Innsbruck Health Promotion Program

NCT06813677 | Recruiting

• 1 other identifier: C_2_A.2-0062_012
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this single-centre. single-arm, unblinded, pre-post interventional study is to evaluate whether a one-time health assessment and intervention affects the overall vascular health evaluated through the Life's Essential 8 overall vascular health score. Secondary goals of this study are, among others:

• to describe incidence and prevalence of vascular risk-factors and behaviours
• to explore prevalence and associations of health and disease in the general population with special focus on cardiovascular risk, cardiovascular diseases, markers of vascular health, signs and (prodromal) symptoms of neurodegeneration as well as psychosocial factors
• to explore the prevalence of hearing disorders in the general population
• to collect voice and speech samples to identify novel biomarkers that correlate to vascular health and/or hearing status

Conditions

Assessment of Vascular Health Risk Factors

Keywords

Life's Essential 8; PBMC; Cardiovascular health; Quality of Life; Mitochondrial function; Hearing impairment

Outcome Measures

Primary Outcomes (1)

• Life's Essential 8 overall cardiovascular health

  Changes in Life's Essential 8 (LE8) overall cardiovascular health metric between baseline and follow-up examination. Scores are categorized as low (0-49), moderate (50-79), or high (80-100). A higher LE8 score indicates better cardiovascular health and is associated with a lower risk of cardiovascular diseases (CVD) and mortality.

  Pre-baseline examination (day 0)

Secondary Outcomes (11)

• Changes in individual components of Life's Essential 8 - Diet

  At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)

• Changes in individual components of Life's Essential 8 - Diet

  At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)

• Changes in individual components of Life's Essential 8 - Physical activity

  At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)

• Changes in individual components of Life's Essential 8 - Nicotine Exposure

  At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)

• Changes in individual components of Life's Essential 8 - Body weight

  At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)

Study Arms (1)

Health promotion arm

EXPERIMENTAL

Over a time period of 12 months participants will receive regular newsletters as part of the health promotion program, informing them about vascular health promotion opportunities in the region. At the end of the study participants are provided with tailored guidance on further optimizing their vascular health to reduce individual risks of stroke and heart attack.

Other: In-person health promotion

Interventions

In-person health promotion OTHER

The results from the initial pre-baseline examination are reviewed during the baseline visit to identify potential risk factors related to the Life's Essential 8 (LE8). Based on these findings, participants receive personalized recommendations to enhance their vascular health and information on local vascular health promotion resources. Additionally, participants receive bi-monthly motivational newsletters designed to support ongoing vascular health improvements.

Health promotion arm

Eligibility Criteria

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

You may qualify if:

• Signed informed consent of subject
• Main area of residence in Innsbruck and Innsbruck-Land

You may not qualify if:

• People who are suspended upon a court order or upon other legal processes or are accommodated according ot the Hospitalization Act, or for whom a custodian is appointed (or appointment is inititated)
• Persons with impaired power of judgement
• Persons who are currently engaged in military or community service

Sponsors & Collaborators

• VASCage GmbH: lead
• Oroboros Instruments: collaborator
• Med-El Corporation: collaborator
• Tirol Kiniken GmbH: collaborator
• Österreichische Gesundheitskasse: collaborator

Study Sites (1)

Medical University Innsbruck - Department of Neurology

Innsbruck, Austria

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr.med. Lukas Mayer-Süß, PhD

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muriel Harloff, MSc

CONTACT

+ 43 51255443513; muriel.harloff@vascage.at

Petr Simurda, MD

CONTACT

+ 43 51255443513; petr.simurda@vascage.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

AU (1)