Intervention for Preventing Myopia and Multimorbidity in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-11
SponsorFangbiao Tao
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children in grades 3-4, aged 8-11 years.
Informed consent obtained.
Disqualifiers
Presence of systemic diseases (e.g., endocrine, cardiac, psychiatric disorders).
Presence of developmental abnormalities.
Inability to complete the follow-up.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard School Health Education
BehavioralParticipants 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
BehavioralA 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.
Treatment groups
4,000 Participants
are divided into 2 treatment groupsGroup A: Usual Education Control GroupActive comparator 1 intervention
Group B: Comprehensive Lifestyle Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fangbiao Tao
Lead sponsor
Anhui Medical University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: