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Results of the Louisiana Obese Subjects Study

Donna H. Ryan, MD; William D. Johnson, PhD; Valerie H. Myers, PhD; Tiffany L. Prather, RN; Meghan M. McGlone, MPH; Jennifer Rood, PhD; Phillip J. Brantley, PhD; George A. Bray, MD; Alok K. Gupta, MD; Alan P. Broussard, MD; Bryan G. Barootes, MD; Brian L. Elkins, MD; David E. Gaudin, MD; Robert L. Savory, MD; Ricky D. Brock, RN; Geralyn Datz, PhD; Srininvasa R. Pothakamuri, MS; G. Tipton McKnight, MD; Kaj Stenlof, MD, PhD; Lars V. Sjöström, MD

Arch Intern Med. 2010;170(2):146-154.

Background  Effective primary care practice (PCP) treatments are needed for extreme obesity. The Louisiana Obese Subjects Study (LOSS) tested whether, with brief training, PCPs could effectively implement weight loss for individuals with a body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) of 40 to 60.

Methods  The LOSS, a 2-year (July 5, 2005, through January 30, 2008) randomized, controlled, "pragmatic clinical trial" trained 7 PCPs and 1 research clinic in obesity management. Primary outcome measure was year-2 percentage change from baseline weight. Volunteers (597) were screened and randomized to intensive medical intervention (IMI) (n = 200) or usual care condition (UCC) (n = 190). The UCC group had instruction in an Internet weight management program. The IMI group recommendations included a 900-kcal liquid diet for 12 weeks or less, group behavioral counseling, structured diet, and choice of pharmacotherapy (sibutramine hydrochloride, orlistat, or diethylpropion hydrochloride) during months 3 to 7 and continued use of medications and maintenance strategies for months 8 to 24.

Results  The mean age of participants was 47 years; 83% were women, and 75% were white. Retention rates were 51% for the IMI group and 46% for the UCC group (P = .30). After 2 years, the results were as follows: (1) among 390 randomized participants, 31% in the IMI group achieved a 5% or more weight loss and 7% achieved a 20% weight loss or more, compared with 9% and 1% of those in the UCC group. (2) The mean ± SEM baseline observation carried forward analysis showed a weight loss of –4.9% ± 0.8% in IMI and –0.2 ± 0.3% in UCC. (3) Last observation carried forward analysis showed a weight loss of –8.3% ± 0.79% for IMI, whereas UCC was –0.0% ± 0.4%. (4) A total of 101 IMI completers lost –9.7% ± 1.3% (–12.7 ± 1.7 kg), whereas 89 UCC completers lost –0.4% ± 0.7% (–0.5 ± 0.9 kg); (P < .001 for all group differences). Many metabolic parameters improved.

Conclusion  Primary care practices can initiate effective medical management for extreme obesity; future efforts must target improving retention and weight loss maintenance.

Trial Registration  clinicaltrials.gov Identifier: NCT00115063

Author Affiliations: Pennington Biomedical Research Center of the Louisiana State University (LSU) System, Baton Rouge (Drs Ryan, Johnson, Myers, Rood, Brantley, Bray, and Gupta and Ms McGlone); Pennington Management of Clinical Trials, Baton Rouge (Ms Prather and Mssrs Brock and Pothakamuri); LSU Health Science Center, New Orleans (Drs Broussard and Barootes); LSU Unit, Lafayette (Dr Broussard); LSU Unit, Lake Charles (Dr Barootes); LSU Health Science Center, Shreveport (Dr Elkins); LSU Unit, Alexandria (Dr Elkins); Willis Knighton–Pierremont Health Center, Shreveport (Dr Savory); and Medical Department, Sahlgrenska University Hospital, University of Gothenburg, Göteborg, Sweden (Drs Stenlof and Sjöström). Dr Gaudin is in private practice in Hammond, Louisiana. Dr Datz is in private practice in Hattiesburg, Mississippi. Dr McKnight is in private practice in Baton Rouge. Ms Prather is now with the Pennington Biomedical Research Center. Mr Brock is now with Aureus Research Consultants LLC. Mr Pothakamuri is now with Cisco Systems Inc.

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