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

Primary Purpose

Cardiovascular Diseases, Atherosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
VASCage GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Cardiovascular Risk Factors, Prevention, Diet, Physical Activity

Eligibility Criteria

14 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department for Neurology, Medical University of InnsbruckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional group

Control group

Arm Description

Lifestyle intervention with focus on increased physical activity and healthy diet.

No lifestyle intervention. No change in physical activity or diet.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Health literacy
The effect of the health intervention on health literacy (measured by means of a CVD (HELMA; score) and stroke knowledge questionnaire (%)).
Pulse-wave velocity change
The effect of the health intervention on pulse-wave velocity (m/s)
Intima-media thickness change
The effect of the health intervention on intima-media thickness (µm).
Liver fat content change
The effect of the health intervention on liver fat content (dB/m).
Blood pressue change
The effect of the health intervention on blood pressure (mmHg).
Body-/fat composition change
The effect of the health intervention on body-/fat composition (%)
Visceral fat thickness change
The effect of the health intervention on abdominal visceral fat thickness (mm).
Physical activity change
The effect of the health intervention on the average minutes of moderate to vigorous physical activity per day (min/day).
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).
Risk profile - e.g. Blood sugar
Risk profiles (e.g. blood sugar (HbA1c (%)) of adolescents will be compared to their legal guardian(s).
Risk profile - Healthy diet
Risk profiles (healty diet (MEPA score;%)) of adolescents will be compared to their legal guardian(s).
Risk profile - Smoking
Risk profiles (smoking (questionnaire, score) of adolescents will be compared to their legal guardian(s).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Long-term Intervention - any deaths
Evaluation of predictors for later mortality in adolescents and their legal guardian by record linkage to death registry.

Full Information

First Posted
December 22, 2022
Last Updated
August 11, 2023
Sponsor
VASCage GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05741827
Brief Title
YOUhealTH - a Study to Improve Cardiovascular Health in Adolescents and Adults
Official Title
YOUhealTH - a Study to Improve Cardiovascular Health in Adolescents and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VASCage GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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 2:1 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Atherosclerosis
Keywords
Cardiovascular Risk Factors, Prevention, Diet, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Lifestyle intervention with focus on increased physical activity and healthy diet.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No lifestyle intervention. No change in physical activity or diet.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
Lifestyle intervention focusing on diet and physical activity
Primary Outcome Measure Information:
Title
Efficacy of health promotion intervention
Description
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.
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary Outcome Measure Information:
Title
Health promotion intervention
Description
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.
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Health literacy
Description
The effect of the health intervention on health literacy (measured by means of a CVD (HELMA; score) and stroke knowledge questionnaire (%)).
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Pulse-wave velocity change
Description
The effect of the health intervention on pulse-wave velocity (m/s)
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Intima-media thickness change
Description
The effect of the health intervention on intima-media thickness (µm).
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Liver fat content change
Description
The effect of the health intervention on liver fat content (dB/m).
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Blood pressue change
Description
The effect of the health intervention on blood pressure (mmHg).
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Body-/fat composition change
Description
The effect of the health intervention on body-/fat composition (%)
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Visceral fat thickness change
Description
The effect of the health intervention on abdominal visceral fat thickness (mm).
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Physical activity change
Description
The effect of the health intervention on the average minutes of moderate to vigorous physical activity per day (min/day).
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Risk profile - e.g. blood lipids
Description
Risk profiles (e.g. blood lipids such as LDL-C (mg/dl)) of adolescents will be compared to their legal guardian(s).
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Risk profile - e.g. Blood sugar
Description
Risk profiles (e.g. blood sugar (HbA1c (%)) of adolescents will be compared to their legal guardian(s).
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Risk profile - Healthy diet
Description
Risk profiles (healty diet (MEPA score;%)) of adolescents will be compared to their legal guardian(s).
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Risk profile - Smoking
Description
Risk profiles (smoking (questionnaire, score) of adolescents will be compared to their legal guardian(s).
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Cardiovascular risk factor description - hypertension
Description
The prevalence of traditional cardiovascular risk factors such as hypertension (mmHg) in the Tyrolean youth and their legal guardians will be described.
Time Frame
Baseline visit until follow-up visit (at 12 +/- 2 months)
Title
Cardiovascular risk factor description - obesity
Description
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.
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Cardiovascular risk factor description - dislipidemia
Description
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.
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Cardiovascular risk factor description - diabetes
Description
The prevalence of traditional cardiovascular risk factors such as diabetes (HbA1c (%)) in the Tyrolean youth and their legal guardians will be described.
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Lifestyle factor description - unhealthy diet
Description
The prevalence of lifestyle factors such as unhealthy diet (MEPA-score; %) in the Tyrolean youth and their legal guardians will be described.
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Lifestyle factor description - sedentary lifestyle
Description
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.
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Lifestyle factor description - smoking
Description
The prevalence of lifestyle factors such as smoking (YES/NO, cigarettes per day) in the Tyrolean youth and their legal guardians will be described.
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
High-risk population exploration
Description
High-risk populations (Life's essential 8 score; %) based on school type, age, sex and region of residence will be explored.
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Time trends
Description
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.
Time Frame
Baseline visit until follow-up visit (at 12+/- 2 months)
Title
Long-term Intervention - CVD events
Description
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.
Time Frame
Every 2-5 years, on average for the duration of 50 years
Title
Long-term Intervention - any deaths
Description
Evaluation of predictors for later mortality in adolescents and their legal guardian by record linkage to death registry.
Time Frame
Every 2-5 years, on average for the duration of 50 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia Kiechl, MD
Phone
+43 512 504 87808
Email
sophia.kiechl@vascage.at
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Daschil, PhD
Email
nina.daschil@vascage.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Knoflach, Assoc.-Prof.
Organizational Affiliation
Medical University of Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Neurology, Medical University of Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Knoflach, Assoc.-Prof.
First Name & Middle Initial & Last Name & Degree
Sophia Kiechl, Dr.
Email
sophia.kiechl@vascage.at

12. IPD Sharing Statement

Plan to Share IPD
No

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

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