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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Wujiang Center for Disease Prevention and Control
  Suzhou, Jiangsu, China Recruiting
• Children's Hospital of Soochow University
  Suzhou, Jiangsu, China Not yet recruiting

Study contacts

• Principal investigator: Xiaoyan Shi, PhD — Children's Hospital of Soochow University
• Study coordinator: Hao Peng, PhD
• Email: penghao@suda.edu.cn
• Phone: +8613814865711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.