Wake Forest University
Grant: $598,465 - National Institutes of Health - Sep. 29, 2009
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Award Description: Look AHEAD is a multi-center randomized clinical trial to determine the long-term impact of weight loss on cardiovascular morbidity and mortality in over 5000 overweight individuals with type 2 diabetes. Participants were randomly assigned to an intensive lifestyle intervention group or to diabetes support and education (control group). The one and four year results indicate that retention has been outstanding and the lifestyle intervention has produced sustained benefits. The specific aims of the supplemental funding for the Look AHEAD coordinating center are designed to increase the rate of scientific discovery of the study group and to permit the hiring and retention of staff. As described, these derive from confidential requests from Look AHEAD Data and Safety Monitoring Board (DSMB) for the coordinating center to conduct a comprehensive analysis of trial data (in addition to its current monitoring reports) and to develop a rigorous new approach for monitoring clinical trials. Due to its nature, the existence and contents of this request have not been shared with the study group. The specific tasks include: 1) conduct statistical analysis and develop reports to meet specific requests from the Look AHEAD DSMB; 2) to develop a more comprehensive scientific basis for recommendations that the Look AHEAD DSMB will consider during the next year and for future publications for the study group; and 3) to expand the expertise in cardiology and diabetes within the Look AHEAD Coordinating Center, as requested by the Look AHEAD DSMB. The coordinating center has an exemplary record in the collaborative conduct of the Look AHEAD trial and an excellent environment for meeting these specific aims during the two year period defined by this award.
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This award's data was last updated on Sep. 29, 2009. Help expand these official descriptions using the wiki below.
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