Genes and Health Behavior: the Impact of Awareness of High Polygenic Risk for Cardiovascular Disease on Health Behavior Among Young Overweight Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,540
- 试验地点
- 2
- 主要终点
- Body mass index (BMI)
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact of awareness of high polygenic risk for CVD on health behavior among young overweight adults. We want to evaluate the impact of awareness of high polygenic risk for CVD on body mass index within 12 months, the impact of awareness of high polygenic risk for CVD on other health indicators (physical activity, systolic blood pressure, cholesterol and triglyceride levels, smoking, waist circumference, CVD risk score), and assess the cost-effectiveness of informing people about the high polygenic risk for CVD.
The trial will be conducted in a primary care setting, for which the high genetic-risk subjects will be invited to visit their family physician. In the course of the first visit, the family physician will assess the participant's health status and will counsel the participant on healthy choices for increasing their level of physical activity and losing weight. If necessary, the family physician will start treatment to lower the participant's blood pressure or cholesterol following current treatment guidelines. The participants in the intervention group will be informed of their high polygenic risk for CVD at the start of the study, while the control subjects at the end of the study. There will be three study visits at 6-month intervals. Between visits, the participants will receive reminders via a mobile health application to change their health behavior. At the end of the trial (month 12), the health indicators of the participants will be assessed and compared between the three trial groups. If a significant difference in BMI is found, it will presumably be related to the fact of learning of the high genetic risk, in which case the use of genetic data in primary prevention may be considered effective.
详细描述
Background
Cardiovascular disease (CVD) is the most prevalent cause of mortality. The risk of CVD can be reduced through effective prevention measures.
The risk of CVD can be assessed using genetic analysis. Large-scale international studies have shown that CVD is a polygenic disease. Based on the interaction of multiple single-nucleotide polymorphisms (SNPs) in individuals, a polygenic risk score (PRS) methodology has been developed for individual risk assessments.
Assessment of polygenic risk for CVD is not yet employed in clinical practice, as it is not clear whether awareness of high risk motivates health behavior to make healthier choices to prevent the related illness. Existing research results are contentious. For example, it is not clear whether informing smokers of their high genetic risk for cancer contributes to their quitting smoking or whether physical activity increases in individuals with a high PRS for diabetes after learning of their genetic risk. As the risk of disease in individuals with a high PRS can be reduced predominantly through healthy choices, knowledge of these issues is important for the inclusion of PRS in treatment guidelines.
Hypothesis
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 44 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index 25-29.99
- •High polygenic risk for cardiovascular disease confirmed
- •Willing and able to participate in the trial
- •Informed consent provided
排除标准
- •Diagnosis of ischemic heart disease (I20-25)
- •Diagnosis of stroke (I60-64, I69, G45)
- •Diagnosis of peripheral vascular occlusion (I65-66, I67.2, I70, I73.9)
- •Diagnosis of diabetes (E10-14)
结局指标
主要结局
Body mass index (BMI)
时间窗: 12 months
The difference in mean BMI between study groups. Weight and height will be combined to report BMI in kg/m2
次要结局
- Waist circumference(12 months)
- Smoking prevalence(12 months)
- Systolic blood pressure(12 months)
- Total Cholesterol(12 months)
- Physical activity(12 months)
- Cardiovascular diseases 10-year risk(12 months)
研究者
Mikk JÜRISSON
Associate Professor of Public Health
University of Tartu
