ObesityNCT00746460
The Healthy Options Feasibility Study
A study testing CVD risk profile in people with Obesity and Sedentary Lifestyle, run by McGill University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Obesity, Sedentary Lifestyle, Dyslipidemia
- What is being tested?
- CVD risk profile
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill Cardiovascular Health Improvement Program
Montreal, Quebec, H3Z 2A7
About this 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.
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.
- Conditions
- Obesity, Sedentary Lifestyle, Dyslipidemia, Hypertension, Cigarette Smoking, Diabetes
- Being tested
- CVD risk profile
- Keywords
- primary prevention, patient knowledge, nurse, exercise, smoking cessation, weight loss
- Medical subject headings
- Obesity, Sedentary Behavior, Dyslipidemias, Hypertension, Cigarette Smoking, Diabetes Mellitus, Motor Activity, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVD risk profileBehavioural
Cardiovascular risk assessment and behavioral counselling
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Behavioral Receives: Behavioral: CVD risk profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using health care providers other than physicians within a GMF to conduct a CV risk assessment and intervention on primary prevention patients
Measured: 10 months
Secondary outcomes (4)
Patient's CV risk factors and overall CV risk
Measured: 16 weeks
Subject's adherence with lifestyle changes and prescribed medications
Measured: 16 weeks
Satisfaction of the nurse
Measured: 10 months
Satisfaction of the patient
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Steven Grover, MD, McGill University
- Investigators
- Steven Grover, MD, Principal investigator, McGill Cardiovascualr Health Improvement Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746460
- Sponsor's protocol ID
- CLIN-08001
- Status last verified
- Jan 2014
- First submitted
- 3 Sep 2008
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00746460
- Acronym / sponsor ID
- CLIN-08001
- Conditions
- Obesity, Sedentary Lifestyle, Dyslipidemia, Hypertension, Cigarette Smoking, Diabetes
- Keywords
- primary prevention, patient knowledge, nurse, exercise, smoking cessation, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: CVD risk profileBehavioral |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVD risk profileCardiovascular risk assessment and behavioral counselling | Behavioural | A |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Web site used by study participantsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Grover, MD principal investigator
McGill Cardiovascualr Health Improvement Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVD risk profile in people with Obesity and Sedentary Lifestyle, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.