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 #
5U01DK056992-14
Application #
8323561
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
$1,205,573
Indirect Cost
$379,838
Name
Miriam Hospital
Department
Type
DUNS #
063902704
City
Providence
State
RI
Country
United States
Zip Code
02906
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Houston, Denise K; Neiberg, Rebecca H; Miller, Michael E et al. (2018) Physical Function Following a Long-Term Lifestyle Intervention Among Middle Aged and Older Adults With Type 2 Diabetes: The Look AHEAD Study. J Gerontol A Biol Sci Med Sci 73:1552-1559
Brinkley, Tina E; Anderson, Andrea; Soliman, Elsayed Z et al. (2018) Long-Term Effects of an Intensive Lifestyle Intervention on Electrocardiographic Criteria for Left Ventricular Hypertrophy: The Look AHEAD Trial. Am J Hypertens 31:541-548
Gregg, Edward W; Lin, Ji; Bardenheier, Barbara et al. (2018) Impact of Intensive Lifestyle Intervention on Disability-Free Life Expectancy: The Look AHEAD Study. Diabetes Care 41:1040-1048

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