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Completed

NCT Number: NCT05741827

YOUhealTH - a Study to Improve Cardiovascular Health in Adolescents and Adults

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.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Motor Activity Vascular Diseases

Age range

14 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Neurology, Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lifestyle Intervention

Behavioral

Lifestyle intervention focusing on diet and physical activity

Primary outcomes

  1. 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.

Secondary outcomes

  1. Health promotion intervention

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    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.

  2. Health literacy

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    The effect of the health intervention on health literacy (measured by means of a CVD (HELMA; score) and stroke knowledge questionnaire (%)).

  3. Pulse-wave velocity change

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    The effect of the health intervention on pulse-wave velocity (m/s)

  4. Intima-media thickness change

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    The effect of the health intervention on intima-media thickness (µm).

  5. Liver fat content change

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    The effect of the health intervention on liver fat content (dB/m).

  6. Blood pressue change

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    The effect of the health intervention on blood pressure (mmHg).

  7. Body-/fat composition change

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    The effect of the health intervention on body-/fat composition (%)

  8. Visceral fat thickness change

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    The effect of the health intervention on abdominal visceral fat thickness (mm).

  9. Physical activity change

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    The effect of the health intervention on the average minutes of moderate to vigorous physical activity per day (min/day).

  10. Risk profile - e.g. blood lipids

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    Risk profiles (e.g. blood lipids such as LDL-C (mg/dl)) of adolescents will be compared to their legal guardian(s).

  11. Risk profile - e.g. Blood sugar

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    Risk profiles (e.g. blood sugar (HbA1c (%)) of adolescents will be compared to their legal guardian(s).

  12. Risk profile - Healthy diet

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    Risk profiles (healty diet (MEPA score;%)) of adolescents will be compared to their legal guardian(s).

  13. Risk profile - Smoking

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    Risk profiles (smoking (questionnaire, score) of adolescents will be compared to their legal guardian(s).

  14. Cardiovascular risk factor description - hypertension

    Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)

    The prevalence of traditional cardiovascular risk factors such as hypertension (mmHg) in the Tyrolean youth and their legal guardians will be described.

  15. Cardiovascular risk factor description - obesity

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    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.

  16. Cardiovascular risk factor description - dislipidemia

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    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.

  17. Cardiovascular risk factor description - diabetes

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    The prevalence of traditional cardiovascular risk factors such as diabetes (HbA1c (%)) in the Tyrolean youth and their legal guardians will be described.

  18. Lifestyle factor description - unhealthy diet

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    The prevalence of lifestyle factors such as unhealthy diet (MEPA-score; %) in the Tyrolean youth and their legal guardians will be described.

  19. Lifestyle factor description - sedentary lifestyle

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    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.

  20. Lifestyle factor description - smoking

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    The prevalence of lifestyle factors such as smoking (YES/NO, cigarettes per day) in the Tyrolean youth and their legal guardians will be described.

  21. High-risk population exploration

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    High-risk populations (Life's essential 8 score; %) based on school type, age, sex and region of residence will be explored.

  22. Time trends

    Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)

    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.

  23. Long-term Intervention - CVD events

    Time frame: Every 2-5 years, on average for the duration of 50 years

    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.

  24. Long-term Intervention - any deaths

    Time frame: Every 2-5 years, on average for the duration of 50 years

    Evaluation of predictors for later mortality in adolescents and their legal guardian by record linkage to death registry.

Sponsors and collaborators

Lead sponsor

VASCage GmbH

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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