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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01008878
Enrollment
60
Registered
2009-11-06
Start date
2004-03-31
Completion date
2006-06-30
Last updated
2009-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Metabolic Syndrome

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.

Interventions

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Weight; fatty mass; features of the metabolic syndrome; food intake; energy expenditure; quality of life; motivation; cost/effectiveness.
Metabolic syndrome characteristics18 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026