Published Online: October 9, 2010. doi:10.1001/jama.2010.1503
Author Contributions: Dr Rock 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: Rock, Pakiz.
Acquisition of data: Flatt, Sherwood, Karanja, Pakiz, Thomson.
Analysis and interpretation of data: Flatt, Sherwood, Karanja, Pakiz, Thomson.
Drafting of the manuscript: Rock, Flatt, Karanja, Thomson.
Critical revision of the manuscript for important intellectual content: Rock, Flatt, Sherwood, Karanja, Pakiz.
Statistical analysis: Rock, Flatt.
Obtained funding: Rock, Pakiz.
Administrative, technical, or material support: Flatt, Sherwood, Karanja, Pakiz.
Study supervision: Rock, Sherwood, Karanja, Pakiz, Thomson.
Financial Disclosures: Dr Rock reported serving on the advisory board for Jenny Craig from 2003-2004. None of the other authors reported any financial disclosures.
Funding/Support: This study was supported by Jenny Craig Inc (Carlsbad, California), which provided program activities, materials, and prepackaged foods to individuals assigned to the commercial weight loss program. Funding was provided through a clinical trial contract to the coordinating center (School of Medicine, University of California, San Diego), which subsequently disbursed funds to the collaborating clinical sites and the laboratories. Data from the clinical sites and the laboratories were forwarded to the coordinating center where they were pooled for analysis.
Role of the Sponsor: Jenny Craig Inc had a minimal role in the design and protocol development. By contractual agreement, scientists at the University of California, San Diego, and the other participating institutions had responsibility and independence regarding data management, analysis, and publication. The funding sponsor had no role in the collection, analysis, or interpretation of the data; or in the preparation, review or approval of the manuscript.
Independent Statistical Analysis: Shirley W. Flatt, MS, a senior statistician at the University of California, San Diego, performed the statistical analysis with consultation provided by Loki Natarajan, PhD, a faculty biostatistician.
Data and Safety Monitoring Committee: Ken Fujioka, MD, Karen Messer, PhD, and Kevin Patrick, MD.
Additional Contributions: We thank the data and safety monitoring committee and also acknowledge Dennis Heath, MS, Mila Pruitt, and Paul Mills, PhD (all with the University of California, San Diego), and Russell Tracy, PhD (University of Vermont), for conducting the laboratory assays; Christine Zoumas-Morse, MS, RD (University of California, San Diego), for managing the project; Annie Hotop, MA, MS (University of Minnesota), Lucy Fulton, DTR (Kaiser Permanente Center for Health Research), Jennifer Ravia, MS, and Emily Nardi, MPH, RD (University of Arizona), and Elizabeth Quintana, MS, RD (University of California, San Diego), for coordinating activities at the clinical sites; and Lea Jacinto, BS (University of California, San Diego), for assistance with administrative support and manuscript preparation. All of these individuals and laboratories were compensated for their labor and contributions through the clinical trial contract.
Additional Information About Trial Registration: The clinical trials registry was initiated by the investigators in early November 2007, before any patient enrollment. When informed at that time that this was a responsibility of the industry sponsor, the responsibility of completing the registration process was reassigned. The registration was in process until March 2008, when it was finalized. The delay was not purposeful and is attributable to inexperience and personnel support limitations. This had no effect on screening, recruitment, enrollment, and management of study participants due to the limited number of geographical sites involved, exclusion and inclusion criteria, and a relatively small total sample size compared with other large-scale population-based clinical trials.