An interventional study of Group-based motivational interviewing and Individual CVD-risk factor feedback in Cardiovascular Disease, sponsored by University Health Network, Toronto. Completed at 3 sites in Canada. Open to participants aged 35 Years to 74 Years. Per ClinicalTrials.gov, last updated 2007-05-15.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Prevention
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.
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 827 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
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Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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≥2 of the following CVD risk factors:
Exclusion Criteria:
Psychometric assessment of change in exercise, diet and smoking
Time frame: Post-treatment and 6-month follow-up
SBP, DBP, total cholesterol, HDL, LDL, triglycerides and 10-year absolute CVD risk
Time frame: 6-month follow-up
Psychometric assessment of symptoms of depression, psychological stress, and social support.
Time frame: post-treatment and 6-month follow-up
The record gives a start of Jan 2002 and a completion of Dec 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.
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