Actively Recruiting
Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians
Led by Deutsches Herzzentrum Muenchen · Updated on 2025-01-29
60
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
D
Deutsches Herzzentrum Muenchen
Lead Sponsor
T
Technical University of Munich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 8 to 14 years
- Diagnosed with a moderate or complex congenital heart defect according to ACC criteria
- Classified as NYHA Class I or II
- Provided written informed consent
You will not qualify if you...
- Cognitive impairments that prevent understanding of tasks
- No sports clearance from pediatric cardiologists
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
München, Germany
Actively Recruiting
Research Team
J
Jan Müller, Prof. Dr.
CONTACT
I
Isabel Uphoff, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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