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

Benoît Bernar, Nina Gande, Katharina A Stock, Anna Staudt, Raimund Pechlaner, Ralf Geiger, Andrea Griesmacher, Stefan Kiechl, Michael Knoflach, Ursula Kiechl-Kohlendorfer, Early Vascular Aging (EVA) Study Group, Mandy Asare, Manuela Bock-Bartl, Maximilian Bohl, Christina Burger, Gregor Brössner, Tatjana Heisinger, Christoph Hochmayr, Julia Klingenschmid, Martina Kothmayer, Julia Marxer, Raimund Pechlaner, Maximilian Pircher, Carmen Reiter, Sophia J Kiechl, Bernhard Winder, Benoît Bernar, Nina Gande, Katharina A Stock, Anna Staudt, Raimund Pechlaner, Ralf Geiger, Andrea Griesmacher, Stefan Kiechl, Michael Knoflach, Ursula Kiechl-Kohlendorfer, Early Vascular Aging (EVA) Study Group, Mandy Asare, Manuela Bock-Bartl, Maximilian Bohl, Christina Burger, Gregor Brössner, Tatjana Heisinger, Christoph Hochmayr, Julia Klingenschmid, Martina Kothmayer, Julia Marxer, Raimund Pechlaner, Maximilian Pircher, Carmen Reiter, Sophia J Kiechl, Bernhard Winder

Abstract

Background: According to the World Health Organization, cardiovascular diseases (CVDs) are the leading non-communicable cause of death. Awareness of the individual risk profile is crucial to implement a healthy lifestyle and prevent CVDs. Multiple studies demonstrated that atherosclerosis, the main cause of CVDs, begins early in life. Therefore, it may be necessary to start prevention programs already in childhood.

Methods: The EVA-Tyrol study is a population-based non-randomized controlled trial that will prospectively enroll 2000 participants from high schools and training companies in North- and East-Tyrol (Austria) and South-Tyrol (Italy). Participants will be assigned to either an intervention (n = 1500) or a control (n = 500) group. Intervention group participants will be enrolled at the 10th school grade (mean age 15-16 years), undergo two examinations within a two-year interval, with follow-up at the 12th grade (mean ages 17-18 years). Control group participants will be enrolled at the 12th grade (mean age 17-18 years). Medical examination will include anthropometric measurements, comprehensive lifestyle and dietary questionnaires, a fasting blood sample, high-resolution ultrasound of the carotid arteries, and measurement of 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) an online health promotion tool and (4) involvement of participants in planning and implementation of health promotion projects. Effectiveness of the intervention will be assessed by comparing the proportion subjects with ideal health metrics as defined by the American Heart Association between study groups.

Discussion: This study aims to improve cardiovascular health in Tyrolean adolescents by demonstrating the efficacy of a multi-layer health promotion program and may yield novel insights into the prevalence of vascular risk conditions and mechanisms of early vascular pathologies in adolescents.

Trial registration: EVA-Tyrol has been retrospectively registered at clinicaltrials.gov under NCT03929692 since April 29, 2019.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schematic illustration of study design
Fig. 2
Fig. 2
SPIRIT diagram: Timeframe of EVA-Tyrol

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Source: PubMed

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