Diabetes Prevention In Estrie

NCT ID: NCT00991549

Last Updated: 2009-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-01-31

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):

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.

Conditions

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Overweight Glucose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

interdisciplinary weight loss intervention

Group Type EXPERIMENTAL

interdisciplinary intervention or meeting-seminars

Intervention Type BEHAVIORAL

one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle

2

Small group seminars without interdisciplinary intervention

Group Type ACTIVE_COMPARATOR

interdisciplinary intervention or meeting-seminars

Intervention Type BEHAVIORAL

one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle

Interventions

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interdisciplinary intervention or meeting-seminars

one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle

Intervention Type BEHAVIORAL

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministere de la Sante et des Services Sociaux

OTHER

Sponsor Role collaborator

Novonordisk endocrine fellowship program

UNKNOWN

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Universitaire de Sherbrooke

Principal Investigators

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Marie-France Langlois, MD

Role: PRINCIPAL_INVESTIGATOR

Medecine department, Division of endocrinology, CHUS

Locations

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Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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Gagnon C, Brown C, Couture C, Kamga-Ngande CN, Hivert MF, Baillargeon JP, Carpentier AC, Langlois MF. A cost-effective moderate-intensity interdisciplinary weight-management programme for individuals with prediabetes. Diabetes Metab. 2011 Nov;37(5):410-8. doi: 10.1016/j.diabet.2011.01.003. Epub 2011 Apr 13.

Reference Type DERIVED
PMID: 21489843 (View on PubMed)

Other Identifiers

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04-087

Identifier Type: -

Identifier Source: org_study_id

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