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 interventios during midlife 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 #
2U01DK057002-15
Application #
8600014
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
2013-09-01
Budget End
2014-07-31
Support Year
15
Fiscal Year
2013
Total Cost
$797,862
Indirect Cost
$275,102
Name
University of Pittsburgh
Department
Miscellaneous
Type
Schools of Education
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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