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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
| Stiftung KinderHerz Deutschland gGmbH | UNKNOWN |
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In adolescents with congenital heart disease physical activity level is reduced which is why promotion to a more active lifestyle with an age-appropriate and modern intervention is needed. In healthy subjects digital health nudging was shown to increase physical activity. However, in adolescents with congenital heart disease such studies have not been conducted yet. In this RCT participants receive daily, short smartphone messages with the primary purpose to increase daily physical activity, which is monitored with a "Garmin vivofit jr." wearable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Health Nudging | Experimental | During 12-week intervention period participants receive daily text messages via WhatsApp on their smartphone to encourage them to be physically active in their daily lives. |
|
| Control | No Intervention | During 12-week control period participants receive no text messages. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health Nudging | Behavioral | Short daily text messages with information and motivation concerning physical activity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objectively measured physical activity | Physical activity is objectively assessed with the wrist worn wearable "Garmin vivofit jr.". Daily physical activity is measured on the basis of active minutes in moderate-to-vigorous intensity. | 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objectively measured daily step count | Daily step count is objectively assessed with the wrist worn wearable "Garmin vivofit jr.". | 25 weeks |
| Activity-related self-efficacy | Perceived self-efficacy in the context of physical activity is measured using the German version of the Physical Activity Self-Efficacy Scale. The scale consists of eight items, each of which is answered on a five-point Likert scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Müller, PD Dr.rer.nat | Technical university munich, Chair of preventive perdiatrics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Congenital Heart Defects and Pediatric Cardiology, German Heart Center | Munich | Bavaria | 80636 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37030491 | Derived | Willinger L, Oberhoffer-Fritz R, Ewert P, Muller J. Digital Health Nudging to increase physical activity in pediatric patients with congenital heart disease: A randomized controlled trial. Am Heart J. 2023 Aug;262:1-9. doi: 10.1016/j.ahj.2023.04.001. Epub 2023 Apr 7. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Baseline, after 12 weeks, after 24 weeks |
| Health-related quality of life | 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. | Baseline, after 12 weeks, after 24 weeks |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |