Assessment of Vascular Health Risk FactorsINNHEALTHNCT06813677
Innsbruck Health Promotion Program
A study testing In-person health promotion in people with Assessment of Vascular Health Risk Factors, run by VASCage GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assessment of Vascular Health Risk Factors
- What is being tested?
- In-person health promotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent of subject
- Main area of residence in Innsbruck and Innsbruck-Land
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck - Department of Neurology
Innsbruck
Lukas Mayer-Süß, Dr.med., +43 512 504 83127, lukas.mayer@i-med.ac.at
Lukas Mayer-Süß, Dr.med.
About this study
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
Read the 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
- Being tested
- In-person health promotion
- Keywords
- Life's Essential 8, PBMC, Cardiovascular health, Quality of Life, Mitochondrial function, Hearing impairment
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person health promotionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: In-person health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-baseline examination (day 0)
Secondary outcomes (11)
Changes in individual components of Life's Essential 8 - Diet
Assessment of change in diet using the Food Frequency Questionnaire
Measured: 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
Assessment of change in diet using the Mediterranean Eating Pattern for Americans (MEPA) Score. Score minimum 0, score maximum 100. A higher score indicates a diet closely aligned with the mediterranean eating pattern.
Measured: 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
Assessment of change in physical activity with focus on amount and intensity of physical activity
Measured: 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
Assessment of change in smoking status
Measured: 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
Assessment of change in body weight (body mass index, kg)
Measured: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Changes in individual components of Life's Essential 8 - Blood lipids
Assessment of change in blood lipid levels: triglyceride (mmol/L), cholesterol (all, mmol/L)
Measured: 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 - Body glucose
Assessment of change in blood glucose levels: fasting glucose (mg/dL, mmol/L)
Measured: 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 - Blood glucose
Assessment of changes in blood glucose levels: HbA1c (%)
Measured: 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 - Blood pressure
Assessment of change in blood pressure (systolic/diastolic, mmHg)
Measured: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Changes in individual components of Life's Essential 8 - Sleep
Assessment of change in sleep quality using the Pittsburgh Sleep Quality Index
Measured: 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 - Sleep
Assessment of change in sleep habits
Measured: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 May 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Vascular Health Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VASCage GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Oroboros Instruments, Med-El Corporation, Tirol Kiniken GmbH, Österreichische Gesundheitskasse
- Responsible party
- Sponsor
- Investigators
- Dr.med. Lukas Mayer-Süß, PhD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813677
- Sponsor's protocol ID
- C_2_A.2-0062_012
- Acronym
- INNHEALTH
- Status last verified
- Nov 2025
- First submitted
- 13 Jan 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innsbruck Health Promotion Program
- ClinicalTrials.gov ID
- NCT06813677
- Acronym / sponsor ID
- INNHEALTH / C_2_A.2-0062_012
- Keywords
- Life's Essential 8, PBMC, Cardiovascular health, Quality of Life, Mitochondrial function, Hearing impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- VASCage GmbHUniversity, hospital or other
- Collaborators
- Oroboros Instruments, Med-El Corporation, Tirol Kiniken GmbH, Österreichische Gesundheitskasse
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health promotion arm | Experimental | Other: In-person health promotionOver 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent of subject
- Main area of residence in Innsbruck and Innsbruck-Land
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person health promotionThe 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. | Other | Health promotion arm |
Primary outcome
Life's Essential 8 overall cardiovascular health
Time frame: Pre-baseline examination (day 0)
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.
11 secondary outcomes
Changes in individual components of Life's Essential 8 - Diet
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Changes in individual components of Life's Essential 8 - Blood lipids
Time frame: 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 - Body glucose
Time frame: 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 - Blood glucose
Time frame: 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 - Blood pressure
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Changes in individual components of Life's Essential 8 - Sleep
Time frame: 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 - Sleep
Time frame: At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
Related trials for Assessment of Vascular Health Risk Factors
Recruiting
A Novel Digital Tool Clinicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
Hypertension, Dyslipidemia
Active, not recruiting
Enhancing Mental and Physical Health of Women Veterans
Cardiovascular Diseases, Overweight
Active, not recruitingObservational study
MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway
Stroke, Cardiovascular Diseases
Recruiting
Impact of Behavioural Modification Working Toolkit Among Women With Gestational Diabetes Mellitus and Hypertension
Gestational Diabetes Mellitus in Pregnancy, Hypertension ,Pregnancy
Not yet recruitingObservational study
Community Blood Pressure Screening and Cardiovascular Risk Assessment in Croatia
Hypertension, Cardiovascular Risk Factors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr.med. Lukas Mayer-Süß, PhD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person health promotion in people with Assessment of Vascular Health Risk Factors, run by VASCage GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muriel Harloff, MSc (+ 43 51255443513, muriel.harloff@vascage.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life's Essential 8 overall cardiovascular health (time frame: Pre-baseline examination (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.