ObesityNCT01385397
Integrated Obesity Care Management System
A study testing Preceptorship and virtual community in people with Obesity, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Obesity is an important public health problem that is taking epidemic proportions worldwide. Indeed, nearly 50% of Canadians are obese and their number has increased dramatically in the last 20 years. Direct costs of obesity added to those of sedentary represent nearly 5% of the health system's budget. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Preceptorship and virtual community
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Nov 2007
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health professionals working in a Family Medicine Group
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculté de médecine, Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Obesity is an important public health problem that is taking epidemic proportions worldwide. Indeed, nearly 50% of Canadians are obese and their number has increased dramatically in the last 20 years. Direct costs of obesity added to those of sedentary represent nearly 5% of the health system's budget. Also, obesity is linked with multiple co-morbidities; furthermore, modest weight loss has significant impact on type 2 diabetes, blood pressure and even reduces mortality. The investigators group has implemented an interdisciplinary team that has demonstrated its effectiveness for obesity management. However, the majority of obese subjects should be treated by primary care physicians (PCPs) that often feel uncomfortable when faced with the management of obesity. The investigators have therefore developed a clinical preceptorship for PCPs; this continuing medical education (CME) activity aims at engaging PCPs in obesity/overweight management. The current research proposal is aimed at the development and implementation of an innovative, integrated, interdisciplinary obesity care management system involving both primary and secondary health care professionals.
The investigators hypothesize that CME based on preceptorships in combination with electronic tools (web site and virtual community), networking primary care (FMGs) and secondary care health professionals, will increase the knowledge, modify attitudes and perceptions of health care professionals and increase their sense of self-efficacy. Furthermore, this intervention should modify health care organization regarding obesity management and eventually improve accessibility to optimal obesity care.
The investigators will use both action (objectives 1-2) and evaluative (objectives 3-5) research in order to attain specific objectives: 1) Develop and implement a preceptorship-based CME complemented by a web site for physicians and nurses working in Family Medicine Groups (FMGs). This CME will be based on needs assessment and will be validated by one FMG using questionnaires and semi structured interviews. Also, references and teaching tools will be available for participants on the web site. 2) Establish a collaborative intra/inter-regional interdisciplinary network to enable on-going expertise update and networking for FMG teams. This tool consists of a discussion forum including exchanges about difficult "cases" and a monthly virtual meeting of all participants. 3) Evaluate the implementation of this integrated system at the level of the ability to form a number of 8 FMGs/year, access and utilization of the electronic tools and participants' satisfaction (physicians, nurses and experts). This will be measured with the help of questionnaires and web logging tools. Questionnaires and group interviews will also be performed in order to evaluate participants' satisfaction. 4) Determine the impact for the participants at the level of knowledge and expertise, attitudes and perceptions, and self-efficacy regarding the management of obesity. Questionnaires and interviews will be used to this purpose. 5) Deliver transferable knowledge for health professionals and decision-makers. Strategies and pitfalls of setting up this program will be identified, performance indicators series will be developed and accessibility to care will be evaluated for each FMG and the 2nd line team. A knowledge transfer plan will be elaborated and applied.
- Conditions
- Obesity
- Being tested
- Preceptorship and virtual community
- Keywords
- Health system organization
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preceptorship and virtual communityOther
| Study group | Role | What they receive |
|---|---|---|
| Preceptorship and virtual community | Experimental | Not described Receives: Other: Preceptorship and virtual community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in attitudes toward obese individual at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startSep 2006
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-France Langlois, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385397
- Sponsor's protocol ID
- 05-109
- Status last verified
- Oct 2011
- First submitted
- 28 Jun 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Baillargeon JP, St-Cyr-Tribble D, Xhignesse M, Brown C, Carpentier AC, Fortin M, Grant A, Simoneau-Roy J, Langlois MF. Impact of an educational intervention combining clinical obesity preceptorship with electronic networking tools on primary care professionals: a prospective study. BMC Med Educ. 2020 Oct 14;20(1):361. doi: 10.1186/s12909-020-02248-5.
PubMed 33054845
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Obesity Care Management System
- ClinicalTrials.gov ID
- NCT01385397
- Acronym / sponsor ID
- 05-109
- Conditions
- Obesity
- Keywords
- Health system organization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Nov 2007 (actual)
- First posted
- 30 Jun 2011 (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.
Obesity is an important public health problem that is taking epidemic proportions worldwide. Indeed, nearly 50% of Canadians are obese and their number has increased dramatically in the last 20 years. Direct costs of obesity added to those of sedentary represent nearly 5% of the health system's budget. Also, obesity is linked with multiple co-morbidities; furthermore, modest weight loss has significant impact on type 2 diabetes, blood pressure and even reduces mortality. The investigators group has implemented an interdisciplinary team that has demonstrated its effectiveness for obesity management. However, the majority of obese subjects should be treated by primary care physicians (PCPs) that often feel uncomfortable when faced with the management of obesity. The investigators have therefore developed a clinical preceptorship for PCPs; this continuing medical education (CME) activity aims at engaging PCPs in obesity/overweight management. The current research proposal is aimed at the development and implementation of an innovative, integrated, interdisciplinary obesity care management system involving both primary and secondary health care professionals.
The investigators hypothesize that CME based on preceptorships in combination with electronic tools (web site and virtual community), networking primary care (FMGs) and secondary care health professionals, will increase the knowledge, modify attitudes and perceptions of health care professionals and increase their sense of self-efficacy. Furthermore, this intervention should modify health care organization regarding obesity management and eventually improve accessibility to optimal obesity care.
The investigators will use both action (objectives 1-2) and evaluative (objectives 3-5) research in order to attain specific objectives: 1) Develop and implement a preceptorship-based CME complemented by a web site for physicians and nurses working in Family Medicine Groups (FMGs). This CME will be based on needs assessment and will be validated by one FMG using questionnaires and semi structured interviews. Also, references and teaching tools will be available for participants on the web site. 2) Establish a collaborative intra/inter-regional interdisciplinary network to enable on-going expertise update and networking for FMG teams. This tool consists of a discussion forum including exchanges about difficult "cases" and a monthly virtual meeting of all participants. 3) Evaluate the implementation of this integrated system at the level of the ability to form a number of 8 FMGs/year, access and utilization of the electronic tools and participants' satisfaction (physicians, nurses and experts). This will be measured with the help of questionnaires and web logging tools. Questionnaires and group interviews will also be performed in order to evaluate participants' satisfaction. 4) Determine the impact for the participants at the level of knowledge and expertise, attitudes and perceptions, and self-efficacy regarding the management of obesity. Questionnaires and interviews will be used to this purpose. 5) Deliver transferable knowledge for health professionals and decision-makers. Strategies and pitfalls of setting up this program will be identified, performance indicators series will be developed and accessibility to care will be evaluated for each FMG and the 2nd line team. A knowledge transfer plan will be elaborated and applied.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preceptorship and virtual community | Experimental | Other: Preceptorship and virtual community |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health professionals working in a Family Medicine Group
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Preceptorship and virtual community | Other | Preceptorship and virtual community |
Primary outcome
Changes from baseline in attitudes toward obese individual at 1 year
Time frame: 1 year
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 17 Oct 2011.
- Derived from this study: PubMed 33054845Baillargeon JP, St-Cyr-Tribble D, Xhignesse M, Brown C, Carpentier AC, Fortin M, Grant A, Simoneau-Roy J, Langlois MF. Impact of an educational intervention combining clinical obesity preceptorship with electronic networking tools on primary care professionals: a prospective study. BMC Med Educ. 2020 Oct 14;20(1):361. doi: 10.1186/s12909-020-02248-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preceptorship and virtual community in people with Obesity, run by Université de Sherbrooke 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 1 inclusion and 0 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 17 Oct 2011. 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?
Changes from baseline in attitudes toward obese individual at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385397, which also lists 1 linked publication.
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 17 Oct 2011.