Look AHEAD is randomized clinical trial examining the long-term health effects of an intensive weight loss intervention in approximately 5,145overweight volunteers with type 2 diabetes. Participants are randomized to an intensivelifestyle 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 MI and stroke and cardiovascular deaths) over a planed follow-up of 11.5 years. The original grant applicationprovided 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 participants 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 events, on CVD risk factors, diabetes 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 #
5U01DK057002-14
Application #
8323513
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
$1,114,882
Indirect Cost
$383,812
Name
University of Pittsburgh
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Peter, Inga; McCaffery, Jeanne M; Kelley-Hedgepeth, Alyson et al. (2012) Association of type 2 diabetes susceptibility loci with one-year weight loss in the look AHEAD clinical trial. Obesity (Silver Spring) 20:1675-82
Redmon, J Bruce; Bertoni, Alain G; Connelly, Stephanie et al. (2010) Effect of the look AHEAD study intervention on medication use and related cost to treat cardiovascular disease risk factors in individuals with type 2 diabetes. Diabetes Care 33:1153-8
Foster, Gary D; Borradaile, Kelley E; Sanders, Mark H et al. (2009) A randomized study on the effect of weight loss on obstructive sleep apnea among obese patients with type 2 diabetes: the Sleep AHEAD study. Arch Intern Med 169:1619-26
Kramer, Holly; Reboussin, David; Bertoni, Alain G et al. (2009) Obesity and albuminuria among adults with type 2 diabetes: the Look AHEAD (Action for Health in Diabetes) Study. Diabetes Care 32:851-3
Williamson, Donald A; Rejeski, Jack; Lang, Wei et al. (2009) Impact of a weight management program on health-related quality of life in overweight adults with type 2 diabetes. Arch Intern Med 169:163-71
Wadden, Thomas A; West, Delia S; Neiberg, Rebecca H et al. (2009) One-year weight losses in the Look AHEAD study: factors associated with success. Obesity (Silver Spring) 17:713-22
Phelan, Suzanne; Kanaya, Alka M; Subak, Leslee L et al. (2009) Prevalence and risk factors for urinary incontinence in overweight and obese diabetic women: action for health in diabetes (look ahead) study. Diabetes Care 32:1391-7
Espeland, Mark A; Regensteiner, Judith G; Jaramillo, Sarah A et al. (2008) Measurement characteristics of the ankle-brachial index: results from the Action for Health in Diabetes study. Vasc Med 13:225-33
Raynor, Hollie A; Jeffery, Robert W; Ruggiero, Andrea M et al. (2008) Weight loss strategies associated with BMI in overweight adults with type 2 diabetes at entry into the Look AHEAD (Action for Health in Diabetes) trial. Diabetes Care 31:1299-304
Gorin, A A; Wing, R R; Fava, J L et al. (2008) Weight loss treatment influences untreated spouses and the home environment: evidence of a ripple effect. Int J Obes (Lond) 32:1678-84

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