Study of the Intervention Effect of Outdoor Activity Period Patterns in Promoting Myopia Among Preschool 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: Increase outdoor activity time during specific time periods.
- Who it may be relevant to
- Registry conditions: Axial Length, Myopia. Basic parameters: 4 years — 5 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
Study on the Association of Time Pattern of Outdoor Activity With Axial Length and Myopia of Preschool Children and Its Intervention
Overview
This study is a randomized controlled trial based on outdoor activity interventions at specific time periods, involving preschool children aged 4 to 5 years. It compared the axial length and myopia incidence between the intervention group and the control group at the 6th and 12th months of the intervention to determine the effect of outdoor activities at specific time periods on the prevention of myopia in preschool children. Additionally, the study investigated the association between outdoor activities at specific time periods and axial length and myopia in preschool children.
Detailed description
Preschool children with insufficient outdoor activity during specific time periods from one kindergarten were assigned to the intervention group, while those from another kindergarten with insufficient outdoor activity during specific time periods were assigned to the control group. The intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, while the control group did not receive any intervention and continued their regular routine. The intervention lasted for one year.
Participants underwent multiple assessments after joining the study. These assessments took place at baseline, at the 6th month of the intervention, and at the 12th month.
Interventions
- Behavioral Increase outdoor activity time during specific time periods
The specific time periods of outdoor activity found to be beneficial for myopia prevention will be used as the intervention "target," and a one-year intervention will be initiated.
Primary outcome measures
- The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention [Time frame: at baseline, at the 6th month of the intervention, and at the 12th month.]
Secondary outcome measures (1)
- The incidence of myopia. [Time frame: at baseline, at the 6th month of the intervention, and at the 12th month.]
Eligibility criteria
Inclusion criteria
- Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.
- Able to cooperate with eye examinations and questionnaires.
Exclusion criteria
- Communication barriers, unable to cooperate.
- Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.
- Children currently using orthokeratology lenses or rigid contact lenses.
- Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.
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
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06607640 · 20240666