Look AHEAD is randomized clinical trial examining the long-term health effects of an intensive weight loss intervention in approximately 5,145 overweight volunteers with type 2 diabetes. Participants are randomized to an intensive lifestyle intervention designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity, or to a control program of diabetes support and education. The primary outcome of Look AHEAD is the aggregate occurrence of severe cardiovascular events (fatal and non-fatal Ml and stroke and cardiovascular deaths) over a planed follow-up of 11.5 years. The original grant application provided funding for the first 7 years of the study (1 year for study design and 6 for execution of the trial). The present grant application is for an additional 7 years of funding to complete the Look AHEAD trial. All aspects of the study have proceeded extremely well - the sample of 5,145 was recruited on time;retention has been excellent and the intervention has been effective in producing initial weight loss and maintaining it over time. All 16 clinical sites have been successful in recruitment, retention, and delivery of the intervention and the DSMB has been very positive about the execution of the trial. The present application reviews the overall design of Look AHEAD, progress to date, and plans for the future.
Specific Aims are to retain the cohort over time, continue to complete annual in-person visits and semi-annual telephone interviews for outcome assessments and continue to administer the lifestyle intervention. These procedures will enable us to analyze the effects of the intervention on serious cardiovascular- related factors and complications, and cost-effectiveness of the intervention.
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|Pownall, Henry J; Schwartz, Anne V; Bray, George A et al. (2016) Changes in regional body composition over 8 years in a randomized lifestyle trial: The look AHEAD study. Obesity (Silver Spring) 24:1899-905|
|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|
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|Look AHEAD Research Group (2016) Prospective Association of GLUL rs10911021 With Cardiovascular Morbidity and Mortality Among Individuals With Type 2 Diabetes: The Look AHEAD Study. Diabetes 65:297-302|
|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|
|Unick, Jessica L; Gaussoin, Sarah A; Hill, James O et al. (2016) Four-Year Physical Activity Levels among Intervention Participants with Type 2 Diabetes. Med Sci Sports Exerc 48:2437-2445|
|Kline, Christopher E; Reboussin, David M; Foster, Gary D et al. (2016) The Effect of Changes in Cardiorespiratory Fitness and Weight on Obstructive Sleep Apnea Severity in Overweight Adults with Type 2 Diabetes. Sleep 39:317-25|
|Look AHEAD Research Group (Appendix A); Greenway, Frank L (2016) Severe hypoglycemia in the Look AHEAD Trial. J Diabetes Complications 30:935-43|
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