LOOK AHEAD: ACTION FOR HEALTH IN DIABETES

描述（由申请人提供）：人口老龄化和肥胖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。该申请响应RFA-DK-12-502，由糖尿病健康行动（向前看）联盟的16个临床中心之一提交。所有16个临床站点和协调中心都提交了平行申请。本申请建议将Look AHEAD临床试验作为一项观察性队列研究继续进行，并对老年肥胖2型糖尿病患者最关注的健康问题进行新的评估。我们将测试是否随机分配到9-11年的强化生活方式干预，与糖尿病支持和教育的控制条件相比，在1)身体功能，损害和残疾，2)认知功能和损害，3)糖尿病控制和微血管并发症，4)晚年抑郁，5)骨折和癌症方面取得了改善。次要目的是检查试验期间观察到的亚组差异（这引起了对既往有心血管疾病史的人进行强化生活方式干预可能产生不利影响的关注）是否持久，以及在没有持续干预活动的情况下，强化生活方式干预组中取得的良好体重减轻是否保持。续期还将支持正在进行的辅助研究，维护新的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发布。我们将继续在16个临床站点跟踪前瞻性队列（约4000名参与者）。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，并以相同的概率随机分配到一组密集的生活方式干预组，这种干预组可以诱导持续的体重减轻和增加体力活动，或者控制病情（糖尿病支持和教育）。双臂都有很好的保持力。干预措施于2012年9月停止，但该队列的随访仍在继续。此申请将资助一次额外的诊所访问

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.