Promoting Lifestyle Change via Tailored mHealth To Improve Health, HL131583

通过定制移动医疗促进生活方式改变以改善健康，HL131583

• 批准号: 9763184
• 负责人: LORA Emilie BURKE
• 金额: $ 5.6万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9763184
• 关键词: Address; Adherence; Adult; Algorithms; Behavior; Behavior Therapy; Bluetooth; Body Weight decreased; Calories; Cardiovascular Diseases; Cellular Phone; Chronic; Data; Development; Devices; Diabetes Mellitus; Diet; Diet Monitoring; Dietary intake; Eating; Fatty acid glycerol esters; Feasibility Studies; Feedback; Frequencies; Goals; Habits; Health; Hour; Individual; Instruction; Intake; Intervention; Investigation; Life Style; Link; Measures; Monitor; Motivation; Obesity; Outcome; Paper; Participant; Pattern; Performance; Persons; Physical activity; Population; Protocols documentation; Psychological reinforcement; Public Health; Randomized; Randomized Clinical Trials; Research; Self-Direction; Structure; System; Technology; Testing; Time; Translating; Treatment Protocols; Weight; Weight maintenance regimen; adult obesity; base; behavior change; cardiovascular risk factor; cost; diaries; evidence base; fitbit; improved; individualized feedback; innovation; intelligent personal assistant; mHealth; mobile computing; novel; programs; smartphone Application; tailored messaging; tool; treatment program; weight loss intervention; weight loss program

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.

抽象的 我们的调查团队十多年来一直在研究自我监控的复杂性，并已 记录表明，与饮食有关的自我监控的一致性和时间与体重显着相关 最近，越来越多的证据支持在自我评估中添加反馈（FB）消息。 监测以加强行为改变并提高动机和依从性。 表明，随着执行者的表现，强化信息传递得越接近 期望的行为越有可能增加期望的行为，所提出的研究就是基于此。 大量证据，部分是由我们团队之前进行的试验提供的，以及有希望的试点数据 先前减肥试验中的受试者更坚持自我监控和建议的干预。 如果他们每天收到一次量身定制的 FB 消息，则更有可能实现 5% 的减肥效果 与那些没有收到 FB 的人相比，他们当天记录的内容有所不同。 开发了一种广泛的 FB 算法，具有 1000 多个条件来解决饮食和身体活动问题。 鉴于我们过去对减肥自我监测的研究结果以及我们试点可行性的结果 为了测试 FB 与 SM 的研究，我们建议进行一项全面的、为期 4 年的随机对照试验，其中 530 名成年人参与其中 将按 1:1 随机分配至以下任一组：1) 自我监测 (SM)，受试者将自我监测饮食、体力活动 和使用市售自我监测应用程序的体重；或 2) SM+FB，其中参与者自我监测 监控并接收实时FB消息 拥有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，并根据受试者的条目进行定制 本研究的主要具体目标是：1) 确定 SM 是否具有定制的 FB。 每天实时发送多达 4 次，对于促进 SM 在 6 个月和 12 个月时的减肥效果极佳 条件和 2) 比较 SM 和 SM+FB 组之间在整个 12 小时内参与的可持续性 通过在第 3、6、9 和 12 个月遵守研究方案的各个部分来衡量我们的研究。 进行创新分析，探索 FB 的频率、时间和类型的时间关系 通过检查连续收集的实时 SM 数据来评估交付的和随后的生活方式行为。 拟议的研究解决了一个重大的公共卫生问题，并且在大规模测试方面具有创新性 一种强化健康行为的新型 FB 算法和程序及其对可持续性的检验 如果被证明是有效的，这种干预措施可以通过整合得到有效转化。 商业应用程序可以完全扩展并传播到大量希望使用的个人 以比现有计划更低的成本改善他们的健康。