%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