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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-14
SponsorDeutsches Herzzentrum Muenchen

About this trial

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

Qualifiers

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

Disqualifiers

Cognitive impairments that inhibit patients from understanding the tasks

No sports clearance by paediatric cardiologists

Trial design

Treatments tested in this trial

  • Digital Health Intervention

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Deutsches Herzzentrum Muenchen

Lead sponsor

Technical University of Munich

Collaborator

Stiftung KinderHerz Deutschland gGmbH

Collaborator