Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study

Atherosclerosis Clinical Trial

— EVA-Tyrol  

Official title:

Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929692
• Other study ID #: EVA1
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: February 2019

Study information

• Verified date: April 2019
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atherosclerosis - the main cause of cardiovascular diseases - starts already in childhood. The Tyrolean Early Vascular Ageing-study aims to improve the vascular health of Tyrolean adolescents by a multi-layer intervention program.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2102
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Intervention group: Participants must be in 10th school grade or aged 15 to 16 years when recruited in training companies.

• Control Group: Participants must be in 12th school grade or aged 17 to 18 years when recruited in training companies.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Atherosclerosis
• Life Style

Intervention

Behavioral:
• Multi-layer health promotion program

Other:
• Standard health education

Locations

Country	Name	City	State
Austria	Department of Pediatrics II (Neonatology), Medical University of Innsbruck	Innsbruck	Tyrol
Italy	Department of Pediatrics, Bruneck Hospital	Bruneck	South Tyrol

Sponsors (7)

Lead Sponsor	Collaborator
Medical University Innsbruck	Austrian Research Promotion Agency FFG (K Project), Genossenschaft Milchhof Sterzing (Dairy Farm Sterzing), InfPro IT Solutions GmbH, Public Health Service of South Tyrol, Italy, Tiroler Gebietskrankenkasse (TGKK), Tiroler Landeskrankenanstalten GmbH (TILAK)

Countries where clinical trial is conducted

Austria,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of health promotion.	Difference in the number of AHA's seven health goals in the ideal range between the intervention and the control Group.	2 years
Secondary	Change in vascular health.	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.	2 years