The aging of the population and the epidemic of obesity have led to a rapid increase in the number of older, obese individuals with diabetes. Little is known about the long-term health effects of lifestyle intervention designed to lower weight and increase physical activity in this population. This application, which responds to RFA-DK-12-502, is submitted by one of the 16 clinical centers in the Action for Health in Diabetes (Look AHEAD) Consortium. All 16 clinical sites and the Coordinating Center have submitted parallel applications. This application proposes to continue the Look AHEAD clinical trial as an observational cohort study and to follow participants with new assessments of the health problems of greatest concern in older, obese individuals with type 2 diabetes. We will test whether random assignment to 9-11 years of intensive lifestyle intervention, compared to a control condition of diabetes support and education, results in improvements in 1) physical function, impairment and disability, 2) cognitive function and impairment, 3) diabetes control and microvascular complications, 4) late life depression, and 5) fractures and cancers. Secondary aims are to examine whether subgroup differences observed during the trial (which raised concern about possible unfavorable effects of intensive lifestyle intervention in those with a prio history of cardiovascular disease) endure and whether the excellent weight losses achieved in the intensive lifestyle intervention arm are maintained despite the absence of continued intervention activities. The Continuation will also support ongoing ancillary studies, maintain infrastructure for new ancillary studies, and sustain thorough analyses and publication of the data collected by Look AHEAD. We will continue to follow the Look AHEAD cohort (approximately 4,000 participants) across the 16 clinical sites. Participants entered the trial 9-1 years ago when they were obese or overweight and aged 45-76, and were randomly assigned with equal probability to either an intensive lifestyle intervention that has induced sustained weight loss and increased physical activity or control condition (diabetes support and education). Both arms have had excellent retention. Interventions were discontinued in Sept, 2012, but follow-up of the cohort continues. This application will fund one additional clinic visit and ongoing telephone-based outcome assessment. This application builds on the remarkable success of the Look AHEAD in inducing and sustaining weight loss and retaining participants. The planned continuation addresses important public health priorities for a rapidly growing and under-studied segment of the US population in a cost-effective manner, leveraging the extensive resources available from Look AHEAD.

Public Health Relevance

The number of older, obese individuals with type 2 diabetes is rapidly increasing and little is known about the impact of lifestyle interventions during midlif on the long-term health of this population. This application seeks to continue to follow the Action for Health in Diabetes (Look AHEAD) cohort as an observational study, and to compare individuals who were randomly assigned to intensive lifestyle intervention with those assigned to the control condition on new measures of the health problems of greatest concern in this population, such as cognitive and physical function, microvascular complications, and late-life depression.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK057078-15
Application #
8600407
Study Section
Special Emphasis Panel (ZDK1-GRB-S (M2))
Program Officer
Evans, Mary
Project Start
1999-09-30
Project End
2015-07-31
Budget Start
2013-09-05
Budget End
2014-07-31
Support Year
15
Fiscal Year
2013
Total Cost
$941,115
Indirect Cost
$288,521
Name
University of Tennessee Health Science Center
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
941884009
City
Memphis
State
TN
Country
United States
Zip Code
38163
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
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
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
Look AHEAD Research Group (2014) Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: a secondary analysis of the Look AHEAD randomised clinical trial. Lancet Diabetes Endocrinol 2:801-9
Unick, Jessica L; Hogan, Patricia E; Neiberg, Rebecca H et al. (2014) Evaluation of early weight loss thresholds for identifying nonresponders to an intensive lifestyle intervention. Obesity (Silver Spring) 22:1608-16
Unick, Jessica L; Beavers, Daniel; Bond, Dale S et al. (2013) The long-term effectiveness of a lifestyle intervention in severely obese individuals. Am J Med 126:236-42, 242.e1-2
Look AHEAD Research Group; Wing, Rena R; Bolin, Paula et al. (2013) Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med 369:145-54
Espeland, Mark A; Rejeski, W Jack; West, Delia S et al. (2013) Intensive weight loss intervention in older individuals: results from the Action for Health in Diabetes Type 2 diabetes mellitus trial. J Am Geriatr Soc 61:912-22

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