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

NCT06620250 | Not Yet Recruiting

• 1 other identifier: 20240808
• Study Type: interventional
• Target: 882
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myopia; Mental Health; Obesity

Outcome Measures

Primary Outcomes (4)

• 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.

  0,6month，12month

• 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.

  0,6month,12month

• 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.

  0, 6month，12month

• 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.

  0,6month,12month

Study Arms (2)

Digital Prevention and control of myopia

EXPERIMENTAL

two articles per month were sent to the parent/primary caregiver for acceptance of the intervention, and one month after the intervention began, an"Expert said" video intervention was added, at the beginning of each month, a video was posted for them to learn; three months after the start of the intervention, the wechat message intervention was added, and relevant knowledge about myopia prevention and control was sent to the wechat group every Tuesday morning; nine months after the start of the intervention, increase the text message intervention, send text messages every Friday evening to remind children of the weekend outdoor activities. In addition, live broadcasts will be held in March September and June 6 to answer parents' questions and concerns.

Combination Product: Digital Prevention and control of myopia

Control Group

NO INTERVENTION

No intervention of any kind

Interventions

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.

Digital Prevention and control of myopia

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• No cognitive impairment and communication impairment
• Volunteer and sign the informed consent
• Fill in the questionnaire
• Skilled in using electronic equipment

You may not qualify if:

• 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

Sponsors & Collaborators

• Fangbiao Tao: lead

MeSH Terms

Conditions

Myopia; Psychological Well-Being; Obesity

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Personal Satisfaction; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fangbiao Tao, Professor

CONTACT

+86 13856986775; taofangbiao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-08