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) factures 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 prior 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 9-11 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 designed to lowe weight and increase physical activity during midlife on the long-term health of this population. This application, which responds to RFA-DK-12-502, is submitted by Johns Hopkins University, one of the 16 clinical centers in the Action for Health in Diabetes (Look AHEAD) Consortium, 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. All 16 clinical sites and the Coordinating Center have submitted parallel applications.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK057149-16
Application #
8728187
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
16
Fiscal Year
2014
Total Cost
$643,750
Indirect Cost
$126,130
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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
Peter, Inga; Papandonatos, George D; Belalcazar, L Maria et al. (2014) Genetic modifiers of cardiorespiratory fitness response to lifestyle intervention. Med Sci Sports Exerc 46:302-11
Fitzpatrick, Stephanie L; Jeffery, Robert; Johnson, Karen C et al. (2014) Baseline predictors of missed visits in the Look AHEAD study. Obesity (Silver Spring) 22:131-40
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
Yang, Ju Dong; Abdelmalek, Manal F; Pang, Herbert et al. (2014) Gender and menopause impact severity of fibrosis among patients with nonalcoholic steatohepatitis. Hepatology 59:1406-14
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

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