๐ฌIn plain words
What the trial is, and whether it could suit you
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 gro
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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;