NCT07203300

Obesity Prevention in School-aged Children

BehavioRal Intervention Assisted by diGital Health Technology for Preventing Obesity Among Children（BRIGHT-POC）

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 7 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

This cluster-randomized trial will develop and test an intervention technology for school-aged children. The program combines digital health technology and personalized behavior intervention through a WeChat platform. Our main question is: Does this integrated approach improve obesity related outcomes and behaviors in children? Investigator will: * Compare children receiving the program with those receiving usual care. * Track physical measures and health behaviors to measure effectiveness of intervention. * Evaluate the program's safety, implementation process, and cost-effectiveness. Findings will determine if this approach should be expanded to more communities.

Detailed description

This study is a one-year cluster randomized controlled trial (cRCT) to be conducted in 10 eligible primary schools. The schools will be randomly allocated to either the intervention group or the control group in a 1:1 ratio. The technical core of this research involves the development of a multi-level collaborative health management technology system based on a WeChat platform. This platform will serve as the core intervention technology, providing functional support to the intervention group schools, their students, and parents. Students in the control group schools will receive routine health education and physical examination procedures during the trial period. To evaluate the effectiveness of this intervention technology, outcome measure data will be collected at multiple time points. All participating students will undergo physical measurements and health behavior questionnaire surveys at baseline (T0) and at the end of the intervention period (T1, i.e., 12 months post-baseline). The changes in primary and secondary outcome measures from baseline (T0) to the end of the intervention (T1) will be compared between the intervention and control groups. Furthermore, to assess the long-term sustainability of the intervention effects, investigator plan to conduct follow-up surveys annually at 24 months (T2) and 36months (T3) post-intervention for both the intervention and control group students. Generalized linear mixed model or Generalized Estimating Equations (GEE) will be constructed to longitudinally analyze the differential trajectories of health outcomes between the two groups, thereby comprehensively evaluating the immediate effects and long-term sustainability of this integrated intervention technology.

Conditions

• Childhood Obesity Prevention

Interventions

Type	Name	Description
BEHAVIORAL	multicomponent, tiered intervention	this intervention is a multi-level collaborative health management system-a digital health platform with four core modules: the Health Education Module, the Growth Monitoring Module, the Health Behavior Module, and the Home-School Partnership Module. The platform facilitates collaboration among schools, families, and hospitals as follows: Schools utilize the platform to manage tasks outlined in health policies, such as delivering educational content, monitoring student activity and diet, and recording monthly height/weight measurements via the Growth Monitoring Module. Families access the platform to receive multi-format health education, set goals, and review personalized feedback. The Home-School Partnership Module also enables communication for motivational interviewing sessions conducted by professionals offline or by phone. Hospitals leverage the platform to provide professional guidance and medical support, ensuring interventions are medically sound.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-09
• Completion: 2028-10-09
• First posted: 2025-10-02
• Last updated: 2026-03-06

Locations

1 site across 1 country: China