Title: A community based primary prevention programme for Type 2 Diabetes integrating identification, lifestyle intervention and community services for prevention.
Funder: Department of Health (England)

Abstract: The National Service Framework emphasise the importance of prevention of type 2 diabetes mellitus (T2DM). However little progress has been made on this area, in contrast to that of the clinical care of established cases. In terms of prevention, there is irrefutable evidence that intensive lifestyle programmes targeted to those at highest risk are effective in European, North American Diabetes Prevention Programme (DPP) and South Asian (SA) populations 1-3. Screening programmes focused on identifying established T2DM will need to include strategies to identify those at highest risk of developing T2DM. In Finland following the success of the Finnish Diabetes Prevention Study (FDPS) a national community based prevention strategy is being implemented. The proposed comprehensive programme of research has a number of objectives. Firstly to validate and modify if required an existing Diabetes Risk Score (DRS) to be fit for purpose to identify those with undiagnosed T2DM and those at highest risk of T2DM in a multi-ethnic UK population. We will use this DRS to identify and engage those at highest risk of T2DM and offer a Lifestyle Modification Programme (LSMP). We will undertake a postal survey and qualitative study to determine beliefs and attitudes regarding T2DM prevention to identify and overcome barriers and facilitate implementation of a community based programme. In parallel, we will baseline existing and future local and national plans for prevention for T2DM and obesity and describe how to integrate these in practice. We will move to a pilot phase and formally test an LSMP based on group care targeting the 5 key areas identified in the DPP and FDPS, using information currently collated in the EU-funded DE-PLAN (Diabetes in Europe; Prevention using Lifestyle Activity and Nutrition intervention) Leicester being the only UK partner. To underpin the LSMP we will develop and test a training and quality assurance programme for community based ‘health trainers' (HTs) including health care professionals or lay educators and deliver the initial LSMP and provide ongoing support. This work will inform our collaborative work to explore the role of a ‘prevention manager’ a community based co-ordinator with a role in sign-posting other prevention activities (including exercise referral schemes) and co-ordinate the support and training of the community based ‘HTs’. Finally we plan to evaluate the prevention programme and its cost-effectiveness. The assembled multi-disciplinary multi-national team has an impressive array of complementary skills and track record in diabetes prevention and screening. There is expertise in successfully running and recruiting to large clinical trials in primary care with an excellent recruitment performance. The study will use the recently established Diabetes Research Network (DRN) and Primary Care Research Network and also has access to over 230 practices with expertise in running complex interventions. The programme will be run according to the MRC good clinical practice guidelines. The sponsor will be University Hospitals of Leicester NHS Trust. The Trust R&D Directorate will oversee research governance arrangements and have an active Diabetes Research Programme Board with patient representation. There will be a programme steering committee with representation from the investigators, the local healthcare community, study management team, patients and/or carers and an independent academic. Public involvement is vital in ensuring the research is relevant to the public needs. We have had active patient input in the strategy for diabetes research and in the planning for this study. There will be active links with the Leicester Centre for Ethnic Health Patient Panel, with representation of all BME communities from our region. We will involve local and national PPI leads to seek their views and at a national level we will ensure there is a close collaborative working with INVOLVE. The proposal has major strengths including the association with the infrastructure and support network of the DRN. There is the strong link with the DESMOND Collaborative and its proven track record undertaking the largest RCT of structured education intervention ever attempted with sucessful recruitment of over 800 patients. The expertise gained in establishing this infrastructure of research at practice level will be invaluable in the context of this current study. The study will also be made possible by the roll out of the DESMOND Training and Quality Assurance programme. There are now 12 regional trainers and over 300 Primary Care staff been trained in the DESMOND philosophy and principles. The experience of establishing this network means we can draw on the expertise of the national and regional training team, a unique strength of the proposal. This proposal represents excellent value for money and the funding requested is completely justified in view of the scale and importance of the proposed research.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: METABOLIC AND ENDOCRINE