Diabetes Prevention In Estrie

Not Applicable

Completed

• Conditions: Overweight; Glucose Intolerance
• Interventions: Behavioral: interdisciplinary intervention or meeting-seminars

• Registration Number: NCT00991549
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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

Eligible participants will be randomized into 2 intervention groups (30 per group):

1. 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.

2. 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.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2007-10
• Study Completion: 2008-01
• Status Verified: 2009-10
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Last Update Submitted: 2009-10-07
• Study First Posted: 2009-10-08
• Last Update Posted: 2009-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	interdisciplinary intervention or meeting-seminars	interdisciplinary weight loss intervention
2	interdisciplinary intervention or meeting-seminars	Small group seminars without interdisciplinary intervention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada