LOOK AHEAD: ACTION FOR HEALTH IN DIABETES

描述(申请人提供)：人口老龄化和肥胖症的流行导致患有糖尿病的老年肥胖者数量迅速增加。人们对旨在减轻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。该申请是对RFA-DK-12-502的响应，由糖尿病健康行动(展望未来)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。这项申请建议继续进行前瞻性临床试验，作为观察性队列研究，并跟踪参与者对患有2型糖尿病的老年肥胖者最关心的健康问题进行新的评估。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控制条件相比，是否会在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)晚年抑郁以及5)骨折和癌症方面产生改善。第二个目标是检查在试验期间观察到的亚组差异(这引发了对有心血管疾病先证者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取得的出色减肥效果是否保持不变。继续进行的工作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，并继续对展望收集的数据进行彻底的分析和发布。我们将继续跟踪16个临床站点的前瞻性队列(约4,000名参与者)。参与者在9-1年前进入试验，当时他们是肥胖或超重的，年龄在45-76岁之间，他们被随机分配到同等概率的强化生活方式干预中，这种干预导致持续的体重减轻和更多的体力活动，或者控制条件(糖尿病支持和教育)。两只胳膊都保持了很好的固位力。干预措施于2012年9月停止，但队列的后续行动仍在继续。这项申请将资助额外的一次诊所就诊。 以及正在进行的基于电话的成果评估。这一应用建立在展望在诱导和维持减肥和留住参与者方面取得的显着成功的基础上。计划中的延续以经济高效的方式为快速增长和未得到充分研究的美国人口部分解决了重要的公共卫生优先事项，利用了Look Advance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.