Clinical trial NCT06626672: Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians
Official title: Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Pediatric ALL
Keywords: Congenital Heart Disease
Congenital Heart Defect
Child
Physical Activity
Exercise
MVPA
Digital Health
Telemedicine
Health literacy
Quality Of Life
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: Stiftung KinderHerz Deutschland gGmbH
First posted: 2024-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study uses a delayed start design with two arms. In Arm 1, participants receive the intervention immediately for 12 weeks. In Arm 2, participants initially do not receive the intervention but will start the same intervention after a 12-week delay to ensure fairness.
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Physical activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Daily step count
timeFrame: 12 weeks
measure: Health-related quality of life
timeFrame: Baseline, after 6 weeks, after 12 weeks
measure: Physical Activity Health Literacy
timeFrame: Baseline, after 6 weeks, after 12 weeks
measure: Nutritional Health Literacy
timeFrame: Baseline, after 6 weeks, after 12 weeks
measure: Health-Related Quality of Life: Parent Version (Proxy-Report)
timeFrame: Baseline, after 6 weeks, after 12 weeks
measure: Health Literacy for Children
timeFrame: Baseline, after 6 weeks, after 12 weeks
measure: Health Literacy for Adults
timeFrame: Baseline, after 6 weeks, after 12 weeks
Other outcomes:
Locations:
city: München
country: Germany
facility: Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
Study officials:
affiliation: Technical University of Munich, Chair of preventive perdiatrics
name: Jan Müller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: