Back to results

The Reversal Intervention for Metabolic Syndrome Study (TRIMS)

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Group lifestyle education

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Primary prevention, Diabetes, Cardiovascular disease, Patient education

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

University of Leicester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group lifestyle education

Routine care

Arm Description

Multi-component behaviour change intervention

Routine care

Outcomes

Primary Outcome Measures

The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria.

Secondary Outcome Measures

The prevalence of metabolic syndrome according to NCEP criteria

Changes in individual components of the metabolic syndrome (fasting plasma glucose, triglycerides, HDL cholesterol, blood pressure, waist circumference), and 2 hour glucose

Changes in biomarkers (hs-CRP, adiponectin, and insulin)

Changes in physical activity as measured by IPAQ and pedometer

Changes in dietary/nutritional intake measured by DINE

Changes in Framingham risk score

Changes in quality of life as measured by EuroQol EQ-5D

Changes in depression/anxiety as measured by HADS

Changes in general self-efficacy as measured by GSE

Full Information

NCT ID

NCT01043770

First Posted

January 6, 2010

Last Updated

January 29, 2020

Sponsor

University of Leicester

Collaborators

University Hospitals, Leicester

1. Study Identification

Unique Protocol Identification Number

NCT01043770

Brief Title

The Reversal Intervention for Metabolic Syndrome Study

Acronym

TRIMS

Official Title

A Randomised Controlled Trial to Investigate the Effects of a Structured Self-management Education Programme for People With Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Leicester

Collaborators

University Hospitals, Leicester

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Metabolic syndrome, Primary prevention, Diabetes, Cardiovascular disease, Patient education

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group lifestyle education

Arm Type

Experimental

Arm Description

Multi-component behaviour change intervention

Arm Title

Routine care

Arm Type

No Intervention

Arm Description

Routine care

Intervention Type

Behavioral

Intervention Name(s)

Group lifestyle education

Intervention Description

Structured group education programme based on lifestyle changes (dietary and increased physical activity)

Primary Outcome Measure Information:

Title

The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria.

Time Frame

12 months follow-up.

Secondary Outcome Measure Information:

Title

The prevalence of metabolic syndrome according to NCEP criteria

Time Frame