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

This study has been completed.
Sponsor:
Information provided by:
Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01008878
First received: November 5, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention
Obesity
Metabolic Syndrome
 Behavioral: interdisciplinary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire de Sherbrooke:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight; fatty mass; features of the metabolic syndrome; food intake; energy expenditure; quality of life; motivation; cost/effectiveness.
  • Metabolic syndrome characteristics [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008878

Locations
Canada, Quebec
Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Universitaire de Sherbrooke
Investigators
Principal Investigator: Marie-France Langlois, MD Medecine Department, Division of endocrinology, CHUS
  More Information

No publications provided

Responsible Party: Dr Marie-France Langlois, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01008878     History of Changes
Other Study ID Numbers: 04-003
Study First Received: November 5, 2009
Last Updated: November 5, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013