Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Physical activity
研究概览
简要总结
Congenital heart disease (CHD) affects approximately 1% of live births, and children with CHD often fail to meet WHO physical activity guidelines. Digital interventions to promote physical activity in CHD patients are limited. This study will develop and test a 12-week digital lifestyle intervention for children (ages 8-13) and their guardians, using a Garmin Vivofit Jr. 2 wearable to continuously monitor physical activity (PA). We will assess its impact on children's moderate to vigorous intensity physical activity (MVPA), daily activity (steps per day), quality of life, nutrition, and health literacy, as well as the quality of life and health literacy of their parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 8-14 years
- •Presence of a congenital heart defect (must be moderate or complex according to ACC criteria)
- •NYHA Class I or II
- •Presence of written informed consent
排除标准
- •Cognitive impairments that inhibit patients from understanding the tasks
- •No sports clearance by paediatric cardiologists
结局指标
主要结局
Physical activity
时间窗: 12 weeks
Physical activity is objectively assessed with the wrist worn wearable "Garmin vivofit jr. 2". Daily physical activity is measured on the basis of active minutes in moderate-to-vigorous intensity.
次要结局
- Daily step count(12 weeks)
- Health-related quality of life(Baseline, after 6 weeks, after 12 weeks)
- Physical Activity Health Literacy(Baseline, after 6 weeks, after 12 weeks)
- Nutritional Health Literacy(Baseline, after 6 weeks, after 12 weeks)
- Health-Related Quality of Life: Parent Version (Proxy-Report)(Baseline, after 6 weeks, after 12 weeks)
- Health Literacy for Children(Baseline, after 6 weeks, after 12 weeks)
- Health Literacy for Adults(Baseline, after 6 weeks, after 12 weeks)