ObesityNCT00328081
State of Obesity Care in Canada Evaluation Registry
An observational study of Obesity and Morbid Obesity, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to see whether care gap(s) exist in the management of obesity and its related conditions in obese patients seen by primary care physicians and specialists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid Obesity
- How many people
- 1,906 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Aug 2007
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older and is able to provide informed consent
- Has not been enrolled in this study at an earlier office visit; and
- Provides signed informed consent
- BMI > = 27 kg/m
Who cannot join
- Participation in a clinical trial
- Hospitalized patient
- Subject expected to have difficulties to come back at follow-up visits
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences - Cardiovascular Obesity Research and Management
Hamilton, Ontario, L8L 2X2
About this study
Official title: State of Obesity Care in Canada Evaluation Registry An Observational Study of Clinical Care of Patients With Obesity
The purpose of this study is to see whether care gap(s) exist in the management of obesity and its related conditions in obese patients seen by primary care physicians and specialists. The study will also look at whether there is a compliance and adherence gap that exists in patients prescribed medication for obesity management.
Read the detailed description
Obesity currently affects over 15% of the adult population in Canada. The economic burden associated with obesity is estimated at $4.3 billion or 2.2% of the total health care costs in Canada. Despite increasing recognition as a public health problem, clinical management of obese patients in Canada has received little attention. This study will collect information on the current status, characteristics and management of subjects with obesity. The design of the study will mirror real-life management of these subjects.There are three goals in this study: the primary goal is to document appropriate obesity management strategies aimed at reducing and maintaining a healthy body weight by participating primary care physicians and specialists. The second goal is to explore factors that determine patients compliance and adherence to anti-obesity medication when prescribed. Obesity management is currently not a priority in tertiary care centres in Canada. An exception being the Bariatric Clinic located at McMaster University, which is one of the few academic centers dedicated to obesity management in Canada. The primary goal of the Bariatric Clinic Substudy is to evaluate the management, compliance and adherence of patients seen at a tertiary care obesity clinic compared to those of primary care physicians and specialists.
- Conditions
- Obesity, Morbid Obesity
- Keywords
- Obesity, Weight gain, Anti-obesity medication, Anti-obesity management strategies, Body Weight
- Medical subject headings
- Obesity, Obesity, Morbid, Weight Gain, Body Weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMay 2006
- Study completionAug 2007
Why it stopped: Principal Investigator left the institution
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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 1,906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Arya M Sharma, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328081
- Sponsor's protocol ID
- SOCCER
- Status last verified
- Sep 2007
- First submitted
- 18 May 2006
- Last updated
- 14 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State of Obesity Care in Canada Evaluation Registry An Observational Study of Clinical Care of Patients With Obesity
- ClinicalTrials.gov ID
- NCT00328081
- Acronym / sponsor ID
- SOCCER
- Conditions
- Obesity, Morbid Obesity
- Keywords
- Obesity, Weight gain, Anti-obesity medication, Anti-obesity management strategies, Body Weight
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator left the institution
- Enrolment
- 1,906 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- May 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 19 May 2006 (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 purpose of this study is to see whether care gap(s) exist in the management of obesity and its related conditions in obese patients seen by primary care physicians and specialists. The study will also look at whether there is a compliance and adherence gap that exists in patients prescribed medication for obesity management.
Detailed description
Obesity currently affects over 15% of the adult population in Canada. The economic burden associated with obesity is estimated at $4.3 billion or 2.2% of the total health care costs in Canada. Despite increasing recognition as a public health problem, clinical management of obese patients in Canada has received little attention. This study will collect information on the current status, characteristics and management of subjects with obesity. The design of the study will mirror real-life management of these subjects.There are three goals in this study: the primary goal is to document appropriate obesity management strategies aimed at reducing and maintaining a healthy body weight by participating primary care physicians and specialists. The second goal is to explore factors that determine patients compliance and adherence to anti-obesity medication when prescribed. Obesity management is currently not a priority in tertiary care centres in Canada. An exception being the Bariatric Clinic located at McMaster University, which is one of the few academic centers dedicated to obesity management in Canada. The primary goal of the Bariatric Clinic Substudy is to evaluate the management, compliance and adherence of patients seen at a tertiary care obesity clinic compared to those of primary care physicians and specialists.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older and is able to provide informed consent
- Has not been enrolled in this study at an earlier office visit; and
- Provides signed informed consent
- BMI > = 27 kg/m
Key exclusion criteria (4 listed)
- Participation in a clinical trial
- Hospitalized patient
- Subject expected to have difficulties to come back at follow-up visits
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Principal Investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2007.
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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.
Arya M Sharma, MD, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Morbid Obesity, run by Hamilton Health Sciences Corporation 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 4 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: stopped early, as of the sponsor's last update on 14 Sep 2007. 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 was stopped early (reason given: Principal Investigator left the institution). Results are not available in the source record.
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.
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 Sep 2007.