A Diabetes Prevention Study Targeting High Risk Individuals With Education and Ongoing Support
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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?
    

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.
    

Intervention name(s): Modified DESMOND education and ongoing support
Intervention type(s): Behavioral
Intervention description(s): 6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diabetes mellitus; prevention; education; impaired glucose tolerance; multi-ethnic