Innsbruck Health Promotion Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVASCage GmbH
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed informed consent of subject
Main area of residence in Innsbruck and Innsbruck-Land
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
In-person health promotion
Other interventionThe 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Health promotion armExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Pre-baseline examination (day 0)Secondary outcomes
1
Changes in individual components of Life's Essential 8 - Diet
Assessment of change in diet using the Food Frequency Questionnaire
Time frame
At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline)2
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.
Time frame
At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)3
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
Time frame
At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)4
Changes in individual components of Life's Essential 8 - Nicotine Exposure
Assessment of change in smoking status
Time frame
At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VASCage GmbH
Lead sponsor
Oroboros Instruments
Collaborator
Med-El Corporation
Collaborator
Tirol Kiniken GmbH
Collaborator
Österreichische Gesundheitskasse
Collaborator
Source ClinicalTrials.gov