Goldstein Stephanie P, Zhang Fengqing, Klasnja Predrag, Hoover Adam, Wing Rena R, Thomas John Graham
Weight Control and Diabetes Research Center, The Miriam Hospital, Providence, RI, United States.
Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, United States.
JMIR Res Protoc. 2021 Dec 6;10(12):e33568. doi: 10.2196/33568.
Behavioral obesity treatment (BOT) is a gold standard approach to weight loss and reduces the risk of cardiovascular disease. However, frequent lapses from the recommended diet stymie weight loss and prevent individuals from actualizing the health benefits of BOT. There is a need for innovative treatment solutions to improve adherence to the prescribed diet in BOT.
The aim of this study is to optimize a smartphone-based just-in-time adaptive intervention (JITAI) that uses daily surveys to assess triggers for dietary lapses and deliver interventions when the risk of lapse is high. A microrandomized trial design will evaluate the efficacy of any interventions (ie, theory-driven or a generic alert to risk) on the proximal outcome of lapses during BOT, compare the effects of theory-driven interventions with generic risk alerts on the proximal outcome of lapse, and examine contextual moderators of interventions.
Adults with overweight or obesity and cardiovascular disease risk (n=159) will participate in a 6-month web-based BOT while using the JITAI to prevent dietary lapses. Each time the JITAI detects elevated lapse risk, the participant will be randomized to no intervention, a generic risk alert, or 1 of 4 theory-driven interventions (ie, enhanced education, building self-efficacy, fostering motivation, and improving self-regulation). The primary outcome will be the occurrence of lapse in the 2.5 hours following randomization. Contextual moderators of intervention efficacy will also be explored (eg, location and time of day). The data will inform an optimized JITAI that selects the theory-driven approach most likely to prevent lapses in a given moment.
The recruitment for the microrandomized trial began on April 19, 2021, and is ongoing.
This study will optimize a JITAI for dietary lapses so that it empirically tailors the provision of evidence-based intervention to the individual and context. The finalized JITAI will be evaluated for efficacy in a future randomized controlled trial of distal health outcomes (eg, weight loss).
ClinicalTrials.gov NCT04784585; http://clinicaltrials.gov/ct2/show/NCT04784585.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33568.
行为性肥胖治疗（BOT）是一种减肥的黄金标准方法，可降低心血管疾病风险。然而，频繁偏离推荐饮食会阻碍体重减轻，并使个体无法实现BOT的健康益处。需要创新的治疗方案来提高BOT中对规定饮食的依从性。
本研究的目的是优化一种基于智能手机的即时自适应干预（JITAI），该干预使用每日调查来评估饮食失误的触发因素，并在失误风险高时提供干预措施。一项微随机试验设计将评估任何干预措施（即理论驱动或通用风险警报）对BOT期间失误近端结果的疗效，比较理论驱动干预措施与通用风险警报对失误近端结果的影响，并检查干预措施的情境调节因素。
超重或肥胖且有心血管疾病风险的成年人（n = 159）将参加为期6个月的基于网络的BOT，同时使用JITAI预防饮食失误。每次JITAI检测到失误风险升高时，参与者将被随机分配到无干预、通用风险警报或4种理论驱动干预措施之一（即强化教育、建立自我效能感、激发动机和改善自我调节）。主要结果将是随机分组后2.5小时内失误的发生情况。还将探索干预效果的情境调节因素（如地点和一天中的时间）。这些数据将为优化的JITAI提供信息，该JITAI会选择在特定时刻最有可能预防失误的理论驱动方法。
微随机试验的招募工作于2021年4月19日开始，目前正在进行中。
本研究将优化针对饮食失误的JITAI，以便根据个体和情境经验性地调整循证干预措施的提供。最终确定的JITAI将在未来一项关于远端健康结果（如体重减轻）的随机对照试验中评估其疗效。
ClinicalTrials.gov NCT04784585；http://clinicaltrials.gov/ct2/show/NCT04784585。
国际注册报告识别码（IRRID）：DERR1-10.2196/33568。
