Clinical trial NCT06813677: Innsbruck Health Promotion Program
Official title: Innsbruck Health Promotion Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Assessment of Vascular Health Risk Factors
Keywords: Life's Essential 8
PBMC
Cardiovascular health
Quality of Life
Mitochondrial function
Hearing impairment
Lead sponsor: VASCage GmbH
Sponsor class: OTHER
Collaborators: name: Oroboros Instruments
name: Med-El Corporation
name: Tirol Kiniken GmbH
name: Österreichische Gesundheitskasse
First posted: 2025-02-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

Detailed description: Cardio- and cerebrovascular diseases are the leading cause of death and disability globally, underscoring the need for primary prevention, especially given that 80% of stroke patients in Tyrol had untreated risk conditions prior to their stroke.

The American Heart Association (AHA) and the American Stroke Association (ASA) identify eight factors that have a fundamental influence on vascular health, collectively known as "Life's Essential 8" or "LE8." The LE8 includes blood pressure, blood sugar, LDL cholesterol, BMI (Body Mass Index), as well as physical activity, sleep, a balanced diet, and avoiding nicotine products.

The INN.HEALTH study aims to evaluate the impact of a single health examination with counseling, supplemented by bi-monthly motivational newsletters, on improving vascular health over one year among a large cohort of Tyrolean adults. For this purpose, 1000 participants (500 men, 500 women) from various age groups are recruited and comprehensively characterized in terms of their demographic information and clinical profiles.

During the initial baseline pre-examination (study visit 1), blood, urine and stool samples are collected, and selected participants receive an actigraphy device for monitoring activity patterns. Additionally, participants complete self-administered questionnaires about their lifestyle habits. Two weeks post pre-examination (baseline, study visit 2) physical assessments and cognitive and sensory tests are performed. Based on these results the participant's health status in relation to the LE8 factors is assessed and the reduction of identified risk factors is discussed in a counseling session. If certain findings require further clarification, participants are referred to a specialist for further evaluation and treatment.One year after the initial examinations, participants are scheduled for two additional appointments: the first one (study visit 3) is identical to the initial baseline pre-examination, the second one marks the final examination (study visit 4), and is identical to baseline.

Over the 12 months between study visits 2 and 3 participants receive regular newsletters as part of the health promotion program, informing them about vascular health promotion opportunities in the region.

In the final consultation at the end of the final examination visit, participants receive a comprehensive assessment of which aspects of their lifestyle have significantly changed over the past year. Participants are then provided with tailored guidance on further optimizing their vascular health to reduce individual risks of stroke and heart attack.

Secondary objectives of this study include analyzing changes in quality of life, medication compliance, healthcare usage, vascular and cognitive health, as well as identifying risk factors and early markers for neurodegenerative disease, with data collected and periodically reviewed long-term. The study also seeks to establish a regional cohort with a biobank for future research on vascular health, aging, and mitochondrial function, and to explore the feasibility of incorporating hearing screenings into routine health exams

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Life's Essential 8 overall cardiovascular health
timeFrame: Pre-baseline examination (day 0)
Secondary outcomes:
measure: Changes in individual components of Life's Essential 8 - Diet
timeFrame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
measure: Changes in individual components of Life's Essential 8 - Diet
timeFrame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
measure: Changes in individual components of Life's Essential 8 - Physical activity
timeFrame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
measure: Changes in individual components of Life's Essential 8 - Nicotine Exposure
timeFrame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
measure: Changes in individual components of Life's Essential 8 - Body weight
timeFrame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
measure: Changes in individual components of Life's Essential 8 - Blood lipids
timeFrame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
measure: Changes in individual components of Life's Essential 8 - Body glucose
timeFrame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
measure: Changes in individual components of Life's Essential 8 - Blood glucose
timeFrame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
measure: Changes in individual components of Life's Essential 8 - Blood pressure
timeFrame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
measure: Changes in individual components of Life's Essential 8 - Sleep
timeFrame: At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)
measure: Changes in individual components of Life's Essential 8 - Sleep
timeFrame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck - Department of Neurology
Study officials:
affiliation: Medical University of Innsbruck
name: Dr.med. Lukas Mayer-Süß, PhD
role: PRINCIPAL_INVESTIGATOR
References: