NCT07184281 Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
| NCT ID | NCT07184281 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Soochow University |
| Condition | Childhood Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,380 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,380 participants in total. It began in 2025-09-26 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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;
Contact & Investigator
Xiaoyan Shi, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT07184281 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 10 Years, studying Childhood Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07184281 currently recruiting?
Yes, NCT07184281 is actively recruiting participants. Contact the research team at penghao@suda.edu.cn for enrollment information.
Where is the NCT07184281 trial being conducted?
This trial is being conducted at Suzhou, China, Suzhou, China.
Who is sponsoring the NCT07184281 clinical trial?
NCT07184281 is sponsored by Children's Hospital of Soochow University. The principal investigator is Xiaoyan Shi, PhD at Children's Hospital of Soochow University. The trial plans to enroll 1,380 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.