Congenital Heart Disease, Pediatric ALL
Conditions
Keywords
Congenital Heart Disease, Congenital Heart Defect, Child, Physical Activity, Exercise, MVPA, Digital Health, Telemedicine, Health literacy, Quality Of Life
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.
Interventions
BEHAVIORALDigital Health Intervention
Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.
Sponsors
Technical University of Munich
Stiftung KinderHerz Deutschland gGmbH
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | Baseline, after 6 weeks, after 12 weeks | 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. |
| Physical Activity Health Literacy | Baseline, after 6 weeks, after 12 weeks | 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. |
| Nutritional Health Literacy | Baseline, after 6 weeks, after 12 weeks | 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. |
| Daily step count | 12 weeks | Children's daily step count is objectively assessed using the wrist-worn wearable device, Garmin Vivofit Jr. 2. |
| Health Literacy for Children | Baseline, after 6 weeks, after 12 weeks | Health Literacy Survey Questionnaire for Children (HLS-Child-Q15) assesses children's ability to seek, evaluate, and use health information, including disease prevention and health promotion. |
| Health Literacy for Adults | Baseline, after 6 weeks, after 12 weeks | Health Literacy Questionnaire (HLS EU-Q16) measures general health literacy in adults, covering access, understanding, and application of health information across various health domains. |
| Health-Related Quality of Life: Parent Version (Proxy-Report) | Baseline, after 6 weeks, after 12 weeks | The KINDL® proxy-report assesses the child's health-related quality of life from the parent's perspective, using the KINDL® questionnaire designed for parents to provide insights on the child's health-related quality of life. |
Countries
Germany
Contacts
Primary ContactJan Müller, Prof. Dr.
Backup ContactIsabel Uphoff, M.Sc.
Outcome results
None listed