An interventional study of Digital Prevention and control of myopia in Myopia, Mental Health and Obesity, sponsored by Fangbiao Tao. Not yet recruiting. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Fangbiao Tao · Not applicable, Interventional, and Prevention
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.
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 882 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Fangbiao Tao is the lead sponsor of 10 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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
No intervention of any kind
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.
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
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
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
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
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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