Clinical Center for Look AHEAD: Action for Health in Diabetes

Look AHEAD 临床中心：糖尿病健康行动

基本信息

批准号：
7927045
负责人：
ANNE L PETERS
金额：
$ 95.18万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
起止时间：
1999-09-30 至 2013-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7927045
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

项目摘要

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）：向前看是随机临床试验，检查了大约5,145个患有2型糖尿病的超重志愿者的强化减肥干预措施的长期健康影响。参与者被随机分配为旨在通过减少热量摄入和增加体育锻炼或糖尿病支持和教育的控制计划来实现和维持体重减轻的密集生活方式干预措施。展望的主要结果是在计划的11。5年的随访中发生了严重的心血管事件（致命和非致命ML以及中风以及心血管死亡）的总体发生。最初的赠款申请为研究的前7年提供了资金（研究设计为期1年，执行审判的6年）。目前的赠款申请将为额外的7年提供资金，以完成前审判的外观。该研究的所有方面都非常好 - 5,145的样本按时招募；保留率非常好，干预措施在产生初始体重减轻并随着时间的推移而保持下去。所有16个临床部位均在干预措施的招聘，保留和交付方面都成功，而DSMB对试验的执行非常积极。本申请会审查未来的整体设计，进度截止日期和未来计划。具体的目标是随着时间的推移保留队列，继续完成年度面对面的访问和半年度电话访谈，以进行结果评估，并继续管理生活方式干预。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。