Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians

NCT06626672 | Recruiting

• 1 other identifier: 2024-337-S-SB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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.

  12 weeks

Secondary Outcomes (7)

• Daily step count

  12 weeks

• Health-related quality of life

  Baseline, after 6 weeks, after 12 weeks

• Physical Activity Health Literacy

  Baseline, after 6 weeks, after 12 weeks

• Nutritional Health Literacy

  Baseline, after 6 weeks, after 12 weeks

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

  Baseline, after 6 weeks, after 12 weeks

Study Arms (2)

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.

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.

Interventions

Digital Health Intervention BEHAVIORAL

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

Digital Health Intervention

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Technical University of Munich: collaborator
• Stiftung KinderHerz Deutschland gGmbH: collaborator

Study Sites (1)

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

München, Germany

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Study Officials

• Jan Müller, Prof. Dr.

  Technical University of Munich, Chair of preventive perdiatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Müller, Prof. Dr.

CONTACT

‭0176 21149304‬; j.mueller@tum.de

Isabel Uphoff, M.Sc.

CONTACT

01639104022; uphoff@dhm.mhn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)