A Study of the Impact of Digital Intervention on Parents/primary Caregivers' Myopia Prevention and Control Health Literacy on Preschoolers' Myopia and Physical and Mental Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorFangbiao Tao

About this trial

The study is a Randomized controlled trial based on digital interventions, involving pre-school children and their parents or major caregivers. To compare the myopia and physical and mental health status of preschool children before and after intervention between intervention group and control group, to confirm the effect of digital intervention on prevention and control of Myopia and physical and mental health of preschool children.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

No cognitive impairment and communication impairment

Volunteer and sign the informed consent

Fill in the questionnaire

Skilled in using electronic equipment

Disqualifiers

Children with congenital glaucoma, cataract, strabismus and other congenital eye diseases

Children with a history of ocular trauma, eye surgery, or complications of myopia

Do not cooperate with the investigation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital Prevention and control of myopia

    Combination product

    The Digital Intervention Programme for parents/primary caregivers is primarily a digital intervention to address the attitudes, knowledge and actions of parents or primary caregivers of pre-school children regarding the prevention and control of myopia.

Treatment groups

882 Participants
are divided into 2 treatment groups
Group A: Digital Prevention and control of myopiaExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Prevention and control of Myopia Health Literacy Rating Scale

The scale was used to assess the prevention and control of myopia health literacy of parents/primary caregivers, including 3 dimensions, 6 aspects and 31 items, each with 3 or 5 options. The forward score was 1,2,3,4,5(1,2,3) , and the reverse score was 5,4,3,2,1(3,2,1) . The scale scores ranged from 0 to 102, the higher the score, the higher the health literacy of prevention and control of myopia.

Time frame
0,6month,12month
2

Myopia screening

Myopia screening includes Naked Eye Far Vision Examination, computer optometry and axial length measurement.In the state of non-ciliary paralysis, SE ≤ -0.50 D, visual acuity ≤4.7 at 3 years old, 4.8 at 4 years old, 4.9 at 5 years old, and less than 5.0 in the naked eye of children and adolescents over 6 years old were considered as screening myopia.

Time frame
0,6month,12month
3

BMI

BMI = weight (kg)/\[ height (m)\]2. The standard deviation method was used to evaluate the physical growth of children(WS/T 423-2022), + 1 SD≤ age BMI ≤ + 2 SD was defined as overweight, + 2 SD ≤ age BMI≤ + 3 SD was defined as Obesity.

Time frame
0, 6month,12month
4

Strength and Difficulties Questionnaire

The mental health status of preschool children was evaluated by Strength and Difficulties Questionnaire, SDQ,SDQ includes 5 dimensions: emotional symptoms, conduct problems, hyperactivity problems, peer interaction problems and prosocial behaviors.The questionnaire was scored on a 3-point scale, and was evaluated from non-conformity (0 points) to full conformity (2 points) . The scale scores ranged from 0 to 40, the higher the score, the more serious the emotional and behavioral problems.

Time frame
0,6month,12month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Fangbiao Tao

Lead sponsor

Anhui Medical University

Sponsor institution

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