Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
1 other identifier
interventional
60
1 country
1
Brief Summary
This study is a randomized, controlled and opened trial designed to compare the effects of an interdisciplinary moderate-intensity lifestyle modification program vs. conventional treatment by primary care physicians. We want to show the benefits of coherent interdisciplinary care in the obesity clinic of CHUS (Centre Hospitalier Universitaire de Sherbrooke) in comparison to the conventional treatment in order to:
- Improve subjects' characteristic features of metabolic syndrome: weight, waist circumference, fatty mass, plasma lipid profile, blood pressure, fasting glycaemia, and HbA1c;
- Improve our patients' nutritive practices;
- Decrease our patients' sedentary lifestyle;
- Improve our patients' motivation to lose weight, and to improve their quality of life; We also wish to define predictors of answer in order to better select the patients if necessary, and evaluate the costs incurred by the health system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Mar 2004
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedNovember 6, 2009
November 1, 2009
2.3 years
November 5, 2009
November 5, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
After 6 months of follow-up, the treatment group proportion achieved a 5% reduction in body weight compared to the control group.
6 months
Secondary Outcomes (2)
Weight; fatty mass; features of the metabolic syndrome; food intake; energy expenditure; quality of life; motivation; cost/effectiveness.
Metabolic syndrome characteristics
18 months
Interventions
Eligibility Criteria
You may qualify if:
- referred to the obesity clinic by a medical doctor;
- BMI \> 27 kg/m²; (Body Mass Index)
- metabolic associated syndrome according to the definition of the NCEP-ATP III
- be able to give an inform consent
You may not qualify if:
- Impossibility to be present at the visits
- Physical/motor incapacity (or other) making one unable and insecure to walk at a moderate to rapid speed for 6 min and more
- Use of an anti-obesity treatment the last 3 months
- Bariatric Surgery in the past
- Planned Pregnancy
- Pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-France Langlois, MD
Medecine Department, Division of endocrinology, CHUS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
March 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
November 6, 2009
Record last verified: 2009-11