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NCT05741827
YOUhealTH - a Study to Improve Cardiovascular Health in Adolescents and Adults
Conditions: Cardiovascular Diseases, Atherosclerosis
Sex: All
Ages: 14 Years – 99 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 450
Sponsor: VASCage GmbH
Location: Austria
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.
Eligibility Criteria
Inclusion Criteria:Adolescents at the age of 14 to 17 years and at least one legal guardian willing to participateSigned informed consent of subjects and legal guardianExclusion Criteria:Persons, who are suspended upon a court order or upon other legal processes or are accommodated according to the Hospitalization Act, or for whom a custodian is appointed (or appointment is initiated).Persons with impaired power of judgmentPersons who are currently engaged in military or community servicePregnancy of study participants
Source: ClinicalTrials.gov (NCT05741827). StuddyBuddy aggregates publicly available trial information.