YOUhealTH - a Study to Improve Cardiovascular Health in Adolescents and Adults

NCT05741827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2025-05-15

No results posted yet for this study

Summary

The goal of this single-center prospective randomized controlled parallel 2-arm intervention study is to test a lifestyle intervention focusing on diet and physical activity in students and at least one legal guardian to improve cardiovascular risk factor profiles.

The primary objective of this study ist to evaluate the efficacy of a health promotion intervention (intervention group) over the course of a year using a participative approach compared to a control group in 14- to 17-year-olds and at least one legal guardian.

Further study objectives are to determine the effect of the health promotion intervention on the change of the score of the individual health metric components, on the absolute health metric score, on the change in intima-media thickness and pulse-wave velocity and cardiovascular health (such as blood pressure, non-HDL-cholesterol, BMI) as well as health literacy with regards to CVDs, especially stroke, in both age-groups.

Furthermore, a biobank will be collected.

Conditions

Interventions

BEHAVIORAL

Lifestyle intervention

Lifestyle intervention focusing on diet and physical activity

Sponsors & Collaborators

  • VASCage GmbH

    lead OTHER

Principal Investigators

  • Michael Knoflach, Assoc.-Prof. · Medical University of Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2025-03-11
Completion
2025-03-11

Countries

  • Austria

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05741827 on ClinicalTrials.gov