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

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。限时进食是间歇性禁食的一种形式，是一种未经测试的生物行为 WLM的战略。这个独立之路奖(K99/R00)的目标是加速候选人的 过渡到一名独立调查员，在制定和评价权重方面具有集中的专业知识 WLM期间的管理策略。在该奖项的K99阶段，候选人将接受以下培训 精通行为维持理论和方法、混合方法、定性分析和胃口 生理学，并进行初步研究，以开发和测试干预方法。候选人将进行 一项试点随机对照试验(n=40；20/ARM)，以测试两种药物的可行性、可接受性和依从性 TRE干预(≤6h和≤10h进食窗)。参与者将包括成年人(25-65岁，BMI和GT；20.5公斤/平方米) 从2个非手术减肥计划招募，他们成功地实现了≥5%的初始体重减轻 重量。在随机化之前，参与者将经历一个磨合阶段，包括为期4周的体重稳定 句号。应聘者将从招聘、留住和接受等方面评估可行性和可接受性 坚持饮食窗口，采用混合方法设计(目标1)。应聘者将进行定性测试 TRE完成后的访谈(n=12/ARM)，以记录参与者对TRE和ARM的体验 确定每个TRE的个人、家庭和社区/社区层面的障碍和促进者 将使用的干预措施，例如动机、文化因素、职业和家庭结构(次级目标1) 加强干预力度。在R00阶段，候选人将使用获得的技能和培训来测试 从K99期确定最佳的TrE干预。在随机对照试验中，候选人将 评估选定的TrE在体重恢复(目标2a)和脂肪量恢复(目标2b)方面的效果。 月份。应聘者将招募最近非手术体重减轻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个手臂中的一个(总共72个；n=36个/手臂)：1)Tre(选自 K99阶段)或2)基线建议控制(CON)。TRE和CON组都将提供基准 宣传成功的WLM的书面材料和策略。TRE小组的参与者将被指导 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。 测量将在基线(0)、3个月、6个月和12个月获得。主要结果是体重恢复。 在12个月的时候。考生将探索随机化分配和WLM对食欲的影响 在6个月和12个月(探索性目标)时，通过视觉模拟量表检测生物标志物和主观食欲。最终， 这将使候选人成为进行跨学科生物行为研究的独立研究员 使用生活方式干预的研究，以成为WLM的领导者。