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Sponsors and Collaborators: |
University Hospitals, Leicester National Institute for Health Research |
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Information provided by: | University Hospitals, Leicester |
ClinicalTrials.gov Identifier: | NCT00677937 |
The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programmme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain theparticipant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.
Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?
Condition | Intervention |
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Type 2 Diabetes Mellitus |
Behavioral: Modified DESMOND education and ongoing support |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
Official Title: | A Randomised Controlled Trial to Investigate an Educational Programme and Continous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-Diabetes in a Multi-Ethnic Population |
Estimated Enrollment: | 816 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Intervention to include education and ongoing support
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Behavioral: Modified DESMOND education and ongoing support
6 hours of education with 1 month of inclusion, 3 years of ongoing support
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2: No Intervention
Control to receive standard care
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T2DM is an increasing chronic disease affecting over 2 million people in England alone, shortens life and consumes 10% of NHS resources. At diagnosis many have established complications involving damage to the eyes, kidneys, feet and heart. There is a need to focus efforts to prevent this devastating disease. One in 7 adults have Pre-diabetes (PDM) with 50% developing T2DM over the next 5-10 years. There is clear evidence that treating subjects with PDM with an intensive lifestyle modification programme (LSMP) dramatically reduces T2DM. These programmes are not cost effective, involve intensive use of resources and are unproven in the UK. Some minority ethnic groups have a higher risk of T2DM, any LSMP would need to be culturally sensitive. Our objective is to test if we can develop a low cost but effective LSMP for the UK. We will develop a training programme to skill healthcare professionals and non-professionals and so called 'lay' educators to deliver the LSMP. Benefits of lay educators are patient involvement in a patient centred service and the contribution to building capacity within the NHS workforce. We will develop a simple self-assessment tool to identify those at highest risk of T2DM. We will conduct a clinical trial, testing the LSMP in 50 practices and 816 patients. The practices will be randomised to either a control or intervention 'arm'. Control practices will give information to patients at risk in line with current best practice. Subjects in the Intervention practices will be invited to the LSMP and will receive 6 hours of group education over 3 months plus ongoing contact. Subjects will be followed for 3 years. The LSMP will encourage individuals to scrutinise information, ask questions, and self-manage their condition, using simple, non-technical language and visual aids. This approach has been effective in T2DM and we will use this model along with expertise in physical activity and lifestyle change, working with leading experts. The study is designed to show if we can significantly reduce the risk of developing T2DM, as well as the effect on weight, blood pressure, patients' quality of life, physical activity and dietary behaviours. We will demonstrate its cost effectiveness to ensure relevance to the NHS. The research team have international expertise in prevention of T2DM.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephen Hiles, BSc | 441162587252 | stephen.hiles@uhl-tr.nhs.uk |
Contact: Jayne Hill | 44116258 | jayne.hill@uhl-tr.nhs.uk |
United Kingdom, Leicestershire | |
University Hospitals, Leicester | |
Leicester, Leicestershire, United Kingdom, LE1 5WW |
Principal Investigator: | Melanie Davies, MD, FRCP | University Hospitals, Leicester |
Principal Investigator: | Kamlesh Khunti | Univeristy of Leicester |
Responsible Party: | University Hospitals, Leicester ( Prof. Melanie Davies ) |
Study ID Numbers: | UHLPRE01 |
Study First Received: | May 13, 2008 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00677937 History of Changes |
Health Authority: | UK: National Health Service |
diabetes melitus prevention education impaired glucose tolerance multi ethnic |
Metabolic Diseases Glucose Intolerance Diabetes Mellitus, Type 2 Prediabetic State Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |