Rethink Organization to iMprove Education and Outcomes (ROMEO): a multicenter randomized 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.


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.
Trento
Marina
M
Laboratory of Clinical Pedagogy, Department of Internal Medicine, University of Turin, Turin, Italy. marina.trento@unito.it
Gamba
Silvia
S
Gentile
Luigi
L
Grassi
Giorgio
G
Miselli
Valerio
V
Morone
Gabriel
G
Passera
Pietro
P
Tonutti
Laura
L
Tomalino
Marco
M
Bondonio
Piervincenzo
P
Cavallo
Franco
F
Porta
Massimo
M
D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006801:Humans; D008019:Life Style; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D016896:Treatment Outcome
D001786:Blood Glucose; D008055:Lipids