Cardiovascular DiseasesNCT05741827
YOUhealTH - a Study to Improve Cardiovascular Health in Adolescents and Adults
A study testing Lifestyle intervention in people with Cardiovascular Diseases and Atherosclerosis, run by VASCage GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerosis
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteAustria
- Study dates
- 9 Feb 2023to 11 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department for Neurology, Medical University of Innsbruck
Innsbruck, Tyrol, 6020
About this study
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.
Read more
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.
Read the detailed description
YOUhealTH is a single-center prospective randomized controlled parallel 2-arm intervention study with the aim 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 lifestyle intervention is designed using a participative approach of adolescents who are part of the study team and design the intervention. This intervention is applied to students aged 14- to 17-years and at least one legal guardian for the duration of one year. At the beginning and the end of the intervention, an examination including a blood draw, a structured medical interview, anthropometrics including blood pressure measurement, ultrasonography of the aorta and the carotid artery, pulse-wave velocity and bioelectrical impedance measurement as well as FibroScan (a liver fat and elasticity measurement) is conducted and the effects of the intervention are evaluated compared to the control group receiving no intervention. Students and their legal guardians are randomized to the intervention or control group in a school-wise manner and in a 4:3 ratio.
The primary objective is to determine the effect of the health intervention with regards to the change of the health metric components diet and physical activity of the Life's Essential Eight score of the American Heart Association. Further study objectives are to evaluate 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 long-term follow-up by means of record linkage is planned and a biobank will be collected.
- Conditions
- Cardiovascular Diseases, Atherosclerosis
- Being tested
- Lifestyle intervention
- Keywords
- Cardiovascular Risk Factors, Prevention, Diet, Physical Activity
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Lifestyle intervention focusing on diet and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Lifestyle intervention with focus on increased physical activity and healthy diet. Receives: Behavioral: Lifestyle intervention |
| Control group | No intervention | No lifestyle intervention. No change in physical activity or diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary outcomes (24)
Health promotion intervention
The effect of the health promotion intervention on both the change and the absolute values of the "2022 cardiovascular health metrics score (0-100 points)" and its components in the whole study group and in adolescents and adults separately.
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Health literacy
The effect of the health intervention on health literacy (measured by means of a CVD (HELMA; score) and stroke knowledge questionnaire (%)).
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Pulse-wave velocity change
The effect of the health intervention on pulse-wave velocity (m/s)
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Intima-media thickness change
The effect of the health intervention on intima-media thickness (µm).
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Liver fat content change
The effect of the health intervention on liver fat content (dB/m).
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Blood pressue change
The effect of the health intervention on blood pressure (mmHg).
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Body-/fat composition change
The effect of the health intervention on body-/fat composition (%)
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Visceral fat thickness change
The effect of the health intervention on abdominal visceral fat thickness (mm).
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Physical activity change
The effect of the health intervention on the average minutes of moderate to vigorous physical activity per day (min/day).
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Risk profile - e.g. blood lipids
Risk profiles (e.g. blood lipids such as LDL-C (mg/dl)) of adolescents will be compared to their legal guardian(s).
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Risk profile - e.g. Blood sugar
Risk profiles (e.g. blood sugar (HbA1c (%)) of adolescents will be compared to their legal guardian(s).
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Risk profile - Healthy diet
Risk profiles (healty diet (MEPA score;%)) of adolescents will be compared to their legal guardian(s).
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Risk profile - Smoking
Risk profiles (smoking (questionnaire, score) of adolescents will be compared to their legal guardian(s).
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - hypertension
The prevalence of traditional cardiovascular risk factors such as hypertension (mmHg) in the Tyrolean youth and their legal guardians will be described.
Measured: Baseline visit until follow-up visit (at 12 +/- 2 months)
Cardiovascular risk factor description - obesity
The prevalence of traditional cardiovascular risk factors such as obesity (e.g.BMI (kg/m^2)) in the Tyrolean youth and their legal guardians will be described.
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - dislipidemia
The prevalence of traditional cardiovascular risk factors such as dyslipidemia (e.g. LDL-C (mg/dl)) in the Tyrolean youth and their legal guardians will be described.
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - diabetes
The prevalence of traditional cardiovascular risk factors such as diabetes (HbA1c (%)) in the Tyrolean youth and their legal guardians will be described.
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - unhealthy diet
The prevalence of lifestyle factors such as unhealthy diet (MEPA-score; %) in the Tyrolean youth and their legal guardians will be described.
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - sedentary lifestyle
The prevalence of lifestyle factors such as sedentary lifestyle (Physical activity component of of Life's Essential 8 assessment; %) in the Tyrolean youth and their legal guardians will be described.
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - smoking
The prevalence of lifestyle factors such as smoking (YES/NO, cigarettes per day) in the Tyrolean youth and their legal guardians will be described.
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
High-risk population exploration
High-risk populations (Life's essential 8 score; %) based on school type, age, sex and region of residence will be explored.
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Time trends
Time trends in risk-profiles will be evaluated by comparison to the data from the "Early vascular Ageing" and the "Early Vascular Ageing in YOUth" study.
Measured: Baseline visit until follow-up visit (at 12+/- 2 months)
Long-term Intervention - CVD events
Evaluation of predictors for later cardio- and cerebrovascular disease (events or deaths) in adolescents and their legal guardian by record linkage to electronic health record.
Measured: Every 2-5 years, on average for the duration of 50 years
Long-term Intervention - any deaths
Evaluation of predictors for later mortality in adolescents and their legal guardian by record linkage to death registry.
Measured: Every 2-5 years, on average for the duration of 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start9 Feb 2023
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- VASCage GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Knoflach, Assoc.-Prof., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741827
- Sponsor's protocol ID
- nC_FNA-0029_004
- Status last verified
- Jul 2024
- First submitted
- 22 Dec 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YOUhealTH - a Study to Improve Cardiovascular Health in Adolescents and Adults
- ClinicalTrials.gov ID
- NCT05741827
- Acronym / sponsor ID
- nC_FNA-0029_004
- Conditions
- Cardiovascular Diseases, Atherosclerosis
- Keywords
- Cardiovascular Risk Factors, Prevention, Diet, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- VASCage GmbHUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 23 Feb 2023 (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 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.
Detailed description
YOUhealTH is a single-center prospective randomized controlled parallel 2-arm intervention study with the aim 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 lifestyle intervention is designed using a participative approach of adolescents who are part of the study team and design the intervention. This intervention is applied to students aged 14- to 17-years and at least one legal guardian for the duration of one year. At the beginning and the end of the intervention, an examination including a blood draw, a structured medical interview, anthropometrics including blood pressure measurement, ultrasonography of the aorta and the carotid artery, pulse-wave velocity and bioelectrical impedance measurement as well as FibroScan (a liver fat and elasticity measurement) is conducted and the effects of the intervention are evaluated compared to the control group receiving no intervention. Students and their legal guardians are randomized to the intervention or control group in a school-wise manner and in a 4:3 ratio.
The primary objective is to determine the effect of the health intervention with regards to the change of the health metric components diet and physical activity of the Life's Essential Eight score of the American Heart Association. Further study objectives are to evaluate 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 long-term follow-up by means of record linkage is planned and a biobank will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: Lifestyle interventionLifestyle intervention with focus on increased physical activity and healthy diet. |
| Control group | No intervention | –No lifestyle intervention. No change in physical activity or diet. |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Lifestyle interventionLifestyle intervention focusing on diet and physical activity | Behavioural | Interventional group |
Primary outcome
Efficacy of health promotion intervention
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
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.
24 secondary outcomes
Health promotion intervention
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Health literacy
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Pulse-wave velocity change
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Intima-media thickness change
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Liver fat content change
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Blood pressue change
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Body-/fat composition change
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Visceral fat thickness change
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Physical activity change
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Risk profile - e.g. blood lipids
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Risk profile - e.g. Blood sugar
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Risk profile - Healthy diet
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Risk profile - Smoking
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - hypertension
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Cardiovascular risk factor description - obesity
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - dislipidemia
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - diabetes
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - unhealthy diet
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - sedentary lifestyle
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - smoking
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
High-risk population exploration
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Time trends
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Long-term Intervention - CVD events
Time frame: Every 2-5 years, on average for the duration of 50 years
Long-term Intervention - any deaths
Time frame: Every 2-5 years, on average for the duration of 50 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael Knoflach, Assoc.-Prof. 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 Lifestyle intervention in people with Cardiovascular Diseases and Atherosclerosis, 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 4 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: finished, as of the sponsor's last update on 15 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of health promotion intervention (time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)). 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 15 May 2025.