LOSS- Louisiana Obese Subjects Study - Full Text View

Sponsor:	Pennington Biomedical Research Center
Collaborator:	Louisiana Office of Group Benefits
Information provided by:	Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT00115063

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Diets Obesity Weight Control

Drug Information available for: Diethylpropion Orlistat Sibutramine Sibutramine hydrochloride monohydrate Diethylpropion hydrochloride Diphenoxylate Diphenoxylate hydrochloride

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:

Percent change from baseline weight [ Time Frame: at 2 years from study start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight loss in kg [ Time Frame: at 2 years and 5 years from study start ] [ Designated as safety issue: No ]
body mass index (BMI) change [ Time Frame: at 2 adn 5 years from study start ] [ Designated as safety issue: No ]
percent excess weight loss [ Time Frame: at 2 dn 5 years from study start ] [ Designated as safety issue: No ]
blood pressure [ Time Frame: at 2 adn 5 years from study start ] [ Designated as safety issue: Yes ]
blood tests (fasting glucose, lipids - cholesterol, HDL, LDL, triglycerides, uric acid) [ Time Frame: at 2 and 5 years from study start ] [ Designated as safety issue: Yes ]
data from questionnaires (health-related quality of life, stress, depression, socioeconomic assessments) [ Time Frame: at 2 dn 5 years from study start ] [ Designated as safety issue: No ]
total medical costs obtained from the OGB data files [ Time Frame: at 2 and 5 years from study start ] [ Designated as safety issue: No ]

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
1: Experimental 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 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".
2: Active Comparator 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

Arms

Assigned Interventions

1: Experimental

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 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".

2: Active Comparator

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participant in the EPO, MCO and 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*
CBC: normal hematocrit, white count and platelet count, unless waived by Principal Investigator
Uric Acid <9.0 mg/dl
Normal Creatinine
Normal 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 HIV positive, hepatitis C or active tuberculosis
Cardiovascular disease event within the past year
Severe congestive heart failure (NYHA class III, IV)
Second degree or greater heart block
Blood Pressure >160 systolic or BP >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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115063

Locations

United States, Louisiana
Pennington Management of Clinical Trials
Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pennington Biomedical Research Center

Louisiana Office of Group Benefits

Investigators

Principal Investigator:

Donna H Ryan, MD

Pennington Biomedical Research Center

More Information

Additional Information:

Pennington Biomedical Research Center home page This link exits the ClinicalTrials.gov site

No publications provided

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:

obesity
Low Calorie Diet
Obesity Pharmacotherapy
Pragmatic Clinical Trial

Additional relevant MeSH terms:

Obesity
Diethylpropion
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Overweight
Pharmacologic Actions
Antidiarrheals
Diphenoxylate
Body Weight
Sibutramine

Signs and Symptoms
Anti-Obesity Agents
Sensory System Agents
Therapeutic Uses
Nutrition Disorders
Appetite Depressants
Overnutrition
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Antidepressive Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 05, 2009