(Revised Abstract) Overweight and obesity are major health problems in the United States, affecting more than 50% of adults. The long-term consequences of being overweight or obese include increased mortality and increased morbidity from a variety of associated disease states. Short-term weight loss has been demonstrated to ameliorate obesity-related metabolic abnormalities and cardiovascular disease risk factors. However, observational studies have raised concerns about negative effects of weight loss and weight cycling over the long term, including increased mortality. Look AHEAD (Action For Health in Diabetes) is a 2-armed randomized controlled clinical trial studying overweight and obese volunteers with type 2 diabetes at 16 clinical centers. Approximately 5,000 volunteers with type 2 diabetes aged 45-75 years with body mass index > 25 kg/m will be recruited, including approximately equal numbers of men and women and at least 33% participants from ethnic minority groups. The primary objective of Look AHEAD is to examine the long-term health effects of an intensive Lifestyle Intervention designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. The Lifestyle intervention is implemented with individual supervision and group sessions and aims to achieve at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity on average and to sustain these goals. This program will be compared to a control condition involving a program of Diabetes Support and Education. The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes cardiovascular death (including fatal myocardial infarction and stroke), non-fatal myocardial infarction, and non-fatal stroke, over a planned follow-up period of up to 11.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to Diabetes Support and Education. The study is projected to have 90% probability of detecting an 18% difference in this primary outcome between the 2 groups. A composite secondary outcome of all deaths, CVD events, and CVD procedures has been defined. Additional outcomes include: diabetes control and complications, fitness, general health, health-related quality of life, and psychological outcomes. The cost and cost effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK057149-06S1
Application #
6921588
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Harrison, Barbara
Project Start
1999-09-30
Project End
2006-07-31
Budget Start
2004-08-01
Budget End
2005-07-31
Support Year
6
Fiscal Year
2004
Total Cost
$99,978
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Pilla, Scott J; Dotimas, James R; Maruthur, Nisa M et al. (2018) Changes in metformin use and other antihyperglycemic therapies after insulin initiation in patients with type 2 diabetes. Diabetes Res Clin Pract 139:221-229
Hayden, Kathleen M; Baker, Laura D; Bray, George et al. (2018) Long-term impact of intensive lifestyle intervention on cognitive function assessed with the National Institutes of Health Toolbox: The Look AHEAD study. Alzheimers Dement (Amst) 10:41-48
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
Johnson, Karen C; Bray, George A; Cheskin, Lawrence J et al. (2017) The Effect of Intentional Weight Loss on Fracture Risk in Persons With Diabetes: Results From the Look AHEAD Randomized Clinical Trial. J Bone Miner Res 32:2278-2287
Rapp, Stephen R; Luchsinger, Jose A; Baker, Laura D et al. (2017) Effect of a Long-Term Intensive Lifestyle Intervention on Cognitive Function: Action for Health in Diabetes Study. J Am Geriatr Soc 65:966-972
Beavers, Kristen M; Leng, Iris; Rapp, Stephen R et al. (2017) Effects of Longitudinal Glucose Exposure on Cognitive and Physical Function: Results from the Action for Health in Diabetes Movement and Memory Study. J Am Geriatr Soc 65:137-145
Chao, Ariana M; Wadden, Thomas A; Gorin, Amy A et al. (2017) Binge Eating and Weight Loss Outcomes in Individuals with Type 2 Diabetes: 4-Year Results from the Look AHEAD Study. Obesity (Silver Spring) 25:1830-1837
Unick, Jessica L; Gaussoin, Sarah A; Hill, James O et al. (2017) Objectively Assessed Physical Activity and Weight Loss Maintenance among Individuals Enrolled in a Lifestyle Intervention. Obesity (Silver Spring) 25:1903-1909
Sanguankeo, Anawin; Lazo, Mariana; Upala, Sikarin et al. (2017) Effects of visceral adipose tissue reduction on CVD risk factors independent of weight loss: The Look AHEAD study. Endocr Res 42:86-95
Marquez, Becky; Anderson, Andrea; Wing, Rena R et al. (2016) The relationship of social support with treatment adherence and weight loss in Latinos with type 2 diabetes. Obesity (Silver Spring) 24:568-75

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