Actively Recruiting
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children: A Cluster-Randomized Controlled Trial
Led by Children's Hospital of Soochow University · Updated on 2025-09-30
1380
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Soochow University
Lead Sponsor
S
Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Childhood obesity is a growing global public health issue that affects both physical and mental health during childhood and may continue into adulthood, increasing cardiovascular disease risk. This research aims to evaluate the effectiveness of a 12-hour time-restricted eating (TRE) program implemented in schools to prevent and control childhood obesity, focusing on children aged 8 to 10 years during a critical period for obesity prevention. The trial is a school-based cluster randomized controlled study comparing TRE combined with routine health education to routine health education alone. In this study, schools are randomly assigned to either an intervention group receiving 12-hour TRE plus routine health education or a control group receiving only routine health education following the "Guiding Outline for Health Education in Primary and Secondary Schools." The TRE involves limiting the daily eating window to 12 hours, with the last meal no later than 19:00, allowing free choice of the eating window and no calorie restriction, with non-caloric drinks permitted during fasting. The intervention lasts 9 months, covering one academic year. Participants will be monitored from enrollment through the end of treatment at 9 months, with researchers measuring changes in BMI-Z score as the primary outcome. Secondary outcomes include changes in overweight or obesity prevalence, BMI, waist-to-hip ratio, blood pressure, eating behavior, physical activity, and quality of life. Daily eating times are recorded, and health education is provided. The study aims to assess how the TRE intervention influences weight management and obesity rates in school-aged children.
CONDITIONS
Brief Title
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 8 to 10 years
- Enrolled in fourth-grade classes
- Attend non-boarding schools that are not ethnic minority or specialty schools
- Schools with more than 50 fourth-year students
- Schools and classes with no plans to relocate, close, merge, or cancel within 2 years
- Class sizes between 30 and 60 students
- Class teachers willing to actively participate in home-school communication
You will not qualify if you...
- History of heart disease, high blood pressure, diabetes, tuberculosis, asthma, hepatitis, or nephritis
- Secondary obesity caused by endocrine disorders or medication side effects
- Abnormal growth conditions such as dwarfism or gigantism
- Physical deformities including severe scoliosis, chicken breasts, claudication, or significant leg deformities
- Limited athletic ability preventing participation in school physical activities
- Recent weight loss induced by vomiting or medication within past 3 months
- Prior bariatric surgery
- Mental disorders, intellectual disabilities, or aphasia
- Taking medications affecting appetite or weight within past 3 months
- Plans to transfer schools within 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 months
Participants receive either a 12-hour time-restricted eating program combined with routine health education or routine health education alone during one academic year to prevent and control childhood obesity.
Periodic visits during the academic year for monitoring and education
Trial Site Locations
Total: 2 locations
1
Children's Hospital of Soochow University
Suzhou, Jiangsu, China, 215123
Not Yet Recruiting
2
Wujiang Center for Disease Prevention and Control
Suzhou, Jiangsu, China, 215299
Actively Recruiting
Research Team
H
Hao Peng, PhD
X
Xiaoyan Zhang, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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