Intervention for Preventing Myopia and Multimorbidity in Children

Fangbiao Tao

Status: Not yet enrolling

Conditions: Cardiovascular Health Status; Myopia; Mental Health

Treatments: Behavioral: Standard School Health Education; Behavioral: Multi-component Health Promotion Package

Study type: Interventional

Funder types: Other

Identifiers

NCT07294222

81250810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 8 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,000 participants in 2 patient groups

Usual Education Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard School Health Education

Comprehensive Lifestyle Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Multi-component Health Promotion Package