LOOK AHEAD: ACTION FOR HEALTH IN DIABETES

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 目的：Look AHEAD项目的主要目的是在超重的2型糖尿病志愿者中检查强化生活方式干预计划的长期影响，该计划旨在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。 研究：将该计划与涉及糖尿病支持和教育计划的受控条件进行比较。 比较的主要依据是严重心血管事件的发生率。 其他结果，包括心血管疾病的危险因素，糖尿病相关的代谢因素和并发症，以及强化干预的成本效益也进行了研究。 研究人群为约5，000名年龄在45-75岁之间且超重（体重指数大于或等于25）的2型糖尿病志愿者。 方法：符合条件的志愿者被随机分配到一个强化的生活方式干预或糖尿病支持和教育。 治疗分配未设盲。 生活方式干预是通过个人监督和小组会议实施的，旨在实现并保持体重较基线至少下降7%，每周体力活动175分钟。 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、卒中和心血管死亡。 本研究为多中心、双组随机对照临床试验。 在5,000名受试者中，该研究有90%的概率检测到干预组之间主要心血管疾病事件的18%差异。

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 subjects, the study has a 90% probability of detecting an 18% difference in major cardiovascular disease events between the intervention groups.