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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 882
- 主要终点
- Prevention and control of Myopia Health Literacy Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No cognitive impairment and communication impairment
- •Volunteer and sign the informed consent
- •Fill in the questionnaire
- •Skilled in using electronic equipment
排除标准
- •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
结局指标
主要结局
Prevention and control of Myopia Health Literacy Rating Scale
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Fangbiao Tao
Professor
Anhui Medical University