LOOK AHEAD: ACTION FOR HEALTH IN DIABETES

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。目的：Look AHEAD项目的主要目的是检查超重2型糖尿病志愿者通过减少热量摄入和增加身体活动来实现和维持体重减轻的强化生活方式干预计划的长期效果。研究计划：本项目与控制条件下的糖尿病支持和教育项目进行比较。比较的主要依据是严重心血管事件的发生率。其他结果，包括心血管疾病危险因素、糖尿病相关代谢因素和并发症，以及强化干预的成本效益也进行了研究。研究人群约为5000名患有2型糖尿病的志愿者，年龄在45-75岁之间，体重超重（体重指数大于或等于25）。方法：符合条件的志愿者被随机分配到强化生活方式干预组或糖尿病支持和教育组。治疗任务是公开的。生活方式干预是通过个人监督和小组会议实施的，目的是实现并保持体重比基线减少至少7%，每周进行175分钟的身体活动。主要结局是在长达11.5年的计划随访期内严重心血管事件的总发生率，包括致死性和非致死性心肌梗死、中风和心血管死亡。该研究是一项多中心、双臂随机对照临床试验。在5000人的研究中，该研究有90%的概率发现干预组之间主要心血管疾病事件的差异为18%。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: The primary objective of the Look AHEAD project is to examine, in overweight volunteers with type 2 diabetes, the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. RESEARCH PLAN: This program is compared to a controlled condition involving a program of diabetes support and education. The primary basis for the comparison is the incidence of serious cardiovascular events. Other outcomes, including cardiovascular disease risk factors, diabetes related metabolic factors and complications, and the cost-effectiveness of the intensive intervention are also studied. Study population will be approximately 5,000 volunteers with type 2 diabetes who are 45-75 years old and overweight (body mass index greater than or equal to 25). METHODS: Eligible volunteers are randomly assigned to an intensive lifestyle intervention or to diabetes support and education. Treatment assignments are unmasked. The lifestyle intervention is implemented with individual supervised and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. The primary outcome is the aggregate occurrence of severe cardiovascular events including fatal and non-fatal myocardial infarctions, stroke, and cardiovascular deaths over a planned follow-up period of up to 11.5 years. The study is a multi-center, two-armed randomized, controlled clinical trial. With 5,000, the study has a 90% probability of detecting an 18% difference in major cardiovascular disease events between the intervention groups.