Promoting Lifestyle Change via Tailored mHealth to Improve Health

摘要 我们的调查团队已经研究自我监控的复杂性超过十年， 记录了与饮食有关的自我监控的一致性和时间与体重显著相关 损失结果。最近，有证据支持在自我反馈中添加反馈（FB）信息。 监测以加强行为改变并增强动机和坚持。经验证据 证明了越接近的强化信息传递后的性能， 期望的行为，就越有可能增加期望的行为。这项研究正是基于此。 证据的主体，部分是由我们的团队进行的先前试验和有希望的试点数据提供的。 建议干预。在先前的减肥试验中，受试者更坚持自我监测， 治疗方案，更有可能实现5%的体重减轻，如果他们收到一个定制的每日一次FB消息 他们所记录的，比那些没有收到FB的人要多。基于这项研究，我们 开发了一个广泛的FB算法，具有1000多个条件，以解决饮食和体力活动。 鉴于我们过去对减肥自我监测的研究结果和我们试点可行性的结果， 一项结合SM测试FB的研究，我们建议进行一项全面的4年RCT，其中530名成年人 将以1：1的比例随机分配至：1）自我监测（SM），受试者将自我监测饮食、体力活动 使用市售的自我监测应用程序测量体重;或2）SM+FB，参与者自我监测体重。 监控和接收实时FB消息。有FB的群组每天最多会收到4条弹出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 智能手机日记本研究的主要具体目的是：1）确定是否有定制FB的SM 每天最多4次的真实的给药在促进6个月和12个月时的体重减轻方面优于SM，上级 条件和2）比较SM和SM+FB组之间在整个12- mo研究，通过在3、6、9和12个月时对研究方案组成部分的依从性进行测量。我们还将 进行创新性分析，探索FB的频率、时间和类型的时间关系 通过连续收集的实时SM数据的检查，提供和随后的生活方式行为。 拟议的研究解决了一个主要的公共卫生问题，并在其大规模测试中具有创新性 一种新的FB算法和程序，以加强健康的行为和其检查的可持续性， 订婚如果证明有效，这种干预措施可以有效地转化，并通过与 商业应用程序可以完全扩展和传播，以达到大量的个人谁希望 以比现有方案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.