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

This study has been completed.
Sponsor:
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Marie-France Langlois, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00969007
First received: August 28, 2009
Last updated: December 11, 2013
Last verified: December 2013
  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: 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 Université de Sherbrooke:

Primary Outcome Measures:
  • 5% weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marie-France Langlois, MD, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00969007     History of Changes
Other Study ID Numbers: 08-083
Study First Received: August 28, 2009
Last Updated: December 11, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 27, 2014