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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Digital Health Intervention
BehavioralAccess to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Digital Health InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Physical activity
Physical activity is objectively assessed with the wrist worn wearable "Garmin vivofit jr. 2". Daily physical activity is measured on the basis of active minutes in moderate-to-vigorous intensity.
Time frame
12 weeksSecondary outcomes
1
Daily step count
Children's daily step count is objectively assessed using the wrist-worn wearable device, Garmin Vivofit Jr. 2.
Time frame
12 weeks2
Health-related quality of life
Children's health-related quality of life is self-assessed via the KINDL® questionnaire. The KINDL® is a generic instrument for assessing health-related quality of life in children and adolescents. The KINDL® is a short, methodologically tested and flexible measurement instrument consisting of 24 questions on the six areas of body/physis, feelings/psychology, self-assessment, family, friends and school.
Time frame
Baseline, after 6 weeks, after 12 weeks3
Physical Activity Health Literacy
Physical Activity Health Literacy Scale for Children (PAHL-C) evaluates children's self-reported knowledge and understanding of physical activity and its benefits through an 8-question scale.
Time frame
Baseline, after 6 weeks, after 12 weeks4
Nutritional Health Literacy
The Nutrition Health Literacy Scale for Children (NHL-C) measures children's self-reported knowledge and understanding of nutrition and healthy eating using an 8-question scale.
Time frame
Baseline, after 6 weeks, after 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Deutsches Herzzentrum Muenchen
Lead sponsor
Technical University of Munich
Collaborator
Stiftung KinderHerz Deutschland gGmbH
Collaborator
Source ClinicalTrials.gov