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

Not Applicable
Completed
Conditions
Life Style
Atherosclerosis
Interventions
Behavioral: Multi-layer health promotion program
Other: Standard health education
Registration Number
NCT03929692
Lead Sponsor
Medical University Innsbruck
Brief 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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2102
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention GroupStandard health educationIntervention 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.
Control GroupStandard health educationAdolescents of same age as intervention group at follow-up examination that did not participate in health promotion program.
Intervention GroupMulti-layer health promotion programIntervention 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.
Primary Outcome Measures
NameTimeMethod
Effect of health promotion.2 years

Difference in the number of AHA's seven health goals in the ideal range between the intervention and the control Group.

Secondary Outcome Measures
NameTimeMethod
Change in vascular health.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.

Trial Locations

Locations (2)

Department of Pediatrics, Bruneck Hospital

🇮🇹

Bruneck, South Tyrol, Italy

Department of Pediatrics II (Neonatology), Medical University of Innsbruck

🇦🇹

Innsbruck, Tyrol, Austria

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