NCT07294222

Intervention for Preventing Myopia and Multimorbidity in Children

Establishment of Appropriate Intervention Methods for Preventing Myopia and Multimorbidity in Children and Conducting a RCT Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: Fangbiao Tao · Academic / Other
• Sex: All
• Age: 8 Years – 11 Years
• Healthy volunteers: Accepted

Summary

This study aims to develop and evaluate a scalable, hybrid intervention model for the co-prevention of myopia, obesity, and mental health issues among children. By integrating cognitive behavioral therapy principles, the model targets key modifiable lifestyle factors-including dietary nutrition, physical activity, screen time, sleep hygiene, light exposure, and psychological adaptation-through coordinated family-school engagement and online-to-offline delivery. Using a cluster randomized controlled trial design in grades 3-4 primary school students, the research will assess the effectiveness of this multi-component strategy in reducing the incidence and burden of these co-occurring conditions.

Detailed description

This study employs a real-world, cluster randomized controlled trial (cRCT) design conducted in primary school settings. Participants will be provided with a 6-month integrated health education program involving both families and schools, accompanied by sustained environmental modifications to support healthy behaviors. Data will be collected at four time points: baseline, immediately after the intervention, 6 months, and 12 months post-baseline, to evaluate the short- and medium-term effects of the intervention.

Conditions

• Myopia
• Mental Health
• Cardiovascular Health Status

Interventions

Type	Name	Description
BEHAVIORAL	Standard School Health Education	Participants receive the existing health education curriculum as provided by their school, following the standard national or local guidelines, without the additional components of the study's intervention package.
BEHAVIORAL	Multi-component Health Promotion Package	A 24-week program integrating: 1) Weekly animated video-based health lessons; 2) Interactive debates and handbook activities; 3) Family engagement via handbooks, meetings, and WeChat updates; 4) Health knowledge reinforcement based on fun health lectures; 5) Creation of a 'Healthy Living Corner' in classrooms; 6) Temporary use of wearable devices to monitor and encourage outdoor activity and sleep.

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-12-30
• Completion: 2027-01-30
• First posted: 2025-12-19
• Last updated: 2025-12-24