YOUhealTH - a Study to Improve Cardiovascular Health in Adolescents and Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- VASCage GmbH
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Efficacy of health promotion intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Efficacy of health promotion intervention
时间窗: 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.
次要结局
- Intima-media thickness change(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Risk profile - e.g. blood lipids(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Risk profile - Healthy diet(Baseline visit until follow-up visit (at 12+/- 2 months))
- Risk profile - Smoking(Baseline visit until follow-up visit (at 12+/- 2 months))
- Cardiovascular risk factor description - hypertension(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Lifestyle factor description - unhealthy diet(Baseline visit until follow-up visit (at 12+/- 2 months))
- Health literacy(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Pulse-wave velocity change(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Visceral fat thickness change(Baseline visit until follow-up visit (at 12+/- 2 months))
- Physical activity change(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Cardiovascular risk factor description - diabetes(Baseline visit until follow-up visit (at 12+/- 2 months))
- Lifestyle factor description - sedentary lifestyle(Baseline visit until follow-up visit (at 12+/- 2 months))
- Health promotion intervention(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Risk profile - e.g. Blood sugar(Baseline visit until follow-up visit (at 12+/- 2 months))
- Cardiovascular risk factor description - obesity(Baseline visit until follow-up visit (at 12+/- 2 months))
- Long-term Intervention - any deaths(Every 2-5 years, on average for the duration of 50 years)
- Liver fat content change(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Lifestyle factor description - smoking(Baseline visit until follow-up visit (at 12+/- 2 months))
- Blood pressue change(Baseline visit until follow-up visit (at 12 +/- 2 months))
- Body-/fat composition change(Baseline visit until follow-up visit (at 12+/- 2 months))
- Cardiovascular risk factor description - dislipidemia(Baseline visit until follow-up visit (at 12+/- 2 months))
- High-risk population exploration(Baseline visit until follow-up visit (at 12+/- 2 months))
- Long-term Intervention - CVD events(Every 2-5 years, on average for the duration of 50 years)
- Time trends(Baseline visit until follow-up visit (at 12+/- 2 months))