NCT07184281

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,380

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Sep 2025Jul 2027

First Submitted

Initial submission to the registry

August 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 26, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

August 18, 2025

Last Update Submit

September 28, 2025

Conditions

Childhood ObesityChildhood Obesity Pevention

Keywords

childhood obesityschool-based interventiontime-restricted eatingcluster randomized trial

Outcome Measures

Primary Outcomes (1)

  • change in BMI-Z score

    change in BMI-Z score from baseline

    From enrollment to the end of treatment at 9 months

Secondary Outcomes (7)

  • change in the prevalence of overweight or obesity

    From enrollment to the end of treatment at 9 months.

  • chang in BMI

    From enrollment to the end of treatment at 9 months.

  • change in waist-to-hip ratio

    From enrollment to the end of treatment at 9 months.

  • change in blood pressure

    From enrollment to the end of treatment at 9 months.

  • change in eating behavior

    From enrollment to the end of treatment at 9 months.

  • +2 more secondary outcomes

Other Outcomes (1)

  • longterm effect

    From enrollment to 1 year after intervention.

Study Arms (2)

TRE group

EXPERIMENTAL

Based on the current health education model, the subjects in the experimental group were administered for 12 hours of TRE.

Behavioral: 12-hour time-restricted eatingBehavioral: health education

Control group

ACTIVE COMPARATOR

The 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".

Behavioral: health education

Interventions

12-hour time-restricted eatingBEHAVIORAL

Based 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.

TRE group
health educationBEHAVIORAL

The 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".

Control groupTRE group

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • All students in the selected classes will be the subject of the study after signing the informed consent, unless they have the following circumstances:
  • 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;
  • Individuals with limited athletic ability who are unable to participate in school physical activities;
  • Individuals who have lost weight by inducing vomiting or taking medication in the past 3 months;
  • Individuals who have undergone prior bariatric surgery;
  • Individuals with mental disorders or intellectual developmental disabilities, as well as aphasia;
  • Individuals who have taken medications that affect appetite or weight within three months (e.g., antipsychotics, hypnotics, weight loss medications, insulin);
  • Individuals who have plans to transfer within 2 years;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215123, China

NOT YET RECRUITING

Wujiang Center for Disease Prevention and Control

Suzhou, Jiangsu, 215299, China

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityIntermittent Fasting

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Officials

  • Xiaoyan Shi, PhD

    Children's Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Peng, PhD

CONTACT

+8613814865711penghao@suda.edu.cn

Xiaoyan Zhang, MPH

CONTACT

05126588007815906295069@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: cluster randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 19, 2025

Study Start

September 26, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The unidentified patient data can be shared.

Locations

CN(2)