Intervention for Preventing Myopia and Multimorbidity in Children

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.

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Key information

Conditions

Myopia Behavior Cardiovascular Health Status Eye Diseases Mental Health Personal Satisfaction Psychological Well-Being Refractive Errors

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fangbiao Tao, M.D.

CONTACT

[email protected]

86-0551-13856986775

Sponsors and collaborators

Lead sponsor

Fangbiao Tao

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Dec 19, 2025
Registry last updated: Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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