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.
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.
|Sanguankeo, Anawin; Lazo, Mariana; Upala, Sikarin et al. (2016) Effects of visceral adipose tissue reduction on CVD risk factors independent of weight loss: The Look AHEAD study. Endocr Res :1-10|
|Espeland, Mark A; Erickson, Kirk; Neiberg, Rebecca H et al. (2016) Brain and White Matter Hyperintensity Volumes After 10 Years of Random Assignment to Lifestyle Intervention. Diabetes Care 39:764-71|
|Belalcazar, L Maria; Papandonatos, George D; Erar, Bahar et al. (2016) Lifestyle Intervention for Weight Loss and Cardiometabolic Changes in the Setting of Glucokinase Regulatory Protein Inhibition: Glucokinase Regulatory Protein-Leu446Pro Variant in Look AHEAD. Circ Cardiovasc Genet 9:71-8|
|Marquez, Becky; Anderson, Andrea; Wing, Rena R et al. (2016) The relationship of social support with treatment adherence and weight loss in Latinos with type 2 diabetes. Obesity (Silver Spring) 24:568-75|
|Zhang, Ping; Hire, Don; Espeland, Mark A et al. (2016) Impact of intensive lifestyle intervention on preference-based quality of life in type 2 diabetes: Results from the Look AHEAD trial. Obesity (Silver Spring) 24:856-64|
|Action for Health in Diabetes (Look AHEAD) Study Group (2016) Association of Weight Loss Maintenance and Weight Regain on 4-Year Changes in CVD Risk Factors: the Action for Health in Diabetes (Look AHEAD) Clinical Trial. Diabetes Care 39:1345-55|
|Casanova, Ramon; Hayasaka, Satoru; Saldana, Santiago et al. (2016) Relative differences in resting-state brain connectivity associated with long term intensive lifestyle intervention. Psychoneuroendocrinology 74:231-239|
|Look AHEAD Research Group (Appendix A); Greenway, Frank L (2016) Severe hypoglycemia in the Look AHEAD Trial. J Diabetes Complications 30:935-43|
|Look AHEAD Research Group (2016) Association of the magnitude of weight loss and changes in physical fitness with long-term cardiovascular disease outcomes in overweight or obese people with type 2 diabetes: a post-hoc analysis of the Look AHEAD randomised clinical trial. Lancet Diabetes Endocrinol 4:913-921|
|Unick, Jessica L; Neiberg, Rebecca H; Hogan, Patricia E et al. (2015) Weight change in the first 2 months of a lifestyle intervention predicts weight changes 8 years later. Obesity (Silver Spring) 23:1353-6|
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