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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK057136-14
Application #
8323568
Study Section
Special Emphasis Panel (ZDK1-GRB-N (M2))
Program Officer
Evans, Mary
Project Start
1999-09-30
Project End
2013-07-31
Budget Start
2012-08-01
Budget End
2013-07-31
Support Year
14
Fiscal Year
2012
Total Cost
$3,337,034
Indirect Cost
$845,663
Name
Wake Forest University Health Sciences
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
Rubin, Richard R; Wadden, Thomas A; Bahnson, Judy L et al. (2014) Impact of intensive lifestyle intervention on depression and health-related quality of life in type 2 diabetes: the Look AHEAD Trial. Diabetes Care 37:1544-53
Look AHEAD Research Group (2014) Eight-year weight losses with an intensive lifestyle intervention: the look AHEAD study. Obesity (Silver Spring) 22:5-13
Gibbs, Bethany Barone; Brancati, Frederick L; Chen, Haiying et al. (2014) Effect of improved fitness beyond weight loss on cardiovascular risk factors in individuals with type 2 diabetes in the Look AHEAD study. Eur J Prev Cardiol 21:608-17
Peter, Inga; Papandonatos, George D; Belalcazar, L Maria et al. (2014) Genetic modifiers of cardiorespiratory fitness response to lifestyle intervention. Med Sci Sports Exerc 46:302-11
Fitzpatrick, Stephanie L; Jeffery, Robert; Johnson, Karen C et al. (2014) Baseline predictors of missed visits in the Look AHEAD study. Obesity (Silver Spring) 22:131-40
Tsai, Adam G; Fabricatore, Anthony N; Wadden, Thomas A et al. (2014) Readiness redefined: a behavioral task during screening predicted 1-year weight loss in the look AHEAD study. Obesity (Silver Spring) 22:1016-23
Lipkin, Edward W; Schwartz, Ann V; Anderson, Andrea M et al. (2014) The Look AHEAD Trial: bone loss at 4-year follow-up in type 2 diabetes. Diabetes Care 37:2822-9
Espeland, Mark A; Lewis, Cora E; Bahnson, Judy et al. (2014) Impact of weight loss on ankle-brachial index and interartery blood pressures. Obesity (Silver Spring) 22:1032-41
Wing, Rena R; Leahey, Tricia; Jeffery, Robert et al. (2014) Do weight loss and adherence cluster within behavioral treatment groups? Obesity (Silver Spring) 22:638-44
Breyer, Benjamin N; Phelan, Suzanne; Hogan, Patricia E et al. (2014) Intensive lifestyle intervention reduces urinary incontinence in overweight/obese men with type 2 diabetes: results from the Look AHEAD trial. J Urol 192:144-9

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