LOSS- Louisiana Obese Subjects Study

NCT00115063 | Terminated Phase 4 Results DMC

• 1 other identifier: PBRC 25002
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

obesity; Low Calorie Diet; Obesity Pharmacotherapy; Pragmatic Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline Weight

  Baseline, 2 years

Secondary Outcomes (5)

• Change in Weight From Baseline in Kilograms (kg)

  Baseline, 2 years

• Change in Blood Pressure

  Baseline, 2 years

• Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid

  Baseline, 2 years

• Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)

  Baseline, 2 years

• Change in Duke Activity Status Index (DASI) Questionnaire Score

  Baseline, 2 years

Study Arms (2)

1

EXPERIMENTAL

Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach

Behavioral: group sessions; Drug: sibutramine, orlistat, diethylpropion; Behavioral: Low Calorie Diet, Health One; Other: Intensive Medical Combination Therapy for Obesity

2

ACTIVE COMPARATOR

Access to Weight Loss Informational Website sponsored by the Mayo Clinic

Other: Control Condition

Interventions

group sessions BEHAVIORAL

group sessions lead by a trained primary care clinic employee

1

sibutramine, orlistat, diethylpropion DRUG

dosage modified according to package insert instructions at discretion of primary care physicians

1

Low Calorie Diet, Health One BEHAVIORAL

liquid diet for 8-12 weeks to induce weight loss

1

Intensive Medical Combination Therapy for Obesity OTHER

Very Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a "Treatment Toolbox".

1

Control Condition OTHER

Access to the Mayo Clinic weight management website and usual care from the primary care physician

2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Louisiana Office of Group Benefits: collaborator

Study Sites (1)

Pennington Management of Clinical Trials

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

• Johnson WD, Brashear MM, Gupta AK, Rood JC, Ryan DH. Incremental weight loss improves cardiometabolic risk in extremely obese adults. Am J Med. 2011 Oct;124(10):931-8. doi: 10.1016/j.amjmed.2011.04.033.

  PMID: 21962313 DERIVED

• Ryan DH, Johnson WD, Myers VH, Prather TL, McGlone MM, Rood J, Brantley PJ, Bray GA, Gupta AK, Broussard AP, Barootes BG, Elkins BL, Gaudin DE, Savory RL, Brock RD, Datz G, Pothakamuri SR, McKnight GT, Stenlof K, Sjostrom LV. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med. 2010 Jan 25;170(2):146-54. doi: 10.1001/archinternmed.2009.508.

  PMID: 20101009 DERIVED

Related Links

• Pennington Biomedical Research Center home page

MeSH Terms

Conditions

Obesity

Interventions

sibutramine; Orlistat; Diethylpropion; Caloric Restriction; One Health; Adiposity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Ethylamines; Amines; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health; Population Characteristics; Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism

Limitations and Caveats

The study was stopped prematurely for efforts to be focused on assisting the Office of Group Benefits (OGB) in translating a policy that would allow for physician certification in order to offer participants the intensive treatment.

Results Point of Contact

• Title: Tiffany Prather, RN, CDE
• Organization: PenningtonBRC

tiffany.prather@pbrc.edu

225-763-2979

Study Officials

• Donna H Ryan, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Adjunct

Study Record Dates

• First Submitted: June 20, 2005
• First Posted: June 21, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2008
• Last Updated: February 22, 2016
• Results First Posted: June 7, 2010

Record last verified: 2016-01

Locations

US (1)