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

NCT ID: NCT00969007

Last Updated: 2013-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Glucose Intolerance; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling

Group Type: EXPERIMENTAL

Lifestyle modification counselling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Lawson Foundation

OTHER

Sponsor Role: collaborator

Marie-France Langlois

OTHER

Sponsor Role: lead

Responsible Party

Marie-France Langlois

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marie-France Langlois

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Jean-Patrice Baillargeon, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

08-083

Identifier Type: -

Identifier Source: org_study_id