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Design of a family-based lifestyle intervention for youth with type 2 diabetes: the TODAY study

A Corrigendum to this article was published on 10 May 2010

Abstract

Type 2 diabetes is associated with obesity and is increasing at an alarming rate in youth. Although weight loss through lifestyle change is one of the primary treatment recommendations for adults with type 2 diabetes, the efficacy of this approach has not been tested with youth. This paper provides a summary of the reviews and meta-analyses of pediatric weight-loss interventions that informed the design and implementation of an intensive, family-based lifestyle weight management program for adolescents with type 2 diabetes and their families developed for the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. A total of 1092 youth have been screened, and 704 families have been randomized for inclusion in this 15-center clinical trial sponsored by the National Institutes of Health. The TODAY study is designed to test three approaches (metformin, metformin plus rosiglitazone and metformin plus an intensive lifestyle intervention) to the treatment of a diverse cohort of youth, 10–17 years of age, within 2 years of their diagnosis. The principal goal of the TODAY Lifestyle Program (TLP) is to decrease baseline weight of youth by 7–10% (or the equivalent for children who are growing in height) through changes in eating and physical activity habits, and to sustain these changes through ongoing treatment contact. The TLP is implemented by interventionists called Personal Activity and Nutrition Leaders (PALs) and delivered to youth with type 2 diabetes, and at least one family support person. The TLP provides a model for taking a comprehensive, continuous care approach to the treatment of severe overweight in youth with comorbid medical conditions such as type 2 diabetes.

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Acknowledgements

This work was completed with funding from NIDDK/NIH grant numbers U01-DK61212, U01-DK61230, U01-DK61239, U01-DK61242, U01-DK61254, from NIMH grant number 1K24MH070446-01 (Dr Wilfley) and from the National Center for Research Resources General Clinical Research Centers Program grant numbers M01-RR00036 (Washington University School of Medicine), M01-RR00043-45 (Children's Hospital Los Angeles), M01-RR00069 (University of Colorado Health Sciences Center), M01-RR00084 (Children's Hospital of Pittsburgh), M01-RR01066 (Massachusetts General Hospital), M01-RR00125 (Yale University) and M01-RR14467 (University of Oklahoma Health Sciences Center). Members of the writing group were D Wilfley (chair), B Berkowitz, L Epstein, K Hirst, A Kriska, L Laffel, M Marcus, T Tibbs and D Van Buren.

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Supplementary Information accompanies the paper on International Journal of Obesity website (http://www.nature.com/ijo)

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Appendix

Appendix

TODAY study group: The following individuals and institutions constitute the TODAY Study Group (* indicates principal investigator or director):

Clinical centers Baylor College of Medicine: M Haymond*, B Anderson, S Gunn, H Holden, M Jones, K Hwu, S McGirk, S McKay, B Schreiner Case Western Reserve University: L Cuttler*, E Abrams, T Casey, W Dahms, D Drotar, S Huestis, C Levers-Landis, P McGuigan, S Sundararajan Childrens Hospital Los Angeles: M Geffner*, N Chang, D Dreimane, M Halvorson, S Hernandez, F Kaufman (Study Chair), V Mansilla, R Ortiz, A Ward, K Wexler, P Yasuda Children's Hospital of Philadelphia: L Levitt Katz*, R Berkowitz, S Boyd, C Carchidi, J Kaplan, C Keating, S Kneeshaw-Price, C Lassiter, T Lipman, S Magge, G McGinley, B. Schwartzman, S Willi Children's Hospital of Pittsburgh: S Arslanian*, F Bacha, S Foster, B Galvin, T Hannon, A Kriska, I Libman, M Marcus, K Porter, T Songer, E Venditti Columbia University Medical Center: R Goland*, R Cain, I Fennoy, D Gallagher, P Kringas, N Leibel, R Motaghedi, D Ng, M Ovalles, M Pellizzari, R Rapaport, K Robbins, D Seidman, L Siegel-Czarkowski, P Speiser Joslin Diabetes Center: L Laffel*, A Goebel-Fabbri, L Higgins, M Malloy, K Milaszewski, L Orkin, A Rodriguez-Ventura Massachusetts General Hospital: D Nathan*, L Bissett, K Blumenthal, L Delahanty, V Goldman, A Goseco, M Larkin, L Levitsky, R McEachern, K Milaszewski, D Norman, B Nwosu, S Park-Bennett, D Richards, N Sherry, B Steiner Saint Louis University: S Tollefsen*, S Carnes, D Dempsher, D Flomo, V Kociela, T Whelan, B Wolff State University of New York Upstate Medical University: R Weinstock*, D Bowerman, K Duncan, R Franklin, J Hartsig, R Izquierdo, J Kanaley, J Kearns, S Meyer, R Saletsky, P Trief University of Colorado Health Sciences Center: P Zeitler* (Steering Committee Chair), A Bradhurst, N Celona-Jacobs, J Glazner, J Higgins, F Hoe, G Klingensmith, K Nadeau, H Strike, N Walders, T Witten University of Oklahoma Health Sciences Center: K Copeland* (Steering Committee Vice-Chair), R Brown, J Chadwick, L Chalmers, C Macha, A Nordyke, T Poulsen, L Pratt, J Preske, J Schanuel, J Smith, S Sternlof, R Swisher University of Texas Health Science Center at San Antonio: D Hale*, N Amodei, R Barajas, C Cody, S Haffner, J Hernandez, J Lynch, E Morales, S Rivera, G Rupert, A Wauters Washington University School of Medicine: N White*, A Arbeláez, J Jones, T Jones, M Sadler, M Tanner, R Welch Yale University: S Caprio*, M Grey, C Guandalini, S Lavietes, P Rose, A Syme, W Tamborlane

Coordinating center George Washington University Biostatistics Center: K Hirst*, L Coombs, S Edelstein, N Grover, C Long, L Pyle

Project office National Institute of Diabetes and Digestive and Kidney Diseases: B Linder*

Central units Central Blood Laboratory (Northwest Lipid Research Laboratories, University of Washington): S Marcovina*, J Chmielewski, M Ramirez, G Strylewicz DEXA Reading Center (University of California at San Francisco): J Shepherd*, B Fan, L Marquez, M Sherman, J Wang Diet Assessment Center (University of South Carolina): E Mayer-Davis*, Y Liu, M Nichols Lifestyle Program Core (Washington University): D Wilfley*, D Aldrich-Rasche, K Franklin, C Massmann, D O'Brien, J Patterson, T Tibbs, D Van Buren

Others: Centers for Disease Control: P Zhang, Hospital for Sick Children, Toronto: M Palmert, State University of New York at Buffalo: L Epstein, University of Florida: J Silverstein

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The TODAY Study Group. Design of a family-based lifestyle intervention for youth with type 2 diabetes: the TODAY study. Int J Obes 34, 217–226 (2010). https://doi.org/10.1038/ijo.2009.195

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