Ng, MPH, MA, Naomi Berry Diabetes Center, Columbia University, New York, New York T. Marcus, PhD, Professor of Psychiatry and Psychology, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania D. Lipman, PhD, Professor of Nutrition and Nursing of Children, University of Pennsylvania School of Nursing M. Ievers-Landis, PhD, Division of Behavioral Pediatrics and Psychology, Rainbow Babies & Children’s Hospital and Case Western Reserve University School of Medicine T.H. Hirst, PhD, Associate Research Professor, George Washington University Biostatistics Center, Rockville, Maryland C. Goebel-Fabbri, PhD, Assistant Professor of Psychiatry, Harvard Medical School, Boston, Massachusetts K. Berkowitz, MD, Associate Professor of Psychiatry and Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania A. The members of the writing group are as follows: Denise Wilfley, PhD (chair), Professor of Psychiatry, Medicine, Pediatrics, and Psychology, Washington University School of Medicine, St. This work was completed with funding from NIDDK/NIH grant numbers U01-DK-61212, U01-DK-61230, U01-DK-61239, U01-DK-61242, and U01-DK-61254 from National Institute of Mental Health Grant 1K24-MH-070446-01 (to D.W.) from the National Center for Research Resources General Clinical Research Centers Program Grants M01-RR-00036 (Washington University School of Medicine), M01-RR-00043-45 (Children’s Hospital Los Angeles), M01-RR-00069 (University of Colorado Denver), M01-RR-00084 (Children’s Hospital of Pittsburgh), M01-RR-01066 (Massachusetts General Hospital), M01-RR-00125 (Yale University), and M01-RR-14467 (University of Oklahoma Health Sciences Center) and from the National Center for Research Resources Clinical and Translational Science Awards Grants UL1-RR-024134 (Children’s Hospital of Philadelphia), UL1-RR-024139 (Yale University), UL1-RR-024153 (Children’s Hospital of Pittsburgh), UL1-RR-024989 (Case Western Reserve University), UL1-RR-024992 (Washington University), UL1-RR-025758 (Massachusetts General Hospital), and UL1-RR-025780 (University of Colorado Denver). Responses to each of the four YEDEQ subscales (restraint, eating, weight, and shape concerns) were totaled and averaged to provide a global subscale score, a measure of overall distress related to eating, weight, and shape concerns. Nonovereaters reported zero for objective overeating episodes and loss of control questions overeaters, ≥1 objective overeating episodes, but zero loss of control episodes subclinical binge eaters, ≥1–<4 binge eating episodes and clinical binge eaters, ≥4 binge eating episodes. Positive responses to both questions were used to establish binge eating, i.e., reporting episodes of objective overeating with an associated loss of control. Responses to “How many times have you eaten what other people would think was a really big amount of food, given the situation?” (objective overeating episodes) and “On how many of these times did you feel like you had lost control while eating?” were used to derive eating categories. Of 704 randomized youth, 678 completed the baseline Youth Eating Disorder Examination Questionnaire (YEDEQ), a self-report measure of eating disorder symptoms ( 7). All participants completed a run-in period to discontinue nonstudy diabetes treatments, achieve hemoglobin A 1c (HbA 1c) <8% on metformin only, and demonstrate adherence to the study protocol.
Eligibility requirements included 10–17 years of age, type 2 diabetes <2 years' duration, BMI ≥85th percentile at diagnosis, and an adult caregiver willing to support study participation. Enrollment began May 2004 and ended February 2009 with a total of 704 participants. All participants provided informed consent, and minor children confirmed assent according to local guidelines. The protocol was approved by an External Evaluation Committee convened by the NIDDK and by Institutional Review Boards at each participating institution. The study design and objectives have been described elsewhere ( 6).
The collaborative study includes 15 clinical centers and a data coordinating center (see Supplementary Data).
BINGE EATING INVENTORY TRIAL
TODAY is a multicenter randomized clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH).