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The Healthy Options Feasibility Study

Primary Purpose

Obesity, Sedentary Lifestyle, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CVD risk profile
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring primary prevention, patient knowledge, nurse, exercise, smoking cessation, weight loss

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill Cardiovascular Health Improvement Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Behavioral

Outcomes

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

Secondary Outcome Measures

Patient's CV risk factors and overall CV risk
Subject's adherence with lifestyle changes and prescribed medications
Satisfaction of the nurse
Satisfaction of the patient

Full Information

First Posted
September 3, 2008
Last Updated
January 10, 2014
Sponsor
McGill University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00746460
Brief Title
The Healthy Options Feasibility Study
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sedentary Lifestyle, Dyslipidemia, Hypertension, Cigarette Smoking, Diabetes
Keywords
primary prevention, patient knowledge, nurse, exercise, smoking cessation, weight loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Behavioral
Intervention Type
Behavioral
Intervention Name(s)
CVD risk profile
Intervention Description
Cardiovascular risk assessment and behavioral counselling
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Patient's CV risk factors and overall CV risk
Time Frame
16 weeks
Title
Subject's adherence with lifestyle changes and prescribed medications
Time Frame
16 weeks
Title
Satisfaction of the nurse
Time Frame
10 months
Title
Satisfaction of the patient
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Grover, MD
Organizational Affiliation
McGill Cardiovascualr Health Improvement Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill Cardiovascular Health Improvement Program
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z 2A7
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.myhealthcheckup.com
Description
Web site used by study participants

Learn more about this trial

The Healthy Options Feasibility Study

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