Rethink Organization To Improve Education And Outcomes (ROMEO). A Multicentre Randomised Trial Of Lifestyle Intervention By Group Care To Manage Type 2 Diabetes

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: Four-year two-armed, multicentre controlled trial in 13 hospital-based diabetes clinics in Italy (Current Controlled Trials ISRCTN19509463). 815 non insulin-treated patients aged <80, with 1 year known diabetes duration were randomised to either group or individual care. Results: After 4 years, patients in Group Care had lower HbA1c, total cholesterol, LDL cholesterol, triglyceride, systolic and diastolic blood pressure, body mass index and serum creatinine, and higher HDL cholesterol (p<0.001, all) than controls receiving individual care, despite similar pharmacological prescriptions. Health behaviours, quality of life and knowledge of diabetes had become better in Group Care patients than controls (p<0.001, all). Conclusions: The favourable clinical, cognitive and psychological outcomes of Group Care can be reproduced in different clinical settings.