week at 9 months). Conclusions: We demonstrated the short-term effectiveness of this intervention; however, by 9 months, although physical activity remained above the baseline, the improvements in self-efficacy were not sustained. Further research should evaluate the minimum dose of coaching required to continue progress after active intervention and the potential of technology to provide effective ongoing automated reinforcement for behavior change. Trial Registration: ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 %M 32130184 %R 10.2196/16665 %U https://mhealth.jmir.org/2020/3/e16665 %U https://doi.org/10.2196/16665 %U http://www.ncbi.nlm.nih.gov/pubmed/32130184 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 5 %N 1 %P e15189 %T Effectiveness of a Digital Lifestyle Change Program in Obese and Type 2 Diabetes Populations: Service Evaluation of Real-World Data %A Idris,Iskandar %A Hampton,James %A Moncrieff,Fiona %A Whitman,Michael %+ OurPath, 56 Wood Lane, London, W12 7SB, United Kingdom, 44 07545478086, michael.whitman@ourpath.co.uk %K weight loss %K mHealth %K type 2 diabetes %K OurPath %K obesity %K dietetics %K cognitive behavioral therapy %K empowerment %K well-being %K mobile app %K behavior change %K prevention %K digital %D 2020 %7 20.1.2020 %9 Original Paper %J JMIR Diabetes %G English %X Background: The prevalence of type 2 diabetes mellitus (T2DM) and obesity is increasing, and the way people interact with health care is evolving. People traditionally access advice and support to improve their lifestyle and learn more about the self-management of T2DM in a face-to-face setting. Although these services have a strong evidence base, they have limitations for reaching specific groups of people. Digital programs could provide a new delivery model to help more people access health education and behavior change support, but long-term data supporting these programs are limited. Objective: The purpose of this service evaluation was to analyze the weight change of people who participated in OurPath (also known as Second Nature), a UK-based digital lifestyle change program, for either weight management or diabetes-related weight management and structured education at 6 and 12 months. Methods: Participants either paid to access the program privately (self-funded clients) or were referred by their general practitioner to participate in the program free of charge (funded by the National Health Service). Additional follow-up support was provided to help people to maintain lifestyle changes. To retrospectively assess potential weight loss, the analysis included data from participants who submitted weight readings at baseline and 6 and 12 months after starting the program. Changes in weight after 6 and 12 months were primary outcome measures. Results: For the 896 participants who submitted baseline and 6- and 12-month data, a significant change in mean weight of −7.12 kg (−7.50%; SD 6.37; P<.001) was observed at 6 months. Data from the same participants at 12 months showed a change in mean weight when compared with a baseline of −6.14 kg (−6.48%; SD 6.97; P<.001). Conclusions: The data presented here had several limitations, and there were too many uncertainties to make any reliable conclusions. However, these results suggest that digital lifestyle change programs could provide a new way to help people to access nutritional advice and support to achieve weight loss. Further research into digital education and coaching platforms is needed to establish their effectiveness. %M 31958064 %R 10.2196/15189 %U http://diabetes.jmir.org/2020/1/e15189/ %U https://doi.org/10.2196/15189 %U http://www.ncbi.nlm.nih.gov/pubmed/31958064 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 12 %P e14647 %T Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial %A Alshehri,Mohammed M %A Alenazi,Aqeel M %A Hoover,Jeffrey C %A Alothman,Shaima A %A Phadnis,Milind A %A Rucker,Jason L %A Befort,Christie A %A Miles,John M %A Kluding,Patricia M %A Siengsukon,Catherine F %+ University of Kansas Medical Center, 8546 Caenen Lake Court, Lenexa, KS, 66215, United States, 1 4125512333, phdalshehri@gmail.com %K insomnia %K type 2 diabetes %K cognitive behavioral therapy %K sleep variability %K self-care %K fatigue %D 2019 %7 19.12.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Insomnia symptoms are a common form of sleep difficulty among people with type 2 diabetes (T2D) affecting sleep quality and health outcomes. Several interventional approaches have been used to improve sleep outcomes in people with T2D. Nonpharmacological approaches, such as cognitive behavioral therapy for insomnia (CBT-I), show promising results regarding safety and sustainability of improvements, although CBT-I has not been examined in people with T2D. Promoting sleep for people with insomnia and T2D could improve insomnia severity and diabetes outcomes. Objective: The objective of this study is to establish a protocol for a pilot randomized controlled trial (RCT) to examine the effect of 6 sessions of CBT-I on insomnia severity (primary outcome), sleep variability, and other health-related outcomes in individuals with T2D and insomnia symptoms. Methods: This RCT will use random mixed block size randomization with stratification to assign 28 participants with T2D and insomnia symptoms to either a CBT-I group or a health education group. Outcomes including insomnia severity; sleep variability; diabetes self-care behavior (DSCB); glycemic control (A1c); glucose level; sleep quality; daytime sleepiness; and symptoms of depression, anxiety, and pain will be gathered before and after the 6-week intervention. Chi-square and independent t tests will be used to test for between-group differences at baseline. Independent t tests will be used to examine the effect of the CBT-I intervention on change score means for insomnia severity, sleep variability, DSCB, A1c, fatigue, sleep quality, daytime sleepiness, and severity of depression, anxiety, and pain. For all analyses, alpha level will be set at .05. Results: This study recruitment began in February 2019 and was completed in September 2019. Conclusions: The intervention, including 6 sessions of CBT-I, will provide insight about its effect in improving insomnia symptoms, sleep variability, fatigue, and diabetes-related health outcomes in people with T2D and those with insomnia symptoms when compared with control. Trial Registration: ClinicalTrials.gov NCT03713996; https://clinicaltrials.gov/ct2/show/NCT03713996 International Registered Report Identifier (IRRID): DERR1-10.2196/14647 %M 31855189 %R 10.2196/14647 %U https://www.researchprotocols.org/2019/12/e14647 %U https://doi.org/10.2196/14647 %U http://www.ncbi.nlm.nih.gov/pubmed/31855189 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 11 %P e14180 %T Remotely Monitored Gamification and Social Incentives to Improve Glycemic Control Among Adults With Uncontrolled Type 2 Diabetes (iDiabetes): Protocol for a Randomized Controlled Trial %A Fortunato,Michael %A Harrison,Joseph %A Oon,Ai Leen %A Small,Dylan %A Hilbert,Victoria %A Rareshide,Charles %A Patel,Mitesh %+ University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, 19103, United States, 1 12158983367, mpatel@pennmedicine.upenn.edu %K behavioral economics %K gamification %K social incentives %K diabetes %K glycemic control weight %K physical activity %K remote monitoring %K wearable devices %D 2019 %7 20.11.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 2 diabetes is a significant cause of morbidity and mortality in the United States. Lifestyle modifications including increasing physical activity and losing weight have been demonstrated to improve glycemic control. However, most patients struggle to make these changes. Many stakeholders are interested in using gamification and social incentives to increase engagement in healthy behaviors. However, these approaches often do not appropriately leverage insights from behavioral economics that could be used to address predictable barriers to behavior change. Objective: This study aimed to describe the protocol for the Influencing DIabetics to Adapt Behaviors related to Exercise and weighT by Enhancing Social incentives (iDiabetes) trial, which aimed to evaluate the effectiveness of gamification interventions that leverage insights from behavioral economics to enhance supportive, competitive, or collaborative social incentives to improve glycemic control, promote weight loss, and increase physical activity among overweight and obese adults with type 2 diabetes. Methods: We are conducting a one-year four-arm randomized controlled trial of 361 overweight and obese patients with type 2 diabetes and a glycated hemoglobin (HbA1c) level ≥8.0. Wireless weight scales and wearable devices are provided to remotely monitor weight and physical activity and transmit data to the study team. Patients are recruited by email, following which they establish a baseline measure of weight, daily step count, HbA1c level, and low-density lipoprotein cholesterol level and then repeat these measures at 6 and 12 months. The control arm receives no other interventions. Patients randomized to one of the three intervention arms are entered into a game designed using insights from behavioral economics to enhance supportive, competitive, or collaborative social incentives. To examine predictors of strong or poor performance, participants completed validated questionnaires on a range of areas including their personality, risk preferences, and social network. Results: Enrollment of 361 patients was completed in January 2019. Results are expected in 2020. Conclusions: The iDiabetes trial represents a scalable model to remotely monitor the daily health behaviors of adults with type 2 diabetes. Results from this trial will help provide insights into how to improve management of patients with type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT02961192; https://clinicaltrials.gov/ct2/show/NCT02961192 International Registered Report Identifier (IRRID): DERR1-10.2196/14180 %M 31746765 %R 10.2196/14180 %U http://www.researchprotocols.org/2019/11/e14180/ %U https://doi.org/10.2196/14180 %U http://www.ncbi.nlm.nih.gov/pubmed/31746765 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 10 %P e13674 %T Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus %A Abu-Saad,Kathleen %A Murad,Havi %A Barid,Rivka %A Olmer,Liraz %A Ziv,Arnona %A Younis-Zeidan,Nuha %A Kaufman-Shriqui,Vered %A Gillon-Keren,Michal %A Rigler,Shmuel %A Berchenko,Yakir %A Kalter-Leibovici,Ofra %+ Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Ramat Gan, 52621, Israel, 972 526896782, kathleena@gertner.health.gov.il %K diabetes mellitus, type 2 %K diabetes-related dietary knowledge %K lifestyle %K software %K culturally congruent care %K ethnic minorities %D 2019 %7 16.10.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Ethnic minority populations exhibit disproportionately high rates of type 2 diabetes mellitus (T2DM). Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM). Objective: This study aimed (1) to develop an adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling among low-socioeconomic status (SES) ethnic minority patients with T2DM and (2) to evaluate its effect on DM-related dietary knowledge and management compared with standard lifestyle advice (SLA) in a randomized controlled trial (RCT). Methods: The I-ACE software, developed in consultation with clinical dieticians, incorporates evidence-based dietary and physical activity (PA) recommendations and educational materials. The features and behavioral change techniques include quantitative lifestyle (dietary intake and PA) assessment and simulation, individually tailored education and recommendations, motivational interviewing, and goal setting. For the unblinded pilot RCT, 50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics and randomly assigned to receive 4 in-person, dietician-delivered counseling sessions over 6 months using either (1) the I-ACE tool (experimental arm) or (2) the SLA methods (comparison arm). All outcome assessments were face-to-face. DM-related dietary knowledge (primary outcome) was measured at baseline, 3, 6, and 12 months. Lifestyle and other parameters were measured before, during, and after the intervention. Multiple linear regression and repeated measures linear mixed models were used to compare the changes in study outcomes and explore time trends in between-group and within-group changes. Results: A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively. DM-related lifestyle knowledge increased more rapidly in the I-ACE arm than in the SLA arm (P value for study arm×time interaction=.02). Within the I-ACE arm, the mean (SE) differences in added sugar and dietary fiber intakes from baseline to 12 months were −2.6% (SE 1.0%) of total energy (P=.03) and 2.7 (SE 0.0) g/1000 kcal (P=.003), respectively. The odds of engaging in any leisure PA at 12 months tended to be higher in the I-ACE arm versus SLA arm, but did not reach statistical significance (odds ratio 2.8; 95% CI 0.7-11.6; P=.16). Both arms exhibited significant reductions in HbA1c (P value for change over time <.001). Conclusions: The use of the I-ACE software in a 6-month, 4-session dietician-delivered lifestyle counseling intervention improved the efficiency of lifestyle education, compared with SLA, among low-SES, ethnic minority patients with T2DM. This pilot trial provides justification for conducting a large-scale trial to evaluate its effectiveness and applicability in routine clinical care among ethnically diverse populations. Trial Registration: ClinicalTrials.gov NCT01858506; https://clinicaltrials.gov/ct2/show/NCT01858506. %M 31621640 %R 10.2196/13674 %U https://www.jmir.org/2019/10/e13674 %U https://doi.org/10.2196/13674 %U http://www.ncbi.nlm.nih.gov/pubmed/31621640 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 9 %P e12956 %T Effects of Mobile Health Prompts on Self-Monitoring and Exercise Behaviors Following a Diabetes Prevention Program: Secondary Analysis From a Randomized Controlled Trial %A MacPherson,Megan M %A Merry,Kohle J %A Locke,Sean R %A Jung,Mary E %+ School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, 3333 University Way, Kelowna, BC, V1V 1V7, Canada, 1 2508079670, mary.jung@ubc.ca %K self-monitoring %K health behavior %K prompts %K mHealth %K mobile apps %K exercise %K high-intensity interval training %K reminder system %D 2019 %7 05.09.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: A number of mobile health (mHealth) apps exist that focus specifically on promoting exercise behavior. To increase user engagement, prompts, such as text messages, emails, or push notifications, are often used. To date, little research has been done to understand whether, and for how long, these prompts influence exercise behavior. Objective: This study aimed to assess the impact of prompts on mHealth self-monitoring and self-reported exercise in the days following a prompt and whether these effects differ based on exercise modality. Methods: Of the possible 99 adults at risk for developing type II diabetes who participated in a diabetes prevention program, 69 were included in this secondary analysis. Participants were randomly assigned to 1 of the following 2 exercise conditions: high-intensity interval training or moderate-intensity continuous training. In the year following a brief, community-based diabetes prevention program involving counseling and supervised exercise sessions, all participants self-monitored their daily exercise behaviors on an mHealth app in which they were sent personalized prompts at varying frequencies. mHealth self-monitoring and self-reported exercise data from the app were averaged over 1, 3, 5, and 7 days preceding and following a prompt and subsequently compared using t tests. Results: In the year following the diabetes prevention program, self-monitoring (t68=6.82; P<.001; d=0.46) and self-reported exercise (t68=2.16; P=.03; d=0.38) significantly increased in the 3 days following a prompt compared with the 3 days preceding. Prompts were most effective in the first half of the year, and there were no differences in self-monitoring or self-reported exercise behaviors between exercise modalities (P values >.05). In the first half of the year, self-monitoring was significant in the 3 days following a prompt (t68=8.61; P<.001; d=0.60), and self-reported exercise was significant in the 3 days (t68=3.7; P<.001; d=0.37), 5 days (t67=2.15; P=.04; d=0.14), and 7 days (t68=2.46; P=.02; d=0.15) following a prompt, whereas no significant changes were found in the second half of the year. Conclusions: This study provides preliminary evidence regarding the potential influence of prompts on mHealth self-monitoring and self-reported exercise and the duration for which prompts may be effective as exercise behavior change tools. Future studies should determine the optimal prompting frequency for influencing self-reported exercise behaviors. Optimizing prompt frequency can potentially reduce intervention costs and promote user engagement. Furthermore, it can encourage consumers to self-monitor using mHealth technology while ensuring prompts are sent when necessary and effective. International Registered Report Identifier (IRRID): DERR2-10.2196/11226 %M 31489842 %R 10.2196/12956 %U http://mhealth.jmir.org/2019/9/e12956/ %U https://doi.org/10.2196/12956 %U http://www.ncbi.nlm.nih.gov/pubmed/31489842 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e13363 %T Efficacy of a Self-Regulation–Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials %A Poppe,Louise %A De Bourdeaudhuij,Ilse %A Verloigne,Maïté %A Shadid,Samyah %A Van Cauwenberg,Jelle %A Compernolle,Sofie %A Crombez,Geert %+ Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, Ghent,, Belgium, 32 9 264 63 63, louise.poppe@ugent.be %K eHealth %K mHealth %K physical activity %K type 2 diabetes %K self-regulation %D 2019 %7 02.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Adopting an active lifestyle plays a key role in the prevention and management of chronic diseases such as type 2 diabetes mellitus (T2DM). Web-based interventions are able to alter health behaviors and show stronger effects when they are informed by a behavior change theory. MyPlan 2.0 is a fully automated electronic health (eHealth) and mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA). Objective: This study aimed to test the short-term effect of MyPlan 2.0 in altering levels of PA and SB and in changing personal determinants of behavior in adults with T2DM and in adults aged ≥50 years. Methods: The study comprised two randomized controlled trials (RCTs) with an identical design. RCT 1 was conducted with adults with T2DM. RCT 2 was performed in adults aged ≥50 years. Data were collected via face-to-face assessments. The participants decided either to increase their level of PA or to decrease their level of SB. The participants were randomly allocated with a 2:1 ratio to the intervention group or the waiting-list control group. They were not blinded for their group allocation. The participants in the intervention group were instructed to go through MyPlan 2.0, comprising 5 sessions with an interval of 1 week between each session. The primary outcomes were objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts). Secondary outcomes were self-reported behavioral determinants for PA and SB (eg, self-efficacy). Separate linear mixed models were performed to analyze the effects of MyPlan 2.0 in the two samples. Results: In RCT 1 (n=54), the PA intervention group showed, in contrast to the control group, a decrease in self-reported time spent sitting (P=.09) and an increase in accelerometer-measured moderate (P=.05) and moderate-to-vigorous PA (P=.049). The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005). A total of 14 participants of RCT 1 dropped out. In RCT 2 (n=63), the PA intervention group showed an increase for self-reported total PA in comparison with the control group (P=.003). Furthermore, in contrast to the control group, the SB intervention group decreased their self-reported time spent sitting (P=.08) and increased their accelerometer-assessed moderate (P=.06) and moderate-to-vigorous PA (P=.07). A total of 8 participants of RCT 2 dropped out. Conclusions: For both the samples, the HAPA-based eHealth and mHealth intervention, MyPlan 2.0, was able to improve only some of the primary outcomes. Trial Registration: ClinicalTrials.gov NCT03291171; http://clinicaltrials.gov/ct2/show/NCT03291171. ClinicalTrials.gov NCT03799146; http://clinicaltrials.gov/ct2/show/NCT03799146. International Registered Report Identifier (IRRID): RR2-10.2196/12413 %M 31376274 %R 10.2196/13363 %U https://www.jmir.org/2019/8/e13363/ %U https://doi.org/10.2196/13363 %U http://www.ncbi.nlm.nih.gov/pubmed/31376274 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 4 %N 2 %P e13857 %T Web-Based Benefit-Finding Writing for Adults with Type 1 or Type 2 Diabetes: Preliminary Randomized Controlled Trial %A Crawford,Joanna %A Wilhelm,Kay %A Proudfoot,Judy %+ Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick, NSW, Sydney, 2031, Australia, 61 2 9382 8310, joanna.crawford@blackdog.org.au %K diabetes %K adult %K distress %K benefit-finding %K depression %K anxiety %K emotions %K internet %K writing %K surveys and questionnaires %K treatment outcome %D 2019 %7 27.06.2019 %9 Original Paper %J JMIR Diabetes %G English %X Background: The high prevalence of diabetes distress and subclinical depression in adults with type 1 and type 2 diabetes mellitus (T1DM and T2DM, respectively) indicates the need for low-intensity self-help interventions that can be used in a stepped care approach to address some of their psychological needs. However, people with diabetes can be reluctant to engage in mental health care. Benefit-finding writing (BFW) is a brief intervention that involves writing about any positive thoughts and feelings concerning a stressful experience such as an illness, avoiding potential mental health stigma. It has been associated with increases in positive affect and positive growth and has demonstrated promising results in trials in other clinical populations. However, BFW has not been examined in people with diabetes. Objective: This study aimed to evaluate the efficacy of a Web-based BFW intervention for reducing diabetes distress and increasing benefit finding in diabetic adults with T1DM or T2DM compared to a control writing condition. Methods: Adults with T1DM or T2DM and diabetes distress were recruited online through the open access Writing for Health program. After completing baseline questionnaires, they were randomly allocated to receive online BFW or an active control condition of online writing about the use of time (CW). Both groups completed 15-minute online writing sessions, once per day, for 3 consecutive days. Online measures were administered at baseline, 1 month, and 3 months postintervention. Participants were also asked to rate their current mood immediately prior to and following each writing session. Results: Seventy-two adults with T1DM or T2DM were recruited and randomly allocated to receive BFW (n=24) or CW (n=48). Participants adhered to the BFW regimen. Greater increases in positive affect immediately postwriting were found in the BFW group than in the CW group. However, there were no significant group-by-time interactions (indicating intervention effects) for benefit finding or diabetes distress at either the 1-month or 3-month follow-up. Both the BFW and CW groups demonstrated small, significant decreases in diabetes distress over time. Conclusions: BFW was well tolerated by adults with diabetes in this study but did not demonstrate efficacy in improving diabetes distress or benefit finding compared to an active control writing condition. However, due to recruitment difficulties, the study was underpowered and the sample was skewed to individuals with minimal diabetes distress and none to minimal depression and anxiety at baseline. Future research should continue to investigate the efficacy of variants of therapeutic writing for adults with T1DM or T2DM, using larger samples of participants with elevated diabetes distress. Trial Registration: Australiand New Zealand Clinical Trials Registry ACTRN12615000241538; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368146 %M 31250827 %R 10.2196/13857 %U http://diabetes.jmir.org/2019/2/e13857/ %U https://doi.org/10.2196/13857 %U http://www.ncbi.nlm.nih.gov/pubmed/31250827 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e12166 %T Coaching and Education for Diabetes Distress (CEDD): Protocol for a Randomized Controlled Trial %A Chima,Charles C %A Salemi,Jason L %A Sidani,Mohamad A %A Zoorob,Roger J %+ Department of Population Health Science, John D Bower School of Population Health, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS, 39216, United States, 1 601 815 9544, cchima@umc.edu %K diabetes mellitus, type 2 %K diabetes distress %K coaching %K health coaching %K counselling %K self care %K behavioral medicine %K health psychology %K health education %K primary care %D 2019 %7 02.04.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with difficulties in performing self-care and inability to meet glycemic targets. Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD, but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD. Objective: The aim of this study is to describe the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress trial, that seeks to assess whether HC effectively reduces DD among primary care patients with diabetes and whether HC is more effective than an educational program targeting DD. Methods: The 2-arm randomized controlled trial is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive 8 HC sessions over a 5-month period. The primary outcome measure is reduction in DD over a 6-month period. Additional outcome measures include changes in hemoglobin A1c and self-care practices (medication-taking, dietary, and physical activity behaviors). Results: As of March 2019, screening and recruitment are ongoing, and the results are expected by July 2020. Conclusions: HC is feasible in primary care and has been successfully applied to improving chronic disease self-management and outcomes. This study will provide evidence as to whether it has significant value in addressing important unmet psychological and behavioral needs of patients with diabetes. Trial Registration: ClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO) International Registered Report Identifier (IRRID): DERR1-10.2196/12166 %M 30938687 %R 10.2196/12166 %U https://www.researchprotocols.org/2019/4/e12166/ %U https://doi.org/10.2196/12166 %U http://www.ncbi.nlm.nih.gov/pubmed/30938687 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e11226 %T Brief Exercise Counseling and High-Intensity Interval Training on Physical Activity Adherence and Cardiometabolic Health in Individuals at Risk of Type 2 Diabetes: Protocol for a Randomized Controlled Trial %A Bourne,Jessica E %A Little,Jonathan P %A Beauchamp,Mark R %A Barry,Julianne %A Singer,Joel %A Jung,Mary E %+ School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, 3333 University Way, Kelowna, BC, V1V 1V7, Canada, 1 250 807 96, mary.jung@ubc.ca %K exercise %K type 2 diabetes %K high-intensity interval training %K prediabetes %D 2019 %7 26.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Worldwide incidence of type 2 diabetes (T2D) is rapidly increasing. Given the numerous negative health consequences associated with T2D, prevention of this disease has become a priority. Lifestyle changes, including regular exercise, can reduce the onset of T2D in those at elevated risk. However, long-term adherence to exercise is often poor in this population. Existing lifestyle interventions targeting exercise are labor intensive and costly for staff and participants. Evidence-informed counseling delivered in a manner that reduces dependence on staff and facilitates self-regulatory skills could alleviate time and financial barriers while promoting independent exercise. Objective: This protocol outlines the design, recruitment, and proposed analysis of a brief, 2-week evidence-informed exercise counseling intervention combined with either high-intensity interval training (HIIT) or traditional moderate-intensity continuous training (MICT). Methods: Small Steps for Big Changes is a 2-arm randomized controlled trial that will examine the effectiveness of combining brief exercise counseling with HIIT or MICT on adherence to moderate and vigorous exercise over 1 year. Cardiorespiratory fitness will be assessed at baseline, post intervention (2 weeks), and at 6- and 12-month follow-up. Physical activity behavior will be examined at baseline, post intervention, and 3-, 6-, 9-, and 12-month follow-up. The impact of the intervention on psychosocial outcomes pertinent to exercise adherence will be examined. Results: Data collection was complete in March 2017. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. Conclusions: The results of this brief intervention have the potential to inform future public health efforts designed to increase exercise in individuals at risk of T2D. Trial Registration: ClinicalTrials.gov NCT02164474; https://clinicaltrials.gov/ct2/show/NCT02164474 (Archived by WebCite at http://www.webcitation.org/74Hx1ipj6) International Registered Report Identifier (IRRID): DERR1-10.2196/11226 %M 30912761 %R 10.2196/11226 %U https://www.researchprotocols.org/2019/3/e11226/ %U https://doi.org/10.2196/11226 %U http://www.ncbi.nlm.nih.gov/pubmed/30912761 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e12413 %T A Self-Regulation–Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial %A Poppe,Louise %A De Bourdeaudhuij,Ilse %A Verloigne,Maïté %A Degroote,Laurent %A Shadid,Samyah %A Crombez,Geert %+ Physical Activity and Health Research Group, Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, Ghent, 9000, Belgium, 32 9 264 63 63, louise.poppe@ugent.be %K protocol %K randomized controlled trial %K eHealth %K mHealth %K type 2 diabetes %K self-regulation %K physical activity %K sedentary behaviour %K mobile phone %D 2019 %7 22.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adoption of an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes have provided mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population’s specific needs. The online intervention “MyPlan 2.0” targets physical activity and sedentary behavior in adults with type 2 diabetes. This intervention is grounded in the self-regulation framework and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population. Objective: The aim of this paper is to thoroughly describe “MyPlan 2.0” and the study protocol that will be used to test the effectiveness of this intervention to alter patients’ levels of physical activity and sedentary behavior. Methods: A two-arm superiority randomized controlled trial will be performed. Physical activity and sedentary behavior will be measured using accelerometers and questionnaires. Furthermore, using questionnaires and diaries, patients’ stressors and personal determinants for change will be explored in depth. To evaluate the primary outcomes of the intervention, multilevel analyses will be conducted. Results: The randomized controlled trial started in January 2018. As participants can start at different moments, we aim to finish all testing by July 2019. Conclusions: This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes increase their level of physical activity and decrease their sedentary time. International Registered Report Identifier (IRRID): DERR1-10.2196/12413 %M 30901002 %R 10.2196/12413 %U http://www.researchprotocols.org/2019/3/e12413/ %U https://doi.org/10.2196/12413 %U http://www.ncbi.nlm.nih.gov/pubmed/30901002 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 4 %N 1 %P e10350 %T Perceptions and Acceptability of Text Messaging for Diabetes Care in Primary Care in Argentina: Exploratory Study %A Moyano,Daniela %A Morelli,Daniela %A Santero,Marilina %A Belizan,Maria %A Irazola,Vilma %A Beratarrechea,Andrea %+ Institute for Clinical Effectiveness and Health Policy (IECS), Dr Emilio Ravignani 2024, Buenos Aires, C1414CPV, Argentina, 54 114777 8767, dmoyano@iecs.org.ar %K mobile phones %K short message service %K diabetes mellitus %K public health %K qualitative research %D 2019 %7 18.03.2019 %9 Original Paper %J JMIR Diabetes %G English %X Background: Engagement in self-care behaviors that are essential to optimize diabetes care is challenging for many patients with diabetes. mHealth interventions have been shown to be effective in improving health care outcomes in diabetes. However, more research is needed on patient perceptions to support these interventions, especially in resource settings in low- and middle-income countries. Objective: The goal of the research was to explore perceptions and acceptability of a short message service (SMS) text messaging intervention for diabetes care in underserved people with diabetes in Argentina. Methods: A qualitative exploratory methodology was adopted as part of the evaluation of a program to strengthen diabetes services in primary care clinics located in low-resource settings. The diabetes program included a text messaging intervention for people with diabetes. A total of 24 semistructured telephone interviews were conducted with people with diabetes. Results: Twenty-four middle-aged persons with diabetes were interviewed. Acceptability was considered adequate in terms of its actual use, frequency, and the role of texts as a reminder. We found that text messages could be a mediating device in the patient’s learning processes. Also, being exposed to the texts seemed to help bring about changes in risk perception and care practices and to function as psychosocial support. Another relevant finding was the role of text messaging as a potential facilitator in diabetes care. In this sense, we observed a strong association between receiving text messages and having a better patient-physician relationship. Additionally, social barriers that affect diabetes care such as socioeconomic and psychosocial vulnerability were identified. Conclusions: Our findings show positive contributions of a text messaging intervention for the care of people with diabetes. We consider that an SMS strategy has potential to be replicated in other contexts. However, further studies are needed to explore its sustainability and long-term impact from the perspective of patients. %M 30882362 %R 10.2196/10350 %U http://diabetes.jmir.org/2019/1/e10350/ %U https://doi.org/10.2196/10350 %U http://www.ncbi.nlm.nih.gov/pubmed/30882362 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 4 %N 1 %P e12140 %T Electronic Health Lifestyle Coaching Among Diabetes Patients in a Real-Life Municipality Setting: Observational Study %A Komkova,Anastasija %A Brandt,Carl Joakim %A Hansen Pedersen,Daniel %A Emneus,Martha %A Sortsø,Camilla %+ Institute of Applied Economics and Health Research Aps, Ewaldsgade 3, Copenhagen, 2200, Denmark, 45 28817307, akom@appliedeconomics.dk %K eHealth %K diabetes mellitus %K healthy lifestyles %K weight reduction %K obesity %D 2019 %7 12.03.2019 %9 Original Paper %J JMIR Diabetes %G English %X Background: Internet and mobile interventions aiming to promote healthy lifestyle have attracted much attention because of their scalability and accessibility, low costs, privacy and user control, potential for use in real-life settings, as well as opportunities for real-time modifications and interactive advices. A real-life electronic health (eHealth) lifestyle coaching intervention was implemented in 8 Danish municipalities between summer 2016 and summer 2018. Objective: The aim of this study was to assess the effects associated with the eHealth intervention among diabetes patients in a real-life municipal setting. The eHealth intervention is based on an initial meeting, establishing a strong empathic relationship, followed by digital lifestyle coaching and collaboration supported by a Web-based community among patients. Methods: We conducted an observational study examining the effect of an eHealth intervention on self-reported weight change among 103 obese diabetes patients in a real-life municipal setting. The patients in the study participated in the eHealth intervention between 3 and 12 months. A weight change was observed at 6, 9, and 12 months. We used regression methods to estimate the impacts of the intervention on weight change. Results: We found that the eHealth intervention significantly reduced weight among diabetes patients, on average 4.3% of the initial body mass, which corresponds to 4.8 kg over a mean period of 7.3 months. Patients who were in intervention for more than 9 months achieved a weight reduction of 6.3% or 6.8 kg. Conclusions: This study brings forward evidence of a positive effect of a real-life eHealth lifestyle intervention on diabetes patients’ lifestyle in a municipal setting. Future research is needed to show if the effect is sustainable from a long-term perspective. %M 30860486 %R 10.2196/12140 %U http://diabetes.jmir.org/2019/1/e12140/ %U https://doi.org/10.2196/12140 %U http://www.ncbi.nlm.nih.gov/pubmed/30860486 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e11707 %T Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI): Protocol for a Pragmatic Randomized Controlled Trial %A Avedzi,Hayford M %A Storey,Kate %A Johnson,Jeffrey A %A Johnson,Steven T %+ Centre for Nursing and Health Studies, Faculty of Health Disciplines, Athabasca University, 1 University Drive Athabasca, Athabasca, AB, T9S 3A3, Canada, 1 877 848 6903, sjohnson@athabascau.ca %K glycemic index %K randomized controlled trial %K type 2 diabetes mellitus %D 2019 %7 06.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rigorous evidence is needed regarding the best approach for increasing the uptake of Diabetes Canada’s evidence-based recommendations to include low-glycemic index (GI) foods in daily meal planning as an effective dietary self-care strategy for glycemic control among people with type 2 diabetes (T2D). Objective: This study aims to present the study design and baseline data from the Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI) trial, which was designed to evaluate the effectiveness of an enhanced GI-targeted nutrition education on GI-related knowledge and mean daily GI among adults with T2D in Edmonton, Alberta. Methods: We used a pragmatic randomized controlled trial design and allocated 67 adults (aged ≥18 years) with T2D living in Edmonton, Alberta, Canada, to a control group that received standard printed copies of Canada’s Food Guide and Diabetes Canada’s GI resources or to an intervention group that received the same materials, plus a customized Web-based platform with 6 self-directed learning modules and print material. Each module included videos, links to reliable websites, chat rooms, and quizzes. Evidence-based GI concept information included GI values of foods and low-GI shopping, recipes, and cooking tips by a registered dietitian. In addition, support through email, text messaging (short message service), phone calls, or postal mail was provided to reinforce participants’ learning. The primary outcome, average dietary GI, was assessed using 3-day food records. Additional measures including GI knowledge and self-efficacy, glycated hemoglobin (HbA1c), lipids, systolic blood pressure, body mass index (BMI; weight, height), waist circumference, and computer proficiency were assessed at baseline and at 3-month postintervention. Results: Between November 2017 and February 2018, we contacted adults (aged ≥18 years) with T2D living in Edmonton, Alberta, screened and recruited eligible participants into the study. All data collection ended in June 2018. Overall, 64% (43/67) participants were males; mean age was 69.5 (SD 9.3) years, with a mean diabetes duration of 19.0 (SD 13.7) years. Mean BMI was 30.1 (SD 5.7) kg/m2, and mean HbA1c value was 7.1% (SD 1.2%). Data analysis was completed in December 2018. Conclusions: The GI concept is often difficult to teach. The HEALD-GI study aims to provide evidence in support of an alternative approach to translating the GI concept to adults with T2D. Findings from this study may help registered dietitians to better disseminate low-GI dietary recommendations using efficient and cost-effective, patient-centered approaches. Furthermore, evidence generated will contribute to addressing some of the controversies regarding the clinical usefulness of the GI concept. International Registered Report Identifier (IRRID): DERR1-10.2196/11707 %M 30839283 %R 10.2196/11707 %U https://www.researchprotocols.org/2019/3/e11707/ %U https://doi.org/10.2196/11707 %U http://www.ncbi.nlm.nih.gov/pubmed/30839283 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 2 %P e11002 %T Examining the Effects of Mindful Eating Training on Adherence to a Carbohydrate-Restricted Diet in Patients With Type 2 Diabetes (the DELISH Study): Protocol for a Randomized Controlled Trial %A Mason,Ashley E %A Saslow,Laura %A Moran,Patricia J %A Kim,Sarah %A Wali,Priyanka K %A Abousleiman,Hiba %A Hartman,Alison %A Richler,Robert %A Schleicher,Samantha %A Hartogensis,Wendy %A Epel,Elissa S %A Hecht,Frederick %+ UCSF Osher Center for Integrative Medicine, Department of Medicine, University of California San Francisco, 1545 Divisadero Street, 4th Floor, San Francisco, CA, 94115, United States, 1 4155146820, Ashley.Mason@ucsf.edu %K treatment adherence and compliance %K mind-body therapies %K diabetes mellitus %K diet, ketogenic %K mindfulness %D 2019 %7 20.02.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diet patterns have a profound influence on glycemic control for individuals with type 2 diabetes mellitus (T2DM), and craving-related eating is an important obstacle to dietary adherence. A growing body of research suggests that carbohydrate-restricted (CR) diets can improve glycemic control and reduce medication dependence in T2DM. However, limited data speak to the effects of long-term adherence to CR diets. Mindful eating training has been shown to reduce craving-related eating in overweight populations but has yet to be examined as a behavioral support for dietary adherence in T2DM. This trial examines behavioral mechanisms, particularly craving-related eating, through which mindful eating training might improve adherence to CR dietary recommendations in T2DM. This will clarify the importance of focusing on craving-related eating in the optimization of dietary adherence interventions. Objective: The aim of this trial is to determine whether providing training in mindful eating increases adherence to a CR dietary recommendation in T2DM. Methods: We are randomizing 60 participants to receive a CR diet with or without mindful eating training (12-week group intervention) and are following participants for 12 weeks after intervention completion. We hypothesize that participants who receive mindful eating training (relative to those who do not) will demonstrate greater adherence to the CR diet. Results: Our primary outcome is change in craving-related eating, as assessed using an ecological momentary assessment mobile phone–based platform. Secondary behavioral pathway outcomes include changes in stress-related eating, impulsivity, glycemic control, weight change, dietary adherence, and resumption of dietary adherence after dietary nonadherence. Conclusions: This theory-driven trial will shed light on the impact of mindfulness training on mechanisms that may impact dietary adherence in T2DM. Trial Registration: ClinicalTrials.gov NCT03207711; https://clinicaltrials.gov/ct2/show/NCT03207711 (Archived by WebCite at http://www.webcitation.org/73pXscwaU)  %M 30545813 %R 10.2196/11002 %U http://www.researchprotocols.org/2019/2/e11002/ %U https://doi.org/10.2196/11002 %U http://www.ncbi.nlm.nih.gov/pubmed/30545813 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 1 %P e12297 %T The Efficacy of Mobile Phone Apps for Lifestyle Modification in Diabetes: Systematic Review and Meta-Analysis %A Wu,Xinghan %A Guo,Xitong %A Zhang,Zhiwei %+ eHealth Research Institute, School of Management, Harbin Institute of Technology, 92 West Dazhi Street, Nangang District, Harbin,, China, 86 451 86414022, xitongguo@gmail.com %K smartphone %K mobile applications %K diabetes mellitus %K lifestyle %K physical activity %K diet %K behavior therapy %D 2019 %7 15.01.2019 %9 Review %J JMIR Mhealth Uhealth %G English %X Background: Diabetes and related complications are estimated to cost US $727 billion worldwide annually. Type 1 diabetes, type 2 diabetes, and gestational diabetes are three subtypes of diabetes that share the same behavioral risk factors. Efforts in lifestyle modification, such as daily physical activity and healthy diets, can reduce the risk of prediabetes, improve the health levels of people with diabetes, and prevent complications. Lifestyle modification is commonly performed in a face-to-face interaction, which can prove costly. Mobile phone apps provide a more accessible platform for lifestyle modification in diabetes. Objective: This review aimed to summarize and synthesize the clinical evidence of the efficacy of mobile phone apps for lifestyle modification in different subtypes of diabetes. Methods: In June 2018, we conducted a literature search in 5 databases (Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, and PsycINFO). We evaluated the studies that passed screening using The Cochrane Collaboration’s risk of bias tool. We conducted a meta-analysis for each subtype on the mean difference (between intervention and control groups) at the posttreatment glycated hemoglobin (HbA1c) level. Where possible, we analyzed subgroups for short-term (3-6 months) and long-term (9-12 months) studies. Heterogeneity was assessed using the I2 statistic. Results: We identified total of 2669 articles through database searching. After the screening, we included 26 articles (23 studies) in the systematic review, of which 18 studies (5 type 1 diabetes, 11 type 2 diabetes, and 2 prediabetes studies) were eligible for meta-analysis. For type 1 diabetes, the overall effect on HbA1c was statistically insignificant (P=.46) with acceptable heterogeneity (I2=39%) in the short-term subgroup (4 studies) and significant heterogeneity between the short-term and long-term subgroups (I2=64%). Regarding type 2 diabetes, the overall effect on HbA1c was statistically significant (P<.01) in both subgroups, and when the 2 subgroups were combined, there was virtually no heterogeneity within and between the subgroups (I2 range 0%-2%). The effect remained statistically significant (P<.01) after adjusting for publication bias using the trim and fill method. For the prediabetes condition, the overall effect on HbA1c was statistically insignificant (P=.67) with a large heterogeneity (I2=65%) between the 2 studies. Conclusions: There is strong evidence for the efficacy of mobile phone apps for lifestyle modification in type 2 diabetes. The evidence is inconclusive for the other diabetes subtypes. %M 30664494 %R 10.2196/12297 %U http://mhealth.jmir.org/2019/1/e12297/ %U https://doi.org/10.2196/12297 %U http://www.ncbi.nlm.nih.gov/pubmed/30664494 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 5 %P e93 %T Usefulness of a Novel Mobile Diabetes Prevention Program Delivery Platform With Human Coaching: 65-Week Observational Follow-Up %A Michaelides,Andreas %A Major,Jennifer %A Pienkosz Jr,Edmund %A Wood,Meghan %A Kim,Youngin %A Toro-Ramos,Tatiana %+ Clinical Research Department, Noom Inc, 229 West 28th Street, 9th Floor, New York, NY,, United States, 1 347 480 8871, tatiana@noom.com %K prediabetes %K body weight %K behavioral interventions %K mHealth %K mobile app %K diabetes prevention %D 2018 %7 03.05.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: It is widely recognized that the prevalence of obesity and comorbidities including prediabetes and type 2 diabetes continue to increase worldwide. Results from a 24-week Diabetes Prevention Program (DPP) fully mobile pilot intervention were previously published showing promising evidence of the usefulness of DPP-based eHealth interventions on weight loss. Objective: This pilot study extends previous findings to evaluate weight loss results of core (up to week 16) and maintenance (postcore weeks) DPP interventions at 65 weeks from baseline. Methods: Originally, 140 participants were invited and 43 overweight or obese adult participants with a diagnosis of prediabetes signed up to receive a 24-week virtual DPP with human coaching through a mobile platform. At 65 weeks, this pilot study evaluates weight loss and engagement in maintenance participants by means of repeated measures analysis of variances and backward multiple linear regression to examine predictors of weight loss. Last observation carried forward was used for endpoint measurements. Results: At 65 weeks, mean weight loss was 6.15% in starters who read 1 or more lessons per week on 4 or more core weeks, 7.36% in completers who read 9 or more lessons per week on core weeks, and 8.98% in maintenance completers who did any action in postcore weeks (all P<.001). Participants were highly engaged, with 80% (47/59) of the sample completing 9 lessons or more and 69% (32/47) of those completing the maintenance phase. In-app actions related to self-monitoring significantly predicted weight loss. Conclusions: In comparison to eHealth programs, this pilot study shows that a fully mobile DPP can produce transformative weight loss. A fully mobile DPP intervention resulted in significant weight loss and high engagement during the maintenance phase, providing evidence for long-term potential as an alternative to in-person DPP by removing many of the barriers associated with in-person and other forms of virtual DPP. %M 29724709 %R 10.2196/mhealth.9161 %U http://mhealth.jmir.org/2018/5/e93/ %U https://doi.org/10.2196/mhealth.9161 %U http://www.ncbi.nlm.nih.gov/pubmed/29724709 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 2 %P e72 %T A Novel Approach for Fully Automated, Personalized Health Coaching for Adults with Prediabetes: Pilot Clinical Trial %A Everett,Estelle %A Kane,Brian %A Yoo,Ashley %A Dobs,Adrian %A Mathioudakis,Nestoras %+ Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Johns Hopkins University, 1830 E. Monument Street, Suite 333, Baltimore, MD, 21287, United States, 1 410 502 8089, nmathio1@jhmi.edu %K mobile health %K prediabetes %K HbA 1c %K weight loss %K blood glucose %D 2018 %7 27.02.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Prediabetes is a high-risk state for the future development of type 2 diabetes, which may be prevented through physical activity (PA), adherence to a healthy diet, and weight loss. Mobile health (mHealth) technology is a practical and cost-effective method of delivering diabetes prevention programs in a real-world setting. Sweetch (Sweetch Health, Ltd) is a fully automated, personalized mHealth platform designed to promote adherence to PA and weight reduction in people with prediabetes.  Objective: The objective of this pilot study was to calibrate the Sweetch app and determine the feasibility, acceptability, safety, and effectiveness of the Sweetch app in combination with a digital body weight scale (DBWS) in adults with prediabetes. Methods: This was a 3-month prospective, single-arm, observational study of adults with a diagnosis of prediabetes and body mass index (BMI) between 24 kg/m2 and 40 kg/m2. Feasibility was assessed by study retention. Acceptability of the mobile platform and DBWS were evaluated using validated questionnaires. Effectiveness measures included change in PA, weight, BMI, glycated hemoglobin (HbA1c), and fasting blood glucose from baseline to 3-month visit. The significance of changes in outcome measures was evaluated using paired t test or Wilcoxon matched pairs test. Results: The study retention rate was 47 out of 55 (86%) participants. There was a high degree of acceptability of the Sweetch app, with a median (interquartile range [IQR]) score of 78% (73%-80%) out of 100% on the validated System Usability Scale. Satisfaction regarding the DBWS was also high, with median (IQR) score of 93% (83%-100%). PA increased by 2.8 metabolic equivalent of task (MET)–hours per week (SD 6.8; P=.02), with mean weight loss of 1.6 kg (SD 2.5; P<.001) from baseline. The median change in A1c was −0.1% (IQR −0.2% to 0.1%; P=.04), with no significant change in fasting blood glucose (−1 mg/dL; P=.59). There were no adverse events reported. Conclusions: The Sweetch mobile intervention program is a safe and effective method of increasing PA and reducing weight and HbA1c in adults with prediabetes. If sustained over a longer period, this intervention would be expected to reduce diabetes risk in this population. Trial Registration: ClincialTrials.gov NCT02896010; https://clinicaltrials.gov/ct2/show/NCT02896010 (Archived by WebCite at http://www.webcitation.org/6xJYxrgse) %M 29487046 %R 10.2196/jmir.9723 %U http://www.jmir.org/2018/2/e72/ %U https://doi.org/10.2196/jmir.9723 %U http://www.ncbi.nlm.nih.gov/pubmed/29487046 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 11 %P e360 %T A Fully Automated Web-Based Program Improves Lifestyle Habits and HbA1c in Patients With Type 2 Diabetes and Abdominal Obesity: Randomized Trial of Patient E-Coaching Nutritional Support (The ANODE Study) %A Hansel,Boris %A Giral,Philippe %A Gambotti,Laetitia %A Lafourcade,Alexandre %A Peres,Gilbert %A Filipecki,Claude %A Kadouch,Diana %A Hartemann,Agnes %A Oppert,Jean-Michel %A Bruckert,Eric %A Marre,Michel %A Bruneel,Arnaud %A Duchene,Emilie %A Roussel,Ronan %+ Hôpitaux Universitaires Paris-Nord Val de Seine, Department of Endocrinology, Diabetology, Nutrition, Assistance Publique-Hôpitaux de Paris, 46 Rue Henri Huchard, Paris, 75018, France, 33 0611307469, boris.hansel@aphp.fr %K e-health %K nutrition %K type 2 diabetes %D 2017 %7 08.11.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The prevalence of abdominal obesity and type 2 diabetes mellitus (T2DM) is a public health challenge. New solutions need to be developed to help patients implement lifestyle changes. Objective: The objective of the study was to evaluate a fully automated Web-based intervention designed to help users improve their dietary habits and increase their physical activity. Methods: The Accompagnement Nutritionnel de l’Obésité et du Diabète par E-coaching (ANODE) study was a 16-week, 1:1 parallel-arm, open-label randomized clinical trial. Patients with T2DM and abdominal obesity (n=120, aged 18-75 years) were recruited. Patients in the intervention arm (n=60) had access to a fully automated program (ANODE) to improve their lifestyle. Patients were asked to log on at least once per week. Human contact was limited to hotline support in cases of technical issues. The dietetic tool provided personalized menus and a shopping list for the day or the week. Stepwise physical activity was prescribed. The control arm (n=60) received general nutritional advice. The primary outcome was the change of the dietary score (International Diet Quality Index; DQI-I) between baseline and the end of the study. Secondary endpoints included changes in body weight, waist circumference, hemoglobin A1c (HbA1c) and measured maximum oxygen consumption (VO2 max). Results: The mean age of the participants was 57 years (standard deviation [SD] 9), mean body mass index was 33 kg/m² (SD 4), mean HbA1c was 7.2% (SD 1.1), and 66.7% (80/120) of participants were women. Using an intention-to-treat analysis, the DQI-I score (54.0, SD 5.7 in the ANODE arm; 52.8, SD 6.2 in the control arm; P=.28) increased significantly in the ANODE arm compared to the control arm (+4.55, SD 5.91 vs -1.68, SD 5.18; between arms P<.001). Body weight, waist circumference, and HbA1c changes improved significantly in the intervention. Conclusions: Among patients with T2DM and abdominal obesity, the use of a fully automated Web-based program resulted in a significant improvement in dietary habits and favorable clinical and laboratory changes. The sustainability of these effects remains to be determined. Trial Registration: ClinicalTrials.gov NCT02343107; http://clinicaltrials.gov/ct2/show/NCT02343107 (Archived by WebCite at http://www.webcitation.org/6uVMKPRzs) %M 29117929 %R 10.2196/jmir.7947 %U http://www.jmir.org/2017/11/e360/ %U https://doi.org/10.2196/jmir.7947 %U http://www.ncbi.nlm.nih.gov/pubmed/29117929 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 2 %N 2 %P e28 %T A Fully Automated Conversational Artificial Intelligence for Weight Loss: Longitudinal Observational Study Among Overweight and Obese Adults %A Stein,Natalie %A Brooks,Kevin %+ Division of Public Health, College of Human Medicine, Michigan State University, 200 East 1st Street, Flint Campus, MI, 48502, United States, 1 810 600 5601, steinna1@msu.edu %K obesity %K artificial intelligence %K self efficacy %K weight loss %K prediabetes %K smartphone %K diabetes %K compassion %K mobile health %K text messaging %D 2017 %7 01.11.2017 %9 Original Paper %J JMIR Diabetes %G English %X Background: Type 2 diabetes is the most expensive chronic disease in the United States. Two-thirds of US adults have prediabetes or are overweight and at risk for type 2 diabetes. Intensive in-person behavioral counseling can help patients lose weight and make healthy behavior changes to improve their health outcomes. However, with the shortage of health care providers and associated costs, such programs do not adequately service all patients who could benefit. The health care system needs effective and cost-effective interventions that can lead to positive health outcomes as scale. This study investigated the ability of conversational artificial intelligence (AI), in the form of a standalone, fully automated text-based mobile coaching service, to promote weight loss and other health behaviors related to diabetes prevention. This study also measured user acceptability of AI coaches as alternatives to live health care professionals. Objective: The objective of this study was to evaluate weight loss, changes in meal quality, and app acceptability among users of the Lark Weight Loss Health Coach AI (HCAI), with the overarching goal of increasing access to compassionate health care via mobile health. Lessons learned in this study can be applied when planning future clinical trials to evaluate HCAI and when designing AI to promote weight loss, healthy behavior change, and prevention and self-management of chronic diseases. Methods: This was a longitudinal observational study among overweight and obese (body mass index ≥25) participants who used HCAI, which encourages weight loss and healthy diet choices through elements of cognitive behavioral therapy. Weight loss, meal quality, physical activity, and sleep data were collected through user input and, for sleep and physical activity, partly through automatic detection by the user’s mobile phone. User engagement was assessed by duration and amount of app use. A 4-question in-app user trust survey assessed app usability and acceptability. Results: Data were analyzed for participants (N=70) who met engagement standards set forth by the Centers for Disease Control and Prevention criteria for Diabetes Prevention Program, a clinically proven weight loss program focused on preventing diabetes. Weight loss (standard error of the mean) was 2.38% (0.69%) of baseline weight. The average duration of app use was 15 (SD 1.0) weeks, and users averaged 103 sessions each. Predictors of weight loss included duration of AI use, number of counseling sessions, and number of meals logged. Percentage of healthy meals increased by 31%. The in-app user trust survey had a 100% response rate and positive results, with a satisfaction score of 87 out of 100 and net promoter score of 47. Conclusions: This study showed that use of an AI health coach is associated with weight loss comparable to in-person lifestyle interventions. It can also encourage behavior changes and have high user acceptability. Research into AI and its application in telemedicine should be pursued, with clinical trials investigating effects on weight, health behaviors, and user engagement and acceptability. %M 30291087 %R 10.2196/diabetes.8590 %U http://diabetes.jmir.org/2017/2/e28/ %U https://doi.org/10.2196/diabetes.8590 %U http://www.ncbi.nlm.nih.gov/pubmed/30291087 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 10 %P e338 %T Encouraging Physical Activity in Patients With Diabetes: Intervention Using a Reinforcement Learning System %A Yom-Tov,Elad %A Feraru,Guy %A Kozdoba,Mark %A Mannor,Shie %A Tennenholtz,Moshe %A Hochberg,Irit %+ Microsoft Research, 13 Shenkar st., Herzeliya, 46875, Israel, 972 747111358, eladyt@yahoo.com %K reinforcement learning %K physical activity %K diabetes type 2 %D 2017 %7 10.10.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Regular physical activity is known to be beneficial for people with type 2 diabetes. Nevertheless, most of the people who have diabetes lead a sedentary lifestyle. Smartphones create new possibilities for helping people to adhere to their physical activity goals through continuous monitoring and communication, coupled with personalized feedback. Objective: The aim of this study was to help type 2 diabetes patients increase the level of their physical activity. Methods: We provided 27 sedentary type 2 diabetes patients with a smartphone-based pedometer and a personal plan for physical activity. Patients were sent short message service messages to encourage physical activity between once a day and once per week. Messages were personalized through a Reinforcement Learning algorithm so as to improve each participant’s compliance with the activity regimen. The algorithm was compared with a static policy for sending messages and weekly reminders. Results: Our results show that participants who received messages generated by the learning algorithm increased the amount of activity and pace of walking, whereas the control group patients did not. Patients assigned to the learning algorithm group experienced a superior reduction in blood glucose levels (glycated hemoglobin [HbA1c]) compared with control policies, and longer participation caused greater reductions in blood glucose levels. The learning algorithm improved gradually in predicting which messages would lead participants to exercise. Conclusions: Mobile phone apps coupled with a learning algorithm can improve adherence to exercise in diabetic patients. This algorithm can be used in large populations of diabetic patients to improve health and glycemic control. Our results can be expanded to other areas where computer-led health coaching of humans may have a positive impact. Summary of a part of this manuscript has been previously published as a letter in Diabetes Care, 2016. %M 29017988 %R 10.2196/jmir.7994 %U http://www.jmir.org/2017/10/e338/ %U https://doi.org/10.2196/jmir.7994 %U http://www.ncbi.nlm.nih.gov/pubmed/29017988 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e145 %T A Web-Based Public Health Intervention to Reduce Functional Impairment and Depressive Symptoms in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial Protocol %A Proudfoot,Judy %A Clarke,Janine %A Gunn,Jane %A Fletcher,Susan %A Sanatkar,Samineh %A Wilhelm,Kay %A Campbell,Lesley %A Zwar,Nicholas %A Harris,Mark %A Lapsley,Helen %A Hadzi-Pavlovic,Dusan %A Christensen,Helen %+ Black Dog Institute, Hospital Road, Randwick, 2031, Australia, 61 2 9382 3767 ext 23767, janine.clarke@unsw.edu.au %K type 2 diabetes %K depression %K Web-based intervention %D 2017 %7 03.08.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Depressive symptoms are common in people with type 2 diabetes and contribute to adverse health consequences that substantially impact social and vocational function. Despite the existence of effective depression treatments, the majority of people with type 2 diabetes do not access these when needed. Web-based alternatives to more traditional psychotherapies offer a potential solution to reducing the personal and economic burdens of type 2 diabetes. Objective: This paper outlines the protocol for a randomized controlled trial (RCT) of myCompass, a Web-based public health psychotherapy intervention, in people with type 2 diabetes. Fully automated, interactive, and delivered via the Internet without clinician support, myCompass teaches cognitive behavioral therapy-based skills and supports symptom monitoring to improve daily functioning and reduce mild-to-moderate mental health symptoms. Methods: A two-arm RCT will be conducted. People with type 2 diabetes and mild-to-moderately severe depressive symptoms will be recruited from the community and general practice settings. Screening and enrollment is via an open-access website. Participants will be randomized to use either myCompass or an active placebo program for 8 weeks, followed by a 4-week tailing-off period. The placebo program is matched to myCompass on mode of delivery, interactivity, and duration. Outcomes will be assessed at baseline and at 3-month, 6-month, and 12-month follow-up. The primary study outcome is work and social functioning. Secondary study outcomes include depressive and anxious symptoms, diabetes-related distress, self-care behaviors, and glycemic control. Results: Nationwide recruitment is currently underway with the aim of recruiting 600 people with type 2 diabetes. Recruitment will continue until October 2017. Conclusions: This is the first known trial of a Web-based psychotherapy program that is not diabetes specific for improving social and vocational function in people with type 2 diabetes and mild-to-moderately severe depressive symptoms. With the increasing prevalence of type 2 diabetes and depression, a potentially scalable public health intervention could play a very large role in reducing unmet mental health need and ameliorating the personal and societal impact of illness comorbidity. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) Number: ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109 (Archived by WebCite at http://www.webcitation.org/ 6rh3imVMh) %M 28778848 %R 10.2196/resprot.7348 %U http://www.researchprotocols.org/2017/8/e145/ %U https://doi.org/10.2196/resprot.7348 %U http://www.ncbi.nlm.nih.gov/pubmed/28778848 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 7 %P e234 %T Use of a Connected Glucose Meter and Certified Diabetes Educator Coaching to Decrease the Likelihood of Abnormal Blood Glucose Excursions: The Livongo for Diabetes Program %A Downing,Janelle %A Bollyky,Jenna %A Schneider,Jennifer %+ Livongo Health, 150 W Evelyn Ave #150, Mountain View, CA, 94041, United States, 1 206 403 8450, jbollyky@livongo.com %K SMBG %K blood glucose self-monitoring %K diabetes remote monitoring %K diabetes management %K diabetes mellitus %K self-care %D 2017 %7 11.07.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: The Livongo for Diabetes Program offers members (1) a cellular technology-enabled, two-way messaging device that measures blood glucose (BG), centrally stores the glucose data, and delivers messages back to the individual in real time; (2) unlimited BG test strips; and (3) access to a diabetes coaching team for questions, goal setting, and automated support for abnormal glucose excursions. The program is sponsored by at-risk self-insured employers, health plans and provider organizations where it is free to members with diabetes or it is available directly to the person with diabetes where they cover the cost. Objective: The objective of our study was to evaluate BG data from 4544 individuals with diabetes who were enrolled in the Livongo program from October 2014 through December 2015. Methods: Members used the Livongo glucose meter to measure their BG levels an average of 1.8 times per day. We estimated the probability of having a day with a BG reading outside of the normal range (70-180 mg/dL, or 3.9-10.0 mmol/L) in months 2 to 12 compared with month 1 of the program, using individual fixed effects to control for individual characteristics. Results: Livongo members experienced an average 18.4% decrease in the likelihood of having a day with hypoglycemia (BG <70 mg/dL) and an average 16.4% decrease in hyperglycemia (BG >180 mg/dL) in months 2-12 compared with month 1 as the baseline. The biggest impact was seen on hyperglycemia for nonusers of insulin. We do not know all of the contributing factors such as medication or other treatment changes during the study period. Conclusions: These findings suggest that access to a connected glucose meter and certified diabetes educator coaching is associated with a decrease in the likelihood of abnormal glucose excursions, which can lead to diabetes-related health care savings. %M 28698167 %R 10.2196/jmir.6659 %U http://www.jmir.org/2017/7/e234/ %U https://doi.org/10.2196/jmir.6659 %U http://www.ncbi.nlm.nih.gov/pubmed/28698167 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 2 %N 2 %P e14 %T Web-Based Weight Loss Intervention for Men With Type 2 Diabetes: Pilot Randomized Controlled Trial %A Haste,Anna %A Adamson,Ashley J %A McColl,Elaine %A Araujo-Soares,Vera %A Bell,Ruth %+ Institute of Health and Society, Faculty of Medical Sciences, Newcastle University, Baddiley Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, United Kingdom, 44 0 191 208 7045, anna.haste@newcastle.ac.uk %K weight loss %K Web-based intervention %K feasibility studies %K pilot RCT %K randomized controlled trial %K pilot projects %K type 2 diabetes %K diabetes mellitus, type 2 %K men %K men's health %K process evaluation %D 2017 %7 07.07.2017 %9 Original Paper %J JMIR Diabetes %G English %X Background: Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. Objective: The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. Methods: We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. Results: General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. Conclusions: Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI) %M 30291100 %R 10.2196/diabetes.7430 %U http://diabetes.jmir.org/2017/2/e14/ %U https://doi.org/10.2196/diabetes.7430 %U http://www.ncbi.nlm.nih.gov/pubmed/30291100 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 2 %P e36 %T An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial %A Saslow,Laura R %A Mason,Ashley E %A Kim,Sarah %A Goldman,Veronica %A Ploutz-Snyder,Robert %A Bayandorian,Hovig %A Daubenmier,Jennifer %A Hecht,Frederick M %A Moskowitz,Judith T %+ Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Room 2178, 400 N Ingalls St, Ann Arbor, MI, 48105, United States, 1 734 764 7836, saslowl@umich.edu %K eHealth %K diet %K weight loss %K type 2 diabetes mellitus %D 2017 %7 13.02.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Type 2 diabetes is a prevalent, chronic disease for which diet is an integral aspect of treatment. In our previous trial, we found that recommendations to follow a very low-carbohydrate ketogenic diet and to change lifestyle factors (physical activity, sleep, positive affect, mindfulness) helped overweight people with type 2 diabetes or prediabetes improve glycemic control and lose weight. This was an in-person intervention, which could be a barrier for people without the time, flexibility, transportation, social support, and/or financial resources to attend. Objective: The aim was to determine whether an online intervention based on our previous recommendations (an ad libitum very low-carbohydrate ketogenic diet with lifestyle factors; “intervention”) or an online diet program based on the American Diabetes Associations’ “Create Your Plate” diet (“control”) would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes. Methods: In this pilot feasibility study, we randomized overweight adults (body mass index ≥25) with type 2 diabetes (glycated hemoglobin [HbA1c] 6.5%-9.0%) to a 32-week online intervention based on our previous recommendations (n=12) or an online diet program based around a plate method diet (n=13) to assess the impact of each intervention on glycemic control and other health outcomes. Primary and secondary outcomes were analyzed by mixed-effects linear regression to compare outcomes by group. Results: At 32 weeks, participants in the intervention group reduced their HbA1c levels more (estimated marginal mean [EMM] –0.8%, 95% CI –1.1% to –0.6%) than participants in the control group (EMM –0.3%, 95% CI –0.6% to 0.0%; P=.002). More than half of the participants in the intervention group (6/11, 55%) lowered their HbA1c to less than 6.5% versus 0% (0/8) in the control group (P=.02). Participants in the intervention group lost more weight (EMM –12.7 kg, 95% CI –16.1 to –9.2 kg) than participants in the control group (EMM –3.0 kg, 95% CI –7.3 to 1.3 kg; P<.001). A greater percentage of participants lost at least 5% of their body weight in the intervention (10/11, 90%) versus the control group (2/8, 29%; P=.01). Participants in the intervention group lowered their triglyceride levels (EMM –60.1 mg/dL, 95% CI –91.3 to –28.9 mg/dL) more than participants in the control group (EMM –6.2 mg/dL, 95% CI –46.0 to 33.6 mg/dL; P=.01). Dropout was 8% (1/12) and 46% (6/13) for the intervention and control groups, respectively (P=.07). Conclusions: Individuals with type 2 diabetes improved their glycemic control and lost more weight after being randomized to a very low-carbohydrate ketogenic diet and lifestyle online program rather than a conventional, low-fat diabetes diet online program. Thus, the online delivery of these very low-carbohydrate ketogenic diet and lifestyle recommendations may allow them to have a wider reach in the successful self-management of type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT01967992; https://clinicaltrials.gov/ct2/show/NCT01967992 (Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq) %M 28193599 %R 10.2196/jmir.5806 %U http://www.jmir.org/2017/2/e36/ %U https://doi.org/10.2196/jmir.5806 %U http://www.ncbi.nlm.nih.gov/pubmed/28193599 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 11 %P e307 %T Text to Move: A Randomized Controlled Trial of a Text-Messaging Program to Improve Physical Activity Behaviors in Patients With Type 2 Diabetes Mellitus %A Agboola,Stephen %A Jethwani,Kamal %A Lopez,Lenny %A Searl,Meghan %A O’Keefe,Sandra %A Kvedar,Joseph %+ Partners Connected Health, Suite 300, 25 New Chardon St, Boston, MA, 02114, United States, 1 617 643 0291, sagboola@partners.org %K type 2 diabetes %K text messaging %K mobile phones %K physical activity %K engagement %K pedometers %D 2016 %7 18.11.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Text messages are increasingly being used because of the low cost and the ubiquitous nature of mobile phones to engage patients in self-care behaviors. Self-care is particularly important in achieving treatment outcomes in type 2 diabetes mellitus (T2DM). Objective: This study examined the effect of personalized text messages on physical activity, as measured by a pedometer, and clinical outcomes in a diverse population of patients with T2DM. Methods: Text to Move (TTM) incorporates physical activity monitoring and coaching to provide automated and personalized text messages to help patients with T2DM achieve their physical activity goals. A total of 126 English- or Spanish-speaking patients with glycated hemoglobin A1c (HbA1c) >7 were enrolled in-person to participate in the study for 6 months and were randomized into either the intervention arm that received the full complement of the intervention or a control arm that received only pedometers. The primary outcome was change in physical activity. We also assessed the effect of the intervention on HbA1c, weight, and participant engagement. Results: All participants (intervention: n=64; control: n=62) were included in the analyses. The intervention group had significantly higher monthly step counts in the third (risk ratio [RR] 4.89, 95% CI 1.20 to 19.92, P=.03) and fourth (RR 6.88, 95% CI 1.21 to 39.00, P=.03) months of the study compared to the control group. However, over the 6-month follow-up period, monthly step counts did not differ statistically by group (intervention group: 9092 steps; control group: 3722 steps; RR 2.44, 95% CI 0.68 to 8.74, P=.17). HbA1c decreased by 0.07% (95% CI –0.47 to 0.34, P=.75) in the TTM group compared to the control group. Within groups, HbA1c decreased significantly from baseline in the TTM group by –0.43% (95% CI –0.75 to –0.12, P=.01), but nonsignificantly in the control group by –0.21% (95% CI –0.49 to 0.06, P=.13). Similar changes were observed for other secondary outcomes. Conclusion: Personalized text messaging can be used to improve outcomes in patients with T2DM by employing optimal patient engagement measures. %M 27864165 %R 10.2196/jmir.6439 %U http://www.jmir.org/2016/11/e307/ %U https://doi.org/10.2196/jmir.6439 %U http://www.ncbi.nlm.nih.gov/pubmed/27864165 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 18 %N 4 %P e86 %T The Impact of Automated Brief Messages Promoting Lifestyle Changes Delivered Via Mobile Devices to People with Type 2 Diabetes: A Systematic Literature Review and Meta-Analysis of Controlled Trials %A Arambepola,Carukshi %A Ricci-Cabello,Ignacio %A Manikavasagam,Pavithra %A Roberts,Nia %A French,David P %A Farmer,Andrew %+ University of Oxford, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, Woodstock Road, Oxford., Oxford, OX2 6GG, United Kingdom, 44 01865 617190, ignacio.riccicabello@phc.ox.ac.uk %K Diabetes mellitus, type 2 %K mobile health %K text messaging %K systematic review %K diet %K physical activity %K self-care %D 2016 %7 19.04.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Brief automated messages have the potential to support self-management in people with type 2 diabetes, but their effect compared with usual care is unclear. Objective: To examine the effectiveness of interventions to change lifestyle behavior delivered via automated brief messaging in patients with type 2 diabetes. Methods: A systematic literature review of controlled trials examined the impact of interventions, delivered by brief messaging, and intended to promote lifestyle change in people with type 2 diabetes, on behavioral and clinical outcomes. Bibliographic databases searched included Medline, Embase, CINAHL, PsycINFO, and ISI WoK. Two reviewers independently screened citations. We extracted information on study risk of bias, setting (high versus low- and middle-income countries) and intervention characteristics (including use of theory and behavior-change techniques). Outcome measures included acceptability of the interventions and their impact on 1) determinants of lifestyle behavior (knowledge about diabetes, self-efficacy, attitudes towards self-management), 2) lifestyle behavior (diet, physical activity), and 3) clinical and patient-reported outcomes. Where possible, we pooled data using random-effects meta-analyses to obtain estimates of effect size of intervention compared to usual care. Results: We identified 15 trials (15 interventions) meeting our inclusion criteria. Most interventions were delivered via short message service text messaging (n=12) and simultaneously targeted diet and physical activity (n=11). Nine interventions consisted of unidirectional messages, whereas six consisted of bidirectional messages, with patients receiving automated tailored feedback based on self-reported data. The acceptability of the interventions, and their impact on lifestyle behavior and its determinants, were examined in a low proportion of trials, with heterogeneous results being observed. In 13 trials (1155 patients) where data were available, there was a difference in glycated hemoglobin of -0.53% (95% CI -0.59% to -0.47%) between intervention groups compared to usual care. In five trials (406 patients) there was a non-significant difference in body mass index of -0.25 kg/m2 (95% CI -1.02 to 0.52). Interventions based on unidirectional messages produced similar effects in the outcomes examined, compared to those based on bidirectional messages. Interventions conducted in low- and middle-income countries showed a greater impact than those conducted in high-income countries. In general, trials were not free of bias and did not use explicit theory. Conclusions: Automated brief messages strategies can improve health outcomes in people with type 2 diabetes. Larger, methodologically robust trials are needed to confirm these positive results. %M 27095386 %R 10.2196/jmir.5425 %U http://www.jmir.org/2016/4/e86/ %U https://doi.org/10.2196/jmir.5425 %U http://www.ncbi.nlm.nih.gov/pubmed/27095386 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 1 %N 1 %P e1 %T Data Mining of a Remote Behavioral Tracking System for Type 2 Diabetes Patients: A Prospective Cohort Study %A Wayne,Noah %A Cercone,Nick %A Li,Jiye %A Zohar,Ariel %A Katz,Joel %A Brown,Patrick %A Ritvo,Paul %+ Health Behaviour Change Lab, School of Kinesiology & Health Science, York University, 136 Chemistry Building, 4700 Keele Street, Toronto, ON, M3J1P3, Canada, 1 416 736 2100 ext 22396, pritvo@yorku.ca %K diabetes mellitus, type 2 %K health coaching %K mhealth %K telehealth %K data mining %D 2016 %7 06.04.2016 %9 Original Paper %J JMIR Diabetes %G English %X Background: Complications from type 2 diabetes mellitus can be prevented when patients perform health behaviors such as vigorous exercise and glucose-regulated diet. The use of smartphones for tracking such behaviors has demonstrated success in type 2 diabetes management while generating repositories of analyzable digital data, which, when better understood, may help improve care. Data mining methods were used in this study to better understand self-monitoring patterns using smartphone tracking software. Objective: Associations were evaluated between the smartphone monitoring of health behaviors and HbA1c reductions in a patient subsample with type 2 diabetes who demonstrated clinically significant benefits after participation in a randomized controlled trial. Methods: A priori association-rule algorithms, implemented in the C language, were applied to app-discretized use data involving three primary health behavior trackers (exercise, diet, and glucose monitoring) from 29 participants who achieved clinically significant HbA1c reductions. Use was evaluated in relation to improved HbA1c outcomes. Results: Analyses indicated that nearly a third (9/29, 31%) of participants used a single tracker, half (14/29, 48%) used two primary trackers, and the remainder (6/29, 21%) of the participants used three primary trackers. Decreases in HbA1c were observed across all groups (0.97-1.95%), but clinically significant reductions were more likely with use of one or two trackers rather than use of three trackers (OR 0.18, P=.04). Conclusions: Data mining techniques can reveal relevant coherent behavior patterns useful in guiding future intervention structure. It appears that focusing on using one or two trackers, in a symbolic function, was more effective (in this sample) than regular use of all three trackers. %M 30291054 %R 10.2196/diabetes.4506 %U http://diabetes.jmir.org/2016/1/e1/ %U https://doi.org/10.2196/diabetes.4506 %U http://www.ncbi.nlm.nih.gov/pubmed/30291054 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 1 %P e32 %T Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study %A Dobson,Rosie %A Carter,Karen %A Cutfield,Richard %A Hulme,Ashley %A Hulme,Richard %A McNamara,Catherine %A Maddison,Ralph %A Murphy,Rinki %A Shepherd,Matthew %A Strydom,Johan %A Whittaker,Robyn %+ National Institute for Health Innovation, School of Population Health, Faculty of Medical and Health Sciences, University of Auckland, National Institute for Health Innovation, School of Population Health, University of Auckland, Tamaki Campus,, Private Bag 92019, Auckland Mail Centre, Auckland 1142, New Zealand, Auckland, , New Zealand, 64 9 3737599 ext 84766, r.dobson@auckland.ac.nz %K mHealth %K diabetes mellitus %K text message %K mobile phone %K SMS %K self-management %D 2015 %7 25.03.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: The increasing prevalence of diabetes and costly long-term complications associated with poor glycemic control are issues facing health services worldwide. Diabetes self-management, with the support of health care providers, is critical for successful outcomes, however, frequent clinical contact is costly. Text messages via short message service (SMS) have the advantage of instant transmission at low cost and, given the ubiquity of mobile phones, may be the ideal platform for the delivery of diabetes self-management support. A tailored text message-based diabetes support intervention called Self-Management Support for Blood Glucose (SMS4BG) was developed. The intervention incorporates prompts around diabetes education, management, and lifestyle factors (healthy eating, exercise, and stress management), as well as blood glucose monitoring reminders, and is tailored to patient preferences and clinical characteristics. Objective: To determine the usability and acceptability of SMS4BG among adults with poorly controlled diabetes. Methods: Adults (aged 17 to 69 years) with type 1 (n=12) or type 2 diabetes (n=30), a hemoglobin A1c (HbA1c) over 70 mmol/mol (8.6%), and who owned a mobile phone (n=42) were recruited to take part in a 3-month pilot study of SMS4BG. At registration, participants selected the modules they would like to receive and, where appropriate, the frequency and timing of blood glucose monitoring reminders. Patient satisfaction and perceptions of the usability of the program were obtained via semistructured phone interviews conducted at completion of the pilot study. HbA1c was obtained from patient records at baseline and completion of the pilot study. Results: Participants received on average 109 messages during the 3-month program with 2 participants withdrawing early from the study. Follow-up interviews were completed with 93% of participants with all reporting SMS4BG to be useful and appropriate to their age and culture. Participants reported a range of perceived positive impacts of SMS4BG on their diabetes and health behaviors. HbA1c results indicated a positive impact of the program on glycemic control with a significant decrease in HbA1c from baseline to follow-up. Conclusions: A tailored text message-based intervention is both acceptable and useful in supporting self-management in people with poorly controlled diabetes. A randomized controlled trial of longer duration is needed to assess the efficacy and sustainability of SMS4BG. %M 25830952 %R 10.2196/mhealth.3988 %U http://mhealth.jmir.org/2015/1/e32/ %U https://doi.org/10.2196/mhealth.3988 %U http://www.ncbi.nlm.nih.gov/pubmed/25830952 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 4 %P e57 %T A Mobile Health Intervention for Self-Management and Lifestyle Change for Persons With Type 2 Diabetes, Part 2: One-Year Results From the Norwegian Randomized Controlled Trial RENEWING HEALTH %A Holmen,Heidi %A Torbjørnsen,Astrid %A Wahl,Astrid Klopstad %A Jenum,Anne Karen %A Småstuen,Milada Cvancarova %A Årsand,Eirik %A Ribu,Lis %+ Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, PB 4 St.Olavs Plass, Oslo, 0130, Norway, 47 90580017, Heidi.Holmen@hioa.no %K self-care %K mobile applications %K cellular phone %K telemedicine %K counseling %K motivational interviewing %K diabetes mellitus, type 2 %K hemoglobin A1c protein, human %D 2014 %7 11.12.2014 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: Self-management is crucial in the daily management of type 2 diabetes. It has been suggested that mHealth may be an important method for enhancing self-management when delivered in combination with health counseling. Objective: The objective of this study was to test whether the use of a mobile phone–based self-management system used for 1 year, with or without telephone health counseling by a diabetes specialist nurse for the first 4 months, could improve glycated hemoglobin A1c (HbA1c) level, self-management, and health-related quality of life compared with usual care. Methods: We conducted a 3-arm prospective randomized controlled trial involving 2 intervention groups and 1 control group. Eligible participants were persons with type 2 diabetes with an HbA1c level ≥7.1% (≥54.1 mmol/mol) and aged ≥18 years. Both intervention groups received the mobile phone–based self-management system Few Touch Application (FTA). The FTA consisted of a blood glucose–measuring system with automatic wireless data transfer, diet manual, physical activity registration, and management of personal goals, all recorded and operated using a diabetes diary app on the mobile phone. In addition, one intervention group received health counseling based on behavior change theory and delivered by a diabetes specialist nurse for the first 4 months after randomization. All groups received usual care by their general practitioner. The primary outcome was HbA1c level. Secondary outcomes were self-management (heiQ), health-related quality of life (SF-36), depressive symptoms (CES-D), and lifestyle changes (dietary habits and physical activity). Data were analyzed using univariate methods (t test, ANOVA) and multivariate linear and logistic regression. Results: A total of 151 participants were randomized: 51 to the FTA group, 50 to the FTA-health counseling (FTA-HC) group, and 50 to the control group. Follow-up data after 1 year were available for 120 participants (79%). HbA1c level decreased in all groups, but did not differ between groups after 1 year. The mean change in the heiQ domain skills and technique acquisition was significantly greater in the FTA-HC group after adjusting for age, gender, and education (P=.04). Other secondary outcomes did not differ between groups after 1 year. In the FTA group, 39% were substantial users of the app; 34% of the FTA-HC group were substantial users. Those aged ≥63 years used the app more than their younger counterparts did (OR 2.7; 95% CI 1.02-7.12; P=.045). Conclusions: The change in HbA1c level did not differ between groups after the 1-year intervention. Secondary outcomes did not differ between groups except for an increase in the self-management domain of skill and technique acquisition in the FTA-HC group. Older participants used the app more than the younger participants did. %M 25499872 %R 10.2196/mhealth.3882 %U http://mhealth.jmir.org/2014/4/e57/ %U https://doi.org/10.2196/mhealth.3882 %U http://www.ncbi.nlm.nih.gov/pubmed/25499872