Title: Development of a structured screening and lifestyle intervention for prevention of Type 2 Diabetes Mellitus in a population with Learning Disabilities
Funder: Department of Health (England)

Abstract: LD Learning Disabilities IGR Impaired Glucose Regulation T2DM Type 2 Diabetes Mellitus Aims and objectives The overall aims of the programme are to: • Establish a programme of research conducted in a population with LD that significantly enhances the knowledge and understanding of IGR and T2DM in people with LD • Test strategies for early identification of IGR and T2DM in people with LD • Develop a diabetes prevention programme through the application of a structured lifestyle education programme and undertake a cost-effectiveness analysis Background T2DM is a serious chronic condition that is associated with an increased risk of cardiovascular disease. IGR is a condition affecting around 12% of the UK adult population where blood glucose concentrations are elevated above the normal range but do not satisfy the criteria for T2DM. IGR represents an important public health problem due to an associated increased risk of developing T2DM and cardiovascular disease. The majority of cases of T2DM can be prevented by changes to lifestyle and lifestyle education interventions have been shown to be cost-effective in delaying or preventing the transition to T2DM in people with IGR. The evidence base for detection and prevention of T2DM has not yet been applied in a population with LD and it cannot be assumed that an intervention beneficial to the general population will be effective for the LD population. The rationale for the intervention is the same as for the general population; to reduce chronic disease and disability, to improve quality of life, to reduce health inequalities and to attenuate future health costs; the intervention itself will be subtly modified to be relevant to the population with LD. Research Plans WP 1 – Development of a structured screening programme to determine the prevalence of T2DM and IGR in people with LD and perform an economic analysis of different screening strategies WP 2 – Development and pilot of a lifestyle intervention for people with LD and IGR WP 3 - Development of quality assurance process for educators delivering the intervention WP 4 - Randomised controlled trial of a lifestyle intervention for people with IGR and LD to increase physical activity in comparison to usual care; conduct a cost-effectiveness evaluation of the screening and intervention programme WP 5 - Qualitative study of participants and their carers to determine attitudes and beliefs which constitute barriers and enablers to provision and uptake of the intervention Research Team The co-applicants represent a unique collaboration between experts in T2DM, LD and behaviour change which is an essential component for the success of this programme. The multi-disciplinary, multi-national team has an impressive array of complementary skills including experience of conducting large scale screening studies, randomised controlled trials in the prevention of T2DM in primary care and working with people with LD. The team has expertise in qualitative research and health economics. Programme Management The research programme will be managed and directed by the Programme Steering Group which will be made up of the co-applicants listed on the application. Researchers and community LD nurses will meet regularly and will report back to the Steering Group. Research Environment The University of Leicester, University Hospitals of Leicester NHS Trust, NHS Leicester City and Leicestershire&Rutland PCT have a strong alliance and provide a strong research environment. There an established record of joint working between Leicester and University of Glasgow. Anticipated outputs, outcomes and impact of this research on the health of patients and/or the public, and on the NHS The proposed research project will directly support government strategy in reducing health inequalities in a population with LD by determing prevalence of T2DM and IGR for this population and developing a a prevention intervention. Patient and Public involvement We have consulted with service users, carers and LD health care professionals resulting in changes to the study design including modification of recruitment strategies and provision of additional support to sustain increases to physical activity. Ethical Considerations Local Research Ethics and Trust approval for each of the sites will be obtained. We have experience of obtaining consent from this vulnerable population and strict standard operating procedures will be followed which follow English legislation. Confidentiality of sensitive data will be ensured by the assignment of unique study identification numbers, data encryption will be used for transfer of data across organisations. Justification for resources requested The majority of costs we have requested are for staff costs for development and implementation of the WPs. Additional costs incurred include reimbursement for particpants, travel and equipment.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;4.4 POPULATION SCREENING
Health categories: MENTAL HEALTH;METABOLIC AND ENDOCRINE