Obesity Prevention in School-aged Children

NCT07203300 | Active Not Recruiting

• 1 other identifier: NO.2025-072
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity Prevention

Keywords

Intervention; Obesity; Overweight; Children; School-aged

Outcome Measures

Primary Outcomes (1)

• children's BMl change

  Calculated based on height and weight using WHO standards. The primary outcome is the difference between two arms in the change of children's BMI from baseline to the end of the follow-up.

  at the end of the 12-month intervention

Secondary Outcomes (8)

• Carotid Intima-Media Thickness,CIMT

  at the end of the 12-month intervention

• Body Mass Index Z-score(BMI-z)

  at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up

• Waist Circumference

  at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up

• waist-to-Height Ratio, WHtR

  at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up.

• Body Composition

  at the end of the 12-month intervention; at 24-month follow-up; at 36-month follow-up

Study Arms (2)

A multi-level collaborative intervention

EXPERIMENTAL

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.

Behavioral: multicomponent, tiered intervention

usual-care control

NO INTERVENTION

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.

Interventions

multicomponent, tiered intervention 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.

A multi-level collaborative intervention

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Shandong Maternal and Child Health Hospital: collaborator

Study Sites (1)

Peking University Health Science Center

Beijing, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed after the baseline survey. The assessors measuring children's health indicators(e.g.,weight and height) will be blinded at follow up phases.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Maternal and Child Health, School of Public Health, Peking University

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): October 9, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)