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Recruiting NCT07184281

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

Trial Parameters

Condition Childhood Obesity
Sponsor Children's Hospital of Soochow University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,380
Sex ALL
Min Age 8 Years
Max Age 10 Years
Start Date 2025-09-26
Completion 2026-07-31
Interventions
12-hour time-restricted eatinghealth education

Brief 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.

Eligibility Criteria

Eligibility criteria for schools: 1. The principal agrees to accept the randomization process and adhere to the study protocol; 2. The total number of fourth-year students in the school must be more than 50; 3. Schools that have not implemented or plan to implement obesity prevention interventions; 4. Non-boarding schools, Ethnic minority schools, or specialty schools; 5. Schools that have no clear plans to relocate or close within the next 2 years; Eligibility criteria for classes: 1. Class teachers are willing and actively involved in home-school liaison; 2. Class sizes should be between 30 and 60 students; 3. The class consists of fourth-grade students; 4. Classes that have no clear plan to merge or cancel in the next 2 years; Exclusion criteria for students: All students in the selected classes will be the subject of the study after signing the informed consent, unless they have the following circumstances: 1. Individuals with a history of heart disease, high blood pressure, diabet

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