Effect of Goal-Setting Approaches Within a Gamification Intervention to Increase Physical Activity Among Economically Disadvantaged Adults at Elevated Risk for Major Adverse Cardiovascular Events: The ENGAGE Randomized Clinical Trial.

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. To test the effectiveness of different ways to set and implement goals within a behaviorally designed gamification intervention to increase physical activity. 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. 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). 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. 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. 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. ClinicalTrials.gov Identifier: NCT03749473.