Development of a lifestyle intervention using the MRC framework for diabetes prevention in people with impaired glucose regulation

A B S T R AC T Background We report development of a group-based lifestyle intervention, Let's Prevent, using the UK Medical Research Council (MRC) framework, and delivered by structured education to prevent type 2 diabetes mellitus (T2DM) in people with impaired glucose regulation (IGR) in a UK multi-ethnic population. Methods Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) is the first national T2DM programme that meets National Institute for Health and Care Excellence criteria and formed the basis for Let's Prevent. An iterative cycle of initial development, piloting, collecting and collating qualitative and quantitative data, and reflection and modification, was used to inform and refine lifestyle intervention until it was fit for evaluation in a definitive randomized controlled trial (RCT). The programme encouraged IGR self-management using simple, non-technical language and visual aids. Results Qualitative and quantitative data suggested that intervention resulted in beneficial short-term behaviour change such as healthier eating patterns, improved health beliefs and greater participant motivation and empowerment. We also demonstrated that recruitment strategy and data collection methods were feasible for RCT implementation. Conclusions Let's Prevent was developed following successful application of MRC framework criteria and the subsequent RCT will determine whether it is feasible, reliable and transferable from research into a real-world NHS primary healthcare setting. Trial Registration ISRCTN80605705. Keywords complex intervention, diabetes prevention, impaired glucose regulation, structured education Introduction Screening studies carried out in primary care in the UK 1 have shown that screening for type 2 diabetes mellitus (T2DM) will identify around 15% of middle aged adults with impaired glucose tolerance or impaired fasting glucose, collectively termed impaired glucose regulation (IGR) and also known as pre-diabetes mellitus. 2 IGR is considered to be a high-risk state for T2DM, cardiovascular disease (CVD) and increased mortality 3,4 and is now referred to as 'at high risk of developing diabetes' under new guidelines on terminology. There is evidence that, in people with IGR, lifestyle modifications can substantially reduce the risk of developing T2DM. 6 Screening and lifestyle interventions are also likely to be costeffective. 7 The Diabetes Prevention Programme 8 and the Finnish Prevention study 9 showed that lifestyle programmes addressing weight loss, healthy diet and physical activity reduce the risk of developing T2DM in those with IGR by 58%. Successful lifestyle programmes have also been carried out in many other countries, including India, 10 China 11 and Japan. 12 There is limited evidence, however, regarding the feasibility of translating this research into practice. Many research-based prevention programmes have involved multiple one-to-one counselling sessions. The Diabetes Prevention Programme had a median of 20 individual counselling sessions over a 4-year period. 9 The intensity of such an intervention, even if cost-effective in the long term, is likely to place acute strain on healthcare resources in the short term. Even resource-rich countries, such as Germany and Finland, where diabetes prevention is a public health priority, have been unable to replicate the intensive nature of diabetes prevention programmes when implemented into clinical practice. 17 New guidelines from the National Institute for Health and Care Excellence (NICE) state that those identified with a moderate or high risk of developing T2DM should be offered culturally appropriate information or support, in a range of formats and languages, including structured education, to help them change their lifestyle. 5 Structured education refers to group-based patient-centred educational programmes that have a clear philosophy and a written curriculum with supporting resources, are underpinned by appropriate learning and psychological theory, and are evidence-based and delivered by trained, quality assessed educators. 19 Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) is the first national programme for T2DM that meets NICE criteria 20,21 and a randomized controlled trial (RCT) has demonstrated its effectiveness in improving weight, smoking behaviours and illness beliefs. 21 The DESMOND model is based on an empowerment philosophy that sees the participant as capable and responsible for their own health decisions and behaviours. The UK Medical Research Council (MRC) Framework for Complex Interventions to Improve Health has internationally recognized criteria to guide the development and evaluation of health behaviour change programmes. The most recent MRC guidance suggests including the following phases: development, feasibility and piloting, evaluation and implementation 23 There is an urgent need to design and test prevention programmes that meet the needs of ethnically diverse communities and are feasible, cost-effective and replicable in a real-world UK healthcare setting. The lifestyle intervention described was developed to meet this need and is currently being formally evaluated in an RCT. Methods Study design and recruitment The Let's Prevent intervention was developed by a core multidisciplinary team in collaboration with the DESMOND collaborative and the National Physical Activity Centre in Loughborough. It was designed as a group educational programme with a written curriculum suitable for the broadest range of participants, to be deliverable in a community setting for ease of access for patients, and to have the potential for integration into future routine clinical care. The session content was founded on a sound evidence base and guided by a review of the literature surrounding nutrition, exercise and educational principles with pragmatic decisions on best practice where the evidence was ambiguous, lacking or conflicting. Using the DESMOND model, the programme was 6 h long, deliverable in either one full day or as two half-day equivalents. It was designed to be facilitated by two trained healthcare professionals (educators) to a group of between 5 and 12 participants with IGR, who had the option of bringing an accompanying person. It was delivered as two versions. The first was broadly suitable for most White European groups, referred to as the Let's Prevent programme, and the second was adapted to suit SA patient groups and referred to as the SA Let's Prevent programme. Both versions of the educational intervention and the educator training programme were modelled and refined using an iterative process, including piloting, feedback, analysis, reflection and modification, based on a methodology previously developed for modifying an educational programme. 30 Key to the process was the collection and analysis of qualitative and quantitative data. A degree of objectivity and a high level of rigour were attained by involving academic researchers in this process. The Qualitative data were gathered to ascertain the experiences of both participants and educators of engaging in the programme. Data were collected via observation, telephone and face-to-face interviews and focus groups. Flexible topic guides were developed by trainers and qualitative researchers to inform and facilitate the qualitative data collection process. The SA Let's Prevent programme was developed concurrently to address the needs of the SA population living in the UK, many of whom do not speak English. Core educational messages were identical to Let's Prevent but changes were made to ensure that food and activity messages were culturally relevant. Teaching resources (images and models) were developed to ensure that the programme was not reliant on the written word. A previous action research project The nutritional goals from the Diabetes Prevention Programme 8 and the Finnish Prevention Study 9 and the physical activity goals from the PREPARE stud