NCT07117149

Early-Life Strategies for Preventing Obesity in Preschool-aged Children

Peking University Smart Monitoring and Responsive Technology for Early Childhood Health (PKU-SMART)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 882 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The PKU-SMART is a cluster randomized controlled trial conducted in Jinan, Shandong Province, China. This preventive intervention study aims to develop and evaluate a comprehensive obesity intervention framework for preschool children that integrates digital health technologies, multi-sectoral collaboration, and tiered management strategies. The effectiveness and cost-effectiveness of this approach will be assessed.

Detailed description

In the past four decades, the number of children and adolescents with obesity worldwide has increased tenfold, making childhood overweight and obesity one of the most pressing public health issues. In China, the prevalence of overweight and obesity among children under six years old in China has reached 10.4%. Children with obesity are more likely to develop health problems than their normal-weight peers. The health impacts of childhood obesity often persist into adulthood, significantly increasing the risk of cardiovascular diseases, endocrine and respiratory disorders, cancers, and other chronic conditions. Therefore, the prevention and management of childhood obesity are critical for promoting both immediate and long-term health. However, current intervention strategies often face challenges such as inconsistent outcomes, poor adherence, and a lack of theoretical foundation. There is a pressing need to develop more effective, scalable, and sustainable approaches. To address this gap, we propose an intervention(PeKing University Smart Monitoring And Responsive Technology for early childhood health, PKU-SMART), a cluster-randomized preventive trial targeting preschool children. This study will develop and evaluate an innovative, digital health-supported, multi-sector, tiered intervention system aimed at improving preschoolers' health behaviors, reducing obesity prevalence, and supporting long-term weight management.

Conditions

• Childhood Obesity Prevention

Interventions

Type	Name	Description
BEHAVIORAL	multicomponent, tiered intervention	Kindergarten: Train teachers and integrate healthy weight management into kindergarten health policies; deliver health education sessions for children; monitor extra dietary intake and physical activity; conduct monthly height and weight measurements. Family: Provide multi-format health education (lectures, short videos, articles) to communicate core intervention messages; set health behavior goals and deliver personalized feedback; conduct motivational interviewing in offline parent meetings or by phone. Hospital: Offer professional health guidance and medical services. PKU-SMART online platform: Health Education Module; Growth Monitoring Module; Health Behavior Module; Home-Kindergarden Partnership Module.

Timeline

• Start date: 2025-10-02
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2025-08-12
• Last updated: 2025-11-24

Locations

1 site across 1 country: China