RecruitingNot ApplicableNCT06626672

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


Sponsor

Deutsches Herzzentrum Muenchen

Enrollment

60 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 14 Years

Inclusion Criteria4

  • 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 Criteria2

  • Cognitive impairments that inhibit patients from understanding the tasks
  • No sports clearance by paediatric cardiologists

Interventions

BEHAVIORALDigital Health Intervention

Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.


Locations(1)

Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)

München, Germany

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NCT06626672


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