School-based 12-hour time-restricted eating to prevent and control childhood obesity

Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children: A Cluster-Randomized Controlled Trial

This project tests whether a 12-hour time-restricted eating schedule delivered through schools helps prevent and control obesity in fourth-grade children.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1380 (estimated)
• Ages: 8 Years to 10 Years
• Sex: All
• Sponsor: Children's Hospital of Soochow University (other)
• Locations: 2 sites (Suzhou, Jiangsu and 1 other locations)
• Trial ID: NCT07184281 on ClinicalTrials.gov

What this trial studies

This cluster randomized design assigns schools to either a 12-hour time-restricted eating (TRE) program plus health education or to usual health education control, enrolling whole fourth-grade classes. The TRE arm asks children to limit daily eating to a 12-hour window without explicit calorie counting, supported by classroom activities and home-school liaison. Outcomes include changes in BMI and obesity prevalence at the class/school level, together with behavioral and feasibility measures. The school-based delivery leverages teachers and routine school time to reach children during a high-risk age for developing obesity.

Who should consider this trial

Good fit: Ideal candidates are fourth-grade students in participating non-boarding primary schools (class sizes 30–60) whose parents consent and who do not have excluded medical conditions.

Not a fit: Children with a history of heart disease, high blood pressure, other medical exclusions, or those unable to adhere to a daily eating window are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the intervention could lower BMI and reduce obesity rates among elementary-school children while offering a feasible school-delivered prevention approach.

How similar studies have performed: Adult TRE trials have shown weight-loss and feasibility benefits and prior comprehensive school-based programs have reduced childhood BMI, but applying TRE specifically in school-aged children is a relatively new approach.

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, diabetes, tuberculosis, asthma, hepatitis or nephritis;
2. Individuals with secondary obesity: obesity due to endocrine disorders or side effects of medications;
3. Individuals with abnormal growth and development, such as dwarfism, gigantism, etc;
4. Individuals with physical deformities, including severe scoliosis, chicken breasts, claudication, significant O-leg/X-shaped legs;
5. Individuals with limited athletic ability who are unable to participate in school physical activities;
6. Individuals who have lost weight by inducing vomiting or taking medication in the past 3 months;
7. Individuals who have undergone prior bariatric surgery;
8. Individuals with mental disorders or intellectual developmental disabilities, as well as aphasia;
9. Individuals who have taken medications that affect appetite or weight within three months (e.g., antipsychotics, hypnotics, weight loss medications, insulin);
10. Individuals who have plans to transfer within 2 years;

Where this trial is running

Suzhou, Jiangsu and 1 other locations

• Children's Hospital of Soochow University — Suzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Wujiang Center for Disease Prevention and Control — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Xiaoyan Shi, PhD — Children's Hospital of Soochow University
• Study coordinator: Hao Peng, PhD

Conditions: Childhood Obesity, Childhood Obesity Pevention, childhood obesity, school-based intervention, time-restricted eating, cluster randomized trial