The Reversal Intervention for Metabolic Syndrome Study (TRIMS)

University of Leicester

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Behavioral: Group lifestyle education

Study type

Interventional

Funder types

Other

Identifiers

NCT01043770

0025

Details and patient eligibility

About

The aim of our study is to see if people with metabolic syndrome who attend a group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes, heart disease and strokes in the future.

Full description

People who have a combination of risk factors termed metabolic syndrome are at increased risk of developing diabetes, heart disease and strokes. Metabolic syndrome is a major public health concern requiring urgent action because 25% of the adult UK population fulfil the criteria, and this will increase as people continue to be less active and levels of overweight and obesity rise.

The aim of our study is to see if people with metabolic syndrome who attend a structured group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes and cardiovascular disease in the future. Overall, we hope to show that this type of education reduces the number of people who have metabolic syndrome.

Subjects recruited with metabolic syndrome will be randomised to intervention or control arms. The intervention arm will receive group education and the control group will receive routine care.

The results will inform primary prevention strategies in people from varied ethnic backgrounds who are at high risk of developing type-2 diabetes and cardiovascular disease.

Enrollment

82 patients

Sex

All

Ages

40 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 40 - 74 years inclusive
Registered with a general practice in Leicester City or Leicester County Primary Care Trust
Availability of data to allow diagnosis of MetS (IDF criteria) collected at a screening visit

Exclusion criteria

Previous diagnosis of T2DM, CVD (stroke/cerebrovascular accident, transient ischaemic attack), peripheral arterial disease, or coronary heart disease (angina, myocardial infarction, coronary artery bypass surgery, angioplasty)
Life-limiting terminal illness
Pregnancy and/or breast feeding
Lack of capacity to give informed consent because of serious mental health problems or learning disability.
People who are housebound
Patients residing in nursing/care homes
Individuals who are unable to speak and understand English. (The intervention will be made appropriate for ethnically diverse populations, but individuals who are unable to understand, speak and read English will be excluded at this stage. However, if the self-management programme is found to be successful we would adapt it for non-English speakers.)