Dataset Information

Remotely Monitored Gamification and Social Incentives to Improve Glycemic Control Among Adults With Uncontrolled Type 2 Diabetes (iDiabetes): Protocol for a Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Fortunato M

PROVIDER: S-EPMC6893558 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Remotely Monitored Gamification and Social Incentives to Improve Glycemic Control Among Adults With Uncontrolled Type 2 Diabetes (iDiabetes): Protocol for a Randomized Controlled Trial.

Fortunato Michael M Harrison Joseph J Oon Ai Leen AL Small Dylan D Hilbert Victoria V Rareshide Charles C Patel Mitesh M

JMIR research protocols 20191120 11

<h4>Background</h4>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 behavio ...[more]

PMID: 31746765

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Project description:ImportanceGamification is increasingly being used to promote healthy behaviors. However, it has not been well tested among patients with chronic conditions and over longer durations.ObjectiveTo test the effectiveness of behaviorally designed gamification interventions to enhance support, collaboration, or competition to promote physical activity and weight loss among adults with uncontrolled type 2 diabetes.Design, setting, and participantsA 4-arm randomized clinical trial with a 1-year intervention was conducted from January 23, 2017, to January 27, 2020, with remotely monitored intervention. Analyses were conducted between February 10 and October 6, 2020. Participants included 361 adults with type 2 diabetes with hemoglobin A1c levels greater than or equal to 8% and body mass index greater than or equal to 25.InterventionsAll participants received a wearable device, smart weight scale, and laboratory testing. Participants in the control group received feedback from their devices but no other interventions. Participants in the gamification arms conducted goal setting and were entered into a 1-year game designed using insights from behavioral economics with points and levels for achieving step goals and weight loss targets. The game varied by trial arm to promote either support, collaboration, or competition.Main outcomes and measuresCo-primary outcomes included daily step count, weight, and hemoglobin A1c level. Secondary outcome was low-density lipoprotein cholesterol level. Intention-to-treat analysis was used.ResultsParticipants had a mean (SD) age of 52.5 (10.1) years; hemoglobin A1c level, 9.6% (1.6%); daily steps, 4632 (2523); weight, 107.4 kg (20.8 kg); and body mass index, 37.1 (6.6). Of the 361 participants, 202 (56.0%) were women, 143 (39.6%) were White, and 185 (51.2%) were Black; with 87 (24.1%) randomized to control; 92 (25.4%) randomized to gamification with support and intervention; 95 (26.3%) randomized to gamification with collaboration; and 87 (24.1%) randomized to gamification with competition. Compared with the control group over 1 year, there was a significant increase in mean daily steps from baseline among participants receiving gamification with support (adjusted difference relative to control group, 503 steps; 95% CI, 103 to 903 steps; P = .01) and competition (606 steps; 95% CI, 201 to 1011 steps; P = .003) but not collaboration (280 steps; 95% CI, -115 to 674 steps; P = .16). All trial arms had significant reductions in weight and hemoglobin A1c levels from baseline, but there were no significant differences between any of the intervention arms and the control arm. There was only 1 adverse event reported that may have been related to the trial (arthritic knee pain).Conclusions and relevanceAmong adults with uncontrolled type 2 diabetes, a behaviorally designed gamification intervention in this randomized clinical trial significantly increased physical activity over a 1-year period when designed to enhance either support or competition but not collaboration. No differences between intervention and control groups were found for other outcomes.Trial registrationClinicalTrials.gov Identifier: NCT02961192.

Project description:BACKGROUND:Social networks influence obesity patterns, but interventions to leverage social incentives to promote weight loss have not been well evaluated. OBJECTIVE:To test the effectiveness of gamification interventions designed using insights from behavioral economics to enhance social incentives to promote weight loss. DESIGN:The Leveraging Our Social Experiences and Incentives Trial (LOSE IT) was a 36-week randomized, controlled trial with a 24-week intervention and 12-week follow-up. PARTICIPANTS:One hundred and ninety-six obese adults (body mass index ≥ 30) comprising 98 two-person teams. INTERVENTIONS:All participants received a wireless weight scale, used smartphones to track daily step counts, formed two-person teams with a family member or friend, and selected a weight loss goal. Teams were randomly assigned to control or one of two gamification interventions for 36 weeks that used points and levels to enhance collaborative social incentives. One of the gamification arms also had weight and step data shared regularly with each participant's primary care physician (PCP). MAIN OUTCOME MEASURES:The primary outcome was weight loss at 24 weeks. Secondary outcomes included weight loss at 36 weeks. KEY RESULTS:At 24 weeks, participants lost significant weight from baseline in the control arm (mean: - 3.9 lbs; 95% CI: - 6.1 to - 1.7; P < 0.001), the gamification arm (mean: - 6.6 lbs; 95% CI: - 9.4 to - 3.9; P < 0.001), and the gamification arm with PCP data sharing (mean: - 4.8 lbs; 95% CI: - 7.4 to - 2.3; P < 0.001). At 36 weeks, weight loss from baseline remained significant in the control arm (mean: - 3.5 lbs; 95% CI: - 6.1 to - 0.8; P = 0.01), the gamification arm (mean: - 6.3 lbs; 95% CI: - 9.2 to - 3.3; P < 0.001), and the gamification arm with PCP data sharing (mean: - 5.2 lbs; 95% CI: - 8.5 to - 2.0; P < 0.01). However, in the main adjusted model, there were no significant differences in weight loss between each of the intervention arms and control at either 12, 24, or 36 weeks. CONCLUSIONS:Using digital health devices to track behavior with a partner led to significant weight loss through 36 weeks, but the gamification interventions were not effective at promoting weight loss when compared to control. TRIAL REGISTRATION:clinicaltrials.gov Identifier: 02564445.

Project description:Background A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes. Methods The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%. Discussion Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings. Trial registration This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.

Project description:BackgroundSub-optimally controlled diabetes increases risks for adverse and costly complications. Self-management including glucose monitoring, medication adherence, and exercise are key for optimal glycemic control, yet, poor self-management remains common.ObjectiveThe main objective of the Trial to Incentivize Adherence for Diabetes (TRIAD) study was to determine the effectiveness of financial incentives in improving glycemic control among type 2 diabetes patients in Singapore, and to test whether process-based incentives tied to glucose monitoring, medication adherence, and physical activity are more effective than outcome-based incentives tied to achieving normal glucose readings.MethodsTRIAD is a randomized, controlled, multi-center superiority trial. A total of 240 participants who had at least one recent glycated hemoglobin (HbA1c) being 8.0% or more and on oral diabetes medication were recruited from two polyclinics. They were block-randomized (blocking factor: current vs. new glucometer users) into the usual care plus (UC +) arm, process-based incentive arm, and outcome-based incentive arm in a 2:3:3 ratio. The primary outcome was the mean change in HbA1c at month 6 and was linearly regressed on binary variables indicating the intervention arms, baseline HbA1c levels, a binary variable indicating titration change, and other baseline characteristics.ResultsOur findings show that the combined incentive arms trended toward better HbA1c than UC + , but the difference is estimated with great uncertainty (difference - 0.31; 95% confidence interval [CI] - 0.67 to 0.06). Lending credibility to this result, the proportion of participants who reduced their HbA1c is higher in the combined incentive arms relative to UC + (0.18; 95% CI 0.04, 0.31). We found a small improvement in process- relative to outcome-based incentives, but this was again estimated with great uncertainty (difference - 0.05; 95% CI - 0.42 to 0.31). Consistent with this improvement, process-based incentives were more effective at improving weekly medication adherent days (0.64; 95% CI - 0.04 to 1.32), weekly physically active days (1.37; 95% CI 0.60-2.13), and quality of life (0.04; 95% CI 0.0-0.07) than outcome-based incentives.ConclusionThis study suggests that both incentive types may be part of a successful self-management strategy. Process-based incentives can improve adherence to intermediary outcomes, while outcome-based incentives focus on glycemic control and are simpler to administer.

Project description:BACKGROUND:HIV prevalence is high among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), particularly among minorities. Despite its proven efficacy and safety, the uptake of and adherence to pre-exposure prophylaxis (PrEP) among YMSM and YTWSM is currently limited. To date, evidence-based interventions to promote and sustain PrEP adherence have been limited and not shown to be highly efficacious. Given the widespread adoption of smartphones, mobile apps can be utilized to increase PrEP adherence for many YMSM and YTWSM. OBJECTIVE:The study consists of a formative research phase to develop an app-based intervention, P3 (Prepared, Protected, emPowered), to increase PrEP adherence, and a randomized controlled trial (RCT) to test its efficacy. P3 is a mobile app built on an established health platform, which includes social networking and game-based components to encourage PrEP adherence among YMSM and YTWSM. P3+ includes all P3 features plus adherence counseling delivered via two-way text messaging (short message service, SMS) through the app. METHODS:The formative research phase includes usability testing to assess users' comprehension of P3's educational content, understanding and use of intervention features, and overall impressions of app functionality, followed by app refinements. A subsequent field trial will identify and resolve any remaining technical challenges. A three-arm RCT (P3, P3+, and standard of care) will then be conducted at 6 iTech subject recruitment venues to assess intervention efficacy and to conduct a comparison of costs to deliver the 2 intervention arms. RESULTS:This is an ongoing research project with initial results from the formative work expected in 2020 and those from the RCT in 2021. CONCLUSIONS:P3 aims to provide an engaging, interactive experience that is highly appealing for the target population, leveraging technology already heavily integrated into the lives of young people, and thus meeting users' needs in a familiar, stimulating way. If efficacious, P3 could be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. TRIAL REGISTRATION:ClinicalTrials.gov NCT03320512; https://clinicaltrials.gov/ct2/show/NCT03320512 (Archived by WebCite at http://www.webcitation.org/74OVZkICl). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/10448.

Dataset Information

Remotely Monitored Gamification and Social Incentives to Improve Glycemic Control Among Adults With Uncontrolled Type 2 Diabetes (iDiabetes): Protocol for a Randomized Controlled Trial.

Publications

Remotely Monitored Gamification and Social Incentives to Improve Glycemic Control Among Adults With Uncontrolled Type 2 Diabetes (iDiabetes): Protocol for a Randomized Controlled Trial.

Similar Datasets

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