The Healthy Options Feasibility Study | NCT00746460

Studies
The Healthy Options Feasibility Study

NCT00746460

Sponsor

McGill University

Status

Completed

Last Update Posted

Jan 14, 2014Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Obesity
Sedentary Lifestyle
Dyslipidemia
Hypertension
Cigarette Smoking
Diabetes

Interventions

CVD risk profile

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Sep 3, 2008

First Submission Date that Met QC Criteria

Sep 3, 2008

First Posted Date

Sep 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Behavioral	Behavioral: CVD risk profile

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CVD risk profile	Behavioral	Cardiovascular risk assessment and behavioral counselling	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Patient's CV risk factors and overall CV risk		16 weeks
Subject's adherence with lifestyle changes and prescribed medications		16 weeks
Satisfaction of the nurse

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Grover, MD	McGill Cardiovascualr Health Improvement Program	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McGill Cardiovascular Health Improvement Program		Montreal	Quebec	H3Z 2A7	Canada

Label	URL
Web site used by study participants	View source

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D057185	Sedentary Behavior
D050171	Dyslipidemias
D006973	Hypertension
D000073865	Cigarette Smoking
D003920	Diabetes Mellitus
D009043	Motor Activity
D016540	Smoking Cessation
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided