An interventional study of Group lifestyle education in Metabolic Syndrome, sponsored by University of Leicester. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by University of Leicester · Not applicable, Interventional, and Prevention
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 82 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Leicester is the lead sponsor of 166 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Multi-component behaviour change intervention
Behavioral: Group lifestyle education
Routine care
Structured group education programme based on lifestyle changes (dietary and increased physical activity)
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.
The prevalence of metabolic syndrome according to NCEP criteria
Time frame: 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
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in biomarkers (hs-CRP, adiponectin, and insulin)
Time frame: 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
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in dietary/nutritional intake measured by DINE
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in Framingham risk score
Time frame: 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
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in depression/anxiety as measured by HADS
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in general self-efficacy as measured by GSE
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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University of Leicester