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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00677937
First received: May 13, 2008
Last updated: September 4, 2012
Last verified: September 2012

May 13, 2008
September 4, 2012
May 2009
July 2014   (final data collection date for primary outcome measure)
Reduction in incidence of diabetes at 3 years [ Time Frame: 3 years from entry into the study ] [ Designated as safety issue: No ]
Reduction in progression to diabetes at 3 years [ Time Frame: 3 years from inclusion ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00677937 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III) [ Time Frame: 3 years from inclusion ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Diabetes Prevention Study Targeting High Risk Individuals With Education and Ongoing Support
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

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?

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Type 2 Diabetes Mellitus
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
  • Experimental: 1
    Intervention to include education and ongoing support
    Intervention: Behavioral: Modified DESMOND education and ongoing support
  • No Intervention: 2
    Control to receive standard care
Gray LJ, Khunti K, Williams S, Goldby S, Troughton J, Yates T, Gray A, Davies MJ; Let's Prevent Collaborators. Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation. Cardiovasc Diabetol. 2012 May 20;11:56.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
748
August 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00677937
UHL10564
Yes
University Hospitals, Leicester
University Hospitals, Leicester
National Institute for Health Research, United Kingdom
Principal Investigator: Melanie Davies, MD, FRCP University Hospitals, Leicester
Principal Investigator: Kamlesh Khunti Univeristy of Leicester
University Hospitals, Leicester
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP