Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
| Stiftung KinderHerz Deutschland gGmbH | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health Intervention | Behavioral | Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily step count | Children's daily step count is objectively assessed using the wrist-worn wearable device, Garmin Vivofit Jr. 2. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Müller, Prof. Dr. | Contact | 0176 21149304 | j.mueller@tum.de | |
| Isabel Uphoff, M.Sc. | Contact | 01639104022 | uphoff@dhm.mhn.de |
| Name | Affiliation | Role |
|---|---|---|
| Jan Müller, Prof. Dr. | Technical University of Munich, Chair of preventive perdiatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM) | Recruiting | München | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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. | 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. | Baseline, after 6 weeks, after 12 weeks |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |