Clinical Center for Look AHEAD: Health in Diabetes

Look AHEAD 临床中心：糖尿病健康

• 批准号: 6796183
• 负责人: KAROL E WATSON
• 金额: $ 50.48万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 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 2005-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6796183
• 关键词: atherosclerosis; behavior therapy; body composition; cardiovascular disorder; chemotherapy; clinical research; clinical trials; comorbidity; cooperative study; diet; disease /disorder proneness /risk; exercise; human subject; human therapy evaluation; noninsulin dependent diabetes mellitus; nutrition related tag; obesity; outcomes research; quality of life; 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.

（修订的摘要） 超重和肥胖是美国的主要健康问题，影响了50％以上的成年人。 超重或肥胖的长期后果包括增加死亡率和各种相关疾病状态的发病率。 已经证明短期体重减轻可以改善与肥胖相关的代谢异常和心血管疾病危险因素。 但是，观察性研究引起了人们对长期体重减轻和体重循环的负面影响的担忧，包括死亡率增加。 展望未来（糖尿病的健康作用）是一项2臂随机对照临床试验，研究超重和肥胖的志愿者在16个临床中心的2型糖尿病。 将招募大约5,000名45-75岁型糖尿病的志愿者，体重指数> 25 kg/m，包括大约相等数量的男性和女性，以及来自少数民族群体的至少33％的参与者。 展望的主要目的是检查旨在通过减少热量摄入和增加体育锻炼来实现和维持体重减轻的密集生活方式干预的长期健康影响。 生活方式干预是通过个人监督和小组会议来实施的，旨在达到至少7％的体重减少7％，平均每周进行体育活动175分钟，以维持这些目标。 该计划将与涉及糖尿病支持和教育计划的控制状况进行比较。 主要的假设是，复合结果的第一次随机后发生的进攻率包括心血管死亡（包括致命的心肌梗死和中风），非致命性心肌梗塞和非致命性中风，在计划中的待遇中，将降低这些分配的待遇，以减少这些分配的待遇，以减少这些分配的待遇，以使这些待遇和待遇分配为待遇。 该研究预计有90％的概率可以检测两组之间的主要结果18％。 已经定义了所有死亡，CVD事件和CVD程序的综合次要结果。 其他结果包括：糖尿病控制和并发症，健身，一般健康，与健康相关的生活质量以及心理结局。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。