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The Healthy Options Feasibility Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by McGill University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT00746460
First received: September 3, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Sedentary Lifestyle
Dyslipidemia
Hypertension
Cigarette Smoking
Diabetes
 Behavioral: CVD risk profile

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's CV risk factors and overall CV risk [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Subject's adherence with lifestyle changes and prescribed medications [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Satisfaction of the nurse [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Satisfaction of the patient [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Behavioral
 Behavioral: CVD risk profile
Cardiovascular risk assessment and behavioral counselling

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746460

Contacts
Contact: Sylvie Marchand, RN 514-846-7973 ext 221 stro@epimgh.mcgill.ca
Contact: Ilka Lowensteyn, PhD 514-846-7973 ext 241 ilka.lowensteyn@mcgill.ca

Locations
Canada, Quebec
McGill Cardiovascular Health Improvement Program Recruiting
Montreal, Quebec, Canada, H3Z 2A7
Contact: Sylvie Marchand, RN     514-846-7973 ext 221     stro@epimgh.mcgill.ca    
Contact: Ilka Lowensteyn, PhD     514-846-7973 ext 241     ilka.lowensteyn@mcgill.ca    
Principal Investigator: Steven Grover, MD            
Sponsors and Collaborators
McGill University
Pfizer
Investigators
Principal Investigator: Steven Grover, MD McGill Cardiovascualr Health Improvement Program
  More Information

Additional Information:
Web site used by study participants  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Steven Grover, McGill Cardiovascular Health Improvement Program
ClinicalTrials.gov Identifier: NCT00746460     History of Changes
Other Study ID Numbers: CLIN-08001
Study First Received: September 3, 2008
Last Updated: September 3, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University:
primary prevention
patient knowledge
nurse
 exercise
smoking cessation
weight loss

Additional relevant MeSH terms:
Hypertension
Obesity
Smoking
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Habits
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013