NCT06626672 Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians
| NCT ID | NCT06626672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Deutsches Herzzentrum Muenchen |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-10-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jan Müller, Prof. Dr.
PRINCIPAL INVESTIGATOR
Technical University of Munich, Chair of preventive perdiatrics
Frequently Asked Questions
Who can join the NCT06626672 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 14 Years, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06626672 currently recruiting?
Yes, NCT06626672 is actively recruiting participants. Contact the research team at j.mueller@tum.de for enrollment information.
Where is the NCT06626672 trial being conducted?
This trial is being conducted at München, Germany.
Who is sponsoring the NCT06626672 clinical trial?
NCT06626672 is sponsored by Deutsches Herzzentrum Muenchen. The principal investigator is Jan Müller, Prof. Dr. at Technical University of Munich, Chair of preventive perdiatrics. The trial plans to enroll 60 participants.