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

Medical University Innsbruck

Status: Completed

Conditions: Life Style; Atherosclerosis

Treatments: Other: Standard health education; Behavioral: Multi-layer health promotion program

Study type: Interventional

Funder types: Other

Identifiers

NCT03929692

EVA1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,102 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,102 participants in 2 patient groups

Intervention Group

Other group

Description:

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.

Treatment:

Other: Standard health education

Behavioral: Multi-layer health promotion program

Control Group

Other group

Description:

Adolescents of same age as intervention group at follow-up examination that did not participate in health promotion program.

Treatment:

Other: Standard health education