The Healthy Options Feasibility Study

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746460
• Other study ID #: CLIN-08001
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: January 10, 2014
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2014
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 79 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cigarette Smoking
• Diabetes
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Obesity
• Sedentary Lifestyle

Intervention

Behavioral:
• CVD risk profile
Cardiovascular risk assessment and behavioral counselling

Locations

Country	Name	City	State
Canada	McGill Cardiovascular Health Improvement Program	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using health care providers other than physicians within a GMF to conduct a CV risk assessment and intervention on primary prevention patients		10 months	No
Secondary	Patient's CV risk factors and overall CV risk		16 weeks	No
Secondary	Subject's adherence with lifestyle changes and prescribed medications		16 weeks	No
Secondary	Satisfaction of the nurse		10 months	No
Secondary	Satisfaction of the patient		16 weeks	No

External Links

•   Web site used by study participants