LOSS- Louisiana Obese Subjects Study
Condition: Obesity
MeSH terms: Obesity
Intervention: group sessions; sibutramine, orlistat, diethylpropion; Low Calorie Diet, Health One; Intensive Medical Combination Therapy for Obesity; Control Condition
Intervention description: group sessions lead by a trained primary care clinic employee; dosage modified according to package insert instructions at discretion of primary care physicians; liquid diet for 8-12 weeks to induce weight loss; Very Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a "Treatment Toolbox".; Access to the Mayo Clinic weight management website and usual care from the primary care physician
Intervention MeSH terms: Orlistat; Sibutramine; Diethylpropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 390.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: obesity; Low Calorie Diet; Obesity Pharmacotherapy; Pragmatic Clinical Trial

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant in the Exclusive Provider Organization (EPO), Managed Care Organization
             (MCO) and Preferred Provider Organization (PPO) programs of the Louisiana State
             Employees Group Benefits Health Insurance

          -  Agree to travel for treatment to the assigned study site

          -  Agree to randomized treatment assignment

          -  Male and females age 20-60 years

          -  Body Mass Index >40kg/m2 but < 60 kg/m2

          -  Females must be non-pregnant and using an approved contraception method

          -  Complete Blood Count (CBC): normal hematocrit, white count and platelet count, unless
             waived by Principal Investigator (PI)

          -  Uric Acid <9.0 mg/dl

          -  Normal Creatinine

          -  Normal Thyroid Stimulating Hormone (TSH)

          -  Negative urine pregnancy test for women of childbearing potential

          -  Able to give written informed consent

          -  Able to comply with study procedures

        Exclusion Criteria:

        Factors that may limit adherence to interventions or affect conduct of the trial:

          -  Unable or unwilling to give informed consent or communicate with local study staff

          -  Hospitalization for psychiatric illness or substance use/abuse within the past year

          -  Self-report of alcohol or substance abuse within the past twelve months

          -  Current major depressive episode or history of suicidal behaviors

          -  Endorsement of significant recent suicidal ideation (as determined by PI)

          -  Travel plans that do not permit participation

          -  History of prior bariatric surgery, small bowel resection, or extensive bowel
             resection

          -  Current use of chronic systemic corticosteroids, appetite suppressants, antipsychotic
             medication, herbal medications for weight loss or any medication not approved by the
             PI.

          -  Another member of the household is a participant or staff member in the study

          -  History of eating disorder such as anorexia nervosa, bulimia, or binge eating

          -  Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or
             personality disorder (as determined by the PI)

          -  Currently pregnant or nursing or plans to become pregnant in the next five years

          -  Except for non-melanoma skin cancer, cancer requiring treatment in the past five
             years, unless the prognosis is excellent

          -  Self report of Human Immunodeficiency Virus (HIV) positive, hepatitis C or active
             tuberculosis

          -  Cardiovascular disease event within the past year

          -  Severe congestive heart failure (New York Heart Association [NYHA] Functional Class
             III, IV)

          -  Second degree or greater heart block

          -  Blood Pressure >160 systolic or >100 diastolic on two consecutive visits, unless
             treated and re-screened

          -  Based upon responses to psychological screening or an interview, patients may be
             excluded by the study psychologist.

          -  Other medical, psychiatric, or behavioral limitations that in the judgment of the
             investigator may interfere with study participation or the ability to follow the
             intervention protocol.

          -  Pregnancy is to be avoided during the study. Women who have not had a hysterectomy or
             oophorectomy must have a negative urine pregnancy test result at screening. Women of
             childbearing potential will be allowed to participate if they have undergone tubal
             ligation, or use one of the following types of contraception: properly used condom or
             diaphragm, oral contraceptives, hormonal implant, or intrauterine device (IUD). Sexual
             abstinence may constitute an acceptable birth control method for this study with
             investigator approval. Women with male partners who have had a successful vasectomy
             (more than one year of unprotected sexual intercourse without pregnancy) are not
             required to use additional birth control methods as long as the relationship remains
             exclusive, and the woman agrees to use an approved contraception method with any other
             male partner. Questions regarding individual patient contraceptive practices should be
             directed to the Principal Investigator.