Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children

NCT ID: NCT07184281

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-26
• Study Completion Date: 2027-07-31

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.

Detailed Description

Childhood obesity has become a major global public health challenge. With rapid economic development, the prevalence of childhood obesity in China has risen from 0.1% in 1985 to 7.3% in 2024. Childhood obesity 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. The age distribution of childhood obesity shows that the peak incidence occurs between 7 and 12 years of age, making this a critical period for prevention and control. During this stage, children are in school, spending half their time there, and exhibit strong behavioral plasticity. Interventions based on school settings may be an effective approach to preventing and controlling childhood obesity. Previous experimental studies have shown that comprehensive school-based interventions (primarily including reducing overeating, high-energy diets, and sedentary behavior, while increasing physical activity) can significantly reduce BMI and childhood obesity prevalence, but their feasibility is limited. 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. Therefore, the investigators hypothesize that a 12-hour TRE program implemented in schools may enhance the prevention and control of childhood obesity, but there is currently a lack of empirical evidence, particularly regarding its preventive effects on childhood obesity. 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

Childhood Obesity; Childhood Obesity Pevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TRE group

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

Group Type: EXPERIMENTAL

12-hour time-restricted eating

Intervention Type: BEHAVIORAL

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.

health education

Intervention Type: BEHAVIORAL

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 group

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".

Group Type: ACTIVE_COMPARATOR

health education

Intervention Type: BEHAVIORAL

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".

Interventions

12-hour time-restricted eating

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.

Intervention Type: BEHAVIORAL

health education

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".

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

All students in the selected classes will be the subject of the study after signing the informed consent, unless they have the following circumstances:

1. Individuals with a history of heart disease, high blood pressure, diabetes, tuberculosis, asthma, hepatitis or nephritis;

2. Individuals with secondary obesity: obesity due to endocrine disorders or side effects of medications;

3. Individuals with abnormal growth and development, such as dwarfism, gigantism, etc;

4. Individuals with physical deformities, including severe scoliosis, chicken breasts, claudication, significant O-leg/X-shaped legs;

5. Individuals with limited athletic ability who are unable to participate in school physical activities;

6. Individuals who have lost weight by inducing vomiting or taking medication in the past 3 months;

7. Individuals who have undergone prior bariatric surgery;

8. Individuals with mental disorders or intellectual developmental disabilities, as well as aphasia;

9. Individuals who have taken medications that affect appetite or weight within three months (e.g., antipsychotics, hypnotics, weight loss medications, insulin);

10. Individuals who have plans to transfer within 2 years;

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Soochow University

OTHER

Sponsor Role: collaborator

Children's Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Xiaoyan Shi

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoyan Shi, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Soochow University

Locations

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: NOT_YET_RECRUITING

Wujiang Center for Disease Prevention and Control

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Peng, PhD

Role: CONTACT

penghao@suda.edu.cn

+8613814865711

Xiaoyan Zhang, MPH

Role: CONTACT

15906295069@163.com

051265880078

Facility Contacts

Mengxuan Ye, MBBS

Role: primary

624442531@qq.com

18801542468

Xiaoyan Shi, PhD

Role: backup

xyshi@suda.edu.cn

Aiming Lu, MPH

Role: primary

13706252150@139.com

0512-63160203

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SYW2025048

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SCHOOL-TRE

Identifier Type: -

Identifier Source: org_study_id