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

Not Applicable

Completed

• Conditions: Obesity; Glucose Intolerance
• Interventions: Behavioral: Lifestyle modification counselling

• Registration Number: NCT00969007
• Lead Sponsor: Marie-France Langlois

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Lifestyle modification counselling	-

Primary Outcome Measures

Name	Time	Method
5% weight loss	1 year

Trial Locations

Locations (1)

Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada