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Digital Lifestyle Program for Children With Heart Defects and Their Parents

Tests a digital activity and nutrition program in children with congenital heart disease.

Plain-language title generated from the registry record
Registry title: Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians

Key facts

Where
München, GermanySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 8 to 14 with a moderate or complex congenital heart defect. It tests a 12-week digital lifestyle programme for the children and their guardians.

Age
8 to 14 years
Sex
All sexes can join.
Disease stage
Moderate or complex congenital heart defect (by ACC criteria), NYHA Class I or II.

Main reasons for not taking part

  • Cognitive problems that stop the child from understanding the tasks
  • No sports clearance from a paediatric cardiologist

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 8 and 14 years old?

Source: NCT06626672, who can take part

Where in Germany

  • Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)München, GermanyContact: Jan Müller, PhDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Deutsches Herzzentrum Muenchen
Trial code
NCT06626672
Record updated
29 January 2025
Original description
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.Read full original descriptionShow less

Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians

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.

Inclusion: 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: No sports clearance by paediatric cardiologists; Cognitive impairments that inhibit patients from understanding the tasks.

ClinicalTrials.gov NCT06626672