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

NCT ID: NCT05741827

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2025-03-11

Brief 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.

Detailed Description

YOUhealTH is a single-center prospective randomized controlled parallel 2-arm intervention study with the aim 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 lifestyle intervention is designed using a participative approach of adolescents who are part of the study team and design the intervention. This intervention is applied to students aged 14- to 17-years and at least one legal guardian for the duration of one year. At the beginning and the end of the intervention, an examination including a blood draw, a structured medical interview, anthropometrics including blood pressure measurement, ultrasonography of the aorta and the carotid artery, pulse-wave velocity and bioelectrical impedance measurement as well as FibroScan (a liver fat and elasticity measurement) is conducted and the effects of the intervention are evaluated compared to the control group receiving no intervention. Students and their legal guardians are randomized to the intervention or control group in a school-wise manner and in a 4:3 ratio.

The primary objective is to determine the effect of the health intervention with regards to the change of the health metric components diet and physical activity of the Life's Essential Eight score of the American Heart Association. Further study objectives are to evaluate 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 long-term follow-up by means of record linkage is planned and a biobank will be collected.

Conditions

Cardiovascular Diseases; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Interventional group

Lifestyle intervention with focus on increased physical activity and healthy diet.

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: BEHAVIORAL

Lifestyle intervention focusing on diet and physical activity

Control group

No lifestyle intervention. No change in physical activity or diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle intervention

Lifestyle intervention focusing on diet and physical activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adolescents at the age of 14 to 17 years and at least one legal guardian willing to participate
• Signed informed consent of subjects and legal guardian

Exclusion 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 judgment
• Persons who are currently engaged in military or community service
• Pregnancy of study participants

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VASCage GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Knoflach, Assoc.-Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Innsbruck

Locations

Department for Neurology, Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Countries

Austria

Other Identifiers

nC_FNA-0029_004

Identifier Type: -

Identifier Source: org_study_id