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AtherosclerosisEVA-TyrolNCT03929692

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

A study testing Multi-layer health promotion program and Standard health education in people with Atherosclerosis and Life Style, run by Medical University Innsbruck at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
Atherosclerosis, Life Style
What is being tested?
Multi-layer health promotion program and Standard health education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,102 participants
Where
2 sitesin 2 countries
Study dates
May 2015to Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • none

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

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

    Innsbruck, Tyrol, 6020

Other trials in Austria

Italy1 site

  • Department of Pediatrics, Bruneck Hospital

    Bruneck, Trentino-Alto Adige, 39031

Other trials in Italy

About this study

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.

Read the 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.

Being tested
Multi-layer health promotion program, Standard health education
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-layer health promotion programBehavioural

  • Standard health educationOther

Study groups in NCT03929692
Study groupRoleWhat they receive
Intervention GroupOtherIntervention 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.
Receives: Behavioral: Multi-layer health promotion program; Other: Standard health education
Control GroupOtherAdolescents of same age as intervention group at follow-up examination that did not participate in health promotion program.
Receives: Other: Standard health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (1)

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2019
  2. Study startMay 2015
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
2,102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03929692
Sponsor's protocol ID
EVA1
Acronym
EVA-Tyrol
Status last verified
Apr 2019
First submitted
24 Apr 2019
Last updated
29 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymized data can be shared in academic cooperations. Request for data can be addressed to the principal investigators with an appropriate research question.

Publications

  • Winder B, Zollner-Kiechl S, Bernar B, Gande N, Staudt A, Stock AK, Hochmayr C, Geiger R, Griesmacher A, Kiechl S, Kiechl-Kohlendorfer U, Knoflach M; Early Vascular Ageing (EVA)-Tyrol Study Group. The association of physical activity and carotid intima-media-thickness in adolescents-data of the prospective early vascular ageing-tyrol cohort study. Front Pediatr. 2025 Feb 6;13:1527132. doi: 10.3389/fped.2025.1527132. eCollection 2025.

    PubMed 39981205

  • Bernar B, Gande N, Stock AK, Staudt A, Pechlaner R, Hochmayr C, Kaltseis K, Winder B, Zollner-Kiechl S, Broessner G, Geiger R, Kiechl S; Early Vascular Ageing (EVA) Tyrol Study Group; Kiechl-Kohlendorfer U, Knoflach M. Early Vascular Ageing in adolescents with migraine with aura: a community-based study. BMC Cardiovasc Disord. 2023 Aug 1;23(1):384. doi: 10.1186/s12872-023-03409-2.

    PubMed 37528337

  • Hochmayr C, Ndayisaba JP, Gande N, Staudt A, Bernar B, Stock K, Zollner-Kiechl S, Geiger R, Griesmaier E, Knoflach M, Kiechl-Kohlendorfer U; Early Vascular Ageing (EVA) Study Group. Cardiovascular health profiles in adolescents being born term or preterm-results from the EVA-Tyrol study. BMC Cardiovasc Disord. 2023 Jul 25;23(1):371. doi: 10.1186/s12872-023-03360-2.

    PubMed 37488472

  • Kaltseis K, Frank F, Bernar B, Zollner-Kiechl S, Winder B, Kiechl-Kohlendorfer U, Knoflach M, Broessner G; Early Vascular Ageing (EVA) Tyrol Study Group. Primary headache disorders in adolescents in North- and South-Tyrol: Findings of the EVA-Tyrol-Study. Cephalalgia. 2022 Sep;42(10):993-1004. doi: 10.1177/03331024221088997. Epub 2022 Mar 25.

    PubMed 35331020

  • Winder B, Zollner-Kiechl S, Gruber NM, Bernar B, Gande N, Staudt A, Stock K, Hochmayr C, Geiger R, Griesmacher A, Anliker M, Kiechl S, Kiechl-Kohlendorfer U, Knoflach M; Early Vascular Ageing (EVA)-Tyrol Study Group. The association of allergic asthma and carotid intima-media thickness in adolescence: data of the prospective early vascular ageing (EVA)-Tyrol cohort study. BMC Cardiovasc Disord. 2022 Jan 18;22(1):11. doi: 10.1186/s12872-021-02452-1.

    PubMed 35042472

  • Kiechl SJ, Staudt A, Stock K, Gande N, Bernar B, Hochmayr C, Winder B, Geiger R, Griesmacher A, Anliker M, Kiechl S, Kiechl-Kohlendorfer U, Knoflach M, Pechlaner R; Early Vascular Ageing (EVA) Study Group *. Predictors of Carotid Intima-Media Thickness Progression in Adolescents-The EVA-Tyrol Study. J Am Heart Assoc. 2021 Sep 21;10(18):e020233. doi: 10.1161/JAHA.120.020233. Epub 2021 Sep 6.

    PubMed 34482715

  • Gande N, Pechlaner R, Bernar B, Staudt A, Stock K, Hochmayr C, Geiger R, Kiechl-Kohlendorfer U, Knoflach M; Early Vascular Aging (EVA) Study Group. Cardiovascular health behaviors and associations of sex, age, and education in adolescents - Results from the EVA Tyrol study. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1286-1292. doi: 10.1016/j.numecd.2020.11.002. Epub 2020 Nov 10.

    PubMed 33558093

  • Bernar B, Gande N, Stock KA, Staudt A, Pechlaner R, Geiger R, Griesmacher A, Kiechl S, Knoflach M, Kiechl-Kohlendorfer U; Early Vascular Aging (EVA) Study Group. The Tyrolean early vascular ageing-study (EVA-Tyrol): study protocol for a non-randomized controlled trial : Effect of a cardiovascular health promotion program in youth, a prospective cohort study. BMC Cardiovasc Disord. 2020 Feb 5;20(1):59. doi: 10.1186/s12872-020-01357-9.

    PubMed 32024473

Questions about this trial

What is this clinical trial studying?

A study testing Multi-layer health promotion program and Standard health education in people with Atherosclerosis and Life Style, run by Medical University Innsbruck at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of health promotion. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03929692, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.

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