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.
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;
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;
Parallel
12-hour time-restricted eating
BehavioralBased 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
BehavioralThe 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".
change in BMI-Z score
change in BMI-Z score from baseline
change in the prevalence of overweight or obesity
change in the prevalence of children with a BMI-Z score over 2 from baseline
chang in BMI
change in BMI from baseline
change in waist-to-hip ratio
change in waist-to-hip ratio from baseline
change in blood pressure
change in blood pressure from baseline
longterm effect
change in BMI-Z score at 1 year after intervention
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Children's Hospital of Soochow University
Lead sponsor
Soochow University
Collaborator
