Rushing J, Wing R, Wadden T A, Knowler W C, Lawlor M, Evans M, Killean T, Montez M, Espeland M A, Zhang P
Department of Biostatistical Sciences Wake Forest School of Medicine Winston-Salem NC USA.
Weight Control and Diabetes Research Center Brown Medical School/The Miriam Hospital Providence RI USA.
Obes Sci Pract. 2017 Mar;3(1):15-24. doi: 10.1002/osp4.92. Epub 2017 Feb 24.
The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention.
The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars.
During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares.
The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost-effectiveness of the ILI and will contain additional follow-up data.
糖尿病健康行动(Look AHEAD)试验是一项随机对照临床试验,旨在比较10年强化生活方式干预(ILI)与糖尿病支持与教育(DSE)对照条件对5000多名2型糖尿病参与者健康结局的影响。在整个试验过程中,ILI的体重减轻显著大于DSE。本分析的目的是描述实施该干预措施的成本。
ILI旨在促进体重减轻并增加身体活动。它包括小组加个人干预课程的组合,在10年中接触频率逐渐降低。该干预采用了多种策略,包括代餐产品,以改善体重减轻效果。干预实施成本来自工作人员工作量调查以及美国16个学术临床试验地点的干预材料记录。成本从付款人的角度计算,并以2012年美元表示。
在第一年,即干预实施最密集的时候,各临床地点ILI参与者的干预实施年度平均成本(标准差)为每人2864.6美元(513.3美元),而DSE参与者为每人202.4美元(76.6美元)。随着干预强度的下降,成本也降低,以至于在试验的第5至9年,ILI参与者的干预年度成本为每人1119.8美元(227.7美元),DSE参与者为每人102.9美元(33.0美元)。在整个试验过程中,人员配备占成本的大部分,代餐和促进依从性的材料占比小。
Look AHEAD干预带来的持续体重减轻得到了干预成本的支持,该成本在其他减肥计划的范围内。未来的工作将包括对ILI成本效益的评估,并将包含更多的随访数据。