Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
Primary Purpose
Obesity, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
interdisciplinary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Criteria Inclusion:
- 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
Criteria Exclusion:
- 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
Sites / Locations
- Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
Outcomes
Primary Outcome Measures
After 6 months of follow-up, the treatment group proportion achieved a 5% reduction in body weight compared to the control group.
Secondary Outcome Measures
Weight; fatty mass; features of the metabolic syndrome; food intake; energy expenditure; quality of life; motivation; cost/effectiveness.
Metabolic syndrome characteristics
Full Information
NCT ID
NCT01008878
First Posted
November 5, 2009
Last Updated
November 5, 2009
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT01008878
Brief Title
Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
Official Title
Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Eligible participants recruited from patients, referred through the obesity clinic were separated into two groups.
The interdisciplinary treatment group received interventions at our clinic for 6 months.. The intervention included a visit every 6 weeks including a nursing consultation (listening, psychological support, anthropometric measurements and blood pressure), an endocrinologist consultation, a nutritionist consultation (initial evaluation of food intake and counselling), a psychologist consultation if needed, an interactive group information session (to discuss the following: diet, psychological aspects associated with obesity, physical education, complications and pharmacological treatments of obesity), and a questionnaire on the individual costs of their visit.
A control group was monitored during this 6 months by their family physician, as per usual.
A biological assessment, questionnaires, and tests will be carried out in beginning and end of program: the questionnaires are to evaluate the physical activity (Sallis, Canada fitness survey); the quality of life (IWQOL-Lite, SF-36); the motivation (analogical visual Scales); knowledge (pretest and post-test); and costs. Tests to assess physical activity (6-minute walk test and accelerometer) will also be administered.
After the first 6 months, both groups were followed at the obesity clinic for another 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
interdisciplinary intervention
Primary Outcome Measure Information:
Title
After 6 months of follow-up, the treatment group proportion achieved a 5% reduction in body weight compared to the control group.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight; fatty mass; features of the metabolic syndrome; food intake; energy expenditure; quality of life; motivation; cost/effectiveness.
Title
Metabolic syndrome characteristics
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria Inclusion:
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
Criteria Exclusion:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-France Langlois, MD
Organizational Affiliation
Medecine Department, Division of endocrinology, CHUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
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