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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03929692

Recruitment Status Completed

First Posted April 29, 2019

Last update posted April 29, 2019

Study Description

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.

  • Condition or Disease:Atherosclerosis
    Life Style
  • Intervention/Treatment: Behavioral: Multi-layer health promotion program
    Other: Standard health education
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 2102 participants
  • Allocation: Non-Randomized
  • 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) ()
  • Primary Purpose: Prevention
  • 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
Arms and interventions
Arm Intervention/treatment
Other: Intervention Group
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
Other: Control Group
Adolescents of same age as intervention group at follow-up examination that did not participate in health promotion program.
Other: Standard health education
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. 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.
Eligibility Criteria
  • Ages Eligible for Study: 14 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts
Locations

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

Italy, South Tyrol
Department of Pediatrics, Bruneck Hospital
Bruneck

Sponsors and Collaborators

Medical University Innsbruck

Tiroler Landeskrankenanstalten GmbH (TILAK)

Tiroler Gebietskrankenkasse (TGKK)

InfPro IT Solutions GmbH

Genossenschaft Milchhof Sterzing (Dairy Farm Sterzing)

Austrian Research Promotion Agency FFG (K Project)

Public Health Service of South Tyrol, Italy

Investigators

Principal Investigator: Ursula Kiechl-Kohlendorfer, MD Medical University of Innsbruck

Principal Investigator: Michael Knoflach, MD Medical University of Innsbruck

More Information
  • Responsible Party: Medical University Innsbruck
  • ClinicalTrials.gov Identifier: NCT03929692 History of Changes
  • Other Study ID Numbers: EVA1
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: April 29, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: Anonymized data can be shared in academic cooperations. Request for data can be addressed to the principal investigators with an appropriate research question.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Atherosclerosis