CVD Risk Reduction Trial (COHRT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Disease |
Behavioral: Group-based motivational interviewing Behavioral: Individual CVD-risk factor feedback Behavioral: Education for protective health behavior change |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Community Outreach Heart Health and Risk Reduction Trial |
- 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 ]
| Enrollment: | 827 |
| Study Start Date: | January 2002 |
| Study Completion Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 35 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Canada, Ontario | |
| Grey-Bruce Health Unit | |
| Owen Sound, Ontario, Canada, N4K 4K5 | |
| Laurentian University / Sudbury and District Health Unit | |
| Sudbury, Ontario, Canada, P3E 2C6 | |
| University Health Network / Sunnybrook and Women's College Health Sciences Centre | |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Principal Investigator: | Robert P Nolan, PhD | University Health Network/University of Toronto |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00473785 History of Changes |
| Other Study ID Numbers: | HSFO4857, HSFO Grant # 4857 |
| Study First Received: | May 11, 2007 |
| Last Updated: | May 14, 2007 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
Cardiovascular disease Prevention Lifestyle |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013