Promoting Lifestyle Change via Tailored mHealth To Improve Health, HL131583

摘要 十多年来，我们的调查团队一直在研究自我监控的复杂性，并已 与饮食有关的自我监控的一致性和时机与体重显著相关 损失后果。最近，越来越多的证据支持将反馈(FB)消息添加到自我 监测加强行为改变，增强动力和坚持性。经验证据 演示了强化消息传递得越近， 期望的行为越有可能增加期望的行为。拟议的研究正是基于这一点。 证据的主体，部分由我们的团队之前进行的试验提供，并有望获得 拟议的干预措施。在之前的减肥试验中，受试者更坚持自我监测， 治疗方案，如果他们每天收到一次定制的FB消息，更有可能实现5%的体重减轻 那些没有收到FB的人比他们当天记录的要多。在这项研究的基础上，我们有 开发了一个包含1000多个条件的广泛的FB算法，以解决饮食和体力活动问题。 鉴于我们过去对减肥自我监测的研究结果和我们试点的可行性 对FB和SM进行联合测试的研究，我们建议在530名成年人中进行一项全面的、为期4年的RCT 将以1：1随机分为：1)自我监测(SM)，受试者将自我监测饮食、体力活动 和体重；或2)SM+FB，其中参与者自我监控 监控和接收实时FB消息。拥有FB的组将收到最多4条每日弹出的FB消息 在他们的智能手机上，在醒着的时候随机发送，并根据受试者的 基于智能手机的日记。这项研究的主要具体目标是：1)确定SM是否具有定制的FB 实时递送，每天最多4次，在促进6个月和12个月的减肥方面优于SM 条件和2)比较SM和SM+FB组在全部12个方面的接触可持续性- 在3、6、9和12个月时，通过遵守研究方案的组成部分来衡量MO研究。我们还将 进行创新性分析，探索FB频率、时间和类型的时间关系 通过检查连续收集的实时SM数据来传递和随后的生活方式行为。 这项拟议的研究解决了一个主要的公共卫生问题，并在大规模测试方面具有创新性 一种新的加强健康行为的FB算法和程序及其对 订婚。如果被证明是有效的，这种干预可以有效地转化，并通过与 商业应用程序可以完全扩展和传播，以接触到大量希望 以比现有计划更低的成本改善他们的健康。

ABSTRACT Our investigative team has been studying the intricacies of self-monitoring for over a decade and has documented that consistency and timing of self-monitoring in relation to eating is significantly related to weight loss outcomes. More recently, evidence is building to support adding feedback (FB) messages to self- monitoring for reinforcing behavior change and enhancing motivation and adherence. Empirical evidence demonstrates that the more proximal the reinforcing message is delivered following the performance of the desired behavior, the more likely it will increase the desired behavior. The proposed study is based on this body of evidence, in part provided by a previous trial conducted by our team and promising pilot data of the proposed intervention. Subjects in the previous weight loss trial were more adherent to self-monitoring and the treatment protocol and more likely to achieve 5% weight loss if they received a once-daily FB message tailored to what they had recorded that day than those who did not receive FB. Building on this study, we have developed an extensive FB algorithm with more than 1000 conditions to address diet and physical activity. Given our findings from our past research on self-monitoring in weight loss and the results of our pilot feasibility study testing the FB in conjunction with SM, we propose to conduct a full-scale, 4-year RCT where 530 adults will be randomized 1:1 to either: 1) self-monitoring (SM), where subjects will self-monitor diet, physical activity and weight using a commercially available self-monitoring application; or 2) SM+FB, where participants self- monitor and receive real-time FB messages. The group with FB will receive up to 4 daily pop-up FB messages on their smartphone delivered randomly during waking hours and tailored to entries in the subjects’ smartphone-based diaries. The primary specific aims for this study are to: 1) determine if SM with tailored FB delivered in real time up to 4 times per day is superior for promoting weight loss at 6 and 12 months to the SM condition and 2) Compare sustainability of engagement between the SM and the SM+FB groups for the full 12- mo study as measured by adherence to components of study protocol at 3, 6, 9 and 12 mos. We will also conduct innovative analyses to explore the temporal relationships of the frequency, timing and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM data. The proposed research addresses a major public health problem and is innovative in its large scale testing of a novel FB algorithm and program to reinforce healthful behaviors and its examination of the sustainability of engagement. If proven efficacious, this intervention could be efficiently translated and through integration with commercial apps could be fully scalable and disseminated to reach large numbers of individuals who wish to improve their health with lower in cost than existing programs.