Time-restricted eating to help keep weight off

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

This trial will test whether limiting eating to a 10-hour window each day helps overweight or obese adults who recently lost at least 5% of their weight avoid regaining it.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Harbin Medical University (other)
• Locations: 10 sites (Shenzhen, Guangdong and 9 other locations)
• Trial ID: NCT07163455 on ClinicalTrials.gov

What this trial studies

This is a multi-center, two-arm randomized trial conducted at several hospitals in China comparing a 10-hour daily time-restricted eating (TRE) schedule versus standard weight maintenance counseling alone. Eligible participants are adults 18–65 who are overweight or obese and have recently achieved at least a 5% short-term weight loss. Both groups receive the same frequency and intensity of nutrition counseling; the TRE group additionally confines all eating to a self-selected 10-hour window while the control group has no eating-window restriction. The primary outcome is prevention of weight regain, and the study will also explore metabolic and behavioral mechanisms underlying any effects of TRE.

Who should consider this trial

Good fit: Adults aged 18–65 with BMI ≥28 kg/m² (or 24.0–27.9 kg/m² with a weight-related comorbidity) who have recently lost at least 5% of body weight and are willing to follow a structured weight-loss/maintenance program are the intended participants.

Not a fit: People with active infections (HIV, hepatitis B/C, tuberculosis), a history of malignancy, severe liver or kidney dysfunction, recent major cardiovascular or cerebrovascular events, severe gastrointestinal disease or recent GI surgery, or certain endocrine disorders are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could help people sustain short-term weight loss and reduce long-term weight regain with a simple daily eating schedule.

How similar studies have performed: Previous short-term trials of time-restricted eating have shown promising but mixed effects on weight and metabolic markers, while long-term, randomized evidence for weight-loss maintenance remains limited.

Eligibility criteria

Inclusion Criteria:

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

  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:

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

  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

Where this trial is running

Shenzhen, Guangdong and 9 other locations

• Shenzhen People's Hospital — Shenzhen, Guangdong, China (RECRUITING)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (RECRUITING)
• Harbin Medical University — Harbin, Heilongjiang, China (RECRUITING)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (RECRUITING)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (RECRUITING)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (RECRUITING)
• Weifang People's Hospital — Weifang, Shandong, China (RECRUITING)
• Air Force Hospital of Western Theater Command,PLA — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Chengdu Seventh People's Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Hongquan Xie, PhD

Conditions: Overweight or Obese Adults