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

NCT07184281 · tracked via the Priya Life Science China tracker

Sponsor

Children's Hospital of Soochow University

Phase

Not applicable

Started

2025-09-26

Last updated

2025-09-30

Condition(s) studied

Childhood ObesityChildhood Obesity Pevention

Investigational drug(s) / intervention(s)

12-hour time-restricted eatinghealth education

12-hour time-restricted eating: Based on the current health education model, the subjects in the experimental group were administered for 12 hours of TRE. Carry out the propaganda and education of the 12-hour TRE feeding mode, the core content is that the eating time window is limited to 12 hours/day, the last meal is no later than 19:00, the study subjects can freely choose the eating time window, do not restrict energy intake during eating, and during the fasting period, they are allowed to drink non-calorie, sugar-free drinks (water, tea, coffee). Record the time of eating every day.

health education: The current health education model is adopted, that is, health education is carried out in accordance with the "Guiding Outline for Health Education in Primary and Secondary Schools".

Study 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

Sex

ALL

Min age

8 Years

Max age

10 Years

Healthy volunteers

Accepted

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;

Primary outcome measure(s)

change in BMI-Z score — From enrollment to the end of treatment at 9 months
change in BMI-Z score from baseline

Trial sites (2)

Facility	City	Region	Status
Children's Hospital of Soochow University	Suzhou	Jiangsu	Not Yet Recruiting
Wujiang Center for Disease Prevention and Control	Suzhou	Jiangsu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07184281 on ClinicalTrials.gov ↗ ← All trials in China