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Background: Medication reviews aim to support patients who take medicines, and they are often led by pharmacists. There are different types of medication reviews undertaken in various settings. Previous research undertaken in 2015 found mixed evidence that medication reviews in community settings improve clinical outcomes, but further work needs to be undertaken to establish their impact on patient-orientated and economic outcomes. Aim: This scoping review aims to explore the extent and range of systematic reviews of medication reviews conducted by pharmacists, the nature of the intervention, the evidence for effectiveness, and reported research gaps. Method: Systematic reviews were included irrespective of participants, settings or outcomes and were excluded if pharmacists did not lead the delivery of the included interventions. Data extracted included the design of included studies, population, setting, main results, description of interventions, and future research recommendations. Results: We identified twenty-four systematic reviews that reported that medication review interventions were diverse, and their nature was often poorly described. Two high-quality reviews reported that there was evidence of no effect on mortality; of these one reported an improvement in medicines-related problems (all studies reported an increase of identified problems), and another a reduction in hospital readmissions (Risk ratio 0.93 [95% CI 0.89, 0.98]). Other lower-quality reviews reported evidence supporting intervention effectiveness for some clinical outcomes (odds ratio: achieving diabetes control = 3.11 95% prediction intervals (PI), 1.48–6.52, achieving blood pressure target = 2.73, 95% PI, 1.05–7.083.50). Conclusion: There is mixed evidence of effectiveness for medication reviews across settings and patient populations. There is limited data about the implementation of medication reviews, therefore is difficult to ascertain which components of the intervention lead to improved outcomes. As medication reviews are widely implemented in practice, further research should explore the nature of the interventions, linking the components of these to outcomes. [ABSTRACT FROM AUTHOR]

Objectives: Women in the criminal justice system and women who have been subject to domestic abuse are at high risk of cancer but underrepresented in health promotion research. We aimed to co‐produce, pilot and evaluate a health promoting programme delivered on group walks. Design: A programme co‐produced by women, based on motivational interviewing, created the opportunity for supportive conversations about cancer prevention. Methods: Programme development in two workshops with women with lived experience using authentic vignettes to prompt help‐seeking conversations. A small pilot and a qualitative evaluation was done using framework analysis. Results: The programme appeared acceptable to women and the walk leaders. Women felt included and found it a safe space for sensitive conversations. They appeared empowered and more confident to seek help. Walk leaders expressed confidence in delivering this informal programme, which used prompts rather than delivering didactic training. Conclusion: Cancer prevention for high‐risk groups can be delivered in a personalised and novel way by creating informal opportunities for supportive conversations about cancer prevention. Careful co‐production of the programme of walks with women, using scenarios and quotes that were authentic vignettes, ensured that these came directly from the women's lived experience and enabled women to talk about change. Our findings indicate that this approach was practical, relevant and acceptable to them with some evidence of women feeling empowered to make informed decisions about their health. We recommend that future cancer prevention programmes for underrepresented groups take an asset‐based approach by utilising pre‐existing community organisations to increase reach and sustainability. Patient and Public Involvement: Women with lived experience co‐designed and tested the programme. Provisional findings were fed back to the women and the women's organisation that partnered with this research. [ABSTRACT FROM AUTHOR]

Aim: To identify and analyse ways in which parents are supported to deliver rehabilitation exercises to their child after traumatic brain injury (TBI), conceptualized as strategies. Method: A systematic search was completed using seven online databases and three grey literature databases, from inception to November 2021. The included studies focused on physical rehabilitation in children after TBI with the involvement of parents as hands‐on deliverers or facilitators of rehabilitation (e.g. supervising the exercise). Intervention descriptions were reviewed to identify strategies; this was followed by fine‐grained analysis using the Behaviour Change Wheel to identify intervention components. Risk of bias was analysed using the revised Cochrane Risk‐of‐Bias Tool for Randomized Trials or the Risk Of Bias In Non‐randomized Studies ‐ of Interventions. Results: Six interventions including 211 participants and one trial protocol met the inclusion criteria. All studies included a proportion of children diagnosed with TBI and four studies included mixed samples of acquired brain injury or cerebral palsy. All interventions included elements of goal setting and instruction. Interpretation: Interventions focus heavily on the initiation of physical rehabilitation, but focus less on the longer‐term maintenance of rehabilitation delivery. Further research should integrate perspectives from parents to inform the development of new interventions. What this paper adds: Parents need support to deliver or supervise rehabilitation exercises.The interventions identified in this review supported goal setting, action planning, and learning rehabilitation exercises.Interventions focused primarily on the initiation of exercises but less on maintenance.Rehabilitation is complex and new approaches are needed to better support parents. [ABSTRACT FROM AUTHOR]

Background: The proportion of the population aged 65 years or older is increasing. Typically, physical activity and health decline with age, which is why action to promote active ageing is a major public health priority, particularly due to health inequalities in older adults. The aim of this study is to assess the effectiveness and cost-effectiveness of the Walk with Me peer-led walking intervention for older adults. Methods: This study is a two-arm, assessor-blind, randomised controlled trial. The intervention is a 12-week peer-led walking intervention based on social cognitive theory. Participants in the control group will receive information on active ageing and healthy nutrition. The study will target 348 community-dwelling older adults, aged 60 years or over living in areas of socio-economic disadvantage communities. Trained peer mentors will deliver the intervention. The primary outcome will be a mean between-group change in moderate-to-vigorous physical activity at 12 months from baseline, measured using an Actigraph accelerometer. Secondary outcomes will include quality of life, mental wellbeing, blood pressure, BMI and waist circumference. An embedded process evaluation will involve focus groups and participant diaries. Discussion: Evidence-based, cost-effective interventions to promote physical activity in older adults living in socio-economically disadvantaged communities are needed to address health inequalities. [ABSTRACT FROM AUTHOR]

Objectives: During COVID‐19 the UK general population has been given strong messages to stay at home. Concurrently unprecedented changes occurred in healthcare access with moves to remote/triage systems. Data have shown that the number of people accessing healthcare services decreased and there are significant concerns that the pandemic has negatively affected help‐seeking for serious conditions, with potentially increased morbidity and mortality. An understanding of help‐seeking is urgently needed to inform public campaigns. We aimed to develop an in‐depth, theory‐based understanding of how, when and why people sought help for potentially serious symptoms (e.g., related to major cardiovascular events or cancer diagnoses) during the pandemic, and what influenced their decisions. Design: Qualitative semi‐structured interviews. Methods: We interviewed 25 adults recruited through a targeted social media campaign. Interviews were conducted via telephone or online platform. Our topic guide was informed by the Model of Pathways to Treatment and the Capability‐Opportunity‐Motivation‐Behaviour model. Results: The analysis identified four main themes: Delay in recognition, Holding on to concerns, Weighing it up and Long‐term impacts. Multiple societal and environmental factors influenced participants' help‐seeking and motivation, capability and opportunity to seek help, with long‐term impacts on well‐being and future help‐seeking. Conclusions: There is a need for clear guidance about pathways to raise concerns about symptoms and gain advice while usual healthcare contacts are paused or stopped. Recommendations for future interventions to support help‐seeking during pandemics include clearer messaging, co‐produced with end‐users, on when, where and how to seek help. [ABSTRACT FROM AUTHOR]

Aim: This study aims to explore the feasibility of using serial MRI without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot, in order to decide whether a large-scale trial is warranted. Methods: A multicentre, randomised, prospective, two arm, open, feasibility study (CADOM) of people with diabetes with a suspected or confirmed diagnosis of Charcot neuroarthropathy. Participants were randomised (1:1) to 'standard care plus', including repeated foot temperature measurements and X-rays, or the intervention arm, with additional three-monthly MRI, until remission of Charcot neuroarthropathy or a maximum 12 months (active phase). Participants were then followed-up for a further 6 months, post remission to monitor for relapse of the Charcot neuroarthropathy (follow-up phase). Feasibility outcomes were recruitment, retention, data completeness, adherence to study procedures and safety of the intervention MRI. We also collected clinical efficacy outcomes, this included time in cast/off-loading device which will be the primary outcome of a future definitive trial. Finally, we collected patient reported outcomes, and data on health and social care usage. Results: One-hundred and five people were assessed for eligibility at five sites. 64/105 potential participants meet the eligibility criteria to participate in the study. Forty-three participants were randomised: 20 to standard care plus and 23 to MRI intervention. The main reason for ineligibility was a previous episode of Charcot neuroarthropathy. Thirteen participants were withdrawn post-randomisation due to an alternative diagnosis being made. Of the remaining 30 participants, 19 achieved remission, 6 had not gone into remission at the end of the 12 month active phase so exited the study. Five participants were lost to follow-up. Of the MRIs that were not disrupted by COVID-19 pandemic 26/31 (84%) were completed. For the visits that were conducted face-to-face, completion rates of patient-reported outcome measures were between 71 and 100%. There were no safety incidents associated with the intervention MRI. As this was a feasibility study it was not designed to test the effectiveness of serial MRI in diagnosing remission. The time in cast/off-loading device was 235 (±108.3) days for the standard care plus arm compared to 292 (±177.4) days for the intervention arm. There was no statistical difference in the time in cast/off-loading device between the two arms of the study: Hazard Ratio (HR) 0.405 (95% CI 0.140–1.172), p = 0.096. Discussion: The findings support a definitive randomised controlled trial to evaluate the effectiveness of MRI in diagnosing remission in Charcot neuroarthropathy. The rates of recruitment, retention, data, and MRI completeness show that a definitive study is feasible. Study registration: ISRCTN, 74101606. Registered on 6 November 2017. [ABSTRACT FROM AUTHOR]

Aim: This study aims to explore the feasibility of using serial MRI without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot, in order to decide whether a large-scale trial is warranted. Methods: A multicentre, randomised, prospective, two arm, open, feasibility study (CADOM) of people with diabetes with a suspected or confirmed diagnosis of Charcot neuroarthropathy. Participants were randomised (1:1) to 'standard care plus', including repeated foot temperature measurements and X-rays, or the intervention arm, with additional three-monthly MRI, until remission of Charcot neuroarthropathy or a maximum 12 months (active phase). Participants were then followed-up for a further 6 months, post remission to monitor for relapse of the Charcot neuroarthropathy (follow-up phase). Feasibility outcomes were recruitment, retention, data completeness, adherence to study procedures and safety of the intervention MRI. We also collected clinical efficacy outcomes, this included time in cast/off-loading device which will be the primary outcome of a future definitive trial. Finally, we collected patient reported outcomes, and data on health and social care usage. Results: One-hundred and five people were assessed for eligibility at five sites. 64/105 potential participants meet the eligibility criteria to participate in the study. Forty-three participants were randomised: 20 to standard care plus and 23 to MRI intervention. The main reason for ineligibility was a previous episode of Charcot neuroarthropathy. Thirteen participants were withdrawn post-randomisation due to an alternative diagnosis being made. Of the remaining 30 participants, 19 achieved remission, 6 had not gone into remission at the end of the 12 month active phase so exited the study. Five participants were lost to follow-up. Of the MRIs that were not disrupted by COVID-19 pandemic 26/31 (84%) were completed. For the visits that were conducted face-to-face, completion rates of patient-reported outcome measures were between 71 and 100%. There were no safety incidents associated with the intervention MRI. As this was a feasibility study it was not designed to test the effectiveness of serial MRI in diagnosing remission. The time in cast/off-loading device was 235 (±108.3) days for the standard care plus arm compared to 292 (±177.4) days for the intervention arm. There was no statistical difference in the time in cast/off-loading device between the two arms of the study: Hazard Ratio (HR) 0.405 (95% CI 0.140–1.172), p = 0.096. Discussion: The findings support a definitive randomised controlled trial to evaluate the effectiveness of MRI in diagnosing remission in Charcot neuroarthropathy. The rates of recruitment, retention, data, and MRI completeness show that a definitive study is feasible. Study registration: ISRCTN, 74101606. Registered on 6 November 2017. [ABSTRACT FROM AUTHOR]

Physical activity is promoted in the asthma population through pulmonary rehabilitation, but limited funding and facilities are available. This review aimed to examine the effectiveness of interventions that promote physical activity and identify the behaviour change techniques (BCTs) and other intervention components used. Five databases were searched, and 25 studies met the inclusion criteria. Interventions had a significant positive effect on physical activity, sedentary behaviour, quality of life and asthma symptoms. BCTs used across intervention and control groups were similar in studies that showed effects and those that did not. Future interventions should employ techniques that help to maintain behaviour change. [ABSTRACT FROM AUTHOR]

The use of multi-agency partnerships, including research-practice partnerships, to facilitate the development, implementation and evaluation of public health interventions has expanded in recent years. However, gaps remain in the understanding of influences on partnership working, and their capacity to facilitate and use evaluation, as well as the characteristics which lead to partnership effectiveness. We applied qualitative methods to explore experiences of stakeholders who were involved in partnerships to deliver and evaluate a national physical activity programme. We combined thematic and network analysis, and drew on concepts of evaluation use, knowledge exchange and organisational systems to interpret our findings and develop a conceptual model of the relationships between partnership characteristics and processes. Our model identifies key partnership characteristics such as high levels of engagement, regular communication and continuity. Furthermore, it highlights the importance of implementing organisational structures and systems to support effective partnership working, knowledge exchange and capacity building. [ABSTRACT FROM AUTHOR]

Aims: Charcot neuroarthropathy (CN) is a complication of neuropathy, in people with diabetes. Treatment requires the prolonged wearing of an offloading device, which can be challenging. The importance of understanding people's perspectives for promoting their engagement in self management is well known. However, no such studies have been done in CN. This qualitative study aimed to understand people's experiences of CN. Methods: Semi‐structured interviews with a purposive sample of 14 participants with CN, recruited from a randomised controlled trial. We gathered opinions, thoughts and the meanings participants attributed to their experiences of CN and its physical, socio‐economic and physiological effects and how this affected their families and relationships. We analysed the interviews using Inductive Thematic Analysis. Results: Four analytic themes were identified: (1) 'Trapped at home isolated and missing social life and daily life routines'; (2) 'Disruption to people's roles, responsibilities, relationships and mobility, which people adapted to try and address and manage'; (3) 'Pain which participants related to the direct or indirect consequences of wearing the cast or boot'; and (4) 'Blame for developing CN, attributed to themselves and healthcare professionals'. Participants described guilt about needing more support, expressing frustration, low mood and low self‐esteem. Conclusion: This study highlights experiential aspects of the previously unrecognised burden of CN. Its physical, social and emotional impacts on participants and their families are substantial and sustained. There is a need to raise clinical awareness of CN and its wider effects. Trial registration: ISRCTN74101606. Registered on 6 November 2017, http://www.isrctn.com/ISRCTN74101606?q=CADom&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic‐search [ABSTRACT FROM AUTHOR]

This study aimed to explore how social distancing and self-isolation measures, aimed at protecting vulnerable groups from COVID-19, affected the wellbeing and physical activity levels among adults diagnosed with asthma. Twenty-seven participants took part across four online focus groups. Transcripts were analysed using thematic analysis. Participants reported becoming more health conscious due to being labelled as vulnerable. Their relationship with the severity of their asthma was altered and they reported making positive changes to increase their physical activity levels. Findings suggest there is a window of opportunity to engage with people diagnosed with asthma to promote beneficial lifestyle changes and self-management. [ABSTRACT FROM AUTHOR]

Background: Physical activity is associated with a reduced risk of type 2 diabetes and cardiovascular disease but limited evidence exists for the sustained promotion of increased physical activity within diabetes prevention trials. The aim of the study was to investigate the long-term effectiveness of the Walking Away programme, an established group-based behavioural physical activity intervention with pedometer use, when delivered alone or with a supporting mHealth intervention.Methods: Those at risk of diabetes (nondiabetic hyperglycaemia) were recruited from primary care, 2013-2015, and randomised to (1) Control (information leaflet); (2) Walking Away (WA), a structured group education session followed by annual group-based support; or (3) Walking Away Plus (WAP), comprising WA annual group-based support and an mHealth intervention delivering tailored text messages supported by telephone calls. Follow-up was conducted at 12 and 48 months. The primary outcome was accelerometer measured ambulatory activity (steps/day). Change in primary outcome was analysed using analysis of covariance with adjustment for baseline, randomisation and stratification variables.Results: One thousand three hundred sixty-six individuals were randomised (median age = 61 years, ambulatory activity = 6638 steps/day, women = 49%, ethnic minorities = 28%). Accelerometer data were available for 1017 (74%) individuals at 12 months and 993 (73%) at 48 months. At 12 months, WAP increased their ambulatory activity by 547 (97.5% CI 211, 882) steps/day compared to control and were 1.61 (97.5% CI 1.05, 2.45) times more likely to achieve 150 min/week of moderate-to-vigorous physical activity. Differences were not maintained at 48 months. WA was no different to control at 12 or 48 months. Secondary anthropometric and health outcomes were largely unaltered in both intervention groups apart from small reductions in body weight in WA (~ 1 kg) at 12- and 48-month follow-up.Conclusions: Combining a pragmatic group-based intervention with text messaging and telephone support resulted in modest changes to physical activity at 12 months, but changes were not maintained at 48 months.Trial Registration: ISRCTN 83465245 (registered on 14 June 2012). [ABSTRACT FROM AUTHOR]

The PAM intervention is a behavioural intervention to support adherence to anti-hypertensive medications and therefore to lower blood pressure. This feasibility trial recruited 101 nonadherent patients (54% male, mean age 65.8 years) with hypertension and high blood pressure from nine general practices in the UK. The trial had 15.5% uptake and 7.9% attrition rate. Patients were randomly allocated to two groups: the intervention group (n = 61) received the PAM intervention as an adjunct to usual care; the control group (n = 40) received usual care only. At 3 months, biochemically validated medication adherence was improved by 20% (95% CI 3–36%) in the intervention than control, and systolic blood pressure was reduced by 9.16 mmHg (95% CI 5.69–12.64) in intervention than control. Improvements in medication adherence and reductions in blood pressure suggested potential intervention effectiveness. For a subsample of patients, improvements in medication adherence and reductions in full lipid profile (cholesterol 1.39 mmol/mol 95% CI 0.64–1.40) and in glycated haemoglobin (3.08 mmol/mol, 95% CI 0.42–5.73) favoured the intervention. A larger trial will obtain rigorous evidence about the potential clinical effectiveness and cost-effectiveness of the intervention. Trial registration Trial date of first registration 28/01/2019. ISRCTN74504989. https://doi.org/10.1186/ISRCTN74504989. [ABSTRACT FROM AUTHOR]

Background: Interventions to improve physical activity behaviour are a core part of public health policy and practice. It is essential that we evaluate these interventions and use the evidence to inform decisions to improve population health. Evaluation of 'real-world' interventions provide an opportunity to generate practice-relevant evidence, however these interventions are difficult to evaluate. Various guidelines have been developed to facilitate evaluation, but evidence about their effectiveness in practice is limited. To explore influences on evaluation practice in an applied context, we conducted a case study of Sport England's 'Get Healthy Get Active' (GHGA) programme. This was a national programme that funded 33 projects that were delivered and evaluated across England. The programme was chosen as it was designed to generate evidence on the role of sport in increasing physical activity and improving health. The study aimed to explore and appraise whether strategies intended to facilitate project evaluation, including funder requirements to use a standardised evaluation framework and specific data collection methods, were effective in generating evidence that enabled the programme to meet its aims. Methods: We applied a collective case study design involving 35 semi-structured interviews, and documentary analysis of multiple sources of evidence from 23 physical activity projects funded by GHGA. We applied thematic and framework analysis. We developed a logic model and mapped actual outcomes against intended outcomes. A narrative synthesis is provided. We discuss implications for the effective commissioning and evaluation of public health interventions. Results: We identified five main themes of influences on evaluation practices that can act as barriers and facilitators to good practice: programme and project design; evaluation design; partnerships; resources; and organisational structures and systems. These influences are context-specific and operate through a complex set of interactions. Conclusion: Developing a better understanding of how influences on evaluation practice can act as facilitators or barriers is vital to help close current gaps in the evidence-based practice cycle. Critically, organisational structures and systems are needed to facilitate collaborative decision making; integration of projects and evaluation across partners organisations; transfer of knowldege and insights between stakeholders; and more rapid feedback and dissemination. [ABSTRACT FROM AUTHOR]

Aim: The management of acute Charcot neuroarthropathy relies on off-loading which is costly and time-consuming. Published studies have used monitoring techniques with unknown diagnostic precision to detect remission. We performed a systematic review of techniques for monitoring response to offloading in acute Charcot neuroarthropathy.Materials and Methods: We included studies of off-loading which evaluated or described monitoring techniques in acute Charcot neuroarthropathy. PubMed, EMBASE, CINAHL and Cochrane databases were searched (January1993-July 2018). We extracted data from papers including study design, setting, population, monitoring techniques and treatment outcomes. We also extracted information on the cost, clinical applicability, sensitivity and specificity, safety and participant acceptability of the monitoring techniques.Results: We screened 1205 titles, 140 abstracts and 45 full-texts, and included 29 studies. All studies were of low quality and at high risk of bias. In seven studies, the primary aim was to evaluate monitoring techniques: three evaluated magnetic resonance imaging, two thermography monitoring, one three-phase bone scanning and one Doppler spectrum analysis. The remaining 22 observational studies reported treatment outcomes and described the monitoring techniques used to assess the Charcot neuroarthropathy. Heterogeneity prevented the pooling of data. Very few studies included data on cost, clinical applicability, sensitivity and specificity, safety and patient acceptability of the monitoring techniques used.Conclusion: Multiple techniques have been used to evaluate remission in acute Charcot neuroathropathy but uncertainty remains about their effectiveness. We recommend further research into the influences of different monitoring techniques on treatment outcomes. [ABSTRACT FROM AUTHOR]

Background: Physical activity and dietary change programmes play a central role in addressing public health priorities. Programme evaluation contributes to the evidence-base about these programmes; and helps justify and inform policy, programme and funding decisions. A range of evaluation frameworks have been published, but there is uncertainty about their usability and applicability to different programmes and evaluation objectives, and the extent to which they are appropriate for practitioner-led or researcher-led evaluation. This review appraises the frameworks that may be applicable to evaluation of physical activity and/or dietary change programmes, and develops a typology of the frameworks to help guide decision making by practitioners, commissioners and evaluators.Methods: A scoping review approach was used. This included a systematic search and consultation with evaluation experts to identify evaluation frameworks and to develop a set of evaluation components to appraise them. Data related to each framework's general characteristics and components were extracted. This was used to construct a typology of the frameworks based on their intended programme type, evaluation objective and format. Each framework was then mapped against the evaluation components to generate an overview of the guidance included within each framework.Results: The review identified 71 frameworks. These were described variously in terms of purpose, content, or applicability to different programme contexts. The mapping of frameworks highlighted areas of overlap and strengths and limitations in the available guidance. Gaps within the frameworks which may warrant further development included guidance on participatory approaches, non-health and unanticipated outcomes, wider contextual and implementation factors, and sustainability.Conclusions: Our typology and mapping signpost to frameworks where guidance on specific components can be found, where there is overlap, and where there are gaps in the guidance. Practitioners and evaluators can use these to identify, agree upon and apply appropriate frameworks. Researchers can use them to identify evaluation components where there is already guidance available and where further development may be useful. This should help focus research efforts where it is most needed and promote the uptake and use of evaluation frameworks in practice to improve the quality of evaluation and reporting. [ABSTRACT FROM AUTHOR]

Background: Charcot neuroarthropathy is a complication of peripheral neuropathy associated with diabetes which most frequently affects the lower limb. It can cause fractures and dislocations within the foot, which may progress to deformity and ulceration. Recommended treatment is immobilisation and offloading, with a below knee non-removable cast or boot. Duration of treatment varies from six months to more than 1 year. Small observational studies suggest that repeated assessment with magnetic resonance imaging improves decision-making about when to stop treatment, but this has not been tested in clinical trials. This study aims to explore the feasibility of using serial magnetic resonance imaging without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot. A nested qualitative study aims to explore participants' lived experience of Charcot neuroarthropathy and of taking part in the feasibility study. Methods: We will undertake a two-arm, open study and randomise 60 people with a suspected or confirmed diagnosis of Charcot neuroarthropathy from five NHS, secondary care multidisciplinary Diabetic Foot Clinics across England. Participants will be randomised 1:1 to receive magnetic resonance imaging at baseline and remission up to 12 months, with repeated foot temperature measurements and X-rays (standard care plus), or standard care plus with additional three-monthly magnetic resonance imaging until remission up to 12 months (intervention). Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial. We will look for opportunities to improve the protocols for monitoring techniques and the clinical, patient-centred and health economic measures used in a future study. For the nested qualitative study, we will invite a purposive sample of 10–14 people able to offer maximally varying experiences from the feasibility study to take part in semi-structured interviews to be analysed using thematic analysis. Discussion: The study will inform the decision whether to proceed to a full-scale trial. It will also allow deeper understanding of the lived experience of Charcot neuroarthropathy, and factors that contribute to engagement in management and contribute to the development of more effective patient-centred strategies. Trial registration: ISRCTN, ISRCTN74101606. Registered on 6 November 2017. [ABSTRACT FROM AUTHOR]

Background: The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS) Health Checks in primary care.Methods and Findings: The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study's limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment.Conclusions: In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up.Trial Registration: Current Controlled Trials (ISRCTN72691150). [ABSTRACT FROM AUTHOR]

Background: Self-reported data have consistently shown South Asians (SAs) to be less physically active than White Europeans (WEs) in developed countries, however objective data is lacking. Differences in sedentary time have not been elucidated in this population. This study aimed to quantify differences in objectively measured physical activity and sedentary behaviour between WEs and SAs recruited from primary care and to investigate differences in demographic and lifestyle correlates of these behaviours.Methodology: Baseline data were utilised from a randomised control trial recruiting individuals identified at high risk of type 2 diabetes from primary care. Light intensity physical activity, moderate-to-vigorous intensity physical activity (MVPA) and steps were measured using the Actigraph GT3X+, while sitting, standing and stepping time were measured using the activPAL3™. Devices were worn concurrently for seven days. Demographic (employment, sex, age, education, postcode) and behavioural (fruit and vegetable consumption, alcohol consumption, smoking status) characteristics were measured via self and interview administered questionnaires.Results: A total of 963 WE (age = 62 ± 8, female 51%) and 289 SA (age = 55 ± 11, female 43%) were included. Compared to WEs, SAs did less MVPA (24 vs 33 min/day, p = 0.001) and fewer steps (6404 vs 7405 per day, p ≤ 0.001), but sat less (516 vs 552 min/day, p ≤ 0.001) and stood more (328 vs 283 min/day, p ≤ 0.001). Ethnicity also modified the extent to which demographic and behavioural factors act as correlates of physical activity and sedentary behaviour. Differences between sex in levels of MVPA and sitting time were greater in SAs compared to WEs, with SA women undertaking the least amount of MVPA (19 min/day), the least sitting time (475 min/day) and most standing time (377 min/day) than any other group. Smoking and alcohol status also acted as stronger correlates of sitting time in SAs compared to WEs. In contrast, education level acted as a stronger correlate of physical activity in WEs compared to SAs.Conclusion: SAs were less active yet less sedentary than WEs, which demonstrates the need to tailor the behavioural targets of interventions in multi-ethnic communities. Common correlates of physical activity and sedentary behaviour also differed between ethnicities.Trial Registration: ISRCTN83465245 Trial registration date: 14/06/2012. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy of a theory-based behavioural intervention to prevent rapid weight gain in formula milk-fed infants.Design: In this single (assessor) blind, randomised controlled trial, 669 healthy full-term infants receiving formula milk within 14 weeks of birth were individually randomised to intervention (n=340) or attention-matched control (n=329) groups. The intervention aimed to reduce formula milk intakes, and promote responsive feeding and growth monitoring to prevent rapid weight gain (≥+0.67 SD scores (SDS)). It was delivered to mothers by trained facilitators up to infant age 6 months through three face-to-face contacts, two telephone contacts and written materials.Results: Retention was 93% (622) at 6 months, 88% (586) at 12 months and 94% attended ≥4/5 sessions. The intervention strengthened maternal attitudes to following infant feeding recommendations, reduced reported milk intakes at ages 3 (-14%; intervention vs control infants), 4 (-12%), 5 (-9%) and 6 (-7%) months, slowed initial infant weight gain from baseline to 6 months (mean change 0.32 vs 0.42 SDS, baseline-adjusted difference (intervention vs control) -0.08 (95% CI -0.17 to -0.004) SDS), but had no effect on the primary outcome of weight gain to 12 months (baseline-adjusted difference -0.04 (-0.17, 0.10) SDS). By 12 months, 40.3% of infants in the intervention group and 45.9% in the control group showed rapid weight gain (OR 0.84, 95% CI 0.59 to 1.17).Conclusions: Despite reducing milk intakes and initial weight gain, the intervention did not alter the high prevalence of rapid weight gain to age 12 months suggesting the need for sustained intervention.Trial Registration Number: ISRCTN20814693. [ABSTRACT FROM AUTHOR]

Objective: Communication of the content of a behaviour change intervention (BCI) involves clear description followed by appropriate recognition and interpretation. We investigated accuracy of recognition of BCI descriptions and the effects of training in the behaviour change taxonomy BCTTv1. Methods: Materials were 166 written descriptions of two BCIs previously written by 166 separate writers after viewing a video of the BCI. Each of the current participants (12 naïve and 12 trained in BCTTv1) was presented with a random sample of the written descriptions and asked to form groups of descriptions they judged to be describing the same intervention. For each participant, we assessed the number of groupings of BCI descriptions, their purity (containing only one BCI) and their differentiation (having a dominant BCI). Results: All except one participant classified the descriptions into more than two groupings. Naïve participants created significantly more groupings, fewer ‘pure’ groupings and less differentiated groupings (all Mann-Whitney p < .05). Conclusions: Written communications of BCI contents may not be recognised and interpreted adequately to support implementation. BCT taxonomy training may lead to some progress in interpreting the active content of interventions but, based on this limited study, further progress is needed if BCIs for accurate implementation. [ABSTRACT FROM AUTHOR]

The article discusses the role of intervention fidelity, strategies used to enhance and monitor the reliability and validity of behavioral interventions, in physical therapy research. It is said that intervention fidelity assesses the extent to which an intervention is implemented as intended by its developers.

Background: Primary care is an ideal setting for physical activity interventions to prevent and manage common long-term conditions. To identify those who can benefit from such interventions and to deliver tailored support, primary care professionals (e.g. GPs, practice nurses, physiotherapists, health care assistants) need reliable and valid tools to assess physical activity. However, there is uncertainty about the best-performing tool.Objective: To identify the tools used in the literature to assess the physical activity in primary care and describe their psychometric properties.Method: A systematic review of published and unpublished literature was undertaken up to 1 December 2016). Papers detailing physical activity measures, tools or approaches used in primary care consultations were included. A synthesis of the frequency and context of their use, and their psychometric properties, was undertaken. Studies were appraised using the Downs and Black critical appraisal tool and the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) initiative checklist.Results: Fourteen papers reported 10 physical activity assessment tools. The General Practice Physical Activity Questionnaire (GPPAQ) was most frequently reported. None of the assessment tools identified showed high reliability and validity. Intra-rater reliability ranged from kappa: 0.53 [Brief Physical Activity Assessment Tool (BPAAT)] to 0.67 (GPPAQ). Criterion validity ranged from Pearson's rho: 0.26 (GPPAQ) to 0.52 (Physical Activity Vital Sign). Concurrent validity ranged from kappa: 0.24 (GPPAQ) to 0.64 (BPAAT).Conclusion: The evidence base about physical activity assessment in primary care is insufficient to inform current practice. [ABSTRACT FROM AUTHOR]

Background: Very brief interventions (VBIs) for physical activity are promising, but there is uncertainty about their potential effectiveness and cost. We assessed potential efficacy, feasibility, acceptability, and cost of three VBIs in primary care, in order to select the most promising intervention for evaluation in a subsequent large-scale RCT. Methods: Three hundred and ninety four adults aged 40-74 years were randomised to a Motivational (n = 83), Pedometer (n = 74), or Combined (n = 80) intervention, delivered immediately after a preventative health check in primary care, or control (Health Check only; n = 157). Potential efficacy was measured as the probability of a positive difference between an intervention arm and the control arm in mean physical activity, measured by accelerometry at 4 weeks. Results: For the primary outcome the estimated effect sizes (95% CI) relative to the Control arm for the Motivational, Pedometer and Combined arms were respectively: +20.3 (-45.0, +85.7), +23.5 (-51.3, +98.3), and -3.1 (-69.3, +63.1) counts per minute. There was a73% probability of a positive effect on physical activity for each of the Motivational and Pedometer VBIs relative to control, but only 46% for the Combined VBI. Only the Pedometer VBI was deliverable within 5 min. All VBIs were acceptable and low cost. Conclusions: Based on the four criteria, the Pedometer VBI was selected for evaluation in a large-scale trial. [ABSTRACT FROM AUTHOR]

Background: Physical activity interventions that are targeted at individuals can be effective in encouraging people to be more physically active. However, most such interventions are too long or complex and not scalable to the general population. This trial will test the effectiveness and cost-effectiveness of a very brief physical activity intervention when delivered as part of preventative health checks in primary care (National Health Service (NHS) Health Check).Methods/design: The Very Brief Intervention (VBI) Trial is a two parallel-group, randomised, controlled trial with 1:1 individual allocation and follow-up at 3 months. A total of 1,140 participants will be recruited from 23 primary care practices in the east of England. Participants eligible for an NHS Health Check and who are considered suitable to take part by their doctor and able to provide written informed consent are eligible for the trial. Participants are randomly assigned at the beginning of the NHS Health Check to either 1) the control arm, in which they receive only the NHS Health Check, or 2) the intervention arm, in which they receive the NHS Health Check plus 'Step It Up' (a very brief intervention that can be delivered in 5 minutes by nurses and/or healthcare assistants at the end of the Health Check). 'Step It Up' includes (1) a face-to-face discussion, including feedback on current activity level, recommendations for physical activity, and information on how to use a pedometer, set step goals, and monitor progress; (2) written material supporting the discussion and tips and links to further resources to help increase physical activity; and (3) a pedometer to wear and a step chart for monitoring progress. The primary outcome is accelerometer counts per minute at 3-month follow-up. Secondary outcomes include the time spent in the different levels of physical activity, self-reported physical activity and economic measures. Trial recruitment is underway.Discussion: The VBI trial will provide evidence on the effectiveness and cost-effectiveness of the Step It Up intervention delivered during NHS Health Checks and will inform policy decisions about introducing very brief interventions into routine primary care practice.Trial Registration: ISRCTN Registry, ISRCTN72691150 . Registered on 17 July 2014. [ABSTRACT FROM AUTHOR]

Background: Behaviour change interventions are likely to be reproducible only if reported clearly. We assessed whether the behaviour change technique taxonomy version 1 (BCTTv1), with and without training in identifying BCTs, improves the clarity and replicability of written reports of observed behaviour change interventions.Methods: Three studies assessed effects of using and training in the use of BCTTv1 on the clarity and replicability of intervention descriptions written after observing videos of smoking cessation interventions. Study 1 examined the effects of using and not using BCTTv1. Study 2 examined the effects of using BCTTv1 and training in use of BCTTv1 compared no use and no training. Study 3 employed a within-group design to assess change in descriptions written before and after training. One-hundred and 66 'writers' watched videos of behaviour change interventions and wrote descriptions of the active components delivered. In all studies, the participants' written descriptions were evaluated by (i) 12 'raters' (untrained in BCTTv1) for clarity and replicability and (ii) 12 'coders' (trained in BCTTv1) for reliability of BCT coding. Writers rated the usability and accessibility of using BCTTv1 to write descriptions.Results: Ratings of clarity and replicability did not differ between groups in study 1 (all ps > 0.05), were poorer for trained users in study 2 (all ps < 0.01) and improved following training in study 3 (all ps < 0.05). BCT identification was more reliable from descriptions written by trained BCTTv1 users (p < 0.05; study 2) but not simple use of BCTTv1 (p = 0.93; study 1) or by writers who had written a description without BCTTv1, before training (p = 0.50; study 3). Writers reported that using BCTTv1 was difficult but 'useful', 'good' and 'desirable' and that their descriptions would be clear and replicable (all means above mid-point of the scale).Conclusions: Effects of training to use BCTTv1 on the quality of written reports of observed interventions were mixed, with some suggestion of improved clarity and replicability of reporting in the within- (study 3) but not the between-group studies (studies 1 and 2). Potential benefits of using BCTTv1 may have been limited by the artificial nature and time constraints of the task. [ABSTRACT FROM AUTHOR]

Objective: To determine whether brief interventions promoting physical activity are cost-effective in primary care or community settings.Design: Systematic review of economic evaluations.Methods and Data Sources: We searched MEDLINE, EMBASE, PsycINFO, CINAHL, EconLit, SPORTDiscus, PEDro, the Cochrane library, National Health Service Economic Evaluation Database and the Cost-Effectiveness Analysis Registry up to 20 August 2014. Web of Knowledge was used for cross-reference search. We included studies investigating the cost-effectiveness of brief interventions, as defined by National Institute for Health and Care Excellence, promoting physical activity in primary care or the community. Methodological quality was assessed using Drummond's checklist for economic evaluations. Data were extracted from individual studies fulfilling selection criteria using a standardised pro forma. Comparisons of cost-effectiveness and cost-utility ratios were made between studies.Results: Of 1840 identified publications, 13 studies fulfilled the inclusion criteria describing 14 brief interventions. Studies varied widely in the methods used, such as the perspective of economic analysis, intervention effects and outcome measures. The incremental cost of moving an inactive person to an active state, estimated for eight studies, ranged from £96 to £986. The cost-utility was estimated in nine studies compared with usual care and varied from £57 to £14 002 per quality-adjusted life year; dominant to £6500 per disability-adjusted life year; and £15 873 per life years gained.Conclusions: Brief interventions promoting physical activity in primary care and the community are likely to be inexpensive compared with usual care. Given the commonly accepted thresholds, they appear to be cost-effective on the whole, although there is notable variation between studies. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this paper is to assess the frequency of identification as well as the inter-coder and test-retest reliability of identification of behavior change techniques (BCTs) in written intervention descriptions.Methods: Forty trained coders applied the "Behavior Change Technique Taxonomy version 1" (BCTTv1) to 40 intervention descriptions published in protocols and repeated this 1 month later.Results: Eighty of 93 defined BCTs were identified by at least one trained coder, and 22 BCTs were identified in 16 (40 %) or more of 40 descriptions. Good inter-coder reliability was observed across 80 BCTs identified in the protocols: 66 (80 %) achieved mean prevalence and bias-adjusted kappa (PABAK) scores of 0.70 or greater, and 59 (74 %) achieved mean scores of 0.80 or greater. There was good within-coder agreement between baseline and 1 month, demonstrating good test-retest reliability.Conclusions: BCTTv1 can be used by trained coders to identify BCTs in intervention descriptions reliably. However, some frequently occurring BCT definitions require further clarification. [ABSTRACT FROM AUTHOR]

Background: Infancy is a period of rapid growth and habit formation and hence could be a critical period for obesity prevention. Excess weight gain during infancy is associated with later obesity and formula-fed babies are more likely to gain excess weight compared to breastfed babies. The primary trial outcome is a change in the weight standard deviation score from birth to 1 year.Methods/design: We will recruit 650 to 700 parents who introduce formula-milk feeds within 14 weeks of their baby's birth to a single (assessor) blind, parallel group, individually randomised controlled trial. The focus of the intervention is the caregiver (usually the mother), and the focus of the primary outcome is the infant. The intervention group will receive the behavioural intervention, which aims to reduce formula-milk intake, promote responsive feeding and healthy weaning, and prevent excessive weight gain during infancy. The intervention is based on Social Cognitive Theory and action planning ('implementation intentions'). It consists of three components: (1) a motivational component to strengthen parents' motivation to follow the Baby Milk feeding guidelines, (2) an action planning component to help translate motivation into action, and (3) a coping planning component to help parents deal with difficult situations. It will be delivered by trained facilitators (research nurses) over 6 months through three face-to-face contacts, two telephone contacts and written materials. The control group will have the same number of contacts with facilitators, and general issues about feeding will be discussed. Anthropometric outcomes will be measured by trained research staff, blind to group allocation, at baseline, 6 months and 12 months following standard operating procedures. Validated questionnaires will assess milk intake, temperament, appetite, sleep, maternal quality of life and maternal psychological factors. A 4-day food diary will be completed at 8 months.Discussion: The results of the trial will help to inform infant feeding guidelines and to understand the links between infant feeding, behaviour, appetite and growth.Trial Registration: ISRTCN20814693 . Registration date 13 January 2011. [ABSTRACT FROM AUTHOR]

Background: The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes.Methods/design: A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4% (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change.Discussion: This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention.Trial Registration: ISRCTN83465245 Trial registration date: 14/06/2012. [ABSTRACT FROM AUTHOR]

Behaviour Change Technique Taxonomy v1 (BCTTv1) has been used to detect active ingredients of interventions. The purpose of this study was to evaluate effectiveness of user training in improving reliable, valid and confident application of BCTTv1 to code BCTs in intervention descriptions. One hundred sixty-one trainees (109 in workshops and 52 in group tutorials) were trained to code frequent BCTs. The following measures were taken before and after training: (i) inter-coder agreement, (ii) trainee agreement with expert consensus, (iii) confidence ratings and (iv) coding competence. Coding was assessed for 12 BCTs (workshops) and for 17 BCTs (tutorials). Trainees completed a course evaluation. Methods improved agreement with expert consensus ( p < .05) but not inter-coder agreement ( p = .08, p = .57, respectively) and increased confidence for BCTs assessed (both p < .05). Methods were as effective as one another at improving coding competence ( p = .55). Training was evaluated positively. The training improved agreement with expert consensus, confidence for BCTs assessed, coding competence but not inter-coder agreement. This varied according to BCT. [ABSTRACT FROM AUTHOR]

Background: There is increasing interest in brief and very brief behaviour change interventions for physical activity as they are potentially scalable to the population level. However, few very brief interventions (VBIs) have been published, and evidence is lacking about their feasibility, acceptability and which 'active ingredients' (behaviour change techniques) would maximise their effectiveness. The aim of this research was to identify and develop promising VBIs for physical activity and test their feasibility and acceptability in the context of preventive health checks in primary care. Methods: The process included two stages, guided by four criteria: effectiveness, feasibility, acceptability, and cost. In Stage 1, we used an iterative approach informed by systematic reviews, a scoping review of BCTs, team discussion, stakeholder consultation, a qualitative study, and cost estimation to guide the development of promising VBIs. In Stage 2, a feasibility study assessed the feasibility and acceptability of the short-listed VBIs, using tape-recordings and interviews with practitioners (n = 4) and patients (n = 68), to decide which VBIs merited further evaluation in a pilot trial. Results: Four VBIs were short-listed: Motivational intervention; Action Planning intervention; Pedometer intervention; and Physical Activity Diary intervention. All were deliverable in around five minutes and were feasible and acceptable to participants and practitioners. Based on the results of interviews with practitioners and patients, techniques from the VBIs were combined into three new VBIs for further evaluation in a pilot trial. Conclusions: Using a two-stage approach, in which we considered the practicability of VBIs (acceptability, feasibility and cost) alongside potential efficacy from the outset, we developed a short-list of four promising VBIs for physical activity and demonstrated that they were acceptable and feasible as part of a preventive health check in primary care. [ABSTRACT FROM AUTHOR]

Background: There is increasing interest in brief and very brief behaviour change interventions for physical activity as they are potentially scalable to the population level. However, few very brief interventions (VBIs) have been published, and evidence is lacking about their feasibility, acceptability and which ‘active ingredients’ (behaviour change techniques) would maximise their effectiveness. The aim of this research was to identify and develop promising VBIs for physical activity and test their feasibility and acceptability in the context of preventive health checks in primary care. Methods: The process included two stages, guided by four criteria: effectiveness, feasibility, acceptability, and cost. In Stage 1, we used an iterative approach informed by systematic reviews, a scoping review of BCTs, team discussion, stakeholder consultation, a qualitative study, and cost estimation to guide the development of promising VBIs. In Stage 2, a feasibility study assessed the feasibility and acceptability of the short-listed VBIs, using tape-recordings and interviews with practitioners (n = 4) and patients (n = 68), to decide which VBIs merited further evaluation in a pilot trial. Results: Four VBIs were short-listed: Motivational intervention; Action Planning intervention; Pedometer intervention; and Physical Activity Diary intervention. All were deliverable in around five minutes and were feasible and acceptable to participants and practitioners. Based on the results of interviews with practitioners and patients, techniques from the VBIs were combined into three new VBIs for further evaluation in a pilot trial. Conclusions: Using a two-stage approach, in which we considered the practicability of VBIs (acceptability, feasibility and cost) alongside potential efficacy from the outset, we developed a short-list of four promising VBIs for physical activity and demonstrated that they were acceptable and feasible as part of a preventive health check in primary care. [ABSTRACT FROM AUTHOR]

Background: Meta-analyses have identified promising behavior change techniques (BCTs) in changing obesity-related behaviors from intervention descriptions. However, it is unclear whether these BCTs are used by intervention participants and are related to outcomes. Purpose: The purpose of this study is to investigate BCT use by participants of an intervention targeting physical activity and diet and whether BCT use was related to behavior change and weight loss. Methods: Intervention participants ( N = 239; 40-69 years) with recently diagnosed type 2 diabetes in the ADDITION- Plus trial received a theory-based intervention which taught them a range of BCTs. BCT usage was reported at 1 year. Results: Thirty-six percent of the participants reported using all 16 intervention BCTs. Use of a higher number of BCTs and specific BCTs (e.g., goal setting) were associated with a reduction in body mass index (BMI). Conclusions: BCT use was associated with weight loss. Future research should identify strategies to promote BCT use in daily life. (Trial Registration: ISRCTN99175498.) [ABSTRACT FROM AUTHOR]

Background: Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence. Purpose: To test the reactive effect of electronic monitoring in a randomized controlled trial. Methods: A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5-25) and HbA at 8 weeks. Results: Non-significantly higher adherence and lower HbA were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI −0.1 to 0.8, p = 0.11]; HbA (mmol/mol), −1.02 [−2.73 to 0.71, p = 0.25]). Conclusions: Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359) [ABSTRACT FROM AUTHOR]

Aims/hypothesis: The aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed type 2 diabetes. Methods: An explanatory randomised controlled trial was conducted in 34 general practices in Eastern England (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus [ADDITION-Plus]). In all, 478 patients meeting eligibility criteria (age 40 to 69 years with recently diagnosed screen or clinically detected diabetes) were individually randomised to receive either intensive treatment ( n = 239) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team ( n = 239). Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms. Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours, including goal setting, self-monitoring and building habits. Primary outcomes included physical activity energy expenditure (individually calibrated heart rate monitoring and movement sensing), change in objectively measured fruit and vegetable intake (plasma vitamin C), medication adherence (plasma drug levels) and smoking status (plasma cotinine levels) at 1 year. Measurements, data entry and laboratory analysis were conducted with staff unaware of participants' study group allocation. Results: Of 475 participants still alive, 444 (93%; intervention group 95%, comparison group 92%) attended 1-year follow-up. There were no significant differences between groups in physical activity (difference: +1.50 kJ kg day; 95% CI −1.74, 4.74), plasma vitamin C (difference: −3.84 μmol/l; 95% CI −8.07, 0.38), smoking (OR 1.37; 95% CI 0.77, 2.43) and plasma drug levels (difference in metformin levels: −119.5 μmol/l; 95% CI −335.0, 95.9). Cardiovascular risk factors and self-reported behaviour improved in both groups with no significant differences between groups. Conclusions/interpretation: For patients with recently diagnosed type 2 diabetes receiving intensive treatment in UK primary care, a facilitator-led individually tailored behaviour change intervention did not improve objectively measured health behaviours or cardiovascular risk factors over 1 year. Trial registration: ISRCTN99175498 Funding: The trial is supported by the Medical Research Council, the Wellcome Trust, National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and National Institute of Health Research under its Programme Grants for Applied Research scheme. The Primary Care Unit is supported by NIHR Research funds. Bio-Rad provided equipment for HbA testing during the screening phase. [ABSTRACT FROM AUTHOR]

Background Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked. Methods 211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded. Results Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients' action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group. Conclusions It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice. The main study results could not be explained by poor delivery of motivational and action planning components, definition of new action plans, improved problem solving or patient-centred communication. Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines, combined with action planning. Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects. [ABSTRACT FROM AUTHOR]

Introduction. We describe our experience of using theMedical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours.We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studieswithmothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial. [ABSTRACT FROM AUTHOR]

Background: CONSORT guidelines call for precise reporting of behavior change interventions: we need rigorous methods of characterizing active content of interventions with precision and specificity. Objectives: The objective of this study is to develop an extensive, consensually agreed hierarchically structured taxonomy of techniques [behavior change techniques (BCTs)] used in behavior change interventions. Methods: In a Delphi-type exercise, 14 experts rated labels and definitions of 124 BCTs from six published classification systems. Another 18 experts grouped BCTs according to similarity of active ingredients in an open-sort task. Inter-rater agreement amongst six researchers coding 85 intervention descriptions by BCTs was assessed. Results: This resulted in 93 BCTs clustered into 16 groups. Of the 26 BCTs occurring at least five times, 23 had adjusted kappas of 0.60 or above. Conclusions: 'BCT taxonomy v1,' an extensive taxonomy of 93 consensually agreed, distinct BCTs, offers a step change as a method for specifying interventions, but we anticipate further development and evaluation based on international, interdisciplinary consensus. [ABSTRACT FROM AUTHOR]

Objective Commonly used theories in health psychology involve multiplicative composites of measures, which have been used as predictors, mediators, and outcomes. The chosen scaling system can affect correlations with other variables. This study evaluated how best to construct composites in the context of the theory of planned behaviour ( TPB), using hierarchical linear regression, a priori defined scaling systems, and optimal scaling. Design Longitudinal. Methods At baseline, 6 and 12 months, 365 trial participants ( Pro Active) completed questionnaires assessing salient beliefs, which were used to construct composites (indirect measures), and direct measures of instrumental and affective attitude, subjective norm, and perceived behavioural control towards becoming more physically active over the next 12 months. Results Linear regression supported a multiplicative model for indirect instrumental attitude and perceived control. Except for perceived control, associations between composites and direct measures were unaffected by different a priori scaling systems. Optimal scaling produced widely differing composites over time for subjective norm and affective attitude and a negative association between composite and direct measure for subjective norm. Conclusions We recommend that researchers who use multiplicative composites first establish clear support for a multiplicative model, before they examine a range of meaningful scaling systems on theoretical and empirical grounds. Caution is needed when using optimal scaling without checking that a multiplicative model is supported and the resulting scaling system meaningful. Statement of contribution What is already known on this subject? Multiplicative composites are included in commonly used theories in health psychology (e.g., theory of planned behaviour). Valid measures are needed as the choice of scaling system (e.g., unipolar or bipolar) can affect estimates of associations between composites and other variables. Ajzen has advocated the use of optimal scaling. What does this study add? The study shows that optimal scaling can result in meaningless measures. We recommend that health psychologists use optimal scaling with great caution and we provide alternative recommendations for constructing composites. [ABSTRACT FROM AUTHOR]

Background There is limited evidence about predictors of health behaviour change in people with type 2 diabetes. The aim of this study was to assess change in health behaviours over one year and to identify predictors of behaviour change among adults with screen-detected and recently clinically diagnosed diabetes. Methods ADDITION-Plus was a randomised controlled trial of a behaviour change intervention among 478 patients (40-69 years). Physical activity and diet were measured objectively (physical activity at 1 year) and by self-report at baseline and one year. Associations between baseline predictors and behaviour change were quantified using multivariable linear regression. Results Participants increased their plasma vitamin C and fruit intake, reduced energy and fat intake from baseline to follow-up. Younger age, male sex, a smaller waist circumference, and a lower systolic blood pressure at baseline were associated with higher levels of objectively measured physical activity at one year. Greater increases in plasma vitamin C were observed in women (beta-coefficient [95% CI]: beta = −5.52 [−9.81, -1.22]) and in those with screen-detected diabetes (beta = 6.09 [1.74, 10.43]). Younger age predicted a greater reduction in fat (beta = −0.43 [−0.72, -0.13]) and energy intake (beta = −6.62 [−13.2, -0.05]). Patients with screen-detected diabetes (beta = 74.2 [27.92, 120.41]) reported a greater increase in fruit intake. There were no significant predictors of change in self-reported physical activity. Beliefs about behaviour change and diabetes did not predict behaviour change. Conclusions Older patients, men and those with a longer duration of diabetes may need more intensive support for dietary change. We recommend that future studies use objective measurement of health behaviours and that researchers add predictors beyond the individual level. Our results support a focus on establishing healthy lifestyle changes early in the diabetes disease trajectory. [ABSTRACT FROM AUTHOR]

Background: Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes. Methods: This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c≥7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medication-monitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-to-treat. Results: 211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction. Conclusions: This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice. Trial registration: Current Controlled Trials ISRCTN30522359 [ABSTRACT FROM AUTHOR]

Effects of behaviour change on cognitions are rarely examined within the Theory of Planned Behaviour. We tested whether increases in physical activity resulted in more positive beliefs about further change among a cohort of sedentary adults participating in a behavioural intervention trial (ProActive). At baseline, 6 and 12 months, 365 adults completed questionnaires assessing physical activity and cognitions about becoming more active over the coming year. Objective activity was assessed at baseline and 12 months. Participants reporting larger increases in activity were no more positive about making further increases than those reporting less behaviour change (p-values > 0.05). Participants with larger increases in objective activity reported weaker perceived control (β = -0.342; p = 0.001) and more negative instrumental attitudes (β = -0.230; p = 0.017) at 12 months. Participants may have felt that they had changed enough or measures of perceived success may be more sensitive to behaviour change. Alternatively, long measurement intervals may have missed immediate cognitive and affective consequences of behaviour change, or such effects may require participants to consistently self-monitor or receive feedback on performance. Future studies could test the effect of such techniques on physical activity and a wider range of cognitive, affective and physiological consequences, using more frequent measurement intervals. [ABSTRACT FROM AUTHOR]

Objective. The objective was to test, in a trial cohort of sedentary adults at risk of Type 2 diabetes, whether theory of planned behaviour (TPB) cognitions about becoming more physically active predicted objective and self-reported activity levels and change. Design. Participants of a randomized controlled trial underwent measurement at baseline, 6 and 12 months. Methods. Participants ( N= 365, 30-50 years) were recruited via their parent or family history registers at 20 general practices in the UK. Energy expenditure was measured objectively at baseline and 1 year. Participants completed questionnaires assessing physical activity and beliefs about becoming more physically active over the next year at baseline, 6 and 12 months. Results. Between baseline and 12 months, objective energy expenditure in the cohort increased by an average of 20 minutes of brisk walking per day. Based on the 252 participants who provided complete data, affective attitude and perceived behavioural control consistently predicted intention, but intention and perceived behavioural control failed to predict physical activity levels or change ( p-values > .05). Conclusions. Failure of the theory to predict behaviour and behaviour change may be due to inapplicability of the theory to this at-risk population or to trial participation and intensive measurement facilitating behaviour change without affecting measured cognitions, or lack of correspondence between cognitive and behavioural measures. A wide range of potential personal and environmental mediators should be considered when designing physical activity interventions among at-risk groups. High-quality experimental tests of the theory are needed in clinical populations. [ABSTRACT FROM AUTHOR]