Rethink Organization to iMprove Education and Outcomes (ROMEO): a multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes

Marina Trento, Silvia Gamba, Luigi Gentile, Giorgio Grassi, Valerio Miselli, Gabriel Morone, Pietro Passera, Laura Tonutti, Marco Tomalino, Piervincenzo Bondonio, Franco Cavallo, Massimo Porta, ROMEO Investigators, Marina Trento, Silvia Gamba, Luigi Gentile, Giorgio Grassi, Valerio Miselli, Gabriel Morone, Pietro Passera, Laura Tonutti, Marco Tomalino, Piervincenzo Bondonio, Franco Cavallo, Massimo Porta, ROMEO Investigators

Abstract

Objective: A trial was performed to establish whether our group care model for lifestyle intervention in type 2 diabetes can be exported to other clinics.

Research design and methods: This study was a 4-year, two-armed, multicenter controlled trial in 13 hospital-based diabetes clinics in Italy (current controlled trials no. ISRCTN19509463). A total of 815 non-insulin-treated patients aged <80 years with > or =1 year known diabetes duration were randomized to either group or individual care.

Results: After 4 years, patients in group care had lower A1C, total cholesterol, LDL cholesterol, triglycerides, systolic and diastolic blood pressure, BMI, and serum creatinine and higher HDL cholesterol (P < 0.001, for all) than control subjects receiving individual care, despite similar pharmacological prescriptions. Health behaviors, quality of life, and knowledge of diabetes had become better in group care patients than in control subjects (P < 0.001, for all).

Conclusions: The favorable clinical, cognitive, and psychological outcomes of group care can be reproduced in different clinical settings.

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