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Abstract Background The benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost. Methods/Design The DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes. The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study. Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring. Discussion The DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study. Trial registration ISRCTN: ISRCTN95696668.

Long-term needs of stroke survivors (especially psychosocial needs and stroke prevention) are not adequately addressed. Self-management programmes exist but the optimal content and delivery approach is unclear. We aim to describe the process undertook to develop a structured self-management programme to address these unmet needs. Based on the Medical Research Council framework for complex interventions, the development involved three phases: "Exploring the idea": Evidence synthesis and patient and public involvement (PPI) with stroke survivors, carers and healthcare professionals. "The iterative phase": Development and iterative refinement of the format, content, underpinning theories and philosophy of the self-management programme My Life After Stroke (MLAS), with PPI. MLAS consists of two individual appointments and four group sessions over nine weeks, delivered interactively by two trained facilitators. It aims to build independence, confidence and hope and focusses on stroke prevention, maximising physical potential, social support and managing emotional responses. MLAS is grounded in the narrative approach and social learning theory. "Ready for research": The refinement of a facilitator curriculum and participant resources to support programme delivery. Through a systematic process, we developed an evidence- and theory-based self-management programme for stroke survivors MLAS warrants evaluation in a feasibility study. My Life After Stroke(MLAS) has been developed using a systematic process, to address the unmet needs of stroke survivors. This systematic process, involved utilising evidence, theories, patient and public involvement, expertise and guidelines from other long-term conditions. This may further help the development of similar self-management programme within the field of stroke. MLAS warrants further evaluation within a feasibility study. [ABSTRACT FROM AUTHOR]

Objectives: To measure the number of people who have identified a behaviour change goal and completed an action-plan to meet their goal on completion of a diabetes self-management education programme (DSME) and level of success in sustaining their action-plan. The DSME people attended was Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND).Methods: Copies of action-plans were collected from participants. Postal questionnaires were sent to participants one week and three months following DESMOND to assess factors associated with setting and sustaining action-plans.Results: 92% (253/275) of participants completed an action-plan. Reducing weight was the area most targeted. Physical activity was the most common goal. 68% (187/275) returned a three month questionnaire. 96% indicated they were still working on their action plan, with 87% reporting they were always/usually meeting their action-plan. 22% said they had discussed their goal with a health care professional (HCP) following DESMOND.Conclusions: Goal-setting as part of a DSME can lead to behaviour change.Practice Implications: Goal-setting as part of a DSME enables participants to set and attain behaviour change goals. Informing HCPs of a person's action-plan following a DSME may further support a person undertaking behaviour change. [ABSTRACT FROM AUTHOR]

Background: People with schizophrenia are two to three times more likely to be overweight than the general population. The UK National Institute of Health and Care Excellence (NICE) recommends an annual physical health review with signposting to, or provision of, a lifestyle programme to address weight concerns and obesity. The purpose of this randomised controlled trial is to assess whether a group-based structured education programme can help people with schizophrenia to lose weight. Methods: Design: a randomised controlled trial of a group-based structured education programme. Setting: 10 UK community mental health trusts. Participants: 396 adults with schizophrenia, schizoaffective, or first-episode psychosis who are prescribed antipsychotic medication will be recruited. Participants will be overweight, obese or be concerned about their weight. Intervention: participants will be randomised to either the intervention or treatment as usual (TAU). The intervention arm will receive TAU plus four 2.5-h weekly sessions of theory-based lifestyle structured group education, with maintenance contact every 2 weeks and ‘booster’ sessions every 3 months. All participants will receive standardised written information about healthy eating, physical activity, alcohol and smoking. Outcomes: the primary outcome is weight (kg) change at 1 year post randomisation. Secondary outcomes, which will be assessed at 3 and 12 months, include: the proportion of participants who maintained or reduced their weight; waist circumference; body mass index; objectively measured physical activity (wrist accelerometer); self-reported diet; blood pressure; fasting plasma glucose, lipid profile and HbA1c (baseline and 1 year only); health-related quality of life (EQ-5D- 5L and RAND SF-36); (adapted) brief illness perception questionnaire; the Brief Psychiatric Rating Scale; the Client Service Receipt Inventory; medication use; smoking status; adverse events; depression symptoms (Patient Health Questionnaire-9); use of weight-loss programmes; and session feedback (intervention only). Outcome assessors will be blind to trial group allocation. Qualitative interviews with a subsample of facilitators and invention-arm participants will provide data on intervention feasibility and acceptability. Assessment of intervention fidelity will also be performed. Discussion: The STEPWISE trial will provide evidence for the clinical and cost-effectiveness of a tailored intervention, which, if successful, could be implemented rapidly in the NHS. [ABSTRACT FROM AUTHOR]

Introduction: Diabetes self-management education (DSME) aims to empower people to engage in effective self-management behaviour and behaviour change. Goal-setting/action planning has been incorporated into many DSMEs to facilitate behaviour change. However, this component of DSMEs is understudied. Using DESMOND as a model of a DSME, this study measures the number of people who have identified a behavioural change goal and completed an action plan to meet their goal on completion of DESMOND and how successful they have been in sustaining an action plan. Methods: Copies of completed goal-setting/action-planning forms were collected from participants following completion of DESMOND. Postal questionnaires were sent to participants at one week and at three months following DESMOND to assess individual factors associated with identifying goals and setting and sustaining of action plans. Results: 55% (279/511) of DESMOND attendees agreed to participate in the study. Four withdrew, leaving 275 for analysis purposes. Of the 275 included in the analysis, 92% (n =253) completed a goal-setting/action plan within one week of completion of DESMOND. 87% (n = 220) selected one or more goals they wanted to target. The most common goals targeted were reducing weight (49%), lowering blood glucose (35%) and lowering cholesterol (26%). Over two thirds included physical activity in their action plan with 24% combining it with dietary changes. 27% of participants focused on diet alone. 68% (186/275) of participants returned a three month questionnaire of which 92% (n = 172) responded to the question on whether they were still working on an action plan. 96% (n = 165) indicated that they were still working on an action plan. 87% were successful in sustaining their action plan with 16% (n = 26) meeting their action plan always and 71% (n = 116) meeting it usually. Discussion: Our results suggest that goal-setting as part of a DSME can lead to behaviour change with the majority of participants sustaining an action plan three months following completion of DESMOND. Over two thirds of people included physical activity as part of their action plan. Conclusion: The majority of participants reported successfully setting and sustaining their behaviour change action plan three months following completion of DESMOND. Lessons learned: Goal-setting as part of a group education self-management programme is acceptable to participants with the majority completing and sustaining their action plans. [ABSTRACT FROM AUTHOR]

Background: Obesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia., Method: In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included., Results: Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI -1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained., Conclusions: Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

Objective: To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years., Design: Three year follow-up of a multicentre cluster randomised controlled trial in primary care, with randomisation at practice level., Setting: 207 general practices in 13 primary care sites in the United Kingdom., Participants: 731 of the 824 participants included in the original trial were eligible for follow-up. Biomedical data were collected on 604 (82.6%) and questionnaire data on 513 (70.1%) participants., Intervention: A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care., Main Outcome Measures: The primary outcome was glycated haemoglobin (HbA(1c)) levels. The secondary outcomes were blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, emotional impact of diabetes, and drug use at three years., Results: HbA(1c) levels at three years had decreased in both groups. After adjusting for baseline and cluster the difference was not significant (difference -0.02, 95% confidence interval -0.22 to 0.17). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years (P<0.01). Depression scores and quality of life did not differ at three years., Conclusion: A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs., Trial Registration: Current Controlled Trials ISRCTN17844016.