Trial of lifestyle intervention by group care in the management of type 2 diabetes (ROMEO Trial)

ISRCTN	ISRCTN19509463
DOI	https://doi.org/10.1186/ISRCTN19509463
Protocol serial number	N/A
Sponsor	University of Turin (Italy)
Funder	European Foundation for the Study of Diabetes/Juvenile Diabetes Research Foundation (EFSD/JDRF)/Novo Nordisk Type 2 Diabetes Research Grant (Denmark)

Submission date: 28/01/2009
Registration date: 10/02/2009
Last edited: 26/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Massimo Porta
Scientific

Laboratory of Clinical Pedagogy
Department of Internal Medicine
University of Turin
Torino
I-10126
Italy

Study information

Primary study design	Interventional
Study design	Randomised controlled multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	ROMEO: Rethink Organisation to iMprove Education and Outcomes. A randomised controlled multi-centre trial of lifestyle intervention by group care in the management of type 2 diabetes
Study acronym	ROMEO
Study objectives	Scarcity of resources, expertise and evidence-based models have so far limited delivery of patient-centred therapeutic education in clinical routine. We have developed and validated a Group Care approach that is applicable to everyday practice and cost-effective in improving metabolic control, knowledge of diabetes, health behaviours and quality of life in type 2 diabetes. A clinical trial (Rethink Organisation to iMprove Education and Outcomes [ROMEO]) was planned to evaluate the applicability and reproducibility of Group Care in other centres and in a larger patient population.
Ethics approval(s)	Ethics Committee of the Molinette san Giovanni Battista University Hospital and Maria Adelaide Hospital, Torino (Comitato Etico Interaziendale AOU San Giovanni Battista di Torino e AO CTO Maria Adelaide di Torino), approved on 27/01/2009 (ref: 0006703).
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	Participants were randomly allocated to the following two groups: Intervention group: Group Care, consisting of a clinical approach in which diabetes care is routinely delivered as group sessions built upon a systemic education programme whereas individual care is dedicated to emerging clinical problems, yearly checks for complications or patients' explicit requests. Each group session lasted on average 50 min. Control group: Traditional one-to-one visits delivered by the same physicians/ nurses/ dieticians/ educators involved in Group Care. Each control individual visit lasted on average 15 min. Visits took place every 3 months for 4 years. Total duration of follow-up: 4 years.
Intervention type	Other
Primary outcome measure(s)	1. Clinical outcomes 1.1.Glycated haemoglobin, measured every 3 months for 4 years 1.2. Low-density lipoprotein (LDL) cholesterol, assessed yearly for 4 years 1.3. Systolic and diastolic blood pressure, measured every 3 months for 4 years 2. Cognitive and psychological outcomes 2.1. Quality of life, assessed yearly for 4 years 2.2. Knowledge of diabetes, assessed every 2 years for 4 years 2.3. Health behaviours, assessed yearly for 4 years
Key secondary outcome measure(s)	1. Cardiovascular events, followed up for 4 years 2. Cost-effectiveness analysis at 4 years
Completion date	14/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	532
Key inclusion criteria	1. Outpatients with non insulin-treated type 2 diabetes millitus (T2DM) of at least 1 year known duration 2. Both males and females, aged <80 3. Normally followed in a diabetes centre
Key exclusion criteria	1. New diagnosis of diabetes 2. Age <40 or >80 3. Insulin treatment 4. Established psychiatric problems 5. Presence of terminal illness
Date of first enrolment	09/05/2000
Date of final enrolment	14/07/2007

Locations

Countries of recruitment

Italy

Study participating centre

Laboratory of Clinical Pedagogy

Torino
I-10126
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No
Results article	results	01/09/2014		Yes	No
Protocol article	protocol in:	01/06/2004		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes