Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial.
Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial.
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DOI：
10.2196/33568
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发表时间：
2021-12-06
影响因子：
1.7
通讯作者：
Thomas JG
中科院分区：
文献类型：
--
作者：
Goldstein SP;Zhang F;Klasnja P;Hoover A;Wing RR;Thomas JG
行为肥胖治疗（BOT）是减肥的金标准方法，可降低心血管疾病的风险。然而，经常偏离推荐的饮食会阻碍减肥，并阻止个人实现BOT的健康益处。需要创新的治疗方案来改善BOT患者对规定饮食的依从性。这项研究的目的是优化基于智能手机的即时适应性干预（JITAI），该干预使用每日调查来评估饮食失误的触发因素，并在失误风险较高时提供干预措施。微观随机试验设计将评价任何干预措施（即理论驱动或一般风险警报）对BOT期间失误近端结局的有效性，比较理论驱动干预措施与一般风险警报对失误近端结局的影响，并检查干预措施的背景调节因素。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检测到失效风险升高时，参与者将被随机分配到无干预，通用风险警报或4种理论驱动的干预措施之一（即加强教育，建立自我效能，培养动机和改善自我调节）。主要结局将是随机化后2.5小时内发生的流产。还将探索干预有效性的背景调节因素（例如，地点和时间）。这些数据将为优化的JITAI提供信息，该JITAI选择最有可能在给定时刻防止失误的理论驱动方法。微随机化试验的招募工作于2021年4月19日开始，目前正在进行中。本研究将优化饮食失误的JITAI，以便根据经验为个人和环境提供基于证据的干预。将在未来的远端健康结局（如体重减轻）随机对照试验中评价最终JITAI的疗效。ClinicalTrials.gov NCT 04784585; http://clinicaltrials.gov/ct2/show/NCT04784585 DERR 1 -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 DERR1-10.2196/33568
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