Study Results
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Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2026-01-26
2028-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Scheduled Weight Maintenance Nutrition Education
Participants will receive standardized nutritional counseling for weight maintenance without any restriction on eating window. Dietary intake timing and body weight will be monitored using digital tracking tools throughout the study period.
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 intake via a mobile application using photograph-based entries with automated time-stamping and will record body weight weekly using Bluetooth-enabled digital scales. To ensure data accuracy, quality control will include twice-monthly brief telephone interviews for unannounced 24-hour dietary recalls.
Time-Restricted Eating (10-Hour Window)
Same standardized sessions and monthly counseling as the control group, with the additional implementation of a 10-hour daily Time-Restricted Eating (TRE) regimen. Dietary intake timing and body weight will be monitored using digital tracking tools throughout the study period.
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 through a mobile application utilizing meal photographs with automated time-stamping; body weight will be recorded weekly using Bluetooth-enabled digital scales. As with the control group, participants will receive twice-monthly unannounced 24-hour dietary recalls and phone interviews to verify dietary records and ensure data quality.
Interventions
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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 intake via a mobile application using photograph-based entries with automated time-stamping and will record body weight weekly using Bluetooth-enabled digital scales. To ensure data accuracy, quality control will include twice-monthly brief telephone interviews for unannounced 24-hour dietary recalls.
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 through a mobile application utilizing meal photographs with automated time-stamping; body weight will be recorded weekly using Bluetooth-enabled digital scales. As with the control group, participants will receive twice-monthly unannounced 24-hour dietary recalls and phone interviews to verify dietary records and ensure data quality.
Eligibility Criteria
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Inclusion Criteria
1. BMI ≥ 28.0 kg/m², or BMI between 24.0-27.9 kg/m² with at least one weight-related comorbidity.
2. Age: 18-65 years.
3. Weight Loss Plan: Willing to undergo a structured weight-loss program.
Exclusion Criteria
1. Infectious Diseases: History of HIV/AIDS, active hepatitis B/C, or active tuberculosis.
2. Malignancy: History of any malignancy.
3. Organ Dysfunction:Severe hepatic impairment.Chronic kidney disease.
4. Cardiovascular/Cerebrovascular Events: History of angina, myocardial infarction, or stroke within the past 6 months.
5. Gastrointestinal Conditions:Severe gastrointestinal diseases (e.g., inflammatory bowel disease).Gastrointestinal surgery within the past 12 months.
6. Endocrine Disorders:Cushing's syndrome, hypothyroidism, acromegaly, or hypothalamic obesity.
7. Medications: Use of drugs affecting weight/energy balance (e.g., antipsychotics, weight-loss medications) within the past 6 months.
8. Pregnancy/Lactation: Currently pregnant, planning pregnancy, or breastfeeding.
9. Compliance Issues: Inability to complete the study (due to health, immigration, or other reasons).
10. Informed Consent: Unwilling or unable to provide informed consent.
11. Weight Stability: \>5% change in body weight within the past 6 months.
12. Individuals unable to use or operate a smartphone
18 Years
65 Years
ALL
No
Sponsors
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Harbin Medical University
OTHER
Responsible Party
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Ying Li
Professor
Locations
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Shenzhen People's Hospital
Shenzhen, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Air Force Hospital of Western Theater Command,PLA
Chengdu, Sichuan, China
Chengdu Seventh People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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YaXin Zhu, PhD
Role: primary
DongHui Lu, PhD
Role: primary
ChunHong Zhang, PhD
Role: primary
XiaoFang Sun, PhD
Role: primary
HaiXia Liu, PhD
Role: primary
Shuo Li, PhD
Role: primary
JingYu Liu, PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
Gill S, Le HD, Melkani GC, Panda S. Time-restricted feeding attenuates age-related cardiac decline in Drosophila. Science. 2015 Mar 13;347(6227):1265-9. doi: 10.1126/science.1256682.
Apolzan JW, Venditti EM, Edelstein SL, Knowler WC, Dabelea D, Boyko EJ, Pi-Sunyer X, Kalyani RR, Franks PW, Srikanthan P, Gadde KM; Diabetes Prevention Program Research Group. Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study. Ann Intern Med. 2019 May 21;170(10):682-690. doi: 10.7326/M18-1605. Epub 2019 Apr 23.
Kim JY. Optimal Diet Strategies for Weight Loss and Weight Loss Maintenance. J Obes Metab Syndr. 2021 Mar 30;30(1):20-31. doi: 10.7570/jomes20065.
Ludwig DS, Ebbeling CB. Weight-loss maintenance--mind over matter? N Engl J Med. 2010 Nov 25;363(22):2159-61. doi: 10.1056/NEJMe1011361. No abstract available.
Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.
Kadam I, Neupane S, Wei J, Fullington LA, Li T, An R, Zhao L, Ellithorpe A, Jiang X, Wang L. A Systematic Review of Diet Quality Index and Obesity among Chinese Adults. Nutrients. 2021 Oct 11;13(10):3555. doi: 10.3390/nu13103555.
Wang L, Zhou B, Zhao Z, Yang L, Zhang M, Jiang Y, Li Y, Zhou M, Wang L, Huang Z, Zhang X, Zhao L, Yu D, Li C, Ezzati M, Chen Z, Wu J, Ding G, Li X. Body-mass index and obesity in urban and rural China: findings from consecutive nationally representative surveys during 2004-18. Lancet. 2021 Jul 3;398(10294):53-63. doi: 10.1016/S0140-6736(21)00798-4.
Sun Z, Sun M, Wei W, Peng W, Wang Y. China launches National Obesity Campaign. Lancet Diabetes Endocrinol. 2025 Jun;13(6):465-466. doi: 10.1016/S2213-8587(25)00131-7. No abstract available.
Other Identifiers
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HMUIRB2025066PRE
Identifier Type: -
Identifier Source: org_study_id
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