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.
Timeline
- Start
- 2005-07
- Primary completion
- 2007-12
- Completion
- 2008-01
Outcome
Met primary endpoint
Stopped: “ethical issues of continuing control group without treatment”
registry Intensive Medical Intervention vs Access to Weight Loss Informational Website; p <0.001; t-test, 2 sided NCT00115063 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orlistat | Small molecule | — | — |
| Subject | Sibutramine | Small molecule | — | — |
| Subject | diethylpropion | Small molecule | — | — |