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Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969007
First Posted: August 31, 2009
Last Update Posted: December 13, 2013
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.
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Marie-France Langlois, Université de Sherbrooke
  Purpose
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 Intervention
Glucose Intolerance Obesity Behavioral: Lifestyle modification counselling

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Marie-France Langlois, Université de Sherbrooke:

Primary Outcome Measures:
  • 5% weight loss [ Time Frame: 1 year ]

Enrollment: 81
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Marie-France Langlois, MD, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00969007     History of Changes
Other Study ID Numbers: 08-083
First Submitted: August 28, 2009
First Posted: August 31, 2009
Last Update Posted: December 13, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Overweight
Glucose Intolerance
Prediabetic State
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases