LOSS- Louisiana Obese Subjects Study
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.
Behavioral: group sessions
Drug: sibutramine, orlistat, diethylpropion
Behavioral: Low Calorie Diet, Health One
Other: Intensive Medical Combination Therapy for Obesity
Other: Control Condition
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Loss - Louisiana Obese Subjects Study|
- Percent Change From Baseline Weight [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]
- Change in Weight From Baseline in Kilograms (kg) [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]
- Change in Blood Pressure [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: Yes ]
- Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: Yes ]
- Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL) [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: Yes ]
- Change in Duke Activity Status Index (DASI) Questionnaire Score [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]The DASI was used to access changes in fuctional capacity during the study. The highest score possible is 58.2 and the lowest is 0. The score for each individual question varied depending on the intensity of the activity being evaluated. The higher the score, the more physically active a person is to this set of activities of daily living questions.
|Study Start Date:||July 2005|
|Study Completion Date:||January 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Behavioral: group sessions
group sessions lead by a trained primary care clinic employeeDrug: sibutramine, orlistat, diethylpropion
dosage modified according to package insert instructions at discretion of primary care physiciansBehavioral: Low Calorie Diet, Health One
liquid diet for 8-12 weeks to induce weight lossOther: Intensive Medical Combination Therapy for Obesity
Very Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a "Treatment Toolbox".
Active Comparator: 2
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Other: Control Condition
Access to the Mayo Clinic weight management website and usual care from the primary care physician
Hide Detailed Description
LOSS is a pragmatic clinical trial designed to evaluate intensive medical treatment for patients with severe obesity who would otherwise qualify as candidates for obesity surgery and who are covered by the Louisiana Office of Group Benefits (OGB) Health Insurance. LOSS will track the efficacy, safety and costs to compare two patient management approaches - intensive medical treatment, or a usual medical care treatment model. Recruitment will be done by mailers to insured patients to identify eligible candidates. We will randomly assign eligible volunteers to intensive medical treatment (n=240) or usual care (n=240). Patients will be evaluated annually and medical treatments are given in eight clinics around Louisiana. The eight sites are in Alexandria, Baton Rouge, Lafayette, Lake Charles, Monroe, Hammond, New Orleans and Shreveport.
We hypothesize that we can achieve weight loss after two and five years that exceeds 20% from baseline with intensive medical management of persons with class III obesity and that this weight loss is greater than that achieved with usual medical care including access to a weight management web site.
Our secondary hypotheses are: 1) that the weight loss at year 2 and 5 in the intensive medical group is associated with improvements in blood pressure, fasting glucose, lipids, health-related quality of life and psychosocial measures and is greater improvement than that achieved with usual medical care and access to a website; and 2) that total medical costs in the intensive medical management group will compare favorably to total medical costs in the usual care group (i.e., total reimbursement from insurance costs will be less, even when the expense of the treatment is considered).
The overarching aim of this study is to observe the effect of an intensive medical management program versus usual care for class III obesity on weight loss, total medical costs and, on measures of health risks associated with weight loss (blood pressure, blood glucose, blood lipids, and health-related quality of life).
Primary: The primary specific aim of the LOSS study is to test the hypothesis that the weight loss efficacy at years 2 and 5 for an intensive medical treatment program for Class III obesity produces greater weight loss, as compared to a condition of usual care.
Secondary: The secondary aims of the study are:
- To evaluate the percent change in body weight, absolute change in body weight (kilograms) and percent excess weight lost from baseline at months 3, 6, 12, 24, 36, 48 and 60 for medically treated patient groups, and at years 1, 2, 3, 4 and 5 for both groups.
- To evaluate the number and proportion of subjects who maintain 100% and 80% of 12 months weight lost at months 24, 36, 48 and 60 for medically treated patients and at years 2, 3, 4 and 5 for both groups.
- To evaluate the changes from baseline in blood pressure, pulse rate, and efficacy laboratory parameters at visits on months 3, 6, 12, 24, 36, 48 and 60 for the medically treated patient group, and at years 1, 2, 3, 4 and 5 for both groups.
- To assess the safety and tolerability of the intervention regimens at months 3, 6, 12, 24, 36, 48 and 60 for the medically treated patient group.
- To assess the total medical costs of the participants treated with intensive medical treatment and for the patients receiving usual care at years 1, 2, 3, 4 and 5.
- To assess additional psychosocial and economic measures (health-related quality of life, pain, depression, and stress) for the intervention group at months 4, 8, 12, 24, 36, 48 and 60 months for both groups at years 1, 2, 3, 4, and 5.
- To compare subgroups of patients with class III obesity to determine if differences in outcome exist for gender, race, education level, decades of age and presence of co-morbid conditions.
The Pennington Biomedical Research Center is the lead institution for the project. Pennington Management of Clinical Trials (PMCT) will serve as the Coordinating Center to manage enrollment and data acquisition and will report all data of health and cost results to a Data Safety Monitoring Board on a regular basis. Major data reports and scientific publications occur at years 2 and 5.
|United States, Louisiana|
|Pennington Management of Clinical Trials|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Donna H Ryan, MD||Pennington Biomedical Research Center|