MyopiaNCT06620250
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
A study of Myopia and Mental Health, run by Fangbiao Tao.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Mental Health, Obesity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 882 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No cognitive impairment and communication impairment
- Volunteer and sign the informed consent
- Fill in the questionnaire
- Skilled in using electronic equipment
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial：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
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.
Read the detailed description
In this study, wechat, online courses, live broadcast and SMS were used to transfer the knowledge of myopia prevention and control to parents/primary caregivers, and to promote their attitude and behavior change. The intervention period was from October to December 2025. The control group did not 2024 any intervention. The prevention and control of Myopia and health literacy of the parents and main adopters were collected at baseline and after the intervention respectively, visual data and physical and mental health status of preschool children were collected every six months.
- Conditions
- Myopia, Mental Health, Obesity
- Being tested
- Digital Prevention and control of myopia
- Medical subject headings
- Myopia, Psychological Well-Being, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Prevention and control of myopiaCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Digital Prevention and control of myopia |
| Control Group | No intervention | No intervention of any kind |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0,6month,12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 882 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620250
- Sponsor's protocol ID
- 20240808
- Status last verified
- Aug 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial：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
- ClinicalTrials.gov ID
- NCT06620250
- Acronym / sponsor ID
- 20240808
- Conditions
- Myopia, Mental Health, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 882 participants (estimated)
- Lead sponsor
- Fangbiao TaoUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, wechat, online courses, live broadcast and SMS were used to transfer the knowledge of myopia prevention and control to parents/primary caregivers, and to promote their attitude and behavior change. The intervention period was from October to December 2025. The control group did not 2024 any intervention. The prevention and control of Myopia and health literacy of the parents and main adopters were collected at baseline and after the intervention respectively, visual data and physical and mental health status of preschool children were collected every six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Prevention and control of myopia | Experimental | Combination Product: Digital Prevention and control of myopiatwo 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. |
| Control Group | No intervention | –No intervention of any kind |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- No cognitive impairment and communication impairment
- Volunteer and sign the informed consent
- Fill in the questionnaire
- Skilled in using electronic equipment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Prevention and control of myopiaThe 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. | Combination product | Digital Prevention and control of myopia |
Primary outcome
Prevention and control of Myopia Health Literacy Rating Scale
Time frame: 0,6month，12month
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.
Myopia screening
Time frame: 0,6month,12month
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.
BMI
Time frame: 0, 6month，12month
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.
Strength and Difficulties Questionnaire
Time frame: 0,6month,12month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study of Myopia and Mental Health, run by Fangbiao Tao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangbiao Tao, Professor (+86 13856986775, taofangbiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention and control of Myopia Health Literacy Rating Scale (time frame: 0,6month，12month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.