Participants' experiences of attending a structured education course (DAFNEplus) informed by behavioural science.

AIMS: As part of a broader process evaluation, we explored participants' experiences of, and engagement with, the DAFNEplus programme's group-based structured education course. This course, which was informed by behavioural science, provided participants with education and instruction to use flexible intensive insulin therapy (FIIT) together with techniques to identify and address unhelpful cognitive and emotional influences on their type 1 diabetes self-management. METHODS: We interviewed n = 28 DAFNEplus participants. Data were analysed thematically and took account of previous work exploring individuals' experiences of standard DAFNE courses. RESULTS: As well as benefitting from the DAFNEplus course's skills-based training and educational curriculum, participants' accounts suggested they had experienced cognitive and emotional changes that had positively influenced their confidence and motivation to adopt and sustain the use of FIIT. These benefits were most keenly felt by those who reported negative emotional states and mind-sets pre-course which had made their diabetes self-management challenging. Participants' cognitive and emotional changes were enabled through techniques used during the course to normalise setbacks and imperfect diabetes self-management, capitalise upon group synergies and encourage the use of social support, including from healthcare professionals. Participants also highlighted motivational gains arising from being reassured that diabetes complications are not common or inevitable if a FIIT regimen is followed. CONCLUSIONS: Our findings suggest that offering training in FIIT, in conjunction with behaviour change techniques that target unhelpful mindsets and emotional resilience, may be more effective in promoting diabetes self-management than offering education and skills training alone.

The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel.

AIMS: Self-management programmes for type 1 diabetes, such as the UK's Dose Adjustment for Normal Eating (DAFNE), improve short-term clinical outcomes but difficulties maintaining behavioural changes attenuate long-term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change. METHODS: A four-step method was based on the BCW intervention development approach: (1) Identifying self-management behaviours and barriers/enablers to maintain them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation-Behaviour (COM-B) model. (2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). (3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. (4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co-designed by stakeholders (diabetologists, psychologists, specialist nurses and dieticians). RESULTS: In all, 34 barriers and 5 enablers to sustaining self-management post-DAFNE were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. In all, 27 BCTs were added, including 'Habit formation', 'Credible source' and 'Conserving mental resources'. In total, 15 stakeholder-agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co-designed components: (1) face-to-face group learning course, (2) individual structured follow-up sessions and (3) technological support, including blood glucose data management. CONCLUSIONS: This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self-management behaviours.

Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes.

INTRODUCTION: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs). METHODS AND ANALYSIS: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation. ETHICS AND DISSEMINATION: Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals. TRIAL REGISTRATION NUMBER: ISRCTN42908016.

Designing the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) self-management and support programme for UK African and Caribbean communities: a culturally tailored, complex intervention under-pinned by behaviour change theory.

BACKGROUND: UK African and Caribbean (AfC) communities are disproportionately burdened by type 2 diabetes (T2D). Promoting healthy eating and physical activity through structured education is the cornerstone of T2D care, however cultural barriers may limit engagement in these communities. In addition, changes in lifestyle behaviour are shaped by normative influences within social groups and contextual factors need to be understood to facilitate healthful behaviour change. The Behaviour Change Wheel (BCW) and associated COM-B framework offer intervention designers a systematic approach to developing interventions. The aim of this study was to apply the BCW in the design of a culturally sensitive self-management support programme for T2D in UK AfC communities. METHODS: An intervention development study was conducted. Focus groups were held with 41 AfC patients with T2D to understand healthful weight-management, diet and physical activity behaviours. The COM-B framework and BCW were used to evaluate the qualitative data, identify appropriate behaviour change techniques and specify the intervention components. RESULTS: Participants were motivated to avoid diabetes-related consequences although did not always understand the negative impact of their current health behaviours on long-term diabetes outcomes. Barriers to healthful behaviour included gaps in knowledge related to diet, physical activity and weight management guidance. In addition, motivation and social opportunity barriers included an acceptance of larger body sizes, rejection of body mass index for weight guidance and cultural identity being strongly linked to consumption of traditional starches. There was a lack of social opportunity to perform moderate to vigorous physical activity, although walking and dance were culturally acceptable. The resulting Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) intervention uses social support, social comparison, credible sources and demonstration as key behaviour change techniques. CONCLUSION: Use of COM-B and the BCW highlighted the need for an intervention to address motivational and social opportunity barriers to engaging in healthful behaviours, as well as addressing key gaps in knowledge. This framework facilitated the linkage of theoretical behaviour constructs with evidence-based behaviour change techniques, which will enable us to evaluate operationalisation of our chosen BCTs and their impact on behaviour change in a future feasibility study.