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NCT Number: NCT06626672

Digital Health Promotion for 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.

Recruiting

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Key information

Conditions

Congenital Heart Disease Behavior Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)

München, Germany

Location status: Recruiting

Location contact

Jan Müller, PhD

CONTACT

[email protected]

+4989289 ext. 24574

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Health Intervention

Behavioral

Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Daily step count

    Time frame: 12 weeks

    Children's daily step count is objectively assessed using the wrist-worn wearable device, Garmin Vivofit Jr. 2.

  2. Health-related quality of life

    Time frame: 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.

  3. Physical Activity Health Literacy

    Time frame: 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.

  4. Nutritional Health Literacy

    Time frame: 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.

  5. Health-Related Quality of Life: Parent Version (Proxy-Report)

    Time frame: 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.

  6. Health Literacy for Children

    Time frame: 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.

  7. Health Literacy for Adults

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Uphoff, M.Sc.

CONTACT

[email protected]

01639104022

Jan Müller, Prof. Dr.

CONTACT

[email protected]

‭0176 21149304‬

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Stiftung KinderHerz Deutschland gGmbH
  • Technical University of Munich

Registry information

Official study title

Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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