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Completed

NCT Number: NCT01008878

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interdisciplinary intervention

Behavioral

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.

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Nov 6, 2009
Registry last updated
Nov 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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