Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00969007 |
|
Recruitment Status :
Completed
First Posted : August 31, 2009
Last Update Posted : December 13, 2013
|
Sponsor:
Marie-France Langlois
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Marie-France Langlois, Université de Sherbrooke
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glucose Intolerance Obesity | Behavioral: Lifestyle modification counselling | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 81 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Lifestyle counseling |
Behavioral: Lifestyle modification counselling
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 Measures :
- 5% weight loss [ Time Frame: 1 year ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969007
Locations
| Canada, Quebec | |
| Universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
Sponsors and Collaborators
Marie-France Langlois
The Lawson Foundation
Investigators
| Principal Investigator: | Marie-France Langlois | Université de Sherbrooke | |
| Principal Investigator: | Jean-Patrice Baillargeon, MD, M.Sc. | Université de Sherbrooke |
| Responsible Party: | Marie-France Langlois, MD, Université de Sherbrooke |
| ClinicalTrials.gov Identifier: | NCT00969007 History of Changes |
| Other Study ID Numbers: |
08-083 |
| First Posted: | August 31, 2009 Key Record Dates |
| Last Update Posted: | December 13, 2013 |
| Last Verified: | December 2013 |
Additional relevant MeSH terms:
|
Glucose Intolerance Prediabetic State Overweight Body Weight Signs and Symptoms |
Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |