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

December 11, 2013 updated by: Marie-France Langlois
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
5% weight loss
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marie-France Langlois

Collaborators

The Lawson Foundation

Investigators

  • Principal Investigator: Marie-France Langlois, Université de Sherbrooke
  • Principal Investigator: Jean-Patrice Baillargeon, MD, M.Sc., Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (Estimate)

August 31, 2009

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Lifestyle modification counselling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe