Cardiovascular Health Status, Mental Health, Myopia
Conditions
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.
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
BEHAVIORALStandard 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.
BEHAVIORALMulti-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.
Sponsors
Fangbiao Tao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactFangbiao Tao, M.D.
Outcome results
None listed