Establishment of Appropriate Intervention Methods for Preventing Myopia and Multimorbidity in Children and Conducting a RCT Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Fangbiao Tao
- 入组人数
- 4,000
- 主要终点
- Number of Participants with a Composite of Myopia, Obesity, Psychological Problems, or Cardiovascular Risk Factors at 12 Months
概览
简要总结
This study aims to develop and evaluate a scalable, hybrid intervention model for the co-prevention of myopia, obesity, and mental health issues among children. By integrating cognitive behavioral therapy principles, the model targets key modifiable lifestyle factors-including dietary nutrition, physical activity, screen time, sleep hygiene, light exposure, and psychological adaptation-through coordinated family-school engagement and online-to-offline delivery. Using a cluster randomized controlled trial design in grades 3-4 primary school students, the research will assess the effectiveness of this multi-component strategy in reducing the incidence and burden of these co-occurring conditions.
详细描述
This study employs a real-world, cluster randomized controlled trial (cRCT) design conducted in primary school settings. Participants will be provided with a 6-month integrated health education program involving both families and schools, accompanied by sustained environmental modifications to support healthy behaviors. Data will be collected at four time points: baseline, immediately after the intervention, 6 months, and 12 months post-baseline, to evaluate the short- and medium-term effects of the intervention.
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
- None
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in grades 3-4, aged 8-11 years.
- •Informed consent obtained.
排除标准
- •Presence of systemic diseases (e.g., endocrine, cardiac, psychiatric disorders).
- •Presence of developmental abnormalities.
- •Inability to complete the follow-up.
结局指标
主要结局
Number of Participants with a Composite of Myopia, Obesity, Psychological Problems, or Cardiovascular Risk Factors at 12 Months
时间窗: From enrollment to the end of treatment at 12 months
次要结局
未报告次要终点