Look AHEAD: Action for Health in Diabetes

描述（由申请人提供）：Look AHEAD是一项随机临床试验，研究了约5145名超重2型糖尿病志愿者进行强化减肥干预的长期健康影响。参与者被随机分配到通过减少热量摄入和增加体力活动来实现和维持体重减轻的强化生活方式干预组，或糖尿病支持和教育控制组。Look AHEAD的主要终点是在11.5年的计划随访期间严重心血管事件（致死性和非致死性Ml、卒中和心血管死亡）的总发生率。最初的拨款申请为研究的前7年提供资金（1年用于研究设计，6年用于试验执行）。目前的拨款申请是额外七年的拨款，以完成“展望”试验。研究的各个方面都进行得非常顺利——5145名样本按时被招募；保留效果非常好，干预措施在产生最初的体重减轻并长期保持有效。所有16个临床站点在招募、保留和提供干预措施方面都取得了成功，DSMB对试验的执行非常积极。本应用程序回顾了展望的总体设计，到目前为止的进展，并计划未来。具体目标是随着时间的推移保留队列，继续完成年度亲自访问和半年度电话访谈以进行结果评估，并继续管理生活方式干预。这些程序将使我们能够分析干预对严重心血管相关因素和并发症的影响，以及干预的成本效益。

DESCRIPTION (provided by applicant): Look AHEAD is randomized clinical trial examining the long-term health effects of an intensive weight loss intervention in approximately 5,145 overweight volunteers with type 2 diabetes. Participants are randomized to an intensive lifestyle intervention designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity, or to a control program of diabetes support and education. The primary outcome of Look AHEAD is the aggregate occurrence of severe cardiovascular events (fatal and non-fatal Ml and stroke and cardiovascular deaths) over a planed follow-up of 11.5 years. The original grant application provided funding for the first 7 years of the study (1 year for study design and 6 for execution of the trial). The present grant application is for an additional 7 years of funding to complete the Look AHEAD trial. All aspects of the study have proceeded extremely well - the sample of 5,145 was recruited on time; retention has been excellent and the intervention has been effective in producing initial weight loss and maintaining it over time. All 16 clinical sites have been successful in recruitment, retention, and delivery of the intervention and the DSMB has been very positive about the execution of the trial. The present application reviews the overall design of Look AHEAD, progress to date, and plans for the future. Specific Aims are to retain the cohort over time, continue to complete annual in-person visits and semi-annual telephone interviews for outcome assessments and continue to administer the lifestyle intervention. These procedures will enable us to analyze the effects of the intervention on serious cardiovascular- related factors and complications, and cost-effectiveness of the intervention.