NCT07184281Recruiting
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children: A Cluster-Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1380 (estimated)
- First submitted
- 18 Aug 2025
- Start date
- 26 Sept 2025
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Children's Hospital of Soochow University
- Diseases
- Obesity
- NCT number
- NCT07184281
What you commit to
- Study type: Interventional
- Planned participants: 1380
- From 26 Sept 2025 to the primary completion date, 31 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who have lost weight by inducing vomiting or taking medication in the past 3 months;
- Individuals who have undergone prior bariatric surgery;
- Individuals who have taken medications that affect appetite or weight within three months (e.g., antipsychotics, hypnotics, weight loss medications, insulin);
Other illness
- Individuals with a history of heart disease, high blood pressure, diabetes, tuberculosis, asthma, hepatitis or nephritis;
- Individuals with secondary obesity: obesity due to endocrine disorders or side effects of medications;
- Individuals with mental disorders or intellectual developmental disabilities, as well as aphasia;
Other
- All students in the selected classes will be the subject of the study after signing the informed consent, unless they have the following circumstances:
- Individuals with abnormal growth and development, such as dwarfism, gigantism, etc;
- Individuals with physical deformities, including severe scoliosis, chicken breasts, claudication, significant O-leg/X-shaped legs;
- Individuals with limited athletic ability who are unable to participate in school physical activities;
- Individuals who have plans to transfer within 2 years;
Criteria the registry did not label
- Eligibility criteria for schools:
- The principal agrees to accept the randomization process and adhere to the study protocol;
- The total number of fourth-year students in the school must be more than 50;
- Schools that have not implemented or plan to implement obesity prevention interventions;
- Non-boarding schools, Ethnic minority schools, or specialty schools;
- Schools that have no clear plans to relocate or close within the next 2 years;
- Eligibility criteria for classes:
- Class teachers are willing and actively involved in home-school liaison;
- Class sizes should be between 30 and 60 students;
- The class consists of fourth-grade students;
- Classes that have no clear plan to merge or cancel in the next 2 years;
Age in the registry: 8 years to 10 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Not yet recruiting |
| Wujiang Center for Disease Prevention and Control Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.