Clinical trial NCT05741827: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Atherosclerosis
Keywords: Cardiovascular Risk Factors
Prevention
Diet
Physical Activity
Lead sponsor: VASCage GmbH
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 171
Sex: ALL
Minimum age (years): 14
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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

Primary outcomes:
measure: Efficacy of health promotion intervention
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Secondary outcomes:
measure: Health promotion intervention
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Health literacy
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Pulse-wave velocity change
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Intima-media thickness change
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Liver fat content change
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Blood pressue change
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Body-/fat composition change
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Visceral fat thickness change
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Physical activity change
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Risk profile - e.g. blood lipids
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Risk profile - e.g. Blood sugar
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Risk profile - Healthy diet
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Risk profile - Smoking
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Cardiovascular risk factor description - hypertension
timeFrame: Baseline visit until follow-up visit (at 12 +/- 2 months)
measure: Cardiovascular risk factor description - obesity
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Cardiovascular risk factor description - dislipidemia
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Cardiovascular risk factor description - diabetes
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Lifestyle factor description - unhealthy diet
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Lifestyle factor description - sedentary lifestyle
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Lifestyle factor description - smoking
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: High-risk population exploration
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Time trends
timeFrame: Baseline visit until follow-up visit (at 12+/- 2 months)
measure: Long-term Intervention - CVD events
timeFrame: Every 2-5 years, on average for the duration of 50 years
measure: Long-term Intervention - any deaths
timeFrame: Every 2-5 years, on average for the duration of 50 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department for Neurology, Medical University of Innsbruck
state: Tirol
Study officials:
affiliation: Medical University of Innsbruck
name: Michael Knoflach, Assoc.-Prof.
role: PRINCIPAL_INVESTIGATOR
References: