Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
NCT07184281 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1380
Last updated 2025-09-30
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.
Conditions
- Childhood Obesity
- Childhood Obesity Pevention
Interventions
- BEHAVIORAL
-
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.
- 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".
Sponsors & Collaborators
-
Soochow University
collaborator OTHER -
Children's Hospital of Soochow University
lead OTHER
Principal Investigators
-
Xiaoyan Shi, PhD · Children's Hospital of Soochow University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-26
- Primary Completion
- 2026-07-31
- Completion
- 2027-07-31
Countries
- China
Study Locations
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