NCT03929692

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,102

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

3.8 years

First QC Date

April 24, 2019

Last Update Submit

April 26, 2019

Conditions

AtherosclerosisLife Style

Outcome Measures

Primary Outcomes (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.

    2 years

Secondary Outcomes (1)

  • Change in vascular health.

    2 years

Study Arms (2)

Intervention Group

OTHER

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 programOther: Standard health education

Control Group

OTHER

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

Other: Standard health education

Interventions

Multi-layer health promotion programBEHAVIORAL
Intervention Group
Standard health educationOTHER
Control GroupIntervention Group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Innsbruck, Tyrol, 6020, Austria

Location

Department of Pediatrics, Bruneck Hospital

Bruneck, Trentino-Alto Adige, 39031, Italy

Location

Related Publications (8)

  • 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.

    PMID: 39981205DERIVED

  • 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.

    PMID: 37528337DERIVED

  • 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.

    PMID: 37488472DERIVED

  • 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.

    PMID: 35331020DERIVED

  • Winder B, Kiechl SJ, 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.

    PMID: 35042472DERIVED

  • 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.

    PMID: 34482715DERIVED

  • 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.

    PMID: 33558093DERIVED

  • 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.

    PMID: 32024473DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ursula Kiechl-Kohlendorfer, MD

    Medical University of Innsbruck

    PRINCIPAL INVESTIGATOR

  • Michael Knoflach, MD

    Medical University of Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

May 1, 2015

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

April 29, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Anonymized data can be shared in academic cooperations. Request for data can be addressed to the principal investigators with an appropriate research question.

Locations

AU(1)IT(1)