The Look AHEAD Continuation: Action for Health in Diabetes

描述（由申请人提供）：人口老龄化和肥胖症的流行导致老年肥胖糖尿病患者数量迅速增加。人们对旨在降低体重和增加体力活动的生活方式干预的长期健康影响知之甚少。本申请是对RFA-DK-12-502的回应，由糖尿病健康行动（Look AHEAD）联盟的16家临床中心之一提交。所有16个临床研究中心和协调中心都提交了平行申请。 本申请建议继续Look AHEAD临床试验作为观察性队列研究，并对参与者进行新的评估，以评估老年肥胖2型糖尿病患者最关注的健康问题。我们将测试随机分配到9-11年的强化生活方式干预，与糖尿病支持和教育的对照条件相比，是否会导致1）身体功能，损伤和残疾，2）认知功能和损伤，3）糖尿病控制和微血管并发症，4）晚年抑郁症，以及5）骨折和癌症的改善。次要目的是检查在试验期间观察到的亚组差异是否持续（这引起了对有心血管疾病既往史的患者中强化生活方式干预可能产生的不利影响的担忧），以及尽管没有持续的干预活动，强化生活方式干预组中获得的出色体重减轻是否得到维持。继续研究还将支持正在进行的辅助研究，维护新辅助研究的基础设施，并维持对Look AHEAD收集的数据的全面分析和出版。 我们将继续在16个临床研究中心跟踪前瞻性队列（约4，000名受试者）。参与者在9-1年前进入试验，当时他们肥胖或超重，年龄在45-76岁之间，并以相等的概率随机分配到一种强化的生活方式干预，这种干预导致持续减肥和增加体力活动或控制条件（糖尿病支持和教育）。双臂保持力极佳。干预于2012年9月停止，但队列随访仍在继续。此应用程序将资助一个额外的诊所访问 和持续的电话结果评估。 该应用程序建立在Look AHEAD在诱导和维持减肥和留住参与者方面取得的显著成功的基础上。计划中的延续以具有成本效益的方式解决了美国人口中快速增长和研究不足的部分的重要公共卫生优先事项，利用了Look AHEAD提供的广泛资源。.

DESCRIPTION (provided by applicant): The aging of the population and the epidemic of obesity have led to a rapid increase in the number of older, obese individuals with diabetes. Little is known about the long-term health effects of lifestyle intervention designed to lower weight and increase physical activity in this population. This application, which responds to RFA-DK-12-502 , is submitted by one of the 16 clinical centers in the Action for Health in Diabetes (Look AHEAD) Consortium. All 16 clinical sites and the Coordinating Center have submitted parallel applications. This application proposes to continue the Look AHEAD clinical trial as an observational cohort study and to follow participants with new assessments of the health problems of greatest concern in older, obese individuals with type 2 diabetes. We will test whether random assignment to 9-11 years of intensive lifestyle intervention, compared to a control condition of diabetes support and education, results in improvements in 1) physical function, impairment and disability, 2) cognitive function and impairment, 3) diabetes control and microvascular complications, 4) late life depression, and 5) fractures and cancers. Secondary aims are to examine whether subgroup differences observed during the trial (which raised concern about possible unfavorable effects of intensive lifestyle intervention in those with a prio history of cardiovascular disease) endure and whether the excellent weight losses achieved in the intensive lifestyle intervention arm are maintained despite the absence of continued intervention activities. The Continuation will also support ongoing ancillary studies, maintain infrastructure for new ancillary studies, and sustain thorough analyses and publication of the data collected by Look AHEAD. We will continue to follow the Look AHEAD cohort (approximately 4,000 participants) across the 16 clinical sites. Participants entered the trial 9-1 years ago when they were obese or overweight and aged 45-76, and were randomly assigned with equal probability to either an intensive lifestyle intervention that has induced sustained weight loss and increased physical activity or control condition (diabetes support and education). Both arms have had excellent retention. Interventions were discontinued in Sept, 2012, but follow-up of the cohort continues. This application will fund one additional clinic visit and ongoing telephone-based outcome assessment. This application builds on the remarkable success of the Look AHEAD in inducing and sustaining weight loss and retaining participants. The planned continuation addresses important public health priorities for a rapidly growing and under-studied segment of the US population in a cost-effective manner, leveraging the extensive resources available from Look AHEAD. .