Author Contributions: Dr Church 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: Church, Blair, Mikus, Nauta.
Acquisition of data: Church, Cocreham, Johannsen, Kramer, Myers, Nauta, Rodarte, Sparks, Thompson, Earnest.
Analysis and interpretation of data: Church, Johannsen, Johnson, Kramer, Earnest.
Drafting of the manuscript: Church, Johannsen, Kramer, Myers, Nauta, Rodarte, Earnest.
Critical revision of the manuscript for important intellectual content: Church, Blair, Cocreham, Johannsen, Johnson, Mikus, Myers, Nauta, Rodarte, Sparks, Thompson, Earnest.
Statistical analysis: Church, Johnson, Thompson.
Obtained funding: Church, Blair, Mikus.
Administrative, technical, or material support: Church, Blair, Cocreham, Mikus, Myers, Nauta, Rodarte, Sparks, Earnest.
Study supervision: Church, Cocreham, Johannsen, Nauta, Sparks.
Financial Disclosures: Dr Church reported that he receives honoraria for lectures from scientific, educational, and lay groups; has received research funding from the American Heart Association and the National Institutes of Health, oversaw study sites for large pharmaceutical trials funded by Sanofi Aventis, Orexigen, Arena, and Amylin; is a member of the Jenny Craig medical advisory board; has served as a consultant to Technogym, Trestle Tree, Neuliven Health, and Coca-Cola; and serves as a paid expert for EverydayHealth.com. Dr Blair reported that he receives book royalties (<$5000 annually) from publisher Human Kinetics; honoraria for service on the scientific/medical advisory Boards for Alere, Technogym, Santech, and Jenny Craig; and honoraria for lectures and consultations from scientific, educational, and lay groups. During the past 5-year period he reported that he has received research grants from the National Institutes of Health, Department of Defense, Body Media, and Coca-Cola. Dr Earnest reported that he receives honoraria for lectures from scientific, educational, and lay groups. No other disclosures were reported.
Funding/Support: This work was supported by grant DK068298 from the National Institutes of Health.
Role of Sponsor: The funding sponsor had no role in the design, protocol development, or in the conducting the trial, data collection, data analysis or preparing the manuscript.
Additional Contributions: We thank all HART-D participants and the Pennington Biomedical Research Center staff members Gina Billiot, Sheletta Donatto, RD, and Ronald Monce, PA-C, for their hard work and commitment. In addition we thank the HART-D data and safety monitoring board and Scientific Advisory Board, and Pennington Biomedical Research Center faculty members William Cefalu, MD, Steve Smith, MD (now at Burnham Institute in Orlando, Florida), and Jennifer Rood, PhD, for their scientific guidance both in planning and conducting the study. Part of Ms Donatto and Mr Monce's salaries were supported through the HART-D grant, and Dr. Rood's laboratory was reimbursed for clinical laboratory measures. Members of the data and safety monitoring board were provided modest honorariums for their time. Drs Cefalu and Dr Smith and the Scientific Advisory Board received no compensation for their contributions.