Ryan Donna H, Johnson William D, Myers Valerie H, Prather Tiffany L, McGlone Meghan M, Rood Jennifer, Brantley Phillip J, Bray George A, Gupta Alok K, Broussard Alan P, Barootes Bryan G, Elkins Brian L, Gaudin David E, Savory Robert L, Brock Ricky D, Datz Geralyn, Pothakamuri Srininvasa R, McKnight G Tipton, Stenlof Kaj, Sjöström Lars V
Pennington Biomedical Research Center of Louisiana State University System, Baton Rouge, LA 70808, USA.
Arch Intern Med. 2010 Jan 25;170(2):146-54. doi: 10.1001/archinternmed.2009.508.
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.
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.
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.
Primary care practices can initiate effective medical management for extreme obesity; future efforts must target improving retention and weight loss maintenance.
clinicaltrials.gov Identifier: NCT00115063.
极端肥胖需要有效的初级保健实践(PCP)治疗方法。路易斯安那肥胖受试者研究(LOSS)旨在测试,经过简短培训后,初级保健医生能否有效地为体重指数(BMI)(计算方法为体重千克数除以身高米数的平方)在40至60之间的个体实施体重减轻计划。
LOSS是一项为期2年(2005年7月5日至2008年1月30日)的随机对照“实用临床试验”,对7名初级保健医生和1家研究诊所进行了肥胖管理培训。主要结局指标是第2年体重相对于基线体重的百分比变化。对597名志愿者进行了筛查,并将其随机分为强化医学干预组(IMI)(n = 200)或常规护理组(UCC)(n = 190)。UCC组接受了互联网体重管理计划的指导。IMI组的建议包括12周或更短时间的900千卡流食、小组行为咨询、结构化饮食,以及在第3至7个月选择药物治疗(盐酸西布曲明、奥利司他或盐酸二乙丙胺),并在第8至第24个月持续使用药物和维持策略。
参与者的平均年龄为47岁;83%为女性,75%为白人。IMI组的保留率为51%,UCC组为46%(P = 0.30)。2年后,结果如下:(1)在390名随机分组的参与者中,IMI组31%的人实现了5%或更多的体重减轻,7%的人实现了20%或更多的体重减轻,而UCC组分别为9%和1%。(2)均值±标准误的基线观察值结转分析显示,IMI组体重减轻了-4.9%±0.8%,UCC组为-0.2±0.3%。(3)末次观察值结转分析显示,IMI组体重减轻了-8.3%±0.79%,而UCC组为-0.0%±0.4%。(4)共有101名完成IMI治疗的参与者体重减轻了-9.7%±1.3%(-12.7±1.7千克),而89名完成UCC治疗的参与者体重减轻了-0.4%±0.7%(-0.5±0.9千克);(所有组间差异P < 0.001)。许多代谢参数得到改善。
初级保健实践可以启动针对极端肥胖的有效医学管理;未来的努力必须致力于提高保留率和维持体重减轻效果。
clinicaltrials.gov标识符:NCT00115063。