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

Tracking Information
First Submitted Date  ICMJE September 3, 2008
First Posted Date  ICMJE September 4, 2008
Last Update Posted Date January 14, 2014
Study Start Date  ICMJE June 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
  • Patient's CV risk factors and overall CV risk [ Time Frame: 16 weeks ]
  • Subject's adherence with lifestyle changes and prescribed medications [ Time Frame: 16 weeks ]
  • Satisfaction of the nurse [ Time Frame: 10 months ]
  • Satisfaction of the patient [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Healthy Options Feasibility Study
Official Title  ICMJE 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.
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 www.myhealthcheckup.com Web site.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Sedentary Lifestyle
  • Dyslipidemia
  • Hypertension
  • Cigarette Smoking
  • Diabetes
Intervention  ICMJE Behavioral: CVD risk profile
Cardiovascular risk assessment and behavioral counselling
Study Arms  ICMJE Experimental: A
Behavioral
Intervention: Behavioral: CVD risk profile
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2008)
150
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746460
Other Study ID Numbers  ICMJE CLIN-08001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Grover, MD, McGill University
Study Sponsor  ICMJE McGill University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Steven Grover, MD McGill Cardiovascualr Health Improvement Program
PRS Account McGill University
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP