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

重要性 健康促进工作通常会传达健康行为的目标，但在高危患者中设计目标设定的最佳方式尚未得到很好的检验。

目的 测试在行为设计的游戏化干预中设定和实施目标以增加身体活动的不同方法的有效性。

2019 年 1 月 15 日至 2020 年 6 月 1 日，对具有替代目标设定体验的游戏化新用途的设计、设置和参与者 进行了评估。为期 24 周的随机临床试验包括远程监控的 8 周介绍性干预期、8周的维持干预期和8周的随访期。共有 500 名来自宾夕法尼亚州费城及周边地区的低收入社区的成年人被纳入研究，他们患有动脉粥样硬化性心血管疾病 (ASCVD) 或 10 年 ASCVD 风险评分大于或等于 7.5%。参与者因注册和完成试验而获得报酬。

干预 所有参与者都使用可穿戴设备来跟踪每日步数，建立基线水平，然后被随机分配到注意力控制或 4 种游戏化干预中的一种，这些干预仅根据每日步数目标的设定方式（自行选择或分配）和实施（立即或逐步）。

主要结果测量 主要结果是平均每日步数从基线到 8 周维持干预期的变化。其他结果包括中度到剧烈体力活动分钟数的变化。所有随机分配的参与者都包括在意向治疗分析中。

结果 在 500 名参与者中，黑人 331 人（66.2%），白人 114 人（22.8%），女性 348 人（69.6%）。平均 (SD) 年龄为 58.5 (10.8) 岁，体重指数为 33.2 (7.8)。共有 215 名参与者 (43.0%) 患有 ASCVD。与对照组相比，具有自我选择和即时目标的参与者在维持干预期间的每日步数显着增加（1384；95% CI，805-1963；P  < .001），在 8 - 周随访（1391；95% CI，785-1998；P  < .001）。在维持干预期间，该组的每日中度至剧烈体力活动分钟数也显着增加（4.1；95% CI，1.8-6.4；P < .001）在随访期间持续存在（3.5；95% CI，1.1-5.8；P  = .004）。与对照组相比，没有其他游戏化手臂的体力活动持续增加。未报告重大不良事件。

结论和相关性 在这项针对主要不良心血管事件风险较高的经济不利成年人的试验中，游戏化干预导致体力活动增加，并且在 8 周的随访期间持续增加，目标是自行选择并立即实施。

试验注册 ClinicalTrials.gov 标识符：NCT03749473