Intervention for Preventing Myopia and Multimorbidity in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard School Health Education, Multi-component Health Promotion Package.
- Who it may be relevant to
- Registry conditions: Myopia, Mental Health, Cardiovascular Health Status. Basic parameters: 8 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Establishment of Appropriate Intervention Methods for Preventing Myopia and Multimorbidity in Children and Conducting a RCT Study
Overview
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07294222 · 81250810