RecruitingRecruiting
Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians
NCT06626672 · Deutsches Herzzentrum Muenchen
In plain English
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Official title
Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
About this study
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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2024-10-01
Estimated completion: 2026-02
Last updated: 2025-01-29
Interventions
Behavioral: Digital Health Intervention
Primary outcomes
- • Physical activity (12 weeks)
Sponsor
Deutsches Herzzentrum Muenchen · other
With: Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH
Contacts & investigators
ContactJan Müller, Prof. Dr. · contact · j.mueller@tum.de · 0176 21149304
ContactIsabel Uphoff, M.Sc. · contact · uphoff@dhm.mhn.de · 01639104022
InvestigatorJan Müller, Prof. Dr. · principal_investigator, Technical University of Munich, Chair of preventive perdiatrics
All locations (1)
Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)Recruiting
München, Germany