Innsbruck Health Promotion Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- VASCage GmbH
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Life's Essential 8 overall cardiovascular health
研究概览
简要总结
The primary goal of this single-centre. single-arm, unblinded, pre-post interventional study is to evaluate whether a one-time health assessment and intervention affects the overall vascular health evaluated through the Life's Essential 8 overall vascular health score.
Secondary goals of this study are, among others:
- to describe incidence and prevalence of vascular risk-factors and behaviours
- to explore prevalence and associations of health and disease in the general population with special focus on cardiovascular risk, cardiovascular diseases, markers of vascular health, signs and (prodromal) symptoms of neurodegeneration as well as psychosocial factors
- to explore the prevalence of hearing disorders in the general population
- to collect voice and speech samples to identify novel biomarkers that correlate to vascular health and/or hearing status
详细描述
Cardio- and cerebrovascular diseases are the leading cause of death and disability globally, underscoring the need for primary prevention, especially given that 80% of stroke patients in Tyrol had untreated risk conditions prior to their stroke.
The American Heart Association (AHA) and the American Stroke Association (ASA) identify eight factors that have a fundamental influence on vascular health, collectively known as "Life's Essential 8" or "LE8." The LE8 includes blood pressure, blood sugar, LDL cholesterol, BMI (Body Mass Index), as well as physical activity, sleep, a balanced diet, and avoiding nicotine products.
The INN.HEALTH study aims to evaluate the impact of a single health examination with counseling, supplemented by bi-monthly motivational newsletters, on improving vascular health over one year among a large cohort of Tyrolean adults. For this purpose, 1000 participants (500 men, 500 women) from various age groups are recruited and comprehensively characterized in terms of their demographic information and clinical profiles.
During the initial baseline pre-examination (study visit 1), blood, urine and stool samples are collected, and selected participants receive an actigraphy device for monitoring activity patterns. Additionally, participants complete self-administered questionnaires about their lifestyle habits. Two weeks post pre-examination (baseline, study visit 2) physical assessments and cognitive and sensory tests are performed. Based on these results the participant's health status in relation to the LE8 factors is assessed and the reduction of identified risk factors is discussed in a counseling session. If certain findings require further clarification, participants are referred to a specialist for further evaluation and treatment.One year after the initial examinations, participants are scheduled for two additional appointments: the first one (study visit 3) is identical to the initial baseline pre-examination, the second one marks the final examination (study visit 4), and is identical to baseline.
Over the 12 months between study visits 2 and 3 participants receive regular newsletters as part of the health promotion program, informing them about vascular health promotion opportunities in the region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent of subject
- •Main area of residence in Innsbruck and Innsbruck-Land
排除标准
- •People who are suspended upon a court order or upon other legal processes or are accommodated according ot the Hospitalization Act, or for whom a custodian is appointed (or appointment is inititated)
- •Persons with impaired power of judgement
- •Persons who are currently engaged in military or community service
结局指标
主要结局
Life's Essential 8 overall cardiovascular health
时间窗: Pre-baseline examination (day 0)
Changes in Life's Essential 8 (LE8) overall cardiovascular health metric between baseline and follow-up examination. Scores are categorized as low (0-49), moderate (50-79), or high (80-100). A higher LE8 score indicates better cardiovascular health and is associated with a lower risk of cardiovascular diseases (CVD) and mortality.
次要结局
- Changes in individual components of Life's Essential 8 - Diet(At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination))
- Changes in individual components of Life's Essential 8 - Physical activity(At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination))
- Changes in individual components of Life's Essential 8 - Nicotine Exposure(At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination))
- Changes in individual components of Life's Essential 8 - Body weight(At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination))
- Changes in individual components of Life's Essential 8 - Blood lipids(At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline))
- Changes in individual components of Life's Essential 8 - Body glucose(At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline))
- Changes in individual components of Life's Essential 8 - Blood glucose(At pre-baseline examination (day 0) and at follow-up pre-examination (12 +/- 2 months after baseline))
- Changes in individual components of Life's Essential 8 - Blood pressure(At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination))
- Changes in individual components of Life's Essential 8 - Sleep(At baseline (day 14) and at follow-up (2 weeks after follow-up pre-examination))