Intervention for Preventing Myopia and Multimorbidity in Children

NCT07294222 | Not Yet Recruiting

• 1 other identifier: 81250810
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myopia; Mental Health; Cardiovascular Health Status

Outcome Measures

Primary Outcomes (1)

• Number of Participants with a Composite of Myopia, Obesity, Psychological Problems, or Cardiovascular Risk Factors at 12 Months

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Usual Education Control Group

ACTIVE COMPARATOR

Participants in this group continue with their usual school health education curriculum and do not receive the specific interventions of this study.

Behavioral: Standard School Health Education

Comprehensive Lifestyle Intervention Group

EXPERIMENTAL

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.

Behavioral: Multi-component Health Promotion Package

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.

Usual Education Control Group

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.

Comprehensive Lifestyle Intervention Group

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children in grades 3-4, aged 8-11 years.
• Informed consent obtained.

You may not qualify if:

• Presence of systemic diseases (e.g., endocrine, cardiac, psychiatric disorders).
• Presence of developmental abnormalities.
• Inability to complete the follow-up.

Sponsors & Collaborators

• Fangbiao Tao: lead

MeSH Terms

Conditions

Myopia; Psychological Well-Being

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Personal Satisfaction; Behavior

Central Study Contacts

Fangbiao Tao, M.D.

CONTACT

86-0551-13856986775; taofangbiao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Key Laboratory of Population Health Across Life Cycle(Anhui Medical University), Ministry of Education of the People's Republic of China

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share