Coordinating Center for Look AHEAD: Health in Diabetes

Look AHEAD 协调中心：糖尿病健康

• 批准号: 6381731
• 负责人: MARK Andrew ESPELAND
• 金额: $ 403.17万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6381731
• 关键词: atherosclerosis; carotid artery; chemotherapy; clinical research; clinical trials; cooperative study; diet; disease /disorder proneness /risk; exercise; human subject; human therapy evaluation; noninsulin dependent diabetes mellitus; nutrition related tag; obesity; outcomes research; weight loss

(Revised Abstract) Overweight and obesity are major health problems in the United States, affecting more than 50% of adults. The long-term consequences of being overweight or obese include increased mortality and increased morbidity from a variety of associated disease states. Short-term weight loss has been demonstrated to ameliorate obesity-related metabolic abnormalities and cardiovascular disease risk factors. However, observational studies have raised concerns about negative effects of weight loss and weight cycling over the long term, including increased mortality. Look AHEAD (Action For Health in Diabetes) is a 2-armed randomized controlled clinical trial studying overweight and obese volunteers with type 2 diabetes at 16 clinical centers. Approximately 5,000 volunteers with type 2 diabetes aged 45-75 years with body mass index > 25 kg/m will be recruited, including approximately equal numbers of men and women and at least 33% participants from ethnic minority groups. The primary objective of Look AHEAD is to examine the long-term health effects of an intensive Lifestyle Intervention designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. The Lifestyle intervention is implemented with individual supervision and group sessions and aims to achieve at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity on average and to sustain these goals. This program will be compared to a control condition involving a program of Diabetes Support and Education. The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes cardiovascular death (including fatal myocardial infarction and stroke), non-fatal myocardial infarction, and non-fatal stroke, over a planned follow-up period of up to 11.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to Diabetes Support and Education. The study is projected to have 90% probability of detecting an 18% difference in this primary outcome between the 2 groups. A composite secondary outcome of all deaths, CVD events, and CVD procedures has been defined. Additional outcomes include: diabetes control and complications, fitness, general health, health-related quality of life, and psychological outcomes. The cost and cost effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed.

（修订摘要） 超重和肥胖是美国的主要健康问题，影响超过50%的成年人。 超重或肥胖的长期后果包括死亡率增加和各种相关疾病状态的发病率增加。 短期减肥已被证明可以改善肥胖相关的代谢异常和心血管疾病的危险因素。 然而，观察性研究已经引起了人们对长期减肥和体重循环的负面影响的担忧，包括死亡率增加。 展望未来（糖尿病健康行动）是一项在16个临床中心研究超重和肥胖2型糖尿病志愿者的2组随机对照临床试验。 将招募约5，000名年龄在45-75岁之间、体重指数> 25 kg/m2的2型糖尿病志愿者，包括大约相同数量的男性和女性，至少33%的参与者来自少数民族群体。 展望未来的主要目标是检查强化生活方式干预的长期健康影响，该干预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。 生活方式干预是通过个人监督和小组会议实施的，旨在实现体重从基线至少下降7%，平均每周进行175分钟的体力活动，并维持这些目标。 该计划将与涉及糖尿病支持和教育计划的对照条件进行比较。 主要假设是，在长达11.5年的计划随访期内，与分配到糖尿病支持和教育组的受试者相比，分配到生活方式干预组的受试者中首次随机化后发生复合结局（包括心血管死亡（包括致死性心肌梗死和卒中）、非致死性心肌梗死和非致死性卒中）的发生率将降低。 该研究预计有90%的概率检测到两组之间主要结局的18%差异。 定义了所有死亡、CVD事件和CVD手术的复合次要结局。 其他结果包括：糖尿病控制和并发症，健身，一般健康，健康相关的生活质量和心理结果。将评估生活方式干预相对于糖尿病支持和教育的成本和成本效益。