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INTRODUCTION: Physical activity is associated with reduced risk of cognitive and functional decline but scalable, sustainable interventions for populations at risk for Alzheimer's disease (AD) and AD and related dementias (ADRD) are lacking. METHODS: A 12-week randomized-controlled trial was conducted with a 3-week follow-up using a national AD prevention registry (GeneMatch). The control group (n = 50) set step goals and received daily feedback. The intervention group (n = 44) also received a behaviorally designed game based on achieving step goals and reinforced by a support partner. RESULTS: Intervention participants (94 participants, mean age 70, 78% female) had greater change in mean daily step count than control of 1699 steps/day (95% confidence interval [CI], 1149-2249), P < 0.0001, which was sustained in the follow-up period at 1219 steps/day (95% CI, 455-1983), P = 0.0018. Carriers of the apolipoprotein E ε4 gene (high risk) did not perform differently than non-carriers; however, high self-reported risk perception was associated with higher activity. DISCUSSION: A gamified intervention was effective in promoting and sustaining higher physical activity in older adults at genetic risk for AD/ADRD. HIGHLIGHTS: A simple game played with a support partner increased walking in older adults at risk for Alzheimer's disease (AD). The game also increased minutes of moderate-to-vigorous physical activity per day. Perception of lifelong AD risk was associated with increased activity but genetic risk (apolipoprotein E ε4+) was not. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05069155.

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Physical activity is known to contribute to good health, but most adults in the United States do not meet recommended physical activity guidelines. Social incentive interventions that leverage insights from behavioral economics have increased physical activity in short-term trials, but there is limited evidence of their effectiveness in community settings or their long-term effectiveness. The STEP Together study is a Hybrid Type 1 effectiveness-implementation study to address these evidence and implementation gaps. This paper describes the process of adapting study procedures prior to the effectiveness trial using Community Engagement (CE) Studios, facilitated meetings during which community members provide feedback on research projects. Six CE Studios were held with community members from the priority population. They were conducted remotely because of the COVID-19 pandemic. Fifteen liaisons representing 13 community organizations and 21 community members from different neighborhoods in Philadelphia participated. Three elements of the study design were modified based on feedback from the CE Studios: lowering the age requirement for an 'older adult', clarifying the definition of family members to include second-degree relatives, and adding a 6-month survey. These adaptations will improve the fit of the effectiveness trial to the local context and improve participant engagement and retention. CE Studios can be used to adapt intervention strategies and other aspects of study design during hybrid implementation-effectiveness trials. This approach was successfully used with remote online participation due to the COVID-19 pandemic and serves as a model for future community-engaged implementation research.

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Importance: Health promotion efforts commonly communicate goals for healthy behavior, but the best way to design goal setting among high-risk patients has not been well examined. Objective: To test the effectiveness of different ways to set and implement goals within a behaviorally designed gamification intervention to increase physical activity. Design, Setting, and Participants: Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences was conducted from January 15, 2019, to June 1, 2020. The 24-week randomized clinical trial included a remotely monitored 8-week introductory intervention period, 8-week maintenance intervention period, and 8-week follow-up period. A total of 500 adults from lower-income neighborhoods in and around Philadelphia, Pennsylvania, who had either an atherosclerotic cardiovascular disease (ASCVD) condition or a 10-year ASCVD risk score greater than or equal to 7.5% were enrolled. Participants were paid for enrolling in and completing the trial. Interventions: All participants used a wearable device to track daily steps, established a baseline level, and were then randomly assigned to an attention control or 1 of 4 gamification interventions that varied only on how daily step goals were set (self-chosen or assigned) and implemented (immediately or gradually). Main Outcome Measures: The primary outcome was change in mean daily steps from baseline to the 8-week maintenance intervention period. Other outcomes included changes in minutes of moderate to vigorous physical activity. All randomly assigned participants were included in the intention-to-treat analysis. Results: Of the 500 participants, 331 individuals (66.2%) were Black, 114 were White (22.8%), and 348 were women (69.6%). Mean (SD) age was 58.5 (10.8) years and body mass index was 33.2 (7.8). A total of 215 participants (43.0%) had an ASCVD condition. Compared with the control arm, participants with self-chosen and immediate goals had significant increases in the number of daily steps during the maintenance intervention period (1384; 95% CI, 805-1963; P < .001) that were sustained during the 8-week follow-up (1391; 95% CI, 785-1998; P < .001). This group also had significant increases in daily minutes of moderate to vigorous physical activity during the maintenance intervention (4.1; 95% CI, 1.8-6.4; P < .001) that were sustained during follow-up (3.5; 95% CI, 1.1-5.8; P = .004). No other gamification arms had consistent increases in physical activity compared with the control arm. No major adverse events were reported. Conclusions and Relevance: In this trial among economically disadvantaged adults at elevated risk for major adverse cardiovascular events, a gamification intervention led to increases in physical activity that were sustained during 8 weeks of follow-up when goals were self-chosen and implemented immediately. Trial Registration: ClinicalTrials.gov Identifier: NCT03749473.

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Importance: Gamification is increasingly being used for health promotion but has not been well tested with financial incentives or among veterans. Objective: To test the effectiveness of gamification with social support, with and without a loss-framed financial incentive, to increase physical activity among veterans classified as having overweight and obesity. Design, Setting, and Participants: This 3-group randomized clinical trial had a 12-week intervention period and an 8-week follow-up period. Participants included veterans with a body mass index greater than or equal to 25 who were receiving care from a single site in Philadelphia, Pennsylvania. Participants underwent a remotely monitored intervention from March 19, 2019, to August 9, 2020. Data analyses were conducted between October 1, 2020, and November 14, 2020. Interventions: All participants received a wearable device to track step counts and selected a step goal. The control group received feedback from their devices only. Participants in the 2 gamification groups were entered into a 12-week game with points and levels designed using behavioral economic principles and selected a support partner to receive weekly updates. Participants in the loss-framed financial incentive group had $120 allocated to a virtual account and lost $10 if weekly goals were not achieved. Main Outcomes and Measures: The primary outcome was the change in mean daily steps from baseline during the intervention. Secondary outcomes include proportion of days goals were achieved and changes during follow-up. Results: A total of 180 participants were randomized, 60 to the gamification with social support group, 60 to the gamification with social support and loss-framed financial incentives group, and 60 to the control group. The participants had a mean (SD) age of 56.5 (12.9) years and a mean (SD) body mass index of 33.0 (5.6); 71 participants (39.4%) were women, 90 (50.0%) were White, and 67 (37.2%) were Black. During the intervention period, compared with control group participants, participants in the gamification with financial incentives group had a significant increase in mean daily steps from baseline (adjusted difference, 1224 steps; 95% CI, 451 to 1996 steps; P = .005), but participants in the gamification without financial incentives group did not (adjusted difference, 433 steps; 95% CI, -337 to 1203 steps; P = .81). The increase for the gamification with financial incentives group was not sustained during the follow-up period, and the step count was not significantly different than that of the control group (adjusted difference, 564 steps; 95% CI, -261 to 1389 steps; P = .37). Compared with the control group, participants in the intervention groups had a significantly higher adjusted proportion of days meeting their step goal during the main intervention and follow-up period (gamification with social support group, adjusted difference from control, 0.21 participant-day; 95% CI, 0.18-0.24 participant-day; P < .001; gamification with social support and loss-framed financial incentive group, adjusted difference from control, 0.34 participant-day; 95% CI, 0.31-0.37 participant-day; P < .001). Conclusions and Relevance: Among veterans classified as having overweight and obesity, gamification with social support combined with loss-framed financial incentives was associated with a modest increase in physical activity during the intervention period, but the increase was not sustained during follow-up. Gamification without incentives did not significantly change physical activity. Trial Registration: ClinicalTrials.gov Identifier: NCT03563027.

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Importance: Gamification is increasingly being used to promote healthy behaviors. However, it has not been well tested among patients with chronic conditions and over longer durations. Objective: To 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 Participants: A 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. Interventions: All 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 Measures: Co-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. Results: Participants 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 Relevance: Among 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 Registration: ClinicalTrials.gov Identifier: NCT02961192.

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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.

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Importance: Gamification, the use of game design elements in nongame contexts, is increasingly being used in workplace wellness programs and digital health applications. However, the best way to design social incentives in gamification interventions has not been well examined. Objective: To assess the effectiveness of support, collaboration, and competition within a behaviorally designed gamification intervention to increase physical activity among overweight and obese adults. Design, Setting, and Participants: This 36-week randomized clinical trial with a 24-week intervention and 12-week follow-up assessed 602 adults from 40 states with body mass indexes (calculated as weight in kilograms divided by height in meters squared) of 25 or higher from February 12, 2018, to March 17, 2019. Interventions: Participants used a wearable device to track daily steps, established a baseline, selected a step goal increase, were randomly assigned to a control (n = 151) or to 1 of 3 gamification interventions (support [n = 151], collaboration [n = 150], and competition [n = 150]), and were remotely monitored. The control group received feedback from the wearable device but no other interventions for 36 weeks. The gamification arms were entered into a 24-week game designed using insights from behavioral economics with points and levels for achieving step goals. No gamification interventions occurred during follow-up. Main Outcomes and Measures: The primary outcome was change in mean daily steps from baseline through the 24-week intervention period. Results: A total of 602 participants (mean [SD] age, 39 [10] years; mean [SD] body mass index, 30 [5]; 427 [70.9%] male) were included in the study. Compared with controls, participants had a significantly greater increase in mean daily steps from baseline during the intervention in the competition arm (adjusted difference, 920; 95% CI, 513-1328; P < .001), support arm (adjusted difference, 689; 95% CI, 267-977; P < .001), and collaboration arm (adjusted difference, 637; 95% CI, 258-1017; P = .001). During follow-up, physical activity remained significantly greater in the competition arm than in the control arm (adjusted difference, 569; 95% CI, 142-996; P = .009) but was not significantly greater in the support (adjusted difference, 428; 95% CI, 19-837; P = .04) and collaboration (adjusted difference, 126; 95% CI, -248 to 468; P = .49) arms than in the control arm. Conclusions and Relevance: All 3 gamification interventions significantly increased physical activity during the 24-week intervention, and competition was the most effective. Physical activity was lower in all arms during follow-up and only remained significantly greater in the competition arm than in the control arm. Trial Registration: ClinicalTrials.gov identifier: NCT03311230.

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