Actively Recruiting
Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
Led by Deutsches Herzzentrum Muenchen · Updated on 2025-01-29
60
Participants Needed
1
Research Sites
4 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 about 1% of live births, and children with CHD often do not meet the World Health Organization's physical activity guidelines. Researchers are studying a 12-week digital lifestyle program designed for children aged 8 to 13 with moderate or complex CHD and their guardians. The study aims to assess the program's impact on children's physical activity levels, quality of life, nutrition, and health knowledge, as well as the well-being and health literacy of their parents. Participants are randomly assigned to one of two groups: one group receives access to a digital platform for 12 weeks that offers weekly workout videos, live sessions, recipes, study summaries, and a consultation hour. Both groups will wear a Garmin Vivofit Jr. 2 device to continuously monitor physical activity. The control group does not have access to the digital platform but still wears the activity tracker for the same duration. Throughout the study, children and their guardians will be monitored for physical activity using the wearable device. Researchers will measure moderate to vigorous physical activity, daily step counts, and quality of life at the start, 6 weeks, and 12 weeks. They will also assess nutritional and physical activity health literacy for both children and adults. The study includes assessments of parent-reported quality of life and ensures safety by requiring medical clearance for sports participation. Total participation lasts 12 weeks.
CONDITIONS
Brief 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
- Presence of a moderate or complex congenital heart defect according to ACC criteria
- Classified as NYHA Class I or II
- Written informed consent provided
You will not qualify if you...
- Cognitive impairments that prevent understanding of study tasks
- No sports clearance by a pediatric cardiologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants access a digital platform with weekly workout videos, live workouts, recipes, study summaries, and a consultation hour to promote physical activity, nutrition, and health literacy.
Weekly digital interactions and assessments at baseline, 6 weeks, and 12 weeks
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.
I
Isabel Uphoff, M.Sc.
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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