Clinical Trial

Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children

Study acronym: SCHOOL-TRE
Recruiting
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Record status
This record was last updated September 30, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Childhood obesity has become a major global public health challenge. Obesity can not only affects children's physical and mental health during childhood but may also persist into adulthood, significantly increasing the risk of cardiovascular disease. Therefore, effective prevention and control of childhood obesity can shift the prevention window forward and promote the prevention of cardiovascular disease. Recently, time-restricted eating (TRE) has gained attention in adult studies for its feasibility, as it involves "time control without calorie restriction," demonstrating weight loss effects comparable to energy restriction and higher feasibility. Here, the investigators designed a school-based cluster randomized controlled trial to investigate the effectiveness of 12-hour TRE in preventing and controlling childhood obesity. Schools were randomly assigned to either the intervention group or the control group, and participants were recruited from each school at the class level, ensuring that each group included at least 690 children. The control group received routine health education, while the intervention group received 12-hour TRE in addition to routine health education. After a 9-month intervention period (one academic year), the two groups will be compared in terms of weight management and childhood obesity prevalence.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-14; most recent amendment 2025-09-28.
Status change: Not Yet Recruiting → Recruiting 2025-09-28
Trial Details
NCT Number NCT07184281
Lead Sponsor Children's Hospital of Soochow University
Collaborators: Soochow University
Conditions Childhood Obesity, Childhood Obesity Pevention
Enrollment 1,380 participants
Start Date 2025-09-26
Primary Completion 2026-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-30