Congenital Heart DiseaseNCT06626672
Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians
A study testing Digital Health Intervention in people with Congenital Heart Disease and Pediatric ALL, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Congenital Heart Disease, Pediatric ALL
- What is being tested?
- Digital Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Cognitive impairments that inhibit patients from understanding the tasks
- No sports clearance by paediatric cardiologists
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
München
Jan Müller, PhD, +4989289 ext. 24574, j.mueller@tum.de
About this study
Official title: 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.
- Conditions
- Congenital Heart Disease, Pediatric ALL
- Being tested
- Digital Health Intervention
- Keywords
- Congenital Heart Disease, Congenital Heart Defect, Child, Physical Activity, Exercise, MVPA, Digital Health, Telemedicine, Health literacy, Quality Of Life
- Medical subject headings
- Heart Defects, Congenital, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health InterventionBehavioural
Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Intervention | Experimental | Children and their guardians are given access to a 12-week digital platform with content to improve their lifestyle.
Physical activity is monitored with a Garmin Vivofit Jr. 2. Receives: Behavioral: Digital Health Intervention |
| Control | No intervention | During 12-week control period participants receive no access the digital platform. Physical activity is monitored with a Garmin Vivofit Jr. 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (7)
Daily step count
Children's daily step count is objectively assessed using the wrist-worn wearable device, Garmin Vivofit Jr. 2.
Measured: 12 weeks
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.
Measured: Baseline, after 6 weeks, after 12 weeks
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.
Measured: Baseline, after 6 weeks, after 12 weeks
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.
Measured: Baseline, after 6 weeks, after 12 weeks
Health-Related Quality of Life: Parent Version (Proxy-Report)
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.
Measured: Baseline, after 6 weeks, after 12 weeks
Health Literacy for Children
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.
Measured: Baseline, after 6 weeks, after 12 weeks
Health Literacy for Adults
Health Literacy Questionnaire (HLS EU-Q16) measures general health literacy in adults, covering access, understanding, and application of health information across various health domains.
Measured: Baseline, after 6 weeks, after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Oct 2024
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH
- Responsible party
- Sponsor
- Investigators
- Jan Müller, Prof. Dr., Principal investigator, Technical University of Munich, Chair of preventive perdiatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626672
- Sponsor's protocol ID
- 2024-337-S-SB
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
- ClinicalTrials.gov ID
- NCT06626672
- Acronym / sponsor ID
- 2024-337-S-SB
- Conditions
- Congenital Heart Disease, Pediatric ALL
- Keywords
- Congenital Heart Disease, Congenital Heart Defect, Child, Physical Activity, Exercise, MVPA, Digital Health, Telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital Health Intervention | Experimental | Behavioral: Digital Health InterventionChildren and their guardians are given access to a 12-week digital platform with content to improve their lifestyle. Physical activity is monitored with a Garmin Vivofit Jr. 2. |
| Control | No intervention | –During 12-week control period participants receive no access the digital platform. Physical activity is monitored with a Garmin Vivofit Jr. 2. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive impairments that inhibit patients from understanding the tasks
- No sports clearance by paediatric cardiologists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health InterventionAccess to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour. | Behavioural | Digital Health Intervention |
Primary outcome
Physical activity
Time frame: 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.
7 secondary outcomes
Daily step count
Time frame: 12 weeks
Health-related quality of life
Time frame: Baseline, after 6 weeks, after 12 weeks
Physical Activity Health Literacy
Time frame: Baseline, after 6 weeks, after 12 weeks
Nutritional Health Literacy
Time frame: Baseline, after 6 weeks, after 12 weeks
Health-Related Quality of Life: Parent Version (Proxy-Report)
Time frame: Baseline, after 6 weeks, after 12 weeks
Health Literacy for Children
Time frame: Baseline, after 6 weeks, after 12 weeks
Health Literacy for Adults
Time frame: Baseline, after 6 weeks, after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Müller, Prof. Dr. principal investigator
Technical University of Munich, Chair of preventive perdiatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Intervention in people with Congenital Heart Disease and Pediatric ALL, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Müller, Prof. Dr. (0176 21149304, j.mueller@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.