Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study (EVA-Tyrol)
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|ClinicalTrials.gov Identifier: NCT03929692|
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis Life Style||Behavioral: Multi-layer health promotion program Other: Standard health education||Not Applicable|
Cardiovascular diseases (CVDs) are the leading non-communicable cause of death. Primary prevention measures aim to improve the awareness of the individual risk profile and promote healthy lifestyle. Multiple evaluations have shown, that atherosclerosis - the main cause of CVDs - begins already early in life. Therefore, prevention programs have to start already in childhood.
The EVA-Tyrol study is a prospective, biomedical cohort study. 2000 participants will be recruited from high schools and training companies spread over North- and East-Tyrol (Austria) and South-Tyrol (Italy). For the 1500 participants included in the intervention group two examinations will be scheduled within a two-year interval. Participants will be in the 10th grade (mean age, 15-16 years) at the baseline and in the 12th grade (mean age, 17-18 years) at the follow-up examination. 500 participants in the 12th grade without participation in a health promotion program will serve as a control group. The 2000 participants equal roughly 5% of the Tyrolean population of the included age-group. Medical examination includes an extensive questionnaire, anthropometric measurements, fasting blood sampling, high-resolution ultrasound of the common carotid artery, and carotid-femoral pulse wave velocity. Active intervention will consist of (1) enhancing knowledge about CVDs, (2) individual medical counseling based on the results of the baseline examination, (3) providing an online health promotion tool and (4) involvement of participants in planning and conduction of health promotion projects. Main outcome parameter is the difference in the number of ideal health metrics as defined by the American Heart Association between the intervention and control group.
This study aims to improve cardiovascular health in Tyrolean adolescents and to evaluate the efficacy of this multi-layer health promotion program. Moreover, the investigators expect numerous insights in the prevalence of vascular risk conditions and early vascular pathologies in adolescents.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2102 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The Intervention Group (mean age 15-16 years at the baseline and 17-18 years at follow-up) will be compared to a Control Group (mean age 17-18 years) that did not participate in the health promotion program.|
|Masking:||None (Open Label)|
|Official Title:||Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||February 2019|
|Actual Study Completion Date :||February 2019|
Intervention will consist of (1) enhancing knowledge about CVDs, (2) individual medical counseling based on the results of the baseline examination, (3) providing an online health promotion tool and (4) involvement of participants in planning and conduction of health promotion projects.
Behavioral: Multi-layer health promotion program
Other: Standard health education
Adolescents of same age as intervention group at follow-up examination that did not participate in health promotion program.
Other: Standard health education
- Effect of health promotion. [ Time Frame: 2 years ]Difference in the number of AHA's seven health goals in the ideal range between the intervention and the control Group.
- Change in vascular health. [ Time Frame: 2 years ]Difference (decrease, stagnation, increase) of the number of achieved number of AHA's seven health goals in the ideal range between the baseline and the follow-up examination of the intervention group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929692
|Department of Pediatrics II (Neonatology), Medical University of Innsbruck|
|Innsbruck, Tyrol, Austria, 6020|
|Department of Pediatrics, Bruneck Hospital|
|Bruneck, South Tyrol, Italy, 39031|
|Principal Investigator:||Ursula Kiechl-Kohlendorfer, MD||Medical University of Innsbruck|
|Principal Investigator:||Michael Knoflach, MD||Medical University of Innsbruck|