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

限时饮食：是减肥维持的有效工具吗

• 批准号: 10591316
• 负责人: Collin Jeffrey Popp
• 金额: $ 14.86万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-07 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10591316
• 关键词: Acceleration; Acylation; Address; Adherence; Adult; Award; Behavior; Behavioral; Biological; Biological Markers; Body Composition; Body Weight; Body Weight decreased; Body mass index; Caloric Restriction; Chronic Disease; Clinic; Conduct Clinical Trials; Control Groups; Counseling; Data; Desire for food; Development; Diet Monitoring; Dietary intake; Eating; Energy Metabolism; Enrollment; Environment; Evaluation; Exclusion; Failure; Family; Fatty acid glycerol esters; Feedback; Foundations; Gastric Inhibitory Polypeptide; Goals; Guidelines; Health; Hour; Hunger; Individual; Insulin; Intermittent fasting; Intervention; Interview; Leptin; Maintenance; Measurement; Measures; Mentors; Mentorship; Methods; Motivation; Muslim religion; Neighborhoods; Non-Insulin-Dependent Diabetes Mellitus; Nutritional Study; Obesity; Occupations; Participant; Pathway interactions; Phase; Physiological; Physiology; Pilot Projects; Policies; Provider; Public Health; Publications; Randomized; Randomized, Controlled Trials; Recommendation; Research; Research Personnel; Rest; Role; Running; Satiation; Strategic Planning; Testing; Time; Time-restricted feeding; Training; United States National Institutes of Health; Visual; Weight; Weight maintenance regimen; Writing; acceptability and feasibility; analog; arm; behavior change; biobehavior; community barrier; design; direct application; efficacy evaluation; efficacy testing; energy balance; experience; family structure; feasibility testing; ghrelin; glucagon-like peptide 1; improved; innovation; lifestyle intervention; oxidation; prevent; primary outcome; programs; recruit; reduced food intake; response; skill acquisition; smartphone application; success; theories; tool; trend; weight loss program; Acceleration; Acylation; Address; Adherence; Adult; Award; Behavior; Behavioral; Biological; Biological Markers; Body Composition; Body Weight; Body Weight decreased; Body mass index; Caloric Restriction; Chronic Disease; Clinic; Conduct Clinical Trials; Control Groups; Counseling; Data; Desire for food; Development; Diet Monitoring; Dietary intake; Eating; Energy Metabolism; Enrollment; Environment; Evaluation; Exclusion; Failure; Family; Fatty acid glycerol esters; Feedback; Foundations; Gastric Inhibitory Polypeptide; Goals; Guidelines; Health; Hour; Hunger; Individual; Insulin; Intermittent fasting; Intervention; Interview; Leptin; Maintenance; Measurement; Measures; Mentors; Mentorship; Methods; Motivation; Muslim religion; Neighborhoods; Non-Insulin-Dependent Diabetes Mellitus; Nutritional Study; Obesity; Occupations; Participant; Pathway interactions; Phase; Physiological; Physiology; Pilot Projects; Policies; Provider; Public Health; Publications; Randomized; Randomized, Controlled Trials; Recommendation; Research; Research Personnel; Rest; Role; Running; Satiation; Strategic Planning; Testing; Time; Time-restricted feeding; Training; United States National Institutes of Health; Visual; Weight; Weight maintenance regimen; Writing; acceptability and feasibility; analog; arm; behavior change; biobehavior; community barrier; design; direct application; efficacy evaluation; efficacy testing; energy balance; experience; family structure; feasibility testing; ghrelin; glucagon-like peptide 1; improved; innovation; lifestyle intervention; oxidation; prevent; primary outcome; programs; recruit; reduced food intake; response; skill acquisition; smartphone application; success; theories; tool; trend; weight loss program

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.

项目摘要/摘要 尽管在实现短期减肥成功方面取得了长足的进步，但长期减肥维持（WLM） 仍然是一个挑战。时间限制的饮食（TRE）是一种间歇性禁食的形式，是未经测试的生物行为 WLM的策略。这项获得独立奖的目标（K99/R00）是加速候选人的 过渡到具有重点专业知识的独立研究人员的体重开发和评估 WLM期间的管理策略。在该奖项的K99阶段，候选人将获得培训 行为维护理论和方法，混合方法和定性分析以及食欲方面的专业知识 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 试点随机对照试验（n = 40; 20/臂），以测试两个的可行性，可接受性和遵守 TRE干预措施（≤6h，≤10h进食窗户）。参与者将包括成年人（25-65y，BMI> 20.5 kg/m2） 从2个非手术减肥计划中招募，他们成功附上了≥5％的初始身体的体重减轻 重量。在随机化之前，参与者将经历一个包括4周重量稳定的磨合阶段 时期。候选人将根据招聘，保留和 使用混合方法设计（AIM 1）遵守饮食窗口。候选人将执行定性 TRE完成后的访谈（n = 12/ARM），以捕捉参与者在TRE和 确定每个TRE的个人，家庭和社区/社区/社区级别的障碍以及促进者 干预措施，例如动机，文化因素，职业和家庭结构（Sub-aim 1） 加强干预措施。在R00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。在一项随机对照试验中，候选人将 评估所选TRE对体重的效率保留（AIM 2A），而脂肪质量仍然存在（AIM 2B）12 月份。候选人将招募具有最近非手术减肥和体重稳定的成年人（类似于 K99阶段）。参与者将被随机分为2个臂之一（n = 72; n = 36/arm）：1）TRE（从 K99期）或2）基线咨询控制（CON）。 TRE和CON组都将提供基线 促进成功WLM的书面材料和策略。将指示TRE组的参与者 在智能手机应用中自我监测的饮食摄入量和体重，并接受行为咨询。 测量将在基线（0），3、6和12个月获得。主要结果是体重恢复 12个月。候选人将探索随机分配和WLM对食欲的影响 生物标志物和主观食欲通过6个MO和12 MO的视觉模拟量表（探索目的）。最终， 这将确立候选人为独立研究人员，进行跨学科生物行为 使用生活方式干预措施的研究成为WLM的领导者。