Actively Recruiting

Phase Not Applicable
Age: 8Years - 14Years
All Genders
NCT06626672

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

Led by Deutsches Herzzentrum Muenchen · Updated on 2025-01-29

60

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

Sponsors

D

Deutsches Herzzentrum Muenchen

Lead Sponsor

T

Technical University of Munich

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 8 to 14 years
  • Diagnosed with a moderate or complex congenital heart defect according to ACC criteria
  • Classified as NYHA Class I or II
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Cognitive impairments that prevent understanding of tasks
  • No sports clearance from pediatric cardiologists

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

München, Germany

Actively Recruiting

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Research Team

J

Jan Müller, Prof. Dr.

CONTACT

I

Isabel Uphoff, M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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