Intervention for Preventing Myopia and Multimorbidity in Children

December 18, 2025 updated by: Fangbiao Tao

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fangbiao Tao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Estimated)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81250810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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