Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
Study NCT ID:
NCT03929692
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2019-04-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-04-26', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of health promotion.', 'timeFrame': '2 years', 'description': "Difference in the number of AHA's seven health goals in the ideal range between the intervention and the control Group."}], 'secondaryOutcomes': [{'measure': 'Change in vascular health.', 'timeFrame': '2 years', '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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atherosclerosis', 'Life Style']}, 'referencesModule': {'references': [{'pmid': '39981205', 'type': 'DERIVED', 'citation': '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': '37528337', 'type': 'DERIVED', 'citation': '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': '37488472', 'type': 'DERIVED', 'citation': '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': '35331020', 'type': 'DERIVED', 'citation': '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': '35042472', 'type': 'DERIVED', '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.'}, {'pmid': '34482715', 'type': 'DERIVED', '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.'}, {'pmid': '33558093', 'type': 'DERIVED', '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.'}, {'pmid': '32024473', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intervention group: Participants must be in 10th school grade or aged 15 to 16 years when recruited in training companies.\n* Control Group: Participants must be in 12th school grade or aged 17 to 18 years when recruited in training companies.\n\nExclusion Criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT03929692', 'acronym': 'EVA-Tyrol', 'briefTitle': 'Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Effect of a Cardiovascular Health Promotion Program in Youth - The Tyrolean Early Vascular Ageing-study', 'orgStudyIdInfo': {'id': 'EVA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention Group', '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.', 'interventionNames': ['Behavioral: Multi-layer health promotion program', 'Other: Standard health education']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Adolescents of same age as intervention group at follow-up examination that did not participate in health promotion program.', 'interventionNames': ['Other: Standard health education']}], 'interventions': [{'name': 'Multi-layer health promotion program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention Group']}, {'name': 'Standard health education', 'type': 'OTHER', 'armGroupLabels': ['Control Group', 'Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Department of Pediatrics II (Neonatology), Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '39031', 'city': 'Bruneck', 'state': 'Trentino-Alto Adige', 'country': 'Italy', 'facility': 'Department of Pediatrics, Bruneck Hospital', 'geoPoint': {'lat': 46.79942, 'lon': 11.93429}}], 'overallOfficials': [{'name': 'Ursula Kiechl-Kohlendorfer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck'}, {'name': 'Michael Knoflach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymized data can be shared in academic cooperations. Request for data can be addressed to the principal investigators with an appropriate research question.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tiroler Landeskrankenanstalten GmbH (TILAK)', 'class': 'UNKNOWN'}, {'name': 'Tiroler Gebietskrankenkasse (TGKK)', 'class': 'UNKNOWN'}, {'name': 'InfPro IT Solutions GmbH', 'class': 'UNKNOWN'}, {'name': 'Genossenschaft Milchhof Sterzing (Dairy Farm Sterzing)', 'class': 'UNKNOWN'}, {'name': 'Austrian Research Promotion Agency FFG (K Project)', 'class': 'UNKNOWN'}, {'name': 'Public Health Service of South Tyrol, Italy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}