Obesity Prevention in School-aged Children

NCT ID: NCT07203300

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-10-09

Brief 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

Study Design

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

Study Groups

A multi-level collaborative intervention

The intervention includes: ① Health education: A trained teacher per class delivered 10 lessons during regular health classes, teaching five core messages in simple terms: not eating excessively; not drinking sugar--sweetened beverage; eating less high--energy food; less sedentary behaviours; performing more physical activity. ② Enhanced physical activity and BMI monitoring: physical education teachers guided daily moderate-to-vigorous activity. Teachers monthly measured height/weight, entered data into an app; children received feedback on BMI category and change. Weekly private weight measurements were also taken. ③ Family involvement: Implemented via offline meetings and a digital platform, the family-focused intervention provides health education and behavior change support, enabling parents to track BMI, log behaviors, review feedback, and access personalized consultations from medical professionals.

Group Type: EXPERIMENTAL

multicomponent, tiered intervention

Intervention Type: BEHAVIORAL

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.

usual-care control

In the control group, participating school-aged children will receive no intervention during the study period and will continue their routine educational and management practices without modification. After the study is fully completed, control group school-aged children will have access to all intervention materials and health education resources developed for this project.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Schools will be selected based on the consent of primary leadership, demonstrated cooperation, and availability of necessary personnel (e.g., school health professionals). Classes will be limited to grades 2 and 3, with teachers showing strong willingness to collaborate. Both parental informed consent and child assent are required for participation.

Exclusion Criteria

• Schools will be excluded if they cater to special populations (e.g., schools for children with disabilities), are involved in other obesity-related interventions within the specified timeframe, or plan to close or relocate within two years. Children will be excluded if they have histories of major organ diseases (e.g., cardiac, pulmonary, hepatic, or renal conditions), special diets (e.g., vegetarian), pathological eating disorders, physical limitations affecting activity, or obesity due to endocrine disorders or medication side effects.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Maternal and Child Health Hospital

UNKNOWN

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Hai-Jun Wang

Professor in Department of Maternal and Child Health, School of Public Health, Peking University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jie chun Yin

Role: CONTACT

yinchunjie@bjmu.edu.cn

+8615652217112

Other Identifiers

NO.2025-072

Identifier Type: -

Identifier Source: org_study_id