Time-restricted eating: Is it an efficacious tool for weight loss maintenance

项目总结/摘要 尽管在实现短期减肥成功方面取得了很大进展，但长期减肥维持（WLM） 仍然是一个挑战。时间限制饮食（TRE），一种间歇性禁食的形式，是一种未经测试的生物行为， WLM的战略。这个独立之路奖（K99/R 00）的目标是加快候选人的 过渡到一个独立的研究者，专注于开发和评估权重 WLM期间的管理策略。在本奖项的K99阶段，候选人将获得以下培训： 在行为维持理论和方法，混合方法和定性分析和食欲的专业知识 生理学，并进行试点研究，以开发和测试干预方法。候选人将进行 一项初步随机对照试验（共40例;每组20例），旨在测试两种药物的可行性、可接受性和依从性， TRE干预（≤6 h和≤ 10 h进食窗）。参与者将包括成年人（25- 65岁，BMI>20.5 kg/m2） 从2个非手术减肥项目招募，成功实现初始体重减轻≥5% 重量.在随机化之前，受试者将经历一个导入期，其中包括4周的体重稳定期 期候选人将从招聘、保留和 使用混合方法设计（目标1）坚持进食窗口。候选人将执行定性 完成TRE后进行访谈（n=12/组），以获取参与者的TRE经验， 确定每个TRE的个人、家庭和邻里/社区层面的障碍和促进因素 干预，如动机，文化因素，职业和家庭结构（子目标1），将被使用 加强干预。在R 00阶段，候选人将使用获得的技能和培训来测试 从K99阶段确定的最佳TRE干预。在随机对照试验中，候选人将 在12岁时评估所选TRE对体重恢复（目标2a）和脂肪量恢复（目标2b）的疗效 个月候选人将招募近期非手术减肥和体重稳定的成年人（类似于 K99相）。参与者将被随机分配到2个组中的一个（总共n=72; n=36/组）：1）TRE（选自 K99阶段）或2）基线建议控制（CON）。TRE和CON组均将提供基线 书面材料和战略，促进成功的WLM。将指导TRE组的参与者 在智能手机应用程序中自我监测饮食摄入量和体重，并接受行为咨询。 将在基线（0）、3、6和12个月时进行测量。主要结果是体重恢复 12个月大的时候候选人将探索随机分配和WLM对食欲的影响 在6个月和12个月时通过视觉模拟量表评估生物标志物和主观食欲（探索性目的）。最后， 这将使候选人成为一名独立的研究人员，进行跨学科的生物行为学研究。 研究使用生活方式干预，成为WLM的领导者。

Project Summary/Abstract Despite great strides in achieving short-term weight loss success, long-term weight loss maintenance (WLM) remains a challenge. Time-restricted eating (TRE), a form of intermittent fasting, is an untested bio-behavioral strategy for WLM. The goal of this Pathway to Independence Award (K99/R00) is to accelerate the candidate's transition to an independent investigator with focused expertise in the development and evaluation of weight management strategies during WLM. In the K99 phase of this award, the candidate will obtain training in expertise in behavior maintenance theories and methods, mixed methods and qualitative analyses and appetite physiology, and conduct pilot studies to develop and test the intervention approach. The candidate will conduct a pilot randomized controlled trial (n=40 total; 20/arm) to test the feasibility, acceptability, and adherence of two TRE interventions (≤6 h and ≤10h eating windows). Participants will include adults (25–65y, BMI>20.5 kg/m2) recruited from 2 nonsurgical weight loss programs who successfully attained a weight loss of ≥5% initial body weight. Prior to randomization, participants will undergo a run-in phase that includes a 4-week weight stabilization period. The candidate will evaluate the feasibility and acceptability in terms of recruitment, retention, and adherence to the eating window using a mixed-methods design (Aim 1). The candidate will perform qualitative interviews (n=12/arm) following completion of the TRE to capture participants' experience with TRE and determine individual-, family-, and neighborhood/community-level barriers and facilitators to each TRE intervention, such as motivation, cultural factors, occupation, and family structure (Sub-aim 1) that will be used to strengthen the intervention. In the R00 phase, the candidate will use acquired skills and training to test the optimum TRE intervention identified from the K99 phase. In a randomized controlled trial, the candidate will assess the efficacy of the selected TRE on body weight regain (Aim 2a), and fat mass regain (Aim 2b) at 12 months. The candidate will recruit adults with recent non-surgical weight loss and weight stabilization (similar to K99 phase). Participants will be randomized to one of 2 arms (n=72 total; n=36/arm): 1) TRE (selected from the K99 phase) or 2) baseline advice control (CON). Both the TRE and CON groups will be provided with baseline written materials and strategies that promote successful WLM. Participants in the TRE group will be instructed to self-monitor dietary intake and body weight in a smartphone application and receive behavioral counseling. Measurements will be obtained at baseline (0), 3, 6, and 12 months. The primary outcome is body weight regain at 12 months. The candidate will explore the effects of randomization assignment and WLM on appetite biomarkers and subjective appetite via a visual analog scale at 6 mos and 12 mos (Exploratory Aim). Ultimately, this will establish the candidate as an independent investigator conducting interdisciplinary bio-behavioral research using lifestyle interventions to become a leader in WLM.