The Look AHEAD Continuation: Action for Health in Diabetes

展望未来续篇：糖尿病健康行动

• 批准号: 8031247
• 负责人: Rena R Wing
• 金额: $ 7.03万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-09 至 2011-03-08
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8031247
• 关键词: Adherence; Adult; Affect; Angioplasty; Applications Grants; Body Weight decreased; Body mass index; Bypass; Cardiovascular Diseases; Cardiovascular system; Carotid Endarterectomy; Cessation of life; Clinical; Community Health Centers; Congestive Heart Failure; Control Groups; Coronary Artery Bypass; Country; Data; Diabetes Mellitus; Diet; Disease; Education; Effectiveness of Interventions; Energy Intake; Epidemic; Event; Facilities and Administrative Costs; Funding; Future; Goals; Grant; Health; Hospitalization; Incidence; Intervention; Long-Term Effects; Longitudinal Studies; Measures; Mediating; Metabolic; Minority; Morbidity - disease rate; Multi-Institutional Clinical Trial; Myocardial Infarction; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Outcome Assessment; Overweight; Participant; Peripheral Vascular Diseases; Persons; Physical activity; Population; Procedures; Process; Protocols documentation; Public Health; Randomized; Randomized Clinical Trials; Recruitment Activity; Research Design; Risk Factors; Sampling; Stroke; Telephone Interviews; Testing; Time; United States; United States National Institutes of Health; Visit; Weight; Weight Gain; arm; base; cardiovascular disorder risk; clinical research site; cohort; coronary angioplasty; cost effectiveness; design; follow-up; hazard; intervention effect; intervention program; lifestyle intervention; mortality; obesity risk; primary outcome; programs; secondary outcome; therapy design; volunteer; weight loss intervention

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.

描述（由申请人提供）：展望未来是一项随机临床试验，研究了约5，145名超重2型糖尿病志愿者强化减肥干预的长期健康影响。参与者随机接受强化生活方式干预，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，或接受糖尿病支持和教育的控制计划。Look AHEAD的主要结局是在计划的11.5年随访期间严重心血管事件（致死性和非致死性MI以及卒中和心血管死亡）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的7年资金，以完成展望未来的试验。这项研究的各个方面都进行得非常好--按时招募了5,145名样本;保持率非常好，干预措施在产生最初的体重减轻并随着时间的推移保持体重方面非常有效。所有16家临床研究中心均成功招募、保留和提供干预措施，DSMB对试验的执行非常积极。本申请回顾了展望未来的总体设计、迄今为止的进展以及未来的计划。具体目标是随着时间的推移保留队列，继续完成年度面对面访视和半年一次的电话访谈以进行结局评估，并继续进行生活方式干预。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。