Impact of an Integrated Obesity Management System on Patient's Care (ROGMF-2)
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
2-day preceptorship on obesity management
Sponsored by
About this trial
This is an interventional health services research trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Patients who have, during the past 2 years, at least 4 documented visits for the targeted diseases group and at least 2 visits for the regular follow-up group
Exclusion Criteria:
- Active mental health problem
- Active psychiatric disorder
- Cancer in the last five years
- Patient with medication that changed in the last 6 months
Sites / Locations
- Université de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Preceptorships
Arm Description
No intervention
Preceptorships with e-learning
Outcomes
Primary Outcome Measures
Among patients from the targeted diseases group, we aim at improving: a)the proportion of subjects who have an initial intervention planned, according to the CCPGO; b)the proportion of subjects who lose at least 5% of their initial weight.
Among patients from the regular follow-up group, we aim at improving: a)the proportion of patients who have measured weight, BMI and waist circumference and b)the proportion of overweight or obese subjects who have an initial intervention planned.
Secondary Outcome Measures
Among health professionals who receive the intervention (vs. those who did not), we aim at ameliorating their attitudes and perceptions towards patients and treatment effectiveness.
Among health professionals who receive the intervention (vs. those who did not), we aim at improving their perception of self-efficacy in managing obesity.
Among health professionals who receive the intervention (vs. those who did not), we aim at increasing their knowledge and expertise on obesity management and changing their practice.
Among patients who are followed by PCPs who receive the intervention (vs. no intervention), we aim at:a) evaluating their attitudes and perceptions regarding obesity/overweight and lifestyle and b)improving their satisfaction regarding their management.
Full Information
NCT ID
NCT00991640
First Posted
October 7, 2009
Last Updated
May 8, 2023
Sponsor
Université de Sherbrooke
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00991640
Brief Title
Impact of an Integrated Obesity Management System on Patient's Care
Acronym
ROGMF-2
Official Title
Impact of an Integrated Obesity Management System on Patient's Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators developed a program aimed at enhancing primary care physician (PCP) teams' expertise, self-efficacy and attitudes with respect to obesity management. The investigators implemented and evaluated this obesity management system based on a preceptorship combined with a virtual learning community favouring continuous support of family medicine groups (FMGs, Groupes de Médecine Familiale) by a team of experts in obesity management; significant improvements regarding their attitudes and perception of self-efficacy were observed immediately after the preceptorship and maintained after one year. Furthermore, the investigators observed significant changes in their practice that were maintained one year later.
The investigators hypothesize that their program combining preceptorships with a virtual community will improve: (1) management and weight loss of obese/overweight subjects who are treated by PCPs for hypertension (HTN), type 2 diabetes (DM2) or impaired glucose tolerance (IGT); and (2) screening and initial management of obesity among unselected patients of PCPs who practice in FMGs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
460 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Preceptorships
Arm Type
Experimental
Arm Description
Preceptorships with e-learning
Intervention Type
Behavioral
Intervention Name(s)
2-day preceptorship on obesity management
Primary Outcome Measure Information:
Title
Among patients from the targeted diseases group, we aim at improving: a)the proportion of subjects who have an initial intervention planned, according to the CCPGO; b)the proportion of subjects who lose at least 5% of their initial weight.
Time Frame
18 months
Title
Among patients from the regular follow-up group, we aim at improving: a)the proportion of patients who have measured weight, BMI and waist circumference and b)the proportion of overweight or obese subjects who have an initial intervention planned.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Among health professionals who receive the intervention (vs. those who did not), we aim at ameliorating their attitudes and perceptions towards patients and treatment effectiveness.
Time Frame
12 months
Title
Among health professionals who receive the intervention (vs. those who did not), we aim at improving their perception of self-efficacy in managing obesity.
Time Frame
12 months
Title
Among health professionals who receive the intervention (vs. those who did not), we aim at increasing their knowledge and expertise on obesity management and changing their practice.
Time Frame
12 months
Title
Among patients who are followed by PCPs who receive the intervention (vs. no intervention), we aim at:a) evaluating their attitudes and perceptions regarding obesity/overweight and lifestyle and b)improving their satisfaction regarding their management.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who have, during the past 2 years, at least 4 documented visits for the targeted diseases group and at least 2 visits for the regular follow-up group
Exclusion Criteria:
Active mental health problem
Active psychiatric disorder
Cancer in the last five years
Patient with medication that changed in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-France Langlois, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26217506
Citation
Baillargeon JP, St-Cyr-Tribble D, Xhignesse M, Grant A, Brown C, Langlois MF. Impact of an integrated obesity management system on patient's care - research protocol. BMC Obes. 2014 Sep 3;1:19. doi: 10.1186/s40608-014-0019-z. eCollection 2014. Erratum In: BMC Obes. 2016;3:23.
Results Reference
derived
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