""""""""Action For Health In Diabetes Continuation (Look AHEAD),"""""""" responds to RFA-DK-12-502: Limited Competition for the Continuation of Look AHEAD (Action for Health in Diabetes) Consortium (U01). 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

Action For Health In Diabetes Continuation (Look AHEAD), responds to RFA-DK-12-502: Limited Competition for the Continuation of Look AHEAD (Action for Health in Diabetes) Consortium (U01). Project Narrative The number of older, obese individuals with type 2 diabetes is rapidly increasing and little is known about the impact of lifestyle interventions 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 #
2U01DK057219-16
Application #
8600500
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
16
Fiscal Year
2013
Total Cost
$648,190
Indirect Cost
$123,436
Name
University of Southern California
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
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
Rushing, J; Wing, R; Wadden, T A et al. (2017) Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial. Obes Sci Pract 3:15-24
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
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
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
Look AHEAD Research Group (2017) Effects of a long-term lifestyle modification programme on peripheral neuropathy in overweight or obese adults with type 2 diabetes: the Look AHEAD study. Diabetologia 60:980-988
Belalcazar, L Maria; Ballantyne, Christie M (2017) Looking Back at Look AHEAD Through the Lens of Recent Diabetes Outcome Trials. Circulation 135:720-723
Houston, Denise K; Neiberg, Rebecca H; Miller, Michael E et al. (2017) 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 :
Espeland, Mark A; Luchsinger, José A; Baker, Laura D et al. (2017) Effect of a long-term intensive lifestyle intervention on prevalence of cognitive impairment. Neurology 88:2026-2035

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