(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 #
5U01DK057136-02
Application #
6177739
Study Section
Special Emphasis Panel (ZDK1-GRB-5 (O1))
Program Officer
Harrison, Barbara
Project Start
1999-09-30
Project End
2006-08-31
Budget Start
2000-09-01
Budget End
2001-08-31
Support Year
2
Fiscal Year
2000
Total Cost
$3,346,466
Indirect Cost
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
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
Espeland, Mark A; Luchsinger, Jose A; Neiberg, Rebecca H et al. (2018) Long Term Effect of Intensive Lifestyle Intervention on Cerebral Blood Flow. J Am Geriatr Soc 66:120-126
Murphy, Cara M; Rohsenow, Damaris J; Johnson, Karen C et al. (2018) Smoking and weight loss among smokers with overweight and obesity in Look AHEAD. Health Psychol 37:399-406
Espeland, Mark A; Carmichael, Owen; Hayden, Kathleen et al. (2018) Long-term Impact of Weight Loss Intervention on Changes in Cognitive Function: Exploratory Analyses from the Action for Health in Diabetes Randomized Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci 73:484-491
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
Espeland, Mark A; Carmichael, Owen; Yasar, Sevil et al. (2018) Sex-related differences in the prevalence of cognitive impairment among overweight and obese adults with type 2 diabetes. Alzheimers Dement 14:1184-1192
Pacanowski, Carly R; Linde, Jennifer A; Faulconbridge, Lucy F et al. (2018) Psychological status and weight variability over eight years: Results from Look AHEAD. Health Psychol 37:238-246
Pilla, Scott J; Yeh, Hsin-Chieh; Juraschek, Stephen P et al. (2018) Predictors of Insulin Initiation in Patients with Type 2 Diabetes: An Analysis of the Look AHEAD Randomized Trial. J Gen Intern Med 33:839-846

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