Accepted for Publication: December 17, 2014.
Published Online: March 2, 2015. doi:10.1001/jamapediatrics.2014.3690.
Study concept and design: Michalsky, Inge, Simmons, Helmrath, Brandt, Harmon, Chen, Daniels, Urbina.
Acquisition, analysis, or interpretation of data: Michalsky, Inge, Simmons, Jenkins, Buncher, Helmrath, Harmon, Courcoulas, Chen, Horlick.
Drafting of the manuscript: Michalsky, Inge, Simmons, Harmon, Chen, Daniels, Urbina.
Critical revision of the manuscript for important intellectual content: Michalsky, Inge, Simmons, Jenkins, Buncher, Harmon, Courcoulas, Chen, Horlick, Daniels, Urbina.
Statistical analysis: Simmons, Jenkins, Buncher, Urbina.
Obtained funding: Inge, Helmrath, Harmon.
Administrative, technical, or material support: Courcoulas, Horlick.
Study supervision: Michalsky, Inge, Helmrath, Harmon, Daniels.
Conflict of Interest Disclosures: Dr Courcoulas received grants from Covidien, EndoGastric Solutions, Nutrisystem, and J&J Ethicon Scientific, and personal fees unrelated to the submitted work from J&J Ethicon Scientific. Dr Inge received grants from Ethicon Endosurgery unrelated to the submitted work. No other disclosures were reported.
Funding/Support: Dr Courcoulas received grants from the National Institutes of Health–National Institute of Diabetes and Digestive and Kidney Diseases. The Teen-LABS consortium was funded by cooperative agreements with the National Institute of Diabetes and Digestive and Kidney Diseases through grants U01DK072493, UM1DK072493, and UM1DK095710 (University of Cincinnati). The study was also supported by grants UL1 TR000077-04 (Cincinnati Children’s Hospital Medical Center), UL1RR025755 (Nationwide Children’s Hospital), M01-RR00188 (Texas Children’s Hospital/Baylor College of Medicine), UL1 RR024153, UL1TR000005 (University of Pittsburgh), and UL1 TR000165 (University of Alabama, Birmingham). We gratefully acknowledge the significant contributions made by the Teen-LABS Consortium and grant U01 DK066557 from our parent study, LABS Consortium.
Role of the Funder/Sponsor: The funders were directly involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The following individuals contributed to the planning or conduct of the study: Thomas Inge, MD, PhD, Meg Zeller, PhD, Michael Helmrath, MD, Avani Modi, PhD, Stavra Xanthakos, MD, MS, Larry Dolan, MD, Todd Jenkins, MPH, PhD, Rosie Miller, RN, CCRC, Rachel Akers, MPH, April Carr, BS, Lindsey Shaw, MS, Cynthia Spikes, CRC, Stephen Daniels, MD, PhD, Tawny Wilson Boyce, MS, MPH, Tara Schafer-Kalkhoff, MA, CCRP, at the Cincinnati Children’s Hospital Medical Center; Ralph Buncher, ScD, and Mark Simmons, MEng, at the University of Cincinnati; Mary Brandt, MD, Vadim Sherman, MD, Margaret Callie Lee, MPH, David Allen, BS, Gia Washington, PhD, and Karin Price, PhD, at the Texas Children’s Hospital, Baylor Medical Center; Carroll M. Harmon, MD, PhD, Ronald Clements, MD, Richard Stahl, MD, Molly Bray, PhD, Beverly Haynes, BSN, at the Children’s Hospital of Alabama, University of Alabama at Birmingham; Anita Courcoulas, MD, Ramesh Ramanathan, MD, Carol A. McCloskey, MD, George M. Eid, MD, Jessie Eagleton, MPH, William Gourash, MSN, CRNP, Sheila Pierson, BS, and Dana Rofey, PhD, MS, at the University of Pittsburgh Medical Center; Marc Michalsky, MD, Steven Teich, MD, Karen Carter, CCRC, Melinda Helton, RN, Bonny Bowen, RN, Robert David Murray, MD, and Amy Baughcum, PhD, at the Nationwide Children’s Hospital; and Mary Horlick, MD, Mary Evans, PhD, Rebecca Torrance, RN, MSN, Rebekah Van Raaphorst, MPH, and Susan Yanovski, MD, at the National Institute of Diabetes and Digestive and Kidney Diseases.
Additional Contributions: We acknowledge the generous contribution of methodological details from the LABS consortium. The consortium is grateful for the important work done by the adjudication committee.
Correction: This article was corrected on March 4, 2015, for a change made in the Discussion.