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

NCT05741827 | Completed

• 1 other identifier: nC_FNA-0029_004
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Atherosclerosis

Keywords

Cardiovascular Risk Factors; Prevention; Diet; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Efficacy of health promotion intervention

  The efficacy of the health promotion intervention to improve cardiovascular health in 14- to 17 year-olds and at least one legal guardian measured by means of change of the "2022 cardiovascular health metrics score (0-100 points)" for the components of diet and physical activity from baseline to follow-up of the intervention group using a participative approach compared to a control-group.

  Baseline visit until follow-up visit (at 12 +/- 2 months)

Secondary Outcomes (24)

• Health promotion intervention

  Baseline visit until follow-up visit (at 12 +/- 2 months)

• Health literacy

  Baseline visit until follow-up visit (at 12 +/- 2 months)

• Pulse-wave velocity change

  Baseline visit until follow-up visit (at 12 +/- 2 months)

• Intima-media thickness change

  Baseline visit until follow-up visit (at 12 +/- 2 months)

• Liver fat content change

  Baseline visit until follow-up visit (at 12 +/- 2 months)

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Behavioral: Lifestyle intervention

Control group

NO INTERVENTION

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

Interventions

Lifestyle intervention BEHAVIORAL

Lifestyle intervention focusing on diet and physical activity

Interventional group

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VASCage GmbH: lead

Study Sites (1)

Department for Neurology, Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Officials

• Michael Knoflach, Assoc.-Prof.

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: February 23, 2023
• Study Start: February 9, 2023
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: May 15, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)