Diabetes Prevention In Estrie

Study Overview
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Brief Summary
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This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes. This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.

Detailed Description
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Eligible participants will be randomized into 2 intervention groups (30 per group): Small Meeting groups: a curriculum of 25 meeting-seminars will take place for 45 minutes, each one approaching various aspects of nutrition, physical activity, psychology, motivation and medical needs. These seminars are administered by the professionals of the obesity clinic and are already in place. However, these are usually only offered to the patients registered with the obesity clinic. Obesity Clinic of CHUS: combination of 25 described meeting-seminars see-high, in addition to individual interviews every 6 weeks with the interdisciplinary team of the obesity clinic of CHUS (usual operation). Subjects will be evaluated initially and then every 3 months during 1 year by the following measurements: questionnaires to evaluate motivation and physical activity; 3 day dietary journals; weight assessment, using both metabolic and mechanical balance; waist circumference; and blood pressure. A medical evaluation with size measure, a test evaluating knowledge of the participants on obesity, OGTT (Oral Glucose Tolerance Test) - a 5 hour determination of secretion and resistance to insulin, insulin-mediated suppression of plasma non-esterified fatty acids, a plasma lipid profile, accelerometry, bio electric impedance, and an activity physical test (6 minute walk test) will be carried out initially, and then repeated for up to 1 year.

Official Title
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Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects

Conditions
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Overweight, Glucose Intolerance

Intervention / Treatment
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* Behavioral: interdisciplinary intervention or meeting-seminars


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pre diabetic state underlined by a marginal fasting glycemia between 6,1 and 6,9 mmol/L and/or a glucose intolerance with glucose confirmed by an OGTT 2 hours overweight or obesity (BMI > 27 kg/m² ; (Body Mass Index)) enlightened assent Exclusion Criteria: Impossibility to be present at the visits Physical/motor incapacity (or other) making one unable and/or insecure to walk at a moderate to rapid speed of 6 min and more Use of an anti-obesity treatment during the last 3 months Bariatric Surgery in the past Planned Pregnancy Pacemaker
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>interdisciplinary weight loss intervention | Behavioral: interdisciplinary intervention or meeting-seminars<br>* one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle<br>|
| Active Comparator: 2<br>Small group seminars without interdisciplinary intervention | Behavioral: interdisciplinary intervention or meeting-seminars<br>* one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a weight loss of 7% in at least 19% of the subjects |  | one year | 
| reduced body weight of at least 5.6 kg in at least 25% of the subjects |  | one year | 
| an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects |  | one year | 
| a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects |  | one year | 
| a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in insulin sensitivity by HOMA |  | one year | 
| change in insulin secretion during an OGTT by deconvolution of plasma c-peptide |  | one year | 
| change in beta cell function by calculation of the disposition index |  | one year | 
| change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT |  | one year | 
| relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, glucose intolerance, pre-diabetes