""""""""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 #
3U01DK057219-17S1
Application #
8926184
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
2014-08-01
Budget End
2015-07-31
Support Year
17
Fiscal Year
2014
Total Cost
$170,000
Indirect Cost
$35,079
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
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
Espeland, Mark A; Dutton, Gareth R; Neiberg, Rebecca H et al. (2018) Impact of a Multidomain Intensive Lifestyle Intervention on Complaints About Memory, Problem-Solving, and Decision-Making Abilities: The Action for Health in Diabetes Randomized Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci 73:1560-1567
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

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