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Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study

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ClinicalTrials.gov Identifier: NCT01008878
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:
Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Behavioral: interdisciplinary intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
Study Start Date : March 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Measures :
  1. Weight; fatty mass; features of the metabolic syndrome; food intake; energy expenditure; quality of life; motivation; cost/effectiveness.
  2. Metabolic syndrome characteristics [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008878


Locations
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Canada, Quebec
Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
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Principal Investigator: Marie-France Langlois, MD Medecine Department, Division of endocrinology, CHUS
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Responsible Party: Dr Marie-France Langlois, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01008878    
Other Study ID Numbers: 04-003
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases