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Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians

RecruitingNAAges 8 Years - 14 YearsAllDeutsches Herzzentrum Muenchen
NCT06626672 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Digital Health Intervention
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Where

1 site
Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
München, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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