Impact of Technology-based Intervention for Improving Self-management Behaviors in Black Adults; Sub-project of Biological and Socio-cultural Determinants and Management of Cardiovascular Health Factors in Multi-ethnic Populations
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Life Simple 7(LS7 the metrics for defining ideal cardiovascular health) score at 6-month follow-up
研究概览
简要总结
The purpose of this research is to test whether a technology application(Health360x) that lets participants set goals for better health and track health can help participants reduce their heart disease risk. Investigators will compare life style intervention using Health360x alone with Health360xs plus health coach on AHA(American Heart Association) LS7 scores after 6 months.
详细描述
Study volunteers' participation in this study will last for 6 months. Investigators will ask participants to examine their own health behaviors. The purpose of the examination is to find the areas that need improvement so participants can work on them. Investigators will use technology in the form of Health360x to support participant efforts to change health behaviors.
This list below, shows the activities you will perform as part of this research.
Arm A ='High tech' Arm B='High tech high touch"
- Recruitment Phone call: During this call, investigators will do the following:
- Collect email address
- Phone# that can receive text messages
- Contact information for 2 close friends/relatives
- Investigators will email participants enrollment and welcome package that contains links to the
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
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Already participating in baseline clinical study
- •Volunteers with AHA LS7 scores of 4 or lower who have access to internet (community or personal),self-reported ability to participate in physical activity, and English fluency.
排除标准
- •CAD documented by CAD diagnosis or prior acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, or chronic angina; aortic stenosis; inability to participate in increased physical activity; history of alcohol or drug abuse or psychiatric diagnosis that would interfere with ability to participate.
- •Pregnant and/or breastfeeding women will be excluded. Cognitive deficits severe enough to preclude participation or any medical or surgical problem that precludes meaningful participation; unwillingness to use the internet
结局指标
主要结局
Life Simple 7(LS7 the metrics for defining ideal cardiovascular health) score at 6-month follow-up
时间窗: 6 months
The LS7 score consists of 4 behavioral and 3 clinical measures. The behavioral measures are smoking, body Mass Index (BMI), physical activity and healthy dietary pattern. The clinical measures are blood pressure, total cholesterol and fasting plasma glucose.Each LS7 component will be given a point score of 0, 1, or 2 to represent poor, intermediate, or ideal health, respectively. Then, an overall LS7 score ranging from 0 to 14 will be calculated as the sum of the LS7 component scores. The overall LS7 score will be further classified as inadequate (0-4), average (5-9), or optimum (10-14) cardiovascular health.
次要结局
- Change in Stress Management(Baseline, then monthly through Month 6)
- Self management skills acquired(6 months)
- Change in Blood Glucose(Baseline, Month 3, Month 6)
- Change in Weight(Baseline, then monthly through Month 6)
- Change in Short Form-12 Health Survey Questionnaire (SF-12) score(Baseline, Month 3, Month 6)
- Change in Diastolic Blood Pressure(Baseline, Month 6)
- Change in Delta Nutrition Intervention Research Initiative Food Frequency Questionnaire (Delta NIRI FFQ)(Baseline, Month 6)
- Change in Tobacco Use(Baseline, then monthly through Month 6)
- Change in Systolic Blood Pressure:(Baseline, Month 6)
- Change in Distance Walked Daily(Baseline, Month 3, Month 6)
研究者
Priscilla Pemu
Professor
Morehouse School of Medicine