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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19509463

Enrollment

532

Registered

2009-02-10

Start date

2000-05-09

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

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 bu

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. New diagnosis of diabetes 2. Age 80 3. Insulin treatment 4. Established psychiatric problems 5. Presence of terminal illness

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
1. Cardiovascular events, followed up for 4 years 2. Cost-effectiveness analysis at 4 years	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026