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A Diabetes Prevention Study Targeting High Risk Individuals With Education and Ongoing Support (PREVENTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00677937
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : December 5, 2014
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University Hospitals, Leicester

Brief Summary:

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 programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant'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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Modified DESMOND education and ongoing support Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population
Study Start Date : May 2009
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Intervention to include education and ongoing support
Behavioral: Modified DESMOND education and ongoing support
6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions

No Intervention: 2
Control to receive standard care

Primary Outcome Measures :
  1. Reduction in incidence of diabetes at 3 years [ Time Frame: 3 years from entry into the study ]

Secondary Outcome Measures :
  1. change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III) [ Time Frame: 3 years from enrollment into the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Patients that will be included into the study if they have either / or

  • Diagnosed with Pre-Diabetes (IGT or IFG)
  • Aged 40 - 75 if English speaking European or 25 - 75 if South Asian
  • Able to attend group education sessions

Exclusion Criteria:

Patients will be excluded from the study if they are:

  • Unable to give consent
  • Unable to attend group education sessions
  • Diagnosis of diabetes at screening or during the study
  • Require an interpreter for language other than South Asian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677937

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United Kingdom
University Hospitals of Leicester
Leicester, Leicestershire, United Kingdom, LE1 5WW
Sponsors and Collaborators
University Hospitals, Leicester
National Institute for Health Research, United Kingdom
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Principal Investigator: Melanie Davies, MD, FRCP University Hospitals, Leicester
Principal Investigator: Kamlesh Khunti Univeristy of Leicester
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00677937    
Other Study ID Numbers: UHL10564
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by University Hospitals, Leicester:
diabetes mellitus
impaired glucose tolerance
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases