Author Contributions: Dr Chen had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Gregg, Wagenknecht, Delahanty, Safford, Pi-Sunyer, Wing.
Acquisition of data: Wagenknecht, Clark, Delahanty, Johnson, Safford, Kitabchi, Pi-Sunyer, Wing.
Analysis and interpretation of data: Gregg, Chen, Wagenknecht, Clark, Delahanty, Bantle, Pownall, Johnson, Safford, Wing, Bertoni.
Drafting of the manuscript: Gregg, Pi-Sunyer.
Critical revision of the manuscript for important intellectual content: Gregg, Chen, Wagenknecht, Clark, Delahanty, Bantle, Pownall, Johnson, Safford, Kitabchi, Pi-Sunyer, Wing, Bertoni.
Statistical analysis: Chen.
Obtained funding: Wagenknecht, Pownall, Johnson, Kitabchi, Pi-Sunyer, Wing.
Administrative, technical, or material support: Gregg, Wagenknecht, Johnson, Kitabchi, Pi-Sunyer, Wing.
Study supervision: Gregg, Wagenknecht, Safford.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Delehanty reported board membership with Eli Lilly, Boeringer Ingelheim, and Johnson and Johnson and consultancy support from Pfizer. Dr Safford reported receiving consultancy support from diaDexus. No other disclosures were reported.
Funding/Support: This study is supported by the US Department of Health and Human Services through the following cooperative agreements from the National Institutes of Health (NIH): DK57136, DK57149, DK56990, DK57177, DK57171, DK57151, DK57182, DK57131, DK57002, DK57078, DK57154, DK57178, DK57219, DK57008, DK57135, and DK56992. The following federal agencies have contributed support: National Institute of Diabetes and Digestive and Kidney Diseases; National Heart, Lung, and Blood Institute; National Institute of Nursing Research; National Center on Minority Health and Health Disparities; NIH Office of Research on Women's Health; and the Centers for Disease Control and Prevention. This research was supported in part by the Intramural Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases. The Indian Health Service (IHS) provided personnel, medical oversight, and use of facilities. Additional support was received from The Johns Hopkins Medical Institutions Bayview General Clinical Research Center (M01RR02719); the Massachusetts General Hospital Mallinckrodt General Clinical Research Center and the Massachusetts Institute of Technology General Clinical Research Center (M01RR01066); the University of Colorado Health Sciences Center General Clinical Research Center (M01RR00051) and Clinical Nutrition Research Unit (P30 DK48520); the University of Tennessee at Memphis General Clinical Research Center (M01RR0021140); the University of Pittsburgh General Clinical Research Center (M01RR000056), the Clinical Translational Research Center funded by Clinical and Translational Science Award UL1 RR 024153 and NIH grant DK 046204; the VA Puget Sound Health Care System Medical Research Service, Department of Veterans Affairs; and the Frederic C. Bartter General Clinical Research Center (M01RR01346). The following organizations have committed to making major contributions to Look AHEAD: FedEx Corp; Health Management Resources; LifeScan Inc, a Johnson and Johnson Company; OPTIFAST of Nestle HealthCare Nutrition Inc; Hoffmann-La Roche Inc; Abbott Nutrition; and Slim-Fast Brand of Unilever North America.
Role of the Sponsor: The primary role of the sponsor (Department of Health and Human Services, including the NIH, Centers for Disease Control and Prevention, and IHS) was to provide funding, administrative oversight, personnel, medical oversight, and use of facilities. In addition, several scientific and administrative representatives of the sponsors contributed to the design and conduct of the overall study as part of the Look AHEAD study group (listed in
the eAppendix). Dr Gregg, a representative of one of the cosponsors, conceptualized and led the analysis, interpretation, and writing of this specific manuscript. The decision to publish was made by the Look AHEAD Steering Committee, with no restrictions imposed by the sponsors.
Disclaimer: The opinions expressed in this article are those of the authors and do not necessarily reflect the views of the IHS or other funding sources.
Members of the Look AHEAD Research Group are listed in