Status:
RECRUITING
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
Lead Sponsor:
Children's Hospital of Soochow University
Collaborating Sponsors:
Soochow University
Conditions:
Childhood Obesity
Childhood Obesity Pevention
Eligibility:
All Genders
8-10 years
Phase:
NA
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, significan...
Detailed Description
Childhood obesity has become a major global public health challenge. With rapid economic development, the prevalence of childhood obesity in China has risen from 0.1% in 1985 to 7.3% in 2024. Childhoo...
Eligibility Criteria
Inclusion
- 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;
- 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:
- 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 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 lost weight by inducing vomiting or taking medication in the past 3 months;
- Individuals who have undergone prior bariatric surgery;
- Individuals with mental disorders or intellectual developmental disabilities, as well as aphasia;
- Individuals who have taken medications that affect appetite or weight within three months (e.g., antipsychotics, hypnotics, weight loss medications, insulin);
- Individuals who have plans to transfer within 2 years;
Exclusion
Key Trial Info
Start Date :
September 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
1380 Patients enrolled
Trial Details
Trial ID
NCT07184281
Start Date
September 26 2025
End Date
July 31 2027
Last Update
September 30 2025
Active Locations (2)
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1
Children's Hospital of Soochow University
Suzhou, Jiangsu, China, 215123
2
Wujiang Center for Disease Prevention and Control
Suzhou, Jiangsu, China, 215299