Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children: A Cluster-Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 10
Healthy Volunteers: t
View:

⁃ Eligibility criteria for schools:

• The principal agrees to accept the randomization process and adhere to the study protocol;

• The total number of fourth-year students in the school must be more than 50;

• Schools that have not implemented or plan to implement obesity prevention interventions;

• Non-boarding schools, Ethnic minority schools, or specialty schools;

• Schools that have no clear plans to relocate or close within the next 2 years;

⁃ Eligibility criteria for classes:

• Class teachers are willing and actively involved in home-school liaison;

• Class sizes should be between 30 and 60 students;

• The class consists of fourth-grade students;

• Classes that have no clear plan to merge or cancel in the next 2 years;

Locations
Other Locations
China
Children's Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Wujiang Center for Disease Prevention and Control
RECRUITING
Suzhou
Contact Information
Primary
Hao Peng, PhD
penghao@suda.edu.cn
+8613814865711
Backup
Xiaoyan Zhang, MPH
15906295069@163.com
051265880078
Time Frame
Start Date: 2025-09-26
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 1380
Treatments
Experimental: TRE group
Based on the current health education model, the subjects in the experimental group were administered for 12 hours of TRE.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Soochow University
Collaborators: Soochow University

This content was sourced from clinicaltrials.gov