Supported by an award (OB-1402-10977) from
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Dr. Katzmarzyk reports receiving donated supplies from Health and Nutrition Technology and Nutrisystem and grant support, paid to Pennington Biomedical Research Center (PBRC), from PCORI; Dr. Martin, Dr. Martin, receiving grant support, paid to PBRC and Louisiana State University (LSU), from the Egg Board and Access Business Group, advisory board fees from EHE Health and NaturallySlim, consulting fees from Florida Hospital, Gila Therapeutics, Metagenics, Openfit, and Zafgen, supplies donated to PBRC and LSU from Health and Nutrition Technology and Nutrisystem, grant support, paid to PBRC and LSU, and advisory board fees from WW, grant support, paid to PBRC and LSU, and fees for serving as a trainer from the Academy of Nutrition and Dietetics, and holding patents (15/946841 and TW201837799A) on a body-weight management and activity tracking system and a trademark (4,777,567;SN 85-764,888), held by PBRC and LSU and licensed to Access Business Group; Drs. Newton and Apolzan, receiving donated supplies from Health and Nutrition Technology and Nutrisystem and grant support, paid to PBRC, from PCORI; Dr. Arnold, receiving grant support, paid to LSU Health Sciences Center, from PBRC; Dr. Price-Haywood, receiving grant support, paid to Ochsner Clinic Foundation, from PBRC; Ms. Denstel, receiving donated supplies from HealthONE and Nutrisystem and grant support, paid to PBRC, from PCORI; Ms. Mire, receiving donated supplies from Health and Nutrition Technology and HealthONE and grant support from PCORI; Dr. Thethi, receiving grant support from Tulane University; Dr. Fonseca, receiving consulting fees from Abbott Diabetes Care, Asahi Group Holdings, Bayer, Novo Nordisk, Sanofi US Services, and Takeda Development Center Americas, and holding a pending patent (62/676273) on the Building, Relating, Assessing, and Validating Outcomes (BRAVO) risk engine; and Dr. Lavie, receiving grant support, paid to Dr. Katzmarzyk, from PBRC. No other potential conflict of interest relevant to this article was reported.
The statements in this article are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI) or its board of governors or methodology committee.
A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
We thank the patients and the members of the patient advisory boards, community monitoring board, and the project management committee (Chris Lodge and Ava Zebrick, M.S.), who contributed greatly to the design and conduct of the trial; the trial patients, assessment technicians, and health coaches, without whom this trial would not have been possible; Willie C. White III, M.P.H., and the David Raines Community Health Centers; Gary Wiltz, M.D., and the Teche Action Clinic sites; Michael G. Griffin and Robert Post, M.D., and the Daughters of Charity Services of New Orleans; the Ochsner Health System and Access Health Louisiana clinic sites; the data and safety monitoring board (Robert Ross, Ph.D. [chair], John Lefante, Ph.D., Michael Rolfson, M.D., and Chris Lodge) for overseeing patient safety and the overall conduct of the trial; and David B. Allison, Ph.D., Andrew W. Brown, Ph.D., Stephanie L. Dickinson, M.S., and Lilian Golzarri-Arroyo, M.S., of the Indiana University School of Public Health–Bloomington for reviewing and verifying the statistical methods and results of this project.