Intervention for Preventing Myopia and Multimorbidity in Children

Sponsor
Fangbiao Tao
Study ID
NCT07294222
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Health Status
  • Mental Health
  • Myopia

Eligibility Criteria

Sex
ALL
Age
8 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

  • Standard School Health Education — BEHAVIORAL
    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.
  • Multi-component Health Promotion Package — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Dec 19, 2025
Start date
Dec 30, 2025
Status verified
Dec 2025
Primary completion
Dec 30, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Usual Education Control Group
    Participants in this group continue with their usual school health education curriculum and do not receive the specific interventions of this study.
  • Experimental: Comprehensive Lifestyle Intervention Group
    Participants in this group receive a multi-component health promotion intervention, including animated health education videos, fun health lectures, family-school environment support, and encouragement of outdoor activities using wearable devices.

Primary Outcome Measure

Number of Participants with a Composite of Myopia, Obesity, Psychological Problems, or Cardiovascular Risk Factors at 12 Months [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts

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