The Reversal Intervention for Metabolic Syndrome Study (TRIMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Group lifestyle education

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE9 6PE
    • University of Leicester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group lifestyle education; Multi-component behaviour change intervention	Behavioral: Group lifestyle education; Structured group education programme based on lifestyle changes (dietary and increased physical activity)
No Intervention: Routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria.	12 months follow-up.

Secondary Outcome Measures

Outcome Measure	Time Frame
The prevalence of metabolic syndrome according to NCEP criteria	Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in individual components of the metabolic syndrome (fasting plasma glucose, triglycerides, HDL cholesterol, blood pressure, waist circumference), and 2 hour glucose	Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in biomarkers (hs-CRP, adiponectin, and insulin)	Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in physical activity as measured by IPAQ and pedometer	Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in dietary/nutritional intake measured by DINE	Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in Framingham risk score	Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in quality of life as measured by EuroQol EQ-5D	Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in depression/anxiety as measured by HADS	Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in general self-efficacy as measured by GSE	Compared at baseline versus 12 months, and for the intervention group versus the control group

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: University Hospitals, Leicester
• Investigators: Principal Investigator: Kamlesh Khunti, MD, FRCGP, Diabetes Research Centre, University of Leicester; Principal Investigator: Melanie J Davies, MD, FRCP, Diabetes Research Centre, University of Leicester

Publications and helpful links

General Publications

• Dunkley AJ, Davies MJ, Stone MA, Taub NA, Troughton J, Yates T, Khunti K. The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data. Trials. 2011 May 4;12:107. doi: 10.1186/1745-6215-12-107.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: January 6, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimate): January 7, 2010

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Diabetes; Metabolic syndrome; Primary prevention; Patient education
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 0025 (Other Identifier: Chuck Noll Foundation)