LOSS- Louisiana Obese Subjects Study

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

Interventions

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".

OTHER

Control Condition

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

Sponsors & Collaborators

• Louisiana Office of Group Benefits

  collaborator UNKNOWN

• Pennington Biomedical Research Center

  lead OTHER

Principal Investigators

• Donna H Ryan, MD · Pennington Biomedical Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-07-31

Primary Completion

2007-12-31

Completion

2008-01-31

Countries

• United States

Study Locations