CVD Risk Reduction Trial

NCT ID: NCT00473785

Last Updated: 2007-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 827 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2005-12-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Group-based motivational interviewing

Intervention Type: BEHAVIORAL

Individual CVD-risk factor feedback

Intervention Type: BEHAVIORAL

Education for protective health behavior change

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Robert P Nolan, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network/University of Toronto

Locations

Laurentian University / Sudbury and District Health Unit

Greater Sudbury, Ontario, Canada

Grey-Bruce Health Unit

Owen Sound, Ontario, Canada

University Health Network / Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

Grace SL, Barry-Bianchi S, Stewart DE, Rukholm E, Nolan RP. Physical activity behavior, motivational readiness and self-efficacy among Ontarians with cardiovascular disease and diabetes. J Behav Med. 2007 Feb;30(1):21-9. doi: 10.1007/s10865-006-9080-5. Epub 2006 Nov 16.

Reference Type: BACKGROUND

PMID: 17109217 (View on PubMed)

Other Identifiers

HSFO Grant # 4857

Identifier Type: -

Identifier Source: secondary_id

HSFO4857

Identifier Type: -

Identifier Source: org_study_id