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Sponsors and Collaborators: |
Pennington Biomedical Research Center Louisiana Office of Group Benefits |
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Information provided by: | Pennington Biomedical Research Center |
ClinicalTrials.gov Identifier: | NCT00115063 |
LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index [BMI] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss. The active treatment period is three years, followed by two years of observation.
Condition | Intervention | Phase |
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Obesity |
Behavioral: group sessions Drug: sibutramine, orlistat, diethylpropion Behavioral: Low Calorie Diet, Health One Other: Intensive Medical Combination Therapy for Obesity Other: Control Condition |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Loss - Louisiana Obese Subjects Study |
Estimated Enrollment: | 480 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
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Behavioral: group sessions
group sessions lead by a trained primary care clinic employee
Drug: sibutramine, orlistat, diethylpropion
dosage modified according to package insert instructions at discretion of primary care physicians
Behavioral: Low Calorie Diet, Health One
liquid diet for 8-12 weeks to induce weight loss
Other: Intensive Medical Combination Therapy for Obesity
Very Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a "Treatment Toolbox".
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2: Active Comparator
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
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Other: Control Condition
Access to the Mayo Clinic weight management website and usual care from the primary care physician
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Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Factors that may limit adherence to interventions or affect conduct of the trial:
United States, Louisiana | |
Pennington Management of Clinical Trials | |
Baton Rouge, Louisiana, United States, 70808 |
Principal Investigator: | Donna H Ryan, MD | Pennington Biomedical Research Center |
Responsible Party: | Pennington Biomedical Research Center ( Donna H Ryan, MD ) |
Study ID Numbers: | PBRC - OGB -1 |
Study First Received: | June 20, 2005 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00115063 |
Health Authority: | United States: Institutional Review Board |
obesity Low Calorie Diet Obesity Pharmacotherapy Pragmatic Clinical Trial |
Sibutramine Body Weight Signs and Symptoms Obesity Orlistat Diethylpropion |
Nutrition Disorders Loperamide Overweight Overnutrition Diphenoxylate |
Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Pharmacologic Actions Antidiarrheals Anti-Obesity Agents Sensory System Agents |
Therapeutic Uses Appetite Depressants Analgesics Peripheral Nervous System Agents Central Nervous System Agents Antidepressive Agents Analgesics, Opioid |