Time-Restricted Eating for Weight-Loss Maintenance

Официальное название

Time-Restricted Eating (10-Hour Window) for Weight-Loss Maintenance in Adults With Recent Intentional Weight Loss: A Multicenter, 12-Month Randomized Controlled Trial

Обзор

Weight regain after intentional short-term weight loss is a common challenge. It often undermines the long-term benefits of obesity treatment. This study is a multi-center 2-arm randomized controlled trial across six regions in China, specifically targeting overweight or obese adults who have recently achieved a short-term weight reduction (≥5% of body weight). The trial will evaluate whether a 10-hour daily Time-Restricted Eating (TRE) regimen can more effectively prevent weight regain compared to standard weight maintenance counseling alone. Both the intervention and control groups will receive the same frequency and intensity of nutritional counseling for weight maintenance; the only difference is that the TRE group will be instructed to confine their daily eating to a self-selected 10-hour window, while the control group has no eating window restriction. In addition to the primary outcome of weight regain, the study will explore potential mechanisms underlying the effects of TRE and assess secondary outcomes including changes in body composition, metabolic health, and quality of life. This study recruits participants from six distinct regions across Eastern, Western, Southern, Northern, and Central China to enhance national representativeness. The study is divided into two phases: the first phase is a 2-month weight loss run-in phase (the screening phase), during which participants will receive standardized lifestyle and diet guidance from trained dietitians. Those who achieve at least a 5% loss of initial body weight by the end of this phase-and maintain a stable weight for approximately three weeks-will proceed to the second phase. In the second phase, participants will be randomly assigned to one of two arms for a 12-month weight maintenance intervention. The Control Arm will receive periodic weight-management nutritional counseling without any eating time restriction, while the TRE Intervention Arm will receive the same guidance plus instructions to follow a daily 10-hour time-restricted eating schedule. This design ensures both groups receive equivalent dietary and lifestyle support, with TRE as the key differential strategy. Following the 12-month intervention phase, participants will be followed for an additional 12 months (without active intervention) to observe longer-term weight outcomes. Data will be collected at multiple time points: baseline (before the weight loss phase), 2 months (end of the weight loss phase and prior to the start of the maintenance phase), 5 months, 8 months, 14 months (end of the weight maintenance phase), as well as 20 months and 26 months (during the post-intervention follow-up). Key outcomes include changes in body weight (to assess weight regain or maintenance), body composition, metabolic health indicators (e.g. blood glucose, lipids), and quality of life measures. To monitor dietary behaviors, participants will be asked to upload meal photos via a designated mobile application with automatic time-stamping, which will be used to assess eating timing and adherence to the prescribed eating window. Body weight will be measured once weekly using Bluetooth-enabled smart scales. To explore potential mechanisms of action, biospecimens (blood and stool) will be collected at baseline, 2 months, 8 months, and 14 months for analysis. In addition, Continuous Glucose Monitoring (CGM) will be performed in a randomly selected subsample of 200 participants (100 from each group) using a standardized device for 14 consecutive days at months 2, 8, and 14. These data will be used to evaluate glycemic stability and adherence to the assigned eating window. Real-time CGM readings will not be disclosed to participants and will not be used to guide individual-level interventions.

Вмешательства

• Поведенческое Scheduled Weight Maintenance Nutrition Education
  Participants will receive a standardized 30-45 minute weight maintenance nutrition education session at the time of randomization, covering principles of balanced dietary intake, reduction of salt, oil, and added sugar, adequate hydration. Thereafter, monthly 15-minute follow-up sessions will be delivered by trained dietitians, matched in frequency and content to those provided in the intervention arm. No temporal restriction will be imposed on eating behaviors. Participants will document meal i
• Поведенческое Time-Restricted Eating (10-Hour Window)
  In addition to receiving the same frequency and content of standardized nutritional counseling as the control group, participants will be instructed to confine all caloric intake to a self-selected 10-hour daily eating window. Outside of this window, only non-caloric beverages (e.g., water, unsweetened tea, black coffee) are permitted. Up to one exception day per week is allowed, during which intake may fall outside the designated window but must still be recorded. Dietary intake will be logged

Первичные конечные точки

• Weight change [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• Percentage of Participants Maintaining ≥5% Weight Loss from Baseline [Срок оценки: At 14, 20, and 26 months]

Вторичные конечные точки (12)

• Change in waist circumference [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• Change in hip circumference [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• Change in body composition [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• Change in blood pressure (systolic pressure and diastolic pressure) [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• Change in heart rate [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• Change in handgrip strength [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• Changes in blood transcriptomics [Срок оценки: At 0 (baseline), 2, 8 and 14 months.]
• Changes in metabolomics in serum and feces [Срок оценки: At 0 (baseline), 2, 8 and 14 months.]
• Change in quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• Change in appetite states measured by the Electronic Visual Analogue Scale (eVAS) [Срок оценки: At 0 (baseline), 2, 5, 8, 14, 20 and 26 months.]
• The DISC Personality Assessment [Срок оценки: At 0 (baseline)]
• Change in quality of life measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Questionnaire [Срок оценки: At 0 (baseline), 2, 8, 14 and 26 months.]

Критерии участия

Критерии включения

• Participants who meet all the following conditions will be included in the trial:

• BMI ≥ 28.0 kg/m², or BMI between 24.0-27.9 kg/m² with at least one weight-related comorbidity.
• Age: 18-65 years.
• Weight Loss Plan: Willing to undergo a structured weight-loss program.

Критерии исключения

• Participants who meet any of the following conditions will be excluded from the trial:

• Infectious Diseases: History of HIV/AIDS, active hepatitis B/C, or active tuberculosis.
• Malignancy: History of any malignancy.
• Organ Dysfunction:Severe hepatic impairment.Chronic kidney disease.
• Cardiovascular/Cerebrovascular Events: History of angina, myocardial infarction, or stroke within the past 6 months.
• Gastrointestinal Conditions:Severe gastrointestinal diseases (e.g., inflammatory bowel disease).Gastrointestinal surgery within the past 12 months.
• Endocrine Disorders:Cushing's syndrome, hypothyroidism, acromegaly, or hypothalamic obesity.
• Medications: Use of drugs affecting weight/energy balance (e.g., antipsychotics, weight-loss medications) within the past 6 months.
• Pregnancy/Lactation: Currently pregnant, planning pregnancy, or breastfeeding.
• Compliance Issues: Inability to complete the study (due to health, immigration, or other reasons).
• Informed Consent: Unwilling or unable to provide informed consent.
• Weight Stability: >5% change in body weight within the past 6 months.
• Individuals unable to use or operate a smartphone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 10 центров

• The Fifth Medical Center of Chinese PLA General Hospital — Пекин
• Army Medical Center of PLA — Чунцин
• Shenzhen People's Hospital — Шэньчжэнь
• The First Affiliated Hospital of Harbin Medical University — Харбин
• Harbin Medical University — Харбин
• The Second Affiliated Hospital of Harbin Medical University — Харбин
• The Second Affiliated Hospital of Xi'an Jiaotong University — Сиань
• The Affiliated Hospital of Qingdao University — Qingdao
• … и ещё 2 центра

Публикации

• Jakubowicz D, Barnea M, Wainstein J, Froy O. High caloric intake at breakfast vs. dinner differentially influences weight loss of overweight and obese women. Obesity (Silver Spring). 2013 Dec;21(12):2504-12. doi: 10.1002/oby.20460. Epub 2013 Jul 2. PMID 23512957
• Mentzelou M, Papadopoulou SK, Psara E, Voulgaridou G, Pavlidou E, Androutsos O, Giaginis C. Chrononutrition in the Prevention and Management of Metabolic Disorders: A Literature Review. Nutrients. 2024 Mar 1;16(5):722. doi: 10.3390/nu16050722. PMID 38474850
• Wilkinson MJ, Manoogian ENC, Zadourian A, Lo H, Fakhouri S, Shoghi A, Wang X, Fleischer JG, Navlakha S, Panda S, Taub PR. Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. Cell Metab. 2020 Jan 7;31(1):92-104.e5. doi: 10.1016/j.cmet.2019.11.004. Epub 2019 Dec 5. PMID 31813824
• Reytor-Gonzalez C, Simancas-Racines D, Roman-Galeano NM, Annunziata G, Galasso M, Zambrano-Villacres R, Verde L, Muscogiuri G, Frias-Toral E, Barrea L. Chrononutrition and Energy Balance: How Meal Timing and Circadian Rhythms Shape Weight Regulation and Metabolic Health. Nutrients. 2025 Jun 27;17(13):2135. doi: 10.3390/nu17132135. PMID 40647240
• Liu HY, Eso AA, Cook N, O'Neill HM, Albarqouni L. Meal Timing and Anthropometric and Metabolic Outcomes: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Nov 4;7(11):e2442163. doi: 10.1001/jamanetworkopen.2024.42163. PMID 39485353
• Duez H, Staels B. Circadian Disruption and the Risk of Developing Obesity. Curr Obes Rep. 2025 Feb 13;14(1):20. doi: 10.1007/s13679-025-00610-6. PMID 39939483
• Ruddick-Collins LC, Morgan PJ, Fyfe CL, Filipe JAN, Horgan GW, Westerterp KR, Johnston JD, Johnstone AM. Timing of daily calorie loading affects appetite and hunger responses without changes in energy metabolism in healthy subjects with obesity. Cell Metab. 2022 Oct 4;34(10):1472-1485.e6. doi: 10.1016/j.cmet.2022.08.001. Epub 2022 Sep 9. PMID 36087576
• Thomas JG, Panza E, Goldstein CM, Hayes JF, Benedict N, O'Leary K, Wing RR. Pragmatic Implementation of Online Obesity Treatment and Maintenance Interventions in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):502-509. doi: 10.1001/jamainternmed.2023.8438. PMID 38466266

Идентификаторы

NCT: NCT07163455 · HMUIRB2025066PRE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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