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

Primary Purpose

Atherosclerosis, Life Style

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Multi-layer health promotion program
Standard health education
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention Group

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 24, 2019
Last Updated
April 26, 2019
Sponsor
Medical University Innsbruck
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03929692
Brief Title
Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study
Acronym
EVA-Tyrol
Official Title
Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Life Style

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
2102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Other
Arm 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.
Arm Title
Control Group
Arm Type
Other
Arm Description
Adolescents of same age as intervention group at follow-up examination that did not participate in health promotion program.
Intervention Type
Behavioral
Intervention Name(s)
Multi-layer health promotion program
Intervention Type
Other
Intervention Name(s)
Standard health education
Primary Outcome Measure Information:
Title
Effect of health promotion.
Description
Difference in the number of AHA's seven health goals in the ideal range between the intervention and the control Group.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in vascular health.
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Kiechl-Kohlendorfer, MD
Organizational Affiliation
Medical University of Innsbruck
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Knoflach, MD
Organizational Affiliation
Medical University of Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics II (Neonatology), Medical University of Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Department of Pediatrics, Bruneck Hospital
City
Bruneck
State/Province
South Tyrol
ZIP/Postal Code
39031
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
35331020
Citation
Kaltseis K, Frank F, Bernar B, 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.
Results Reference
derived
PubMed Identifier
35042472
Citation
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.
Results Reference
derived
PubMed Identifier
34482715
Citation
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.
Results Reference
derived
PubMed Identifier
33558093
Citation
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.
Results Reference
derived
PubMed Identifier
32024473
Citation
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.
Results Reference
derived

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

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