Actively Recruiting

Phase Not Applicable
Age: 8Years - 10Years
All Genders
Healthy Volunteers
NCT07184281

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

Age: 8Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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