Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects
Primary Purpose
Glucose Intolerance, Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lifestyle modification counselling
Sponsored by
About this trial
This is an interventional treatment trial for Glucose Intolerance
Eligibility Criteria
Inclusion Criteria:
- BMI between 27-40 kg/m2
- impaired glucose tolerance, confirmed by an oral glucose tolerance test (OGTT = fasting glucose lower than 7.0 mmol/l and glucose 2 hours post 75g of glucose between 7.8-11.0 mmol/l), or impaired fasting glucose (6.1-6.9 mmol/L)
- 18 years old or more
- Being able to read and give an informed consent
Exclusion Criteria:
- Conditions that affects weight or glucose metabolism
Sites / Locations
- Universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle counseling
Arm Description
Outcomes
Primary Outcome Measures
5% weight loss
Secondary Outcome Measures
Full Information
NCT ID
NCT00969007
First Posted
August 28, 2009
Last Updated
December 11, 2013
Sponsor
Marie-France Langlois
Collaborators
The Lawson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00969007
Brief Title
Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects
Official Title
Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marie-France Langlois
Collaborators
The Lawson Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to identify baseline and early predictors of favorable and unfavorable response to lifestyle intervention. As a secondary objective, the investigators would like to validate our questionnaire or other identified predictors as clinical tools to guide us in selection of the most suitable candidates for lifestyle intervention programs. Assuming the same capacity of our questionnaire to predict an absence of weight loss (≥5%) or a loss to follow-up (likelihood ratio for a positive test, LR+ = 9.9), 70 subjects need to be included in this study in order to find a lower limit of the 95% confidence interval above 2.0 for this LR+, which is the limit of an acceptable test. The investigators will enroll participants with pre-diabetes and BMI 27-40 in our program and administer to them at baseline and at 3 months the designed questionnaire, as well as other already well validated questionnaires assessing state of change and readiness to implement diet or exercise modifications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification counselling
Intervention Description
Patients meet individually every six weeks, a nurse or kinesiologist, and a dietitian (as well as a psychologist, if needed) and every three months an endocrinologist. A unique patient chart is shared by members of the interdisciplinary team, allowing sharing of the information and avoiding repetitions. Individualized behavioural intervention is proposed and focuses on attainable goals and progressive but sustained small changes in nutrition and physical activity. In addition, the participants have access to 24 weekly group seminars, on different aspects of excess weight and modification of lifestyle, to reinforce behaviour and commitment to lifestyle changes. Our approach meets all criteria suggested for clinical intervention in the 2006 Canadian clinical practice guidelines on the management and prevention of obesity in adults and children.
Primary Outcome Measure Information:
Title
5% weight loss
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI between 27-40 kg/m2
impaired glucose tolerance, confirmed by an oral glucose tolerance test (OGTT = fasting glucose lower than 7.0 mmol/l and glucose 2 hours post 75g of glucose between 7.8-11.0 mmol/l), or impaired fasting glucose (6.1-6.9 mmol/L)
18 years old or more
Being able to read and give an informed consent
Exclusion Criteria:
Conditions that affects weight or glucose metabolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-France Langlois
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Patrice Baillargeon, MD, M.Sc.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects
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