NCT06626672Recruiting
Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians
Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
Source: ClinicalTrials.gov · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 2 Oct 2024
- Start date
- 1 Oct 2024
- Primary completion date
- Jan 2026
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- NCT number
- NCT06626672
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Oct 2024 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- No sports clearance by paediatric cardiologists
Other
- Cognitive impairments that inhibit patients from understanding the tasks
Who the study is looking for
- 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
Age in the registry: 8 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM) Coordinator of this site? Confirm its status | München | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.