Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Physical activity
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Cognitive impairments that inhibit patients from understanding the tasks
- •No sports clearance by paediatric cardiologists
Outcomes
Primary Outcomes
Physical activity
Time Frame: 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.
Secondary Outcomes
- 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)