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Background: People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia. However, many struggle to sustain these improvements over time. To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants' self-management behaviours after attending structured education and their need for support to sustain improvements in glycaemic control., Methods: We undertook a meta-ethnography of relevant qualitative studies, identified using systematic search methods. Studies were included which focused on participants' experiences of self-managing type 1 diabetes after attending structured education which incorporated training in flexible intensive insulin therapy. A line of argument approach was used to synthesise the findings., Results: The search identified 18 papers from six studies. The studies included were judged to be of high methodological quality. The line of argument synthesis developed the Follow-Up Support for Effective type 1 Diabetes self-management (FUSED) model. This model outlines the challenges participants encounter in maintaining diabetes self-management practices after attending structured education, and describes how participants try to address these barriers by adapting, simplifying or personalising the self-management approaches they have learned. To help participants maintain the skills taught during courses, the FUSED model presents ten recommendations abstracted from the included papers to provide a logic model for a programme of individualised and responsive follow-up support., Conclusions: This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour. To help people sustain diabetes self-management skills after attending structured education, it is recommended that support be provided over the longer-term by appropriately trained healthcare professionals which is responsive to individuals' needs. Although developed to inform support for people with type 1 diabetes, the FUSED model provides a framework that could also be applied to support individuals with other long term conditions which require complex self-management skills to be learned and sustained over time., Trial Registration: PROSPERO registration: CRD42017067961 .

Background: The increasing prevalence of type 2 diabetes and suboptimal glycaemic control in Kuwait requires novel, wide-reaching, low-cost interventions to motivate and mobilise individuals towards more effective self-management. More than 2 million people in Kuwait own mobile phones. We will test whether automated personalised health text messages based on principles of motivational interviewing and are responsive to biodata delivered remotely is potentially effective in improving glycaemic control compared to usual care., Methods: This is a two-arm parallel single-blind randomised controlled trial of 572 individuals with type 2 diabetes in Kuwait. We will develop a culturally appropriate database of text messages supporting positive lifestyle changes in type 2 diabetes. A computer programme will deliver over 400 text messages over a 12-month period using algorithms which provide participants with information on diet and physical activity as well as personalised messages regarding motivators to change behaviours. Individuals aged 18-75 years with established type 2 diabetes who are fluent in Arabic or English and officially resident in Kuwait will be identified via screening of hospital diabetes clinic and primary care practices and invited to participate. A sample of 572 participants will be randomised to usual care or usual care plus the DATES text message intervention. Randomisation will be conducted by an independent Clinical Trials Unit and researchers collecting baseline and outcome data will be blinded to treatment allocation. The primary outcome is change in HbA1c and weight at 12 months in both study arms. Secondary outcomes will include changes in physical activity, fasting lipids and quality of life in both study arms., Discussion: The potential of mobile phones in improving diabetes self-care in settings with a high prevalence of diabetes and widespread mobile phone usage has face validity. Mobile phones and text messaging are an understudied virtual communication media which can deliver discrete focused psychological support to motivate and enable diabetes self-care changes., Trial Registration: ISRCTN10342151 . 11/03/2015.

Background: Randomised controlled trials (RCTs) of complex interventions often begin with a pilot phase to test the proposed methods and refine the intervention before it is trialled. Although the Medical Research Council (MRC) recommends regular communication between the practitioners delivering the intervention and the researchers evaluating it during the pilot phase, there is a lack of practical guidance about how to undertake this aspect of pre-trial work. This paper describes a novel structured process for collaborative working, which we developed to iteratively refine a complex intervention prior to an RCT. We also describe an in-built qualitative study to learn lessons about how this approach could be used by future study teams., Methods: This work forms part of a broader research programme to develop and trial a complex intervention for people with type 1 diabetes, called DAFNE plus . The intervention is being piloted in three National Health Service (NHS) diabetes centres in two waves, with refinements being incrementally implemented between each wave in response to real-time, collective learning (combining practitioner experience, process evaluation data and patient and public involvement via an advisory group). A structured 'Collaborative Working Group' (CWG) process, comprising monthly teleconferences and four strategically timed face-to-face meetings, is being used to identify and respond systematically to emerging implementation challenges and research findings. The group involves 25 members of the study team, including the multi-disciplinary practitioners delivering the intervention, the research teams conducting the process evaluation, the study manager and Chief Investigator. An in-built qualitative study comprising documentary analysis of meeting materials, discourse analysis of meeting transcripts, reflexive note taking, and thematic analysis of focus groups and interviews with CWG members is being undertaken to explore how the CWG works and how its processes and procedures might be improved., Discussion: The CWG process offers a potential model for collaborative working in future pre-trial pilot phases and intervention development studies that operationalises MRC guidance to progressively develop a complex intervention and foster shared ownership through genuine collaboration. The findings from the qualitative study will provide insight into how to best support collaborative working to achieve optimal intervention design., Competing Interests: JPB is a clinical academic research fellow at the University of Dundee and Lead for Allied Health Professions Research at NHS Tayside. She is an HCPC-registered occupational therapist and an experienced qualitative researcher, with an interest in innovative methods and implementation research. CG is a specialist diabetes dietitian working at Sheffield Teaching Hospitals NHSF Trust. She has expertise in developing diabetes structured education programmes and is an experienced diabetes educator. NdZ is a senior clinical psychologist working at King’s College Hospital, London. She has expertise in working with people with long-term conditions, including diabetes, developing interventions to promote behaviour change and providing training for healthcare professionals. JL is a professor of Health and Social Science at the Usher Institute for Population Health Sciences and Informatics, University of Edinburgh. She oversees a programme of qualitative research which mostly coheres around clinical trials. DR is a research fellow at the Usher Institute for Population Health Sciences and Informatics, University of Edinburgh. He is an experienced qualitative researcher who has specialised in diabetes research for the last 10 years. EC is a research associate at the Sheffield Clinical Trials Research Unit, in the School of Health and Related Research at the University of Sheffield. She is an experienced qualitative researcher in health services research.Ethical approval for the qualitative study was granted by the Usher Research Ethics Group (UREG) at the University of Edinburgh.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: Competencies in psychological techniques delivered by primary care nurses to support diabetes self-management were compared between the intervention and control arms of a cluster randomised controlled trial as part of a process evaluation. The trial was pragmatic and designed to assess effectiveness. This article addresses the question of whether the care that was delivered in the intervention and control trial arms represented high fidelity treatment and attention control, respectively., Methods: Twenty-three primary care nurses were either trained in motivational interviewing (MI) and cognitive behavioural therapy (CBT) skills or delivered attention control. Nurses' skills in these treatments were evaluated soon after training (treatment arm) and treatment fidelity was assessed after treatment delivery for sessions midway through regimen (both arms) using the Motivational Interviewing Treatment Integrity (MITI) domains and Behaviour Change Counselling Index (BECCI) based on consultations with 151 participants (45% of those who entered the study). The MITI Global Spirit subscale measured demonstration of MI principles: evocation, collaboration, autonomy/support., Results: After training, median MITI MI-Adherence was 86.2% (IQR 76.9-100%) and mean MITI Empathy was 4.09 (SD 1.04). During delivery of treatment, in the intervention arm mean MITI Spirit was 4.03 (SD 1.05), mean Empathy was 4.23 (SD 0.89), and median Percentage Complex Reflections was 53.8% (IQR 40.0-71.4%). In the attention control arm mean Empathy was 3.40 (SD 0.98) and median Percentage Complex Reflections was 55.6% (IQR 41.9-71.4%)., Conclusions: After MI and CBT skills training, detailed assessment showed that nurses had basic competencies in some psychological techniques. There appeared to be some delivery of elements of psychological treatment by nurses in the control arm. This model of training and delivery of MI and CBT skills integrated into routine nursing care to support diabetes self-management in primary care was not associated with high competency levels in all skills., Trial Registration: ISRCTN75776892 ; date registered: 19/05/2010.

Background: Interventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour change techniques integrating MI and CBT result in favourable changes in weight and physical activity in those at high risk of CVD. A group and individual intervention will be compared to usual care. A group intervention offers potential benefits from social support and may be more cost effective., Methods/design: Individuals aged between 40 and 74 years in 11 South London Clinical Commissioning Groups who are at high risk of developing CVD (≥20%) in the next 10 years will be recruited. A sample of 1,704 participants will be randomised to receive the enhanced MI intervention, delivered by trained healthy lifestyle facilitators (HLFs), in group or individual formats, in 10 sessions (plus an introductory session) over one year, or usual care. Randomisation will be conducted by King's College London Clinical Trials Unit and researchers collecting outcome data will be blinded to treatment allocation. At 12-month and 24-month follow-up assessments, primary outcomes will be change in weight and physical activity (average steps per day). Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Incidence of CVD events since baseline will be recorded. A process evaluation will be conducted to evaluate factors which impact on delivery, adherence and outcome. An economic evaluation will estimate relative cost-effectiveness of each type of intervention delivery., Discussion: This RCT assesses the effectiveness of a healthy lifestyle intervention for people at high risk of CVD. Benefits of the study include the ethnic and socioeconomic diversity of the study population and that, via social support within the group setting and long-term follow-up period, the intervention offers the potential to support maintenance of a healthy lifestyle., Trial Registration: This trial is registered with the ISRCTN registry (identifier: ISRCTN84864870, registered 15 May 2012).