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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by Universitaire de Sherbrooke.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

The Lawson Foundation

Information provided by:

Universitaire de Sherbrooke

ClinicalTrials.gov Identifier:

NCT00969007

First received: August 28, 2009

Last updated: May 7, 2010

Last verified: August 2009

History of Changes

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:

MedlinePlus related topics: Obesity Pre-diabetes Weight Control

U.S. FDA Resources

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2011
Estimated 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.

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

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

Universitaire de Sherbrooke

The Lawson Foundation

Investigators

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

More Information

No publications provided

Responsible Party:	Marie-France Langlois- Principal Investigator, Université de Sherbrooke
ClinicalTrials.gov Identifier:	NCT00969007 History of Changes
Other Study ID Numbers:	08-083
Study First Received:	August 28, 2009
Last Updated:	May 7, 2010
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Obesity
Glucose Intolerance
Prediabetic State
Overweight
Overnutrition
Nutrition Disorders
Body Weight

Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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