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The Healthy Options Feasibility Study

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. Identifier: NCT00746460
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Steven Grover, MD, McGill University

Brief Summary:
The investigators hypothesize that having health care providers other than physicians within a "Groupe de Médecine de Famille" conduct cardiovascular risk assessments and teach lifestyle interventions to primary prevention patients will increase the likelihood that patients will adopt and maintain healthy lifestyles. These objectives will be supported by providing subjects with a cardiovascular risk profile estimating the subject's risk of cardiovascular disease and teaching them how to use the resources related to lifestyle changes available on the Web site.

Condition or disease Intervention/treatment Phase
Obesity Sedentary Lifestyle Dyslipidemia Hypertension Cigarette Smoking Diabetes Behavioral: CVD risk profile Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of CVD Risk Profiles When Used by Allied Health Care Providers (HCP) Within a "Groupe de Médecine de Famille": The Healthy Options Feasibility Study.
Study Start Date : June 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: A
Behavioral: CVD risk profile
Cardiovascular risk assessment and behavioral counselling

Primary Outcome Measures :
  1. Feasibility of using health care providers other than physicians within a GMF to conduct a CV risk assessment and intervention on primary prevention patients [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Patient's CV risk factors and overall CV risk [ Time Frame: 16 weeks ]
  2. Subject's adherence with lifestyle changes and prescribed medications [ Time Frame: 16 weeks ]
  3. Satisfaction of the nurse [ Time Frame: 10 months ]
  4. Satisfaction of the patient [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects 30-79 years of age without known cardiovascular disease but with one or more risk factors such as obesity, a sedentary lifestyle, dyslipidemia, hypertension, cigarette smoking, or diabetes
  • Have provided informed consent
  • Recent (past 6 months) fasting lipid profile results in the medical charts

Exclusion Criteria:

  • Unable or unlikely to follow and/or complete study or evidence of uncooperative attitude
  • Subject is not literate in either French or English
  • Subject does not have easy and regular access to the Internet
  • Exercise or weight loss are contra-indicated for medical reasons

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 identifier (NCT number): NCT00746460

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Canada, Quebec
McGill Cardiovascular Health Improvement Program
Montreal, Quebec, Canada, H3Z 2A7
Sponsors and Collaborators
McGill University
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Principal Investigator: Steven Grover, MD McGill Cardiovascualr Health Improvement Program
Additional Information:
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Responsible Party: Steven Grover, MD, Medical Director McGill Comprehensive Health Improvement Program, McGill University Identifier: NCT00746460    
Other Study ID Numbers: CLIN-08001
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Steven Grover, MD, McGill University:
primary prevention
patient knowledge
smoking cessation
weight loss
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases