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Abstract Background Identifying clusters of multiple long-term conditions (MLTCs), also known as multimorbidity, and their associated burden may facilitate the development of effective and cost-effective targeted healthcare strategies. This study aimed to identify clusters of MLTCs and their associations with long-term health-related quality of life (HRQoL) in two UK population-based cohorts. Methods Age-stratified clusters of MLTCs were identified at baseline in UK Biobank (n = 502,363, 54.6% female) and UKHLS (n = 49,186, 54.8% female) using latent class analysis (LCA). LCA was applied to people who self-reported ≥ 2 LTCs (from n = 43 LTCs [UK Biobank], n = 13 LTCs [UKHLS]) at baseline, across four age-strata: 18–36, 37–54, 55–73, and 74 + years. Associations between MLTC clusters and HRQoL were investigated using tobit regression and compared to associations between MLTC counts and HRQoL. For HRQoL, we extracted EQ-5D index data from UK Biobank. In UKHLS, SF-12 data were extracted and mapped to EQ-5D index scores using a standard preference-based algorithm. HRQoL data were collected at median 5 (UKHLS) and 10 (UK Biobank) years follow-up. Analyses were adjusted for available sociodemographic and lifestyle covariates. Results LCA identified 9 MLTC clusters in UK Biobank and 15 MLTC clusters in UKHLS. Clusters centred around pulmonary and cardiometabolic LTCs were common across all age groups. Hypertension was prominent across clusters in all ages, while depression featured in younger groups and painful conditions/arthritis were common in clusters from middle-age onwards. MLTC clusters showed different associations with HRQoL. In UK Biobank, clusters with high prevalence of painful conditions were consistently associated with the largest deficits in HRQoL. In UKHLS, clusters of cardiometabolic disease had the lowest HRQoL. Notably, negative associations between MLTC clusters containing painful conditions and HRQoL remained significant even after adjusting for number of LTCs. Conclusions While higher LTC counts remain important, we have shown that MLTC cluster types also have an impact on HRQoL. Health service delivery planning and future intervention design and risk assessment of people with MLTCs should consider both LTC counts and MLTC clusters to better meet the needs of specific populations.

Objective Helping people to change their health behaviours is becoming a greater feature within the role of health professionals, including through whole system initiatives such as Making Every Contact Count. Health services provide an ideal setting to routinely promote health behaviours, including physical activity. Snacktivity is a novel approach that promotes small bouts of physical activity (activity snacks) throughout the day. This study explored health professionals’ initial experiences of delivering a Snacktivity intervention to promote physical activity within routine health consultations. A further aim was to investigate health professionals’ ability/fidelity in delivering the Snacktivity intervention to their patients.Design Semistructured interviews (n=11) and audio recording of consultations (n=46).Setting and participants Healthcare professionals from a variety of specialisms who delivered the Snacktivity intervention within patient consultations.Results Analyses revealed two higher-level themes of interest: (1) health professionals’ conceptualisation of Snacktivity (subthemes: observations/reflections about patients’ understanding, engagement and enthusiasm for delivering the Snacktivity intervention) and (2) health professionals’ understanding of Snacktivity and experience in delivering the intervention (subthemes: delivering Snacktivity; limitations, challenges and possible improvements). Consultation audio recordings demonstrated health professionals delivered the Snacktivity intervention with high levels of fidelity. Health professionals were proficient and supportive of delivering the Snacktivity intervention within consultations although practical barriers to implementation such as time constraints were raised, and confidence in doing so was mixed.Conclusions Health professionals were proficient and supportive of delivering the Snacktivity intervention within consultations. The primary barrier to implementation was the time to deliver it, however, gaining greater experience in the intervention and improving behaviour change counselling skills may reduce this barrier.Trial registration number ISRCTN64851242.

Objectives e-coachER was a web-based intervention designed to support uptake and maintenance of physical activity for people attending exercise referral schemes (ERS) for weight loss, diabetes, hypertension, osteoarthritis or a history of depression/low mood. The aim of this study was to explore the mechanisms of impact of the e-coachER intervention, specifically how participants interacted with e-coachER and the key mediators of increased physical activity.Design This was a qualitative one-on-one interview study. Interviews were audio-recorded and transcribed and analysed using thematic analysis.Setting UK primary care ERS.Participants A purposive sample of adult patients randomised to the intervention arm of the e-coachER randomised controlled trial.Results Twenty-six participants (20 female), who had logged on to e-coachER at least once were recruited, resulting in a total of 38 interviews (mean duration 48 min). Four broad, inter-related themes were generated from the data (1) catalyst for change, (2) goals and aspirations, (3) support and (4) engagement with the e-coachER programme. Most participants who took part in e-coachER were already motivated to improve their health and perceived e-coachER as an additional source of motivation and accountability. Many felt that the opportunity to set goals and self-monitor supported participant’s competence and autonomy by enabling them to progress at their own pace. Many participants reported on how e-coachER helped them to foster a sense of relatedness by encouraging them to seek support from others. Finally, e-coachER was regarded as being generally accessible and engaging. Despite this, some found it too simplistic, and others found it hard to maintain engagement over time.Conclusions The e-coachER intervention seemed to be generally motivating in the early stages of initiating behaviour change, but engagement waned over time. Our findings highlight how important an online package might be in supporting behaviour change while also highlighting the challenges of achieving sustained physical activity changes.Trial registration number ISRCTN15644451.

Abstract Background The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic evaluation. ACE aims to test the effectiveness and cost-effectiveness of a peer-volunteer led active ageing intervention designed to support older adults at risk of mobility disability to become more physically and socially active within their communities and to reduce or reverse, the progression of functional limitations associated with ageing. Methods/design Community-dwelling, older adults aged 65 years and older (n = 515), at risk of mobility disability due to reduced lower limb physical functioning (Short Physical Performance Battery (SPPB) score of 4–9 inclusive) will be recruited. Participants will be randomised to receive either a minimal control intervention or ACE, a 6-month programme underpinned by behaviour change theory, whereby peer volunteers are paired with participants and offer them individually tailored support to engage them in local physical and social activities to improve lower limb mobility and increase their physical activity. Outcome data will be collected at baseline, 6, 12 and 18 months. The primary outcome analysis (difference in SPPB score at 18 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. Discussion ACE is the largest, pragmatic, community-based randomised controlled trial in the UK to target this high-risk segment of the older population by mobilising community resources (peer volunteers). A programme that can successfully engage this population in sufficient activity to improve strength, coordination, balance and social connections would have a major impact on sustaining health and independence. ACE is also the first study of its kind to conduct a full economic and comprehensive process evaluation of this type of community-based intervention. If effective and cost-effective, the ACE intervention has strong potential to be implemented widely in the UK and elsewhere. Trial registration ISRCTN, ISRCTN17660493. Registered on 30 September 2021. Trial Sponsor: University of Birmingham, Contact: Dr Birgit Whitman, Head of Research Governance and Integrity; Email: researchgovernance@contacts.bham.ac.uk. Protocol Version 5 22/07/22.

Introduction Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes.Methods and analysis A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention.Ethics and dissemination The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public.Trial registration number ISRCTN68786622.Protocol version 2.0 (16 May 2023).

Background System mapping has mainly been used to develop theories and understanding of complex systems; to hypothesise how an intervention might work in a complex system or to inform intervention development. There are a few examples of the use of system mapping as part of process evaluation. In this paper, we describe an innovative approach to using system mapping as part of the process evaluation of a randomised controlled trial of the Active, Connected, Engaged (ACE) community-based active ageing programme.Method Ten participatory workshops were held across three of the ACE sites (Cardiff, Stoke-on-Trent and Manchester, UK). These involved over 100 participants, volunteers and stakeholders (from National Health Service, statutory and voluntary sectors). Their aim was to gather area-specific information on participants’ barriers and facilitators to physical activity and the needs of peer volunteers and service providers; and create ‘baseline’ system maps before the launch of the programme in the three areas of ACE delivery.Results System maps were produced showing the main outcome (physical activity) and the interactions between the key motivators and barriers described by older people, as well as ideas from stakeholders and volunteers about how these barriers can be addressed. Findings led to refinements to ACE intervention processes and the study’s logic model.Conclusions System mapping helped to refine the ACE processes and fine-tune the logic model. The value of this approach will increase in the next phase when it will be used to explore any changes to the physical activity system including changes to stakeholders’ ways of working and collaborating to tackle barriers to activity following the completion of the ACE trial.Trial registration number ISRCTN17660493.

Abstract Background Physical activity (PA) is beneficial for older adults’ health, however they remain the least active age group in the UK. This qualitative longitudinal study aims to understand motivations in older adults receiving the REACT physical activity intervention, through the lens of self-determination theory. Methods Participants were older adults randomised to the intervention arm of the Retirement in ACTion (REACT) Study, a group-based physical activity and behaviour maintenance intervention to prevent decline of physical functioning in older adults (≥ 65 years). Stratified purposive sampling by physical functioning (Short Physical Performance Battery scores) and 3-month attendance was employed. Fifty-one semi-structured interviews were conducted at 6, 12 and 24-months with twenty-nine older adults (Mean age (baseline) = 77.9 years, SD 6.86, 69% female) and at 24-months with twelve session leaders and two service managers. Interviews were audio recorded, transcribed verbatim and analysed using Framework Analysis. Results Perceptions of autonomy, competence and relatedness were associated with adherence to the REACT programme and maintenance of an active lifestyle. Motivational processes and participants’ support needs, changed during the 12-month REACT intervention and across the 12-months post-intervention. Group interactions were an important source of motivation during the first six months but increased competence and mobility drove motivation at the later stages (12 months) and post-intervention (24 months). Conclusions Motivational support needs vary in different stages of a 12-month group-based programme (adoption and adherence) and post-intervention (long-term maintenance). Strategies to accommodate those needs include, (a) making exercise social and enjoyable, (b) understanding participants’ capabilities and tailoring the programme accordingly, (c) capitalising on group support to motivate participants to try other activities and prepare sustainable active living plans. Trial registration The REACT study was a pragmatic multi-centre, two-arm, single-blind, parallel-group, RCT (ISRCTN registration number 45627165).

Abstract Background Many people do not regularly participate in physical activity, which may negatively impact their health. Current physical activity guidelines are focused on promoting weekly accumulation of at least 150 min of moderate to vigorous intensity physical activity (MVPA). Whilst revised guidance now recognises the importance of making small changes to physical activity behaviour, guidance still focuses on adults needing to achieve at least 150 min of MVPA per week. An alternative ‘whole day’ approach that could motivate the public to be more physically active, is a concept called Snacktivity™. Instead of focusing on achieving 150 min per week of physical activity, for example 30 min of MVPA over 5 days, Snacktivity™ encourages the public to achieve this through small, but frequent, 2–5 min ‘snacks’ of MVPA throughout the whole day. Methods The primary aim is to undertake a feasibility trial with nested qualitative interviews to assess the feasibility and acceptability of the Snacktivity™ intervention to inform the design of a subsequent phase III randomised trial. A two-arm randomised controlled feasibility trial aiming to recruit 80 inactive adults will be conducted. Recruitment will be from health and community settings and social media. Participants will be individually randomised (1:1 ratio) to receive either the Snacktivity™ intervention or usual care. The intervention will last 12 weeks with assessment of outcomes completed before and after the intervention in all participants. We are interested in whether the Snacktivity™ trial is appealing to participants (assessed by the recruitment rate) and if the Snacktivity™ intervention and trial methods are acceptable to participants (assessed by Snacktivity™/physical activity adherence and retention rates). The intervention will be delivered by health care providers within health care consultations or by researchers. Participants’ experiences of the trial and intervention, and health care providers’ views of delivering the intervention within health consultations will be explored. Discussion The development of physical activity interventions that can be delivered at scale are needed. The findings from this study will inform the viability and design of a phase III trial to assess the effectiveness and cost-effectiveness of Snacktivity™ to increase physical activity. Trial registration ISRCTN: 64851242.

Abstract Background The e-coachER trial aimed to determine whether adding web-based behavioural support to exercise referral schemes (ERS) increased long-term device-measured physical activity (PA) for patients with chronic conditions, compared to ERS alone, within a randomised controlled trial. This study explores the mechanisms of action of the e-coachER intervention using measures of the behaviour change processes integral to the intervention’s logic model. Methods Four hundred fifty adults with obesity, diabetes, hypertension, osteoarthritis or history of depression referred to an ERS were recruited in Plymouth, Birmingham and Glasgow. The e-coachER intervention comprising 7-Steps to Health was aligned with Self-Determination Theory and mapped against evidence-based behaviour change techniques (BCTs). Participants completed questionnaires at 0, 4, and 12 months to assess PA and self-reported offline engagement with core BCTs in day-to-day life (including action planning and self-monitoring) and beliefs relating to PA (including perceived importance, confidence, competence, autonomy and support). We compared groups at 4 and 12 months, controlling for baseline measures and other covariates. Mediation analysis using the product of coefficients method was used to determine if changes in process variables mediated intervention effects on moderate to vigorous physical activity (MVPA) recorded by accelerometer and self-report at 4- and 12-months. Results The internal reliability (Cronbach’s alpha) for all multi-item scales was > 0.77. At 4-months, those randomised to e-coachER reported higher levels of PA beliefs relating to importance (1.01, 95% confidence interval (CI): 0.42 to 1.61, p = 0.001), confidence (1.28, 95% CI: 0.57 to 1.98, p

Abstract Background Physical inactivity is a leading risk factor for chronic disease. Brief physical activity counselling delivered within healthcare systems has been shown to increase physical activity levels; however, implementation efforts have mostly targeted primary healthcare and uptake has been sub-optimal. The Brief Physical Activity Counselling by Physiotherapists (BEHAVIOUR) trial aims to address this evidence-practice gap by evaluating (i) the effectiveness of a multi-faceted implementation strategy, relative to usual practice for improving the proportion of patients receiving brief physical activity counselling as part of their routine hospital-based physiotherapy care and (ii) effectiveness of brief physical activity counselling embedded in routine physiotherapy care, relative to routine physiotherapy care, at improving physical activity levels among patients receiving physiotherapy care. Methods Effectiveness-implementation hybrid type II cluster randomised controlled trial with embedded economic evaluation, qualitative study and culturally adapted patient-level outcome measures. The trial will be conducted across five hospitals in a local health district in Sydney, Australia, with a lower socioeconomic and culturally diverse population. The evidence-based intervention is brief physical activity counselling informed by the 5As counselling model and behavioural theory, embedded into routine physiotherapy care. The multi-faceted strategy to support the implementation of the counselling intervention was developed with key stakeholders guided by the Consolidated Framework for Implementation Research and the Capabilities, Opportunities, Motivation-Behaviour (COM-B) theoretical model, and consists of clinician education and training, creating a learning collaborative, tailored strategies to address community referral barriers, team facilitation, and audit and feedback. Thirty teams of physiotherapists will be randomised to receive the multi-faceted implementation strategy immediately or after a 9-month delay. Each physiotherapy team will recruit an average of 10 patients (n=300) to collect effectiveness outcomes at baseline and 6 months. The primary effectiveness outcome is self-reported planned physical activity using the Incidental and Planned Exercise Questionnaire, and the primary implementation outcome is reach (proportion of eligible new physiotherapy patients who receive brief physical activity counselling). Secondary effectiveness and implementation outcomes will also be collected. Discussion This project focuses on physiotherapists as health professionals with the requisite skills and patterns of practice to tackle the increasing burden of chronic disease in a high-risk population. Trial registration ANZCTR, ACTRN12621000194864 . Registered on 23 February 2021.

Abstract Background The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes. Methods We screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months. Results We randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m2, and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference −2.57 mmol/mol; 95% CI −4.5, −0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (−0.55 mmol/mol; 95% CI −2.46, 1.35; p = 0.57), or INT vs CON arms (−2.14 mmol/mol; 95% CI −4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (−7.0 mmol/mol; 95% CI −11.5, −2.5; p = 0.003). Conclusion The NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months. Trial registration ISRCTN34805606 . Retrospectively registered 14.4.16

Abstract Background Whilst almost 50% of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. Methods Process evaluation sub-study parallels to a single-centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients’ and caregivers’ experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and seven caregivers. Results Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) responses to the REACH-HF intervention. Fidelity analysis found the interventions to be delivered adequately with scope for improvement in caregiver engagement. The differing professional backgrounds of REACH-HF facilitators in this study demonstrate the possibility of delivery of the intervention by healthcare staff with expertise in HF, cardiac rehabilitation, or both. Conclusions The REACH-HF home-based facilitated intervention for HFpEF appears to be a feasible and a well-accepted model for the delivery of rehabilitation, with the potential to address key unmet needs of patients and their caregivers who are often excluded from HF and current cardiac rehabilitation programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial. Trial registration ISRCTN78539530 (date of registration 7 July 2015).

Abstract Background Although there is trial evidence that complex interventions are effective for the self-management of heart failure, little evidence supports their effectiveness in routine practice. We used Social Practice Theory to guide a Type 1 Hybrid Trial: a mixed methods process evaluation of a complex intervention for heart failure. The objective of this paper is to explore the value of Social Practice Theory for implementation science. Methods Social Practice Theory informed a mixed methods process evaluation of a multi-centre randomised controlled trial of a 12 week home-based intervention to optimise self-care support for people with heart failure and their caregivers - Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF). Interviews were conducted with 19 people with heart failure and 17 caregivers at 4 months and 12 months after recruitment into the trial. Cases were constructed at the level of the individual, couple, facilitator and centre; and included multi-modal process and outcome data. Evaluative coding and subsequent within- and cross-case analyses enabled the development of a typology of relationships linking fidelity of intervention delivery and tailoring of content to individual needs and concerns. Social Practice Theory was used to interrogate the relationships between elements of the intervention and their implementation. Results Of 216 trial participants, 107 were randomised to the intervention (REACH-HF plus usual care). The intervention was most effective when fidelity was high and delivery was tailored to the individual’s needs, but less effective when both tailoring and fidelity were low. Theory-based analysis enabled us to model complex relationships between intervention elements (competencies, materials and meanings) and social context. The findings illustrate how intervention fidelity and tailoring are contextual and how the effectiveness of the REACH-HF intervention depended on both optimal alignment and implementation of these elements. Conclusion The study demonstrates the utility of theory-based analysis which integrates data from multiple sources to highlight contexts and circumstances in which interventions work best. Social Practice Theory provides a framework for guiding and analysing the processes by which a complex intervention is evaluated in a clinical trial, and has the potential to guide context-specific implementation strategies for clinical practice. Trial registration ISRCTN, IISRCTN86234930 . Registered 13th November 2014.

Abstract Background Behavioural approaches to weight loss are often initially successful but less so in the longer term, as some people maintain the necessary behaviour changes while others do not. This study aimed to derive possible explanations for this using a qualitative approach with a view to improving intervention effectiveness. Methods Thirty-six participants in a development and feasibility study for a weight loss and maintenance intervention (called SkiM) were interviewed three times over 18 months regarding their experiences before, during and after the intervention. Data were analysed thematically. The accounts of those who were more and less successful in terms of longer term weight loss were compared, and a conceptual model linking the main analytic themes was developed. Results Five interpretative themes were generated: encountering and managing key situations; the impact of emotion; the source of control; personal values; and acquiring knowledge and skills. These themes were linked through a model of decision-making during key situations. In this model, behavioural decisions emerge from a dynamic interplay between several drivers: emotional state and needs, perceived control, personal values, the individual’s knowledge and skills, and their existing habits. The individual’s response in key situations generates experiential learning that can influence decisional dynamics in similar situations in future. These dynamics appeared to differ between participants, and between those who were more and less successful in weight management. Conclusions Our analysis and model of decision-making during weight-management have implications for the development and delivery of behavioural weight management interventions. By helping individuals to identify the drivers of their decision-making in key situations, and equipping them to manage these drivers, programmes may enhance their capacity to sustain the behaviour changes needed for long-term weight loss.

Introduction Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists.Methods and analysis This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other.Ethics and dissemination Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers.Trial registration number ACTRN12618001983291.

Background: There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity. Objectives: To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes. Design: A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control). Setting: Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow. Participants: There were 450 participants aged 16–74 years, with a body mass index of 30–40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users. Intervention: e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven ‘steps to health’. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme. Primary outcome measure: Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day. Secondary outcomes: Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation. Results: Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval –2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval –£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year. Limitations: A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation. Future work: The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions. Conclusions: Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model. Trial registration: Current Controlled Trials ISRCTN15644451. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 63. See the NIHR Journals Library website for further project information.

Introduction Cardiac rehabilitation (CR) improves health-related quality of life and reduces hospital admissions. However, patients with heart failure (HF) often fail to attend centre-based CR programmes. Novel ways of delivering healthcare, such as home-based CR programmes, may improve uptake of CR. Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is a new, effective and cost-effective home-based CR programme for people with HF. The aim of this prospective mixed-method implementation evaluation study is to assess the implementation of the REACH-HF CR programme in the UK National Health Service (NHS). The specific objectives are to (1) explore NHS staff perceptions of the barriers and facilitators to the implementation of REACH-HF, (2) assess the quality of delivery of the programme in real-life clinical settings, (3) consider the nature of any adaptation(s) made and how they might impact on intervention effectiveness and (4) compare real-world patient outcomes to those seen in a prior clinical trial.Methods and analysis REACH-HF will be rolled out in four NHS CR centres across the UK. Three healthcare professionals from each site will be trained to deliver the 12-week programme. In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme. Consultations for 48 patients (12 per site) will be audio recorded and scored using an intervention fidelity checklist. Outcomes routinely recorded in the National Audit of Cardiac Rehabilitation will be analysed and compared with outcomes from a recent randomised controlled trial: the Minnesota Living with HF Questionnaire and exercise capacity (Incremental Shuttle Walk Test). Qualitative research findings will be mapped onto the Normalisation Process Theory framework and presented in the form of a narrative synthesis. Results of the study will inform national roll-out of REACH-HF.Ethics and dissemination The study (IRAS 261723) has received ethics approval from the South Central (Hampshire B) Research Ethics Committee (19/SC/0304). Written informed consent will be obtained from all health professionals and patients participating in the study. The research team will ensure that the study is conducted in accordance with the Declaration of Helsinki, the Data Protection Act 2018, General Data Protection Regulations and in accordance with the Research Governance Framework for Health and Social Care (2005). Findings will be published in scientific peer-reviewed journals and presented at local, national and international meetings to publicise and explain the research methods and findings to key audiences to facilitate the further uptake of the REACH-HF intervention.

Objective To identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.Design Mixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).Setting Four centres in the UK (Birmingham, Cornwall, Gwent and York).Participants People with heart failure with reduced ejection fraction (HFrEF) and their caregivers.Methods The REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.Outcome measures Quantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.Results Intervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents’ comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.Conclusions By combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.Trial registration number ISRCTN25032672; Pre-results.

Objective Intensive lifestyle interventions reduce the risk of type 2 diabetes in populations at highest risk, but staffing levels are usually unable to meet the challenge of delivering effective prevention strategies to a very large at-risk population. Training volunteers with existing type 2 diabetes to support healthcare professionals deliver lifestyle interventions is an attractive option.Methods We identified 141 973 people at highest risk of diabetes in the East of England, screened 12 778, and randomized 1764 into a suite of type 2 diabetes prevention and screen detected type 2 diabetes management trials. A key element of the program tested the value of volunteers with type 2 diabetes, trained to act as diabetes prevention mentors (DPM) when added to an intervention arm delivered by healthcare professionals trained to support participant lifestyle change.Results We invited 9951 people with type 2 diabetes to become DPM and 427 responded (4.3%). Of these, 356 (83.3%) were interviewed by phone, and of these 131 (36.8%) were interviewed in person. We then appointed 104 of these 131 interviewed applicants (79%) to the role (mean age 62 years, 55% (n=57) male). All DPMs volunteered for a total of 2895 months, and made 6879 telephone calls to 461 randomized participants. Seventy-six (73%) DPMs volunteered for at least 6 months and 66 (73%) for at least 1 year.Discussion Individuals with type 2 diabetes can be recruited, trained and retained as DPM in large numbers to support a group-based diabetes prevention program delivered by healthcare professionals. This volunteer model is low cost, and accesses the large type 2 diabetes population that shares a lifestyle experience with the target population. This is an attractive model for supporting diabetes prevention efforts.

Abstract Background This 7 year NIHR programme [2011–2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. Methods NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. Discussion The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice. Trial registration ISRCTN34805606 (Retrospectively registered 16.3.16)

Background: The treatment of people with diabetes with metformin can reduce cardiovascular disease (CVD) and may reduce the risk of cancer. However, it is unknown whether or not metformin can reduce the risk of these outcomes in people with elevated blood glucose levels below the threshold for diabetes [i.e. non-diabetic hyperglycaemia (NDH)]. Objective: To assess the feasibility of the Glucose Lowering In Non-diabetic hyperglycaemia Trial (GLINT) and to estimate the key parameters to inform the design of the full trial. These parameters include the recruitment strategy, randomisation, electronic data capture, postal drug distribution, retention, study medication adherence, safety monitoring and remote collection of outcome data. Design: A multicentre, individually randomised, double-blind, parallel-group, pragmatic, primary prevention trial. Participants were individually randomised on a 1 : 1 basis, blocked within each site. Setting: General practices and clinical research facilities in Cambridgeshire, Norfolk and Leicestershire. Participants: Males and females aged ≥ 40 years with NDH who had a high risk of CVD. Interventions: Prolonged-release metformin (500 mg) (Glucophage® SR, Merck KGaA, Bedfont Cross, Middlesex, UK) or the matched placebo, up to three tablets per day, distributed by post. Main outcome measures: Recruitment rates; adherence to study medication; laboratory results at baseline and 3 and 6 months; reliability and acceptability of study drug delivery; questionnaire return rates; and quality of life. Results: We sent 5251 invitations, with 511 individuals consenting to participate. Of these, 249 were eligible and were randomised between March and November 2015 (125 to the metformin group and 124 to the placebo group). Participants were followed up for 0.99 years [standard deviation (SD) 0.30 years]. The use of electronic medical records to identify potentially eligible individuals in individual practices was resource intensive. Participants were generally elderly [mean age 70 years (SD 6.7 years)], overweight [mean body mass index 30.1 kg/m2 (SD 4.5 kg/m2)] and male (88%), and the mean modelled 10-year CVD risk was 28.8% (SD 8.5%). Randomisation, postal delivery of the study drug and outcome assessment using registers/medical records were feasible and acceptable to participants. Most participants were able to take three tablets per day, but premature discontinuation of the study drug was common (≈30% of participants by 6 months), although there were no differences between the groups. All randomised participants returned questionnaires at baseline and 67% of participants returned questionnaires by the end of the study. There was no between-group difference in Short Form questionnaire-8 items or EuroQol-5 Dimensions scores. Compared with placebo, metformin was associated with small improvements in the mean glycated haemoglobin level [–0.82 mmol/mol, 95% confidence interval (CI) –1.39 to –0.24 mmol/mol], mean estimated glomerular filtration rate (2.31 ml/minute/1.73 m2, 95% CI –0.2 to 4.81 ml/minute/1.73 m2) and mean low-density lipoprotein cholesterol level (–0.11 mmol/l, 95% CI –0.25 to 0.02 mmol/l) and a reduction in mean plasma vitamin B12 level (–16.4 ng/l, 95% CI –32.9 to –0.01 ng/l). There were 35 serious adverse events (13 in the placebo group, 22 in the metformin group), with none deemed to be treatment related. Limitations: Changes to sponsorship reduced the study duration, the limited availability of information in medical records reduced recruitment efficiency and discontinuation of study medication exceeded forecasts. Conclusions: A large, pragmatic trial comparing the effects of prolonged-release metformin and placebo on the risk of CVD events is potentially feasible. However, changes to the study design and conduct are recommended to enable an efficient scaling up of the trial. Recommendations include changing the inclusion criteria to recruit people with pre-existing CVD to increase the recruitment and event rates, using large primary/secondary care databases to increase recruitment rates, conducting follow-up remotely to improve efficiency and including a run-in period prior to randomisation to optimise trial adherence. Trial registration: Current Controlled Trials ISRCTN34875079. Funding: The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 18. See the NIHR Journals Library website for further project information. Merck KGaA provided metformin and matching placebo.

We review here some of our recent work on the synthesis and characterisation of new perovskite-related oxide fluorides. We demonstrate the use of low temperature fluorination methods for the preparation of new phases with high fluorine contents. We also show how fluorine can be accommodated in different sites according to the structural details of the initial oxide and the fluorine content. Importantly, we describe how Mössbauer spectroscopy is a powerful technique for monitoring changes in cation oxidation state as a result of fluorination and for examining the complex magnetic interactions which result from the accommodation of fluorine within the structures and how these can be related to structural properties and changes to the superexchange pathways.

Background: Promoting physical activity (PA) via primary care exercise referral schemes (ERS) is common but there is no rigorous evidence for long term changes in PA (Pavey et al, 2011) among those with chronic conditions. From July 2015, for 15 months, the e-coachER trial began to recruit 1400 patients (in SW England, Birmingham and Glasgow) with one or more chronic conditions including diabetes, obesity, hypertension, osteoarthritis, or depression, who are eligible and about to attend an ERS. The two-arm parallel RCT is powered to determine if the addition of a web-based, interactive, theory-driven and evidence-based support system (hosted on the ‘LifeGuide’ platform) will result in at least 10% more patients who do 150 mins or more per week of accelerometer assessed moderate or vigorous physical activity (MVPA) at 12 months. Aims: This presentation will provide details on the intervention development and data to be captured to inform a process evaluation. Methods: An initial version of e-coachER was produced, building on experiences from obesity and diabetes self-management interventions using the Lifeguide platform, and beta tested over 7 months. Co-applicants and researchers then provided feedback on a time-truncated version, and ERS patients on a real-time version, for 5 months before it was locked for the RCT. Within the trial, after participants are screened, provide consent and complete baseline assessments, they are randomised to receive usual ERS at each site or usual ERS plus a mailed Welcome Pack (including a user friendly guide to register for e-coachER access in-line, a free pedometer and a fridge magnet with daily recording strips for step counts or minutes of MVPA). Contact details for an e-coachER facilitator are provided for additional technical support. Results: At the core of the intervention are ‘7 Steps to Health’ aimed to last 5-10 mins each, to encourage patients to think about the benefits of PA, seek support from an ERS practitioner (and friends/family, and the web), to self-monitor PA with a pedometer and upload steps or minutes of MVPA, set progressive goals, build confidence, autonomy and relatedness (from Self-Determination Theory), find ways to increase sustainable PA more broadly, and deal with setbacks. An avatar (to avoid having to represent a range of individual characteristics such as age, gender, and ethnicity) and brief narratives are used throughout to normalise and support behaviour change and encourage e-coachER use. Automatic or patient chosen e-mails from the Lifeguide system promote on-going use of functions such as recording weekly PA and goal setting. For each site, participants are able to access links to reputable generic websites for further information about chronic conditions and lifestyle, links to other sites and apps for self-monitoring health behaviour and health, as well as modifiable options for local physical activity options. Conclusion: The Lifeguide platform for e-coachER is able to collect data on individual usage, and this will be used, along with semi-structured interviews, to conduct a process evaluation to fully understand if, for whom, and how the intervention facilitated long-term PA changes. Supported with funding from the NIHR (HTA) Project: 13/25/20