Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2009-08-31
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group lifestyle education
Multi-component behaviour change intervention
Group lifestyle education
Structured group education programme based on lifestyle changes (dietary and increased physical activity)
Routine care
Routine care
No interventions assigned to this group
Interventions
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Group lifestyle education
Structured group education programme based on lifestyle changes (dietary and increased physical activity)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
40 Years
74 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
University of Leicester
OTHER
Responsible Party
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Principal Investigators
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Kamlesh Khunti, MD, FRCGP
Role: PRINCIPAL_INVESTIGATOR
Diabetes Research Centre, University of Leicester
Melanie J Davies, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Diabetes Research Centre, University of Leicester
Locations
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University of Leicester
Leicester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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0025
Identifier Type: -
Identifier Source: org_study_id
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