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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741827
• Other study ID #: nC_FNA-0029_004
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: VASCage GmbH
• Contact: Sophia Kiechl, MD
• Phone: +43 512 504 87808
• Email: sophia.kiechl[@]vascage.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases

Intervention

Behavioral:
• Lifestyle intervention
Lifestyle intervention focusing on diet and physical activity

Locations

Country	Name	City	State
Austria	Department for Neurology, Medical University of Innsbruck	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
VASCage GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	Health literacy	The effect of the health intervention on health literacy (measured by means of a CVD (HELMA; score) and stroke knowledge questionnaire (%)).	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	Pulse-wave velocity change	The effect of the health intervention on pulse-wave velocity (m/s)	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	Intima-media thickness change	The effect of the health intervention on intima-media thickness (µm).	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	Liver fat content change	The effect of the health intervention on liver fat content (dB/m).	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	Blood pressue change	The effect of the health intervention on blood pressure (mmHg).	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	Body-/fat composition change	The effect of the health intervention on body-/fat composition (%)	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	Visceral fat thickness change	The effect of the health intervention on abdominal visceral fat thickness (mm).	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	Physical activity change	The effect of the health intervention on the average minutes of moderate to vigorous physical activity per day (min/day).	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	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).	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	Risk profile - e.g. Blood sugar	Risk profiles (e.g. blood sugar (HbA1c (%)) of adolescents will be compared to their legal guardian(s).	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	Risk profile - Healthy diet	Risk profiles (healty diet (MEPA score;%)) of adolescents will be compared to their legal guardian(s).	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	Risk profile - Smoking	Risk profiles (smoking (questionnaire, score) of adolescents will be compared to their legal guardian(s).	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Baseline visit until follow-up visit (at 12+/- 2 months)
Secondary	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.	Every 2-5 years, on average for the duration of 50 years
Secondary	Long-term Intervention - any deaths	Evaluation of predictors for later mortality in adolescents and their legal guardian by record linkage to death registry.	Every 2-5 years, on average for the duration of 50 years