Title: CAADDi - Carbohydrate Awareness Advice by Dietitians in Diabetes
Funder: Health Education England

Abstract: Background Diabetes Mellitus affects over 3 million people in the UK; 90% have Type 2 diabetes. Obesity accounts for the huge increase in numbers both in the UK and worldwide (Diabetes UK 2012; IDF 2012). Treating diabetes and its complications is estimated to cost the NHS 1 million per hour. Diet and lifestyle interventions are central to the management of Type 2 diabetes and their effectiveness has been demonstrated in numerous studies (Franz, Boucher, Green-Pastors et al. 2008). However, evidence is limited for the ideal quantity of carbohydrate in the diet; the only nutrient with a direct and immediate effect on blood glucose (Dyson, Kelly, Deakin et al. 2011). Registered Dietitians (RDs) have unique expertise in this field; however a study of their practice in relation to carbohydrate advice found wide variation (McArdle 2013). The lack of evidence means carbohydrate advice in Type 2 diabetes is poorly defined, leading to inconsistent advice and potential confusion for patients, which in turn limits their ability to make appropriate dietary choices. This can impact patients' quality of life and blood glucose control, increase the need for medications, increase weight gain and increase the risk of diabetes complications. Conversely, evidence suggests that high quality dietary advice, such as that provided under clinical trial conditions (Franz et al. 2008), can lead to improvements in blood glucose control and consequently a reduced risk of complications. Aims This research aims to develop and define the intervention Carbohydrate Awareness Advice', so that the quality and consistency of dietary advice to patients may be improved, resulting in better outcomes for patients. It can then also be tested in Randomised Controlled Trials in the future. The research questions being addressed are: What carbohydrate awareness advice should be provided for people with Type 2 diabetes? What is the suitable language for conveying carbohydrate awareness advice to patients or their carers? Plan of Investigation This mixed-methods research will be conducted in 2 phases over a period of 3 years: Phase 1 Pre-clinical: Systematic Review: Carbohydrate Advice in Type 2 Diabetes Phase 2 Modelling: Qualitative interviews with adults with diabetes Focus groups with Registered Dietitians Synthesis with Stakeholder Group leading to intervention design The phases planned for this research match those recommended by the Medical Research Council's guidance on Developing & Evaluating Complex Interventions (MRC 2008). In preparation for Phase 3, the exploratory trial phase, the final stages of the Fellowship will be used to develop a protocol for feasibility and definitive trials. Potential Benefits to Patients and the NHS Patients will benefit by receiving clearer and more consistent advice about carbohydrate, which is more tailored to their needs. Through consistent education and support to improve understanding of dietary carbohydrate, patients may change their behaviour. Changes might include the total quantity of carbohydrate eaten, the types of carbohydrate or how it is distributed across the day. This may in turn affect the total calorific intake and therefore impact on body weight. Patients may also make changes to their medication doses. Empowering patients to manage their lifelong condition through better quality dietary advice will result in improved diabetes outcomes and improved quality of life for patients. The NHS will benefit by improving the quality of care and outcomes for people with Type 2 diabetes within current resources. If the effectiveness of this intervention is demonstrated through future clinical trials, both patients and Registered Dietitians will have access to an approach that is clearly defined and evidence based, leading to reduced risks of diabetes complications, thereby reducing both the financial cost to the NHS and the personal cost for patients.

Lay abstract: Dietary carbohydrate plays an important role in controlling blood glucose in Type 2 diabetes. Research studies show conflicting results for the ideal amount of carbohydrate. Dietitians have expertise to tailor carbohydrate advice to individuals. Practice in this area lacks consistency, due to conflicting evidence. Inconsistent or poor quality dietary advice could lead to confusion for patients, poor diabetes control and poor outcomes. This research will develop and define carbohydrate awareness advice, to improve consistency without sacrificing the ability to tailor advice to individuals. This will improve the quality of dietary advice, leading to better diabetes control and improved patient outcomes.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: METABOLIC AND ENDOCRINE