Digital health program for children with congenital heart disease and their families
Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
This study is testing a 12-week digital program using a fitness tracker to help children with congenital heart disease and their families become more active and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 14 Years |
| Sex | All |
| Sponsor | Deutsches Herzzentrum Muenchen Academic / other |
| Locations | 1 site (München) |
| Trial ID | NCT06626672 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate a 12-week digital lifestyle intervention designed for children aged 8-13 with congenital heart disease and their guardians. Participants will use a Garmin Vivofit Jr. 2 wearable device to monitor their physical activity levels continuously. The intervention focuses on increasing moderate to vigorous physical activity, improving daily activity, enhancing quality of life, and boosting health literacy for both children and their parents. The study will assess the effectiveness of this digital approach in promoting healthier lifestyles among affected families.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8-14 years with moderate to complex congenital heart defects who are classified as NYHA Class I or II.
Not a fit: Patients with cognitive impairments that prevent them from understanding the tasks or those without sports clearance from pediatric cardiologists may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve physical activity levels and overall quality of life for children with congenital heart disease and their guardians.
How similar studies have performed: While digital interventions for promoting physical activity in children with congenital heart disease are limited, similar approaches in other pediatric populations have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
München
- Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM) — München, Germany (Recruiting)
Study contacts
- Principal investigator: Jan Müller, Prof. Dr. — Technical University of Munich, Chair of preventive perdiatrics
- Study coordinator: Jan Müller, Prof. Dr.
- Email: j.mueller@tum.de
- Phone: 0176 21149304
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.