Community Outreach Heart Health and Risk Reduction Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 827
- 试验地点
- 6
- 主要终点
- Psychometric assessment of change in exercise, diet and smoking
研究概览
简要总结
The purpose of this study is to provide lifestyle counselling for protective health behavior (exercise, diet, smoking cessation) to small groups (6-8 subjects) via teleconference. The sample includes individuals at elevated risk for cardiovascular disease (CVD) as well as individuals with established CVD. Our hypothesis is that telephone-based lifestyle counselling will (1) significantly increase protective lifestyle behavior (diet, exercise, smoke-free living) and (2) significantly reduce CVD risk factors at 6-month follow-up.
详细描述
COHRT was a 2 parallel-group randomized controlled trial that was designed to assess the efficacy of a community outreach strategy for cardiovascular disease (CVD) risk reduction among individuals at elevated risk for CV events. Randomization was stratified for diagnosis of CHD, type 1 or 2 diabetes, sex, and clinical depression, and blocked within our northern, rural, and urban recruitment sites. A 2X3 mixed factorial design was utilized: 2 Groups (Usual Care, UC/Lifestyle Counselling,LC) X 3 Intervals (Baseline, post-treatment, 6-month follow-up). All subjects received personal CVD risk factor feedback and standardized handouts on heart healthy lifestyle change. The LC group received 6 weekly 1-hour sessions of lifestyle counseling that was provided via teleconference in small groups (4-8 persons). Group facilitators were trained in a manualized protocol of motivational interviewing that was designed for CVD risk reduction through lifestyle change. Weekly supervision was also provided. We hypothesized that the LC group (vs. UC) would significantly increase protective health behavior (exercise, diet, smoke-free living) at post-treatment and 6-month follow-up. The secondary hypothesis was that LC would significantly reduce (1) CVD risk factors, (SBP, DBP, total cholesterol, LDL cholesterol), (2) 10-year absolute risk among subjects without CVD, and (3) significantly increase quality of life as measured by symptoms of depression, psychological stress, and social support.
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
- Single
入排标准
- 年龄范围
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 to 74 years of age,
- •Diagnosis of CVD or Type 1 or 2 diabetes, or
- •≥2 of the following CVD risk factors:
- •Confirmed diagnosis of hypertension,
- •Dyslipidemia,
- •Males aged ≥55 years/females aged ≥60 years,
- •Family history of CHD or stroke;
- •Current smoker, or
- •BMI ≥ 27.
排除标准
- •Diagnosis of clinically significant cardiac complications (e.g. arrhythmia, unstable angina) or a congenital cardiac condition;
- •Major psychiatric illness (e.g. psychosis), history of alcohol or drug dependence within the previous year, or residence in a non-private setting.
结局指标
主要结局
Psychometric assessment of change in exercise, diet and smoking
时间窗: Post-treatment and 6-month follow-up
次要结局
- SBP, DBP, total cholesterol, HDL, LDL, triglycerides and 10-year absolute CVD risk(6-month follow-up)
- Psychometric assessment of symptoms of depression, psychological stress, and social support.(post-treatment and 6-month follow-up)