Actively Recruiting
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
Led by Children's Hospital of Soochow University · Updated on 2025-09-30
1380
Participants Needed
2
Research Sites
96 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 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.
CONDITIONS
Official 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...
- Child is between 8 and 10 years old
- Child is a fourth-grade student
- Child attends a school where the principal agrees to the study protocol and randomization
- School has more than 50 fourth-year students
- School has not implemented or plans to implement obesity prevention interventions
- School is a non-boarding, ethnic minority, or specialty school
- School has no clear plans to relocate or close within 2 years
- Class teachers are willing and actively involved in home-school liaison
- Class size is between 30 and 60 students
- Class consists of fourth-grade students
- Class has no clear plan to merge or cancel within 2 years
You will not qualify if you...
- History of heart disease, high blood pressure, diabetes, tuberculosis, asthma, hepatitis, or nephritis
- Secondary obesity due to endocrine disorders or medication side effects
- Abnormal growth and development such as dwarfism or gigantism
- Physical deformities including severe scoliosis, chicken breasts, claudication, significant O-leg/X-shaped legs
- Limited athletic ability preventing participation in school physical activities
- Weight loss by inducing vomiting or medication in the past 3 months
- Prior bariatric surgery
- Mental disorders, intellectual developmental disabilities, or aphasia
- Use of medications affecting appetite or weight in the past 3 months (e.g., antipsychotics, hypnotics, weight loss drugs, insulin)
- Plans to transfer schools within 2 years
AI-Screening
AI-Powered Screening
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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
CONTACT
X
Xiaoyan Zhang, MPH
CONTACT
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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