Community Outreach Heart Health and Risk Reduction Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- University Health Network, Toronto
- Enrollment
- 827
- Locations
- 3
- Primary Endpoint
- Psychometric assessment of change in exercise, diet and smoking
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Psychometric assessment of change in exercise, diet and smoking
Time Frame: Post-treatment and 6-month follow-up
Secondary Outcomes
- 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)