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CVD Risk Reduction Trial (COHRT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473785
First Posted: May 15, 2007
Last Update Posted: May 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Health Network, Toronto
  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
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Community Outreach Heart Health and Risk Reduction Trial

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Psychometric assessment of change in exercise, diet and smoking [ Time Frame: Post-treatment and 6-month follow-up ]

Secondary Outcome Measures:
  • 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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473785


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
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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
First Submitted: May 11, 2007
First Posted: May 15, 2007
Last Update Posted: May 15, 2007
Last Verified: May 2007

Keywords provided by University Health Network, Toronto:
Cardiovascular disease
Prevention
Lifestyle

Additional relevant MeSH terms:
Cardiovascular Diseases