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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 Thirteen participants were withdrawn post-randomisation due to an alternative diagnosis being made.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]

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]

This article reports on a clinical trial in Great Britain that tested behavioural interventions to promote physical exercise among overweight people who are at risk for diabetes due to family history. The subjects were assigned to one of two intervention groups or to a comparison group. All subjects were given a leaflet promoting exercise. One group was given a 1-year behaviour change program run by trained personnel at the patient's home while the other group had no personal contact but was given the same information over the telephone. The study found no real differences between the three groups and says a leaflet is as good a promotion for physical activity as are behavioural programs.

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: 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: 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]

This systematic review of reviews aims to investigate how brief interventions (BIs) are defined, whether they increase physical activity, which factors influence their effectiveness, who they are effective for, and whether they are feasible and acceptable. We searched CINAHL, Cochrane database of systematic reviews, DARE, HTA database, EMBASE, MEDLINE, PsycINFO, Science Citation Index-Expanded and Social Sciences Citation Index, and Scottish Intercollegiate Guidelines Network from their inception until May 2015 to identify systematic reviews of the effectiveness of BIs aimed at promoting physical activity in adults, reporting a physical activity outcome and at least one BI that could be delivered in a primary care setting. A narrative synthesis was conducted. We identified three specific BI reviews and thirteen general reviews of physical activity interventions that met the inclusion criteria. The BI reviews reported varying definitions of BIs, only one of which specified a maximum duration of 30min. BIs can increase self-reported physical activity in the short term, but there is insufficient evidence about their long-term impact, their impact on objectively measured physical activity, and about the factors that influence their effectiveness, feasibility and acceptability. Current definitions include BIs that are too long for primary care consultations. Practitioners, commissioners and policy makers should be aware of this when interpreting evidence about BIs, and future research should develop and evaluate very brief interventions (of 5min or less) that could be delivered in a primary care consultation. [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: 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: 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]

Standard theory of planned behavior (TPB) questions to elicit salient behavioral beliefs may elicit instrumental consequences of behavior, and overlook affective consequences. Two hundred thirteen English adults (35 to 75 years of age) completed a questionnaire that contained closed measures of TPB constructs, and open-ended questions that asked not only about advantages and disadvantages, but also what respondents would like or enjoy and dislike or hate about being more physically active. Beliefs elicited by affective questions were associated more strongly with a closed affective attitude scale. Beliefs elicited by instrumental questions were associated more strongly with a closed instrumental attitude scale. Closed measures of the standard TPB variables explained 48% of the variance in intention to increase physical activity, while affective attitude explained an additional 11% of the variance. Applications of the TPB should consider affective and not just instrumental determinants of behavior. [ABSTRACT FROM AUTHOR]

An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]

Aims and objectives: This paper describes a pilot non-randomised controlled study of a highly tailored 56-day text messaging and smartphone app prototype intervention to increase adherence to anti-hypertensive medication in primary care. The aim of this study was to evaluate the acceptability of the intervention and obtain patients' views about the intervention content, the delivery mode, and the mechanisms by which the intervention supported medication adherence. Methods: Patients diagnosed with hypertension were invited and recruited to the study via general practice text messages and attended a face to face meeting with a member of the researcher team. Participants were asked to test the text messaging intervention for 28 consecutive days and switch to the smartphone app for 28 more days. Participants completed baseline and follow-up questionnaires and took part in semi-structured telephone interviews. Digital log files captured patients' engagement with the intervention. Participant transcripts were analysed using thematic analysis. Descriptive statistics were used to summarise data from questionnaires and log files. A mixed methods analysis generated data to respond to the research questions. Results: Seventy-nine patients expressed interest to participate in this study, of whom 23 (64% male, 82% above 60 years old) were registered to take part. With one drop-out, 22 participants tested the text messaging delivery mode (with 20 being interviewed) and four of them (17%) switched to the app (with 3 being interviewed). All participants engaged and interacted with the text messages and app notifications, and all participants found the intervention content and delivery mode acceptable. They also self-reported that the interactive elements of the intervention motivated them to take their medications as prescribed. Conclusion: This study provides evidence that the digital intervention is acceptable by hypertensive patients recruited in primary care. Future research could usefully investigate its feasibility and effectiveness using rigorous research methods. Trial registration: ISRCTN12805654 [ABSTRACT FROM AUTHOR]

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., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Craske et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., (© 2024 The Author(s). Health Expectations published by John Wiley & Sons Ltd.)

Introduction: Pharmacist-led medication reviews are an established intervention to support patients prescribed multiple medicines or with complex medication regimes. For this systematic review, a medication review was defined as 'a consultation between a pharmacist and a patient to review the patient's total medicines use with a view to improve patient health outcomes and minimise medicines-related problems'. It is not known how varying approaches to medication reviews lead to different outcomes., Aim: To explore the common themes associated with positive outcomes from pharmacist-led medication reviews., Method: Randomised controlled trials of pharmacist-led medication reviews in adults aged 18 years and over were included. The search terms used in MEDLINE, EMBASE and Web of Science databases were "medication review", "pharmacist", "randomised controlled trial" and their synonyms, time filter 2015 to September 2023. Studies published before 2015 were identified from a previous systematic review. Risk of bias was assessed using the Cochrane risk of bias 2 tool. Descriptions of medication reviews' components, implementation and outcomes were narratively synthesised to draw out common themes. Results are presented in tables., Results: Sixty-eight papers describing 50 studies met the inclusion criteria. Common themes that emerged from synthesis include collaborative working which may help reduce medicines-related problems and the number of medicines prescribed; patient involvement in goal setting and action planning which may improve patients' ability to take medicines as prescribed and help them achieve their treatment goals; additional support and follow-up, which may lead to improved blood pressure, diabetes control, quality of life and a reduction of medicines-related problems., Conclusion: This systematic review identified common themes and components, for example, goal setting, action planning, additional support and follow-up, that may influence outcomes of pharmacist-led medication reviews. Researchers, health professionals and commissioners could use these for a comprehensive evaluation of medication review implementation., Prospero Registration Number: CRD42020173907., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© 2024 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.)

Introduction: Physical inactivity and sedentary behaviour are linked to increased risk of cardiovascular disease, infections and dementia, as well as placing a significant economic burden on healthcare systems. The implementation of COVID-19 pandemic lockdown measures aimed at reducing virus transmission posed challenges to the opportunity to be physically active. This study investigates how the first UK COVID-19 lockdown affected objectively measured physical activity in older adults at higher risk of cardiovascular disease., Methods: We studied 48 individuals aged 55-74 years (81.3% female) with self-reported PA levels < 90 min/week and a QRISK2 score ≥ 10 (indicative of a ≥ 10% risk of a major cardiovascular event in the next 10 years) without mild cognitive impairment or dementia. Physical activity data was collected using objective wrist-based activity monitors and analysed across three time periods, usual activity (pre-pandemic), the precautionary phase when the UK began advising on limiting social contact and finally during the first UK lockdown period was collected (27 January 2020 and 07 June 2020). Data was analysed using linear mixed effects model was used to investigate PA levels over the measured 12-week period. Effects of BMI, age, deprivation score and baseline PA levels on PA across the three measurement periods were also examined. Focus-group and individual interviews were conducted, and data were thematically analysed., Results: Average daily step count (-34% lower, p < 0.001) and active energy expenditure (-26% lower, p < 0.001) were significantly lower during the precautionary period compared with the usual activity period. Physical activity remained low during the UK lockdown period. Participants with a lower BMI engaged in significantly more (+45% higher daily steps p < 0.001) physical activity and those over 70 years old were more physically active than those under 70 years across the 12-week period (+23% higher daily steps p < 0.007). The risk of COVID-19 infection and restrictions because of lockdown measures meant some individuals had to find alternative methods to staying physical active. Participants described a lack of access to facilities and concerns over health related to COVID-19 as barriers to engaging in physical activity during lockdown. For some, this resulted in a shift towards less structured activities such as gardening or going for a walk., Discussion: The data presented shows that lockdown measures during the COVID-19 pandemic significantly reduced physical activity among older individuals at risk of cardiovascular disease, particularly those with a higher body mass index. To support this population group in staying active during future lockdowns, a multifaceted strategy is needed, emphasizing psychosocial benefits and home-based physical activity. The MedEx-UK study was pre-registered with ClinicalTrials.gov (NCT03673722)., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Elsworthy, Jong, Hanson, Shannon, Jennings, Gillings, Siervo, Hornberger, Hardeman, Mathers, Minihane and Aldred.)

Introduction: Physical activity (PA) is protective against type 2 diabetes (T2D). However, data on pragmatic long-term interventions to reduce the risk of developing T2D via increased PA are lacking. This study investigated the cost-effectiveness of a pragmatic PA intervention in a multiethnic population at high risk of T2D., Materials and Methods: We adapted the School for Public Health Research diabetes prevention model, using the PROPELS trial data and analyses of the NAVIGATOR trial. Lifetime costs, lifetime quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for each intervention (Walking Away (WA) and Walking Away Plus (WA+)) versus usual care and compared with National Institute for Health and Care Excellence's willingness-to-pay of £20 000-£30 000 per QALY gained. We conducted scenario analyses on the outcomes of the PROPELS trial data and a threshold analysis to determine the change in step count that would be needed for the interventions to be cost-effective., Results: Estimated lifetime costs for usual care, WA, and WA+ were £22 598, £23 018, and £22 945, respectively. Estimated QALYs were 9.323, 9.312, and 9.330, respectively. WA+ was estimated to be more effective and cheaper than WA. WA+ had an ICER of £49 273 per QALY gained versus usual care. In none of our scenario analyses did either WA or WA+ have an ICER below £20 000 per QALY gained. Our threshold analysis suggested that a PA intervention costing the same as WA+ would have an ICER below £20 000/QALY if it were to achieve an increase in step count of 500 steps per day which was 100% maintained at 4 years., Conclusions: We found that neither WA nor WA+ was cost-effective at a limit of £20 000 per QALY gained. Our threshold analysis showed that interventions to increase step count can be cost-effective at this limit if they achieve greater long-term maintenance of effect., Trial Registration Number: ISRCTN registration: ISRCTN83465245: The PRomotion Of Physical activity through structuredEducation with differing Levels of ongoing Support for those with pre-diabetes (PROPELS)https://doi.org/10.1186/ISRCTN83465245., Competing Interests: Competing interests: KK reports that he acted as an advisor to NICE Guidance. SJG reports grants from NIHR HTA, during the conduct of the study. DJP reports non-financial support from Novo Nordisk, non-financial support from Eli Lilly and Company Limited, non-financial support from Abbott, Diabetes Care, non-financial support from Sanofi-Aventis, and non-financial support from Medtronic, outside the submitted work. TY reports grants from NIHR Leicester Biomedical Research Unit, during the conduct of the study and was involved in contributing to an adapted version of the Walking Away intervention that is part of the framework for the National Health Service Diabetes Prevention Programme, led by Ingeus (main contractor) and the Leicester Diabetes Centre, University Hospitals of Leicester (subcontractor)., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Many people quit smoking during pregnancy, but postpartum smoking relapse is common. Maintaining smoking abstinence achieved during pregnancy is key to improving maternal and child health. There are no evidence-based interventions for preventing postpartum smoking relapse. This trial aims to determine whether an intervention to prevent postpartum relapse is effective and cost-effective., Methods and Analysis: A randomised controlled trial of a complex intervention to prevent postpartum smoking relapse (BabyBreathe), with internal pilot, economic and process evaluations. Participants are adults who are pregnant and who report having quit smoking in the 12 months before, or during pregnancy. Participants are eligible if they read and understand English, and provide informed consent. Following consent and biochemical validation of smoking abstinence, participants are randomised to intervention or usual care/control (no specific relapse prevention support). The BabyBreathe intervention consists of manualised advice from a trained member of the health visiting service, health information leaflets for participants and partners, access to the BabyBreathe website and app. At the time of birth, participants are posted the BabyBreathe box and support is provided by text message for up to 12 months postpartum. Target sample size is 880, recruiting across midwifery services at four hubs in England and Scotland and through remote advertising in England, Scotland, Wales and Northern Ireland. Outcomes are collected at 6 and 12 months. The primary outcome is self-reported sustained smoking abstinence at 12 months, carbon monoxide verified. Secondary outcomes include self-reported abstinence, time to relapse, partner smoking status and quality of life., Ethics and Dissemination: The trial was approved by the North West Preston Research Ethics committee (21/NW/0017). Dissemination will include publication in peer-reviewed journals, presentation at academic and public conferences including patient and public involvement and to policymakers and practitioners., Trial Registration Number: ISRCTN70307341., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Charcot neuroarthropathy (CN) was first described over 150 years ago. Despite this there remains uncertanity around the factors that contribute to its development, and progression. This article will discuss the current controversies around the pathogenesis, epidemiology, diagnosis, assessment and management of the condition. The exact pathogenesis of CN is not fully understood, and it is likely to be multifactorial, with perhaps currently unknown mechanisms contributing to its development. Further studies are needed to examine opportunities to help screen for and diagnose CN. As a result of many of these factors, the true prevalence of CN is still largely unknown. Almost all of the recommendations for the assessment and treatment of CN are based on low-quality level III and IV evidence. Despite recommendations to offer people with CN nonremovable devices, currently only 40-50% people are treated with this type of device. Evidence is also lacking about the optimal duration of treatment; reported outcomes range from 3 months to more than a year. The reason for this variation is not entirely clear. A lack of standardised definitions for diagnosis, remission and relapse, heterogeneity of populations, different management approaches, monitoring techniques with unknown diagnostic precision and variation in follow-up times prevent meaningful comparison of outcome data. If people can be better supported to manage the emotional and physical consequences of CN, then this could improve people's quality of life and well-being. Finally, we highlight the need for an internationally coordinated approach to research in CN., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article., (© The Author(s), 2023.)

Background: Supporting cancer survivors in self-management can empower them to take an active role in managing the long-term physical and psychosocial consequences of cancer treatment. Healthcare practitioners are key to supporting patients to self-manage, however, they do not routinely engage in these discussions. This review aimed to establish what works for whom and in what circumstances in relation to facilitating healthcare practitioners to provide self-management support in people living with long-term consequences of cancer treatment., Methods: The review follows five steps: define the review's scope, develop initial programme theories, evidence search, selection and appraisal, and data extraction and synthesis. Database searches of Medline, EMBASE, CINAHL, Scopus, PsycINFO, ERIC and AMED databases, to September 2019 were supplemented with practitioner surveys. Insights into the mechanisms that operate in particular contexts to produce successful outcomes were illustrated using realist programme theories, developed using the Theoretical Domains Framework. Data selection was based on relevance and rigour. Data were extracted and synthesised iteratively to illuminate causal links between contexts, mechanisms and outcomes., Results: Five programme theories were identified from 20 included articles and seven practitioner surveys: practitioners will engage patients in discussions about self-management if they have appropriate (1) knowledge and (2) consultations skills, (3) a clear understanding of their self-management support role and responsibilities, and if (4) organisational strategies and (5) health system configuration enable integration into routine care. The mechanisms facilitating practitioners to support self-management were practitioner confidence, mutual trust and shared responsibility between practitioners and cancer survivors, organisational prioritisation and ease of delivery of self-management support., Conclusion: The findings articulate the necessary components for embedding self-management support into routine cancer care. Operationalisation of these components into effective self-management support interventions will require reconfiguration of pathways and adaptation for local context, using strategies such as quality improvement and co-design to guide intervention development, implementation and evaluation., Competing Interests: Declaration of competing interest None., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

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.

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., (© 2022 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Background: Bariatric surgery promotes weight loss and improves co-morbid conditions, with patients who are more physically active having better outcomes. However, levels of physical activity and sedentary behaviour often remain unchanged following surgery., Objectives: To identify interventions and components thereof that are able to facilitate changes in physical activity and sedentary behaviour., Eligibility: Physical activity and/or sedentary behaviour must have been measured, pre and post intervention, in patients who have undergone bariatric surgery., Study Appraisal and Synthesis Methods: Four databases were searched with key-words. Two researchers conducted paper screening, data extraction and risk-of-bias assessment., Results: Twelve studies were included; eleven were randomised. Two were delivered presurgery and ten postsurgery; five found positive effect. Moderate to vigorous physical activity increased in three studies, two of which also found a significant increase in step count. The fourth found a significant increase in strenuous activity and the fifth a significant increase in metabolic equivalent of task/day and reduced time spent watching television., Limitations: Meta-analysis could not be conducted due to heterogeneity of outcomes and the tools used., Conclusion and Implications of Key Findings: This review has identified interventions and components thereof that were able to provoke positive effect. However, intervention and control conditions were not always well described particularly in terms of behaviour change techniques and the rationale for their use., Systematic Review Registration Number: PROSPERO (CRD42019121372)., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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.

Neonatal intensive care units (NICUs) have a disproportionately higher number of parents who smoke tobacco compared to the general population. A baby's NICU admission offers a unique time to prompt behaviour change, and to emphasise the dangerous health risks of environmental tobacco smoke exposure to vulnerable infants. We sought to explore the views of mothers, fathers, wider family members, and healthcare professionals to develop an intervention to promote smoke-free homes, delivered on NICU. This article reports findings of a qualitative interview and focus group study with parents whose infants were in NICU (n = 42) and NICU healthcare professionals (n = 23). Thematic analysis was conducted to deductively explore aspects of intervention development including initiation, timing, components and delivery. Analysis of inductively occurring themes was also undertaken. Findings demonstrated that both parents and healthcare professionals supported the need for intervention. They felt it should be positioned around the promotion of smoke-free homes, but to achieve that end goal might incorporate direct cessation support during the NICU stay, support to stay smoke free (relapse prevention), and support and guidance for discussing smoking with family and household visitors. Qualitative analysis mapped well to an intervention based around the '3As' approach (ask, advise, act). This informed a logic model and intervention pathway.

Objectives: To explore patients' and healthcare practitioners' (HCPs) views about non-adherence to hypertension medication and potential content of a combined very brief face-to-face discussion (VBI) and digital intervention (DI)., Methods: A qualitative study (N=31): interviews with patients with hypertension (n=6) and HCPs (n=11) and four focus groups with patients with hypertension (n=14). Participants were recruited through general practices in Eastern England and London. Topic guides explored reasons for medication non-adherence and attitudes towards a potential intervention to support adherence. Stimuli to facilitate discussion included example SMS messages and smartphone app features, including mobile sensing. Analysis was informed methodologically by the constant comparative approach and theoretically by perceptions and practicalities approach., Results: Participants' overarching explanations for non-adherence were non-intentional (forgetting) and intentional (concerns about side effects, reluctance to medicate). These underpinned their views on intervention components: messages that targeted forgetting medication or obtaining prescriptions were considered more useful than messages providing information on consequences of non-adherence. Tailoring the DI to the individuals' needs, regarding timing and number of messages, was considered important for user engagement. Patients wanted control over the DI and information about data use associated with any location sensing. While the DI was considered limited in its potential to address intentional non-adherence, HCPs saw the potential for a VBI in addressing this gap, if conducted in a non-judgemental manner. Incorporating a VBI into routine primary care was considered feasible, provided it complemented existing GP practice software and HCPs received sufficient training., Conclusions: A combined VBI-DI can potentially address intentional and non-intentional reasons for non-adherence to hypertension medication. For optimal engagement, recommendations from this work include a VBI conducted in a non-judgmental manner and focusing on non-intentional factors, followed by a DI that is easy-to-use, highly tailored and with provision of data privacy details about any sensing technology used., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Increased physical activity and reduced sedentary behaviour can encourage favourable outcomes after bariatric surgery. However, there is a lack of evidence as to how to support patients with behaviour change. The aim of this study is to assess the feasibility of a physiotherapist led, online group-based behaviour change intervention to increase physical activity and reduce sedentary behaviour following bariatric surgery., Methods and Analysis: Single arm feasibility study of a theory and evidence-based group behaviour change intervention based on the Behaviour Change Wheel and Theoretical Domains Framework using behaviour change techniques from the Behaviour Change Technique Taxonomy v1. The intervention has eight objectives and specifies behaviour change techniques that will be used to address each of these. Groups of up to eight participants who have had surgery within the previous 5 years will meet weekly over 6 weeks for up to 1½ hours. Groups will be held online led by a physiotherapist and supported by an intervention handbook. Feasibility study outcomes include: rate of recruitment, retention, intervention fidelity, participant engagement and acceptability. Secondary outcomes include: physical activity, sedentary behaviour, body composition, self-reported health status and will be analysed descriptively. Change in these outcomes will be used to calculate the sample size for a future evaluation study. Qualitative interviews will explore participants' views of the intervention including its acceptability. Data will be analysed according to the constant comparative approach of grounded theory., Ethics and Dissemination: This study has National Health Service Research Ethics Committee approval; Haydock 20/NW/0472. All participants will provide informed consent and can withdraw at any point. Findings will be disseminated through peer-reviewed journals, conference and clinical service presentations., Trial Registration Number: ISRCTN31524689., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown., Objectives: To investigate whether or not Walking Away from Diabetes (Walking Away) - a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes - leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control., Design: Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months., Setting: Primary care and the community., Participants: Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA 1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019., Interventions: Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation., Main Outcome Measures: The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed., Results: A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m 2 , median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval -290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval -282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study., Limitations: Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation., Conclusions: Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months., Future Work: Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term., Trial Registration: Current Controlled Trials ISRCTN83465245., 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. 25, No. 77. See the NIHR Journals Library website for further project information.

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.

Introduction: Dementia prevalence continues to increase, and effective interventions are needed to prevent, delay or slow its progression. Higher adherence to the Mediterranean diet (MedDiet) and increased physical activity (PA) have been proposed as strategies to facilitate healthy brain ageing and reduce dementia risk. However, to date, there have been no dementia prevention trials in the UK focussed on combined dietary and PA interventions. This study aims to: (1) assess feasibility and acceptability of a theory-underpinned digital and group-based intervention for dementia risk reduction in an 'at risk' UK cohort; (2) evaluate behaviour change responses to the intervention; and, (3) provide information on cognitive, neurological, vascular and physiological outcomes to inform the design of a follow-on, full-scale efficacy trial., Methods: One hundred and eight participants aged 55 to 74 years with a QRISK2 score of ≥10% will be recruited to take part in this 24-week multi-site study. Participants will be randomised into three parallel arms: (1) Control; (2) MedDiet; and, (3) MedDiet+PA. The study will evaluate a personalised website, group session and food delivery intervention to increase MedDiet adherence and PA in older adults at risk of dementia. Diet and PA will be monitored prior to, during and following the intervention. Feasibility, acceptability and hypothesised mediators will be assessed in addition to measures of cognitive function, brain structure/perfusion (MRI), vascular function and metabolic markers (blood, urine and faecal) prior to, and following, the intervention., Discussion: This trial will provide insights into the feasibility, acceptability and mechanism of effect of a multi-domain intervention focussed on the MedDiet alone and PA for dementia risk reduction in an 'at risk' UK cohort., Ethics and Dissemination: The study has received NHS REC and HRA approval (18/NI/0191). Findings will be disseminated via conference presentations, public lectures, and peer-reviewed publications., Trial Registration Details: ClinicalTrials.gov NCT03673722., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Evaluation of physical activity interventions is vital to inform, and justify, evidence-based policy and practice to support population-wide changes in physical activity. Several evaluation frameworks and guidance documents have been developed to facilitate the evaluation and reporting of evaluation studies in public health. However, there is a lack of evidence about whether frameworks are being used to guide evaluation. There continues to be claims of poor and inconsistent reporting in evaluation studies. The aim of this review was to assess the use of evaluation frameworks and the quality of reporting of how they were applied within evaluation studies of physical activity interventions., Objectives: 1. To identify whether evaluation frameworks are reported to have been used within evaluation studies of physical activity interventions, and which frameworks have been used. 2. To appraise the quality of reporting with regards to how evaluation frameworks have been used., Method: We developed a checklist of indicators to enable a critical appraisal of the use and reporting of different evaluation frameworks in evaluation studies. We conducted a systematic search and review of evaluation studies published between 2015 and the date of the search to appraise the use and reporting of evaluation frameworks. A narrative synthesis is provided., Results: The review identified 292 evaluation studies of physical activity interventions, only 69 (23%) of these mentioned using an evaluation framework, and only 16 different frameworks were referred to. There was variation in the quality of reporting of framework use. 51 (74%) studies were identified as being explicitly based on the stated framework, however only 26 (38%) provided detailed descriptions consistently across all the checklist indicators. Details of adaptations and limitations in how frameworks were applied were less frequently reported. The review also highlighted variability in the reporting of intervention components. More consistent and precise reporting of framework and intervention components is needed., Conclusion: Evaluation frameworks can facilitate a more systematic evaluation report and we argue their limited use suggests missed opportunities to apply frameworks to guide evaluation and reporting in evaluation studies. Variability in the quality of reporting of framework use limits the comparability and transferability of evidence. Where a framework has been used, the checklist of indicators can be employed to facilitate the reporting of an evaluation study and to review the quality of an evaluation report.

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.

Introduction: There is no routine support to prevent postpartum smoking relapse, due to lack of effective interventions. Previous reviews have identified behaviour change techniques (BCTs) within pregnancy cessation trials to specify which components might be incorporated into more effective interventions, but no reviews have identified BCTs for prevention of smoking relapse postpartum. We reviewed BCTs and potential delivery modes, to inform future interventions., Methods: We searched Medline and EMBASE from January 2015-May 2017; and identified trials published before 2015 by handsearching systematic reviews. We included RCTs where: i) ≥1 intervention component aimed to maintain smoking abstinence versus a less intensive intervention; ii) participants included pregnant or postpartum smoking quitters; iii) smoking status was reported in the postpartum period. We extracted trial characteristics and used the Behaviour Change Technique Taxonomy v1 to extract BCTs. We aimed to identify 'promising' BCTs i.e. those frequently occurring and present in ≥2 trials that demonstrated long-term effectiveness (≥6 months postpartum). Data synthesis was narrative., Results: We included 32 trials, six of which demonstrated long-term effectiveness. These six trials used self-help, mainly in conjunction with counselling, and were largely delivered remotely. We identified six BCTs as promising: 'problem solving', 'information about health consequences', 'information about social and environmental consequences', 'social support', 'reduce negative emotions' and 'instruction on how to perform a behaviour'., Conclusions: Future interventions to prevent postpartum smoking relapse might include these six BCTs to maximise effectiveness. Tailored self-help approaches, with/without counselling, may be favourable modes of delivery of BCTs. Registration: PROSPERO CRD42018075677., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Progress in mobile health (mHealth) technology has enabled the design of just-in-time adaptive interventions (JITAIs). We define JITAIs as having three features: behavioural support that directly corresponds to a need in real-time; content or timing of support is adapted or tailored according to input collected by the system since support was initiated; support is system-triggered. We conducted a systematic review of JITAIs for physical activity to identify their features, feasibility, acceptability and effectiveness., Methods: We searched Scopus, Medline, Embase, PsycINFO, Web of Science, DBLP, ACM Digital Library, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and the ISRCTN register using terms related to physical activity, mHealth interventions and JITAIs. We included primary studies of any design reporting data about JITAIs, irrespective of population, age and setting. Outcomes included physical activity, engagement, uptake, feasibility and acceptability. Paper screening and data extraction were independently validated. Synthesis was narrative. We used the mHealth Evidence Reporting and Assessment checklist to assess quality of intervention descriptions., Results: We screened 2200 titles, 840 abstracts, 169 full-text papers, and included 19 papers reporting 14 unique JITAIs, including six randomised studies. Five JITAIs targeted both physical activity and sedentary behaviour, five sedentary behaviour only, and four physical activity only. JITAIs prompted breaks following sedentary periods and/or suggested physical activities during opportunistic moments, typically over three to four weeks. Feasibility challenges related to the technology, sensor reliability and timeliness of just-in-time messages. Overall, participants found JITAIs acceptable. We found mixed evidence for intervention effects on behaviour, but no study was sufficiently powered to detect any effects. Common behaviour change techniques were goal setting (behaviour), prompts/cues, feedback on behaviour and action planning. Five studies reported a theory-base. We found lack of evidence about cost-effectiveness, uptake, reach, impact on health inequalities, and sustained engagement., Conclusions: Research into JITAIs to increase physical activity and reduce sedentary behaviour is in its early stages. Consistent use and a shared definition of the term 'JITAI' will aid evidence synthesis. We recommend robust evaluation of theory and evidence-based JITAIs in representative populations. Decision makers and health professionals need to be cautious in signposting patients to JITAIs until such evidence is available, although they are unlikely to cause health-related harm., Reference: PROSPERO 2017 CRD42017070849.

Intervention fidelity is a key component of the design and conduct of physical therapy research, defined as "the methodological strategies used to enhance and monitor the reliability and validity of behavioral interventions." This includes enhancing and assessing the extent to which an intervention is implemented as intended by its developers, including how they envisage the participants or patients to interact with the intervention. The authors of this Viewpoint focus predominantly on the fidelity of intervention delivery; highlight the importance of intervention fidelity for the physical therapy profession and its relevance for both physical therapy researchers and practitioners; and explore potential barriers to enhancing and assessing the fidelity of intervention delivery in physical therapy research. J Orthop Sports Phys Ther 2017;47(12):895-898. doi:10.2519/jospt.2017.0609.

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., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Mobile technologies for health (mHealth) represent a promising strategy for reducing type 2 diabetes (T2DM) risk. The PROPELS trial investigates whether structured group-based education alone or supplemented with a follow-on support program combining self-monitoring with pedometers and tailored text-messaging is effective in promoting and maintaining physical activity among people at high risk of T2DM., Objective: This paper describes the iterative development of the PROPELS follow-on support program and presents evidence on its acceptability and feasibility., Methods: We used a modified mHealth development framework with four phases: (1) conceptualization of the follow-on support program using theory and evidence, (2) formative research including focus groups (n=15, ages 39-79 years), (3) pre-testing focus groups using a think aloud protocol (n=20, ages 52-78 years), and (4) piloting (n=11). Analysis was informed by the constant comparative approach, with findings from each phase informing subsequent phases., Results: The first three phases informed the structure, nature, and content of the follow-on support program, including the frequency of text messages, the need for tailored content and two-way interaction, the importance of motivational messages based on encouragement and reinforcement of affective benefits (eg, enjoyment) with minimal messages about weight and T2DM risk, and the need for appropriate language. The refined program is personalized and tailored to the individual's perceived confidence, previous activity levels, and physical activity goals. The pilot phase indicated that the program appeared to fit well with everyday routines and was easy to use by older adults., Conclusions: We developed a feasible and innovative text messaging and pedometer program based on evidence and behavior change theory and grounded in the experiences, views, and needs of people at high diabetes risk. A large scale trial is testing the effectiveness of this 4-year program over and above structured group education alone., Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 83465245; http://www.controlled-trials.com/ISRCTN83465245/83465245 (Archived by WebCite at http://www.webcitation.org/6dfSmrVAe).

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.

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(-1) day(-1); 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 HbA1c testing during the screening phase.

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 (ProActive) 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., (© 2012 The British Psychological Society.)

Background: The aim was to identify predictors of change in objectively measured physical activity over 12 months in the ProActive cohort to improve understanding of factors influencing change in physical activity., Methods: ProActive is a physical activity promotion trial that took place in Eastern England (1999-2004). 365 offspring of people with type 2 diabetes underwent measurement of physical activity energy expenditure (PAEE) using heart rate monitoring, fitness, and anthropometric and biochemical status at baseline and 1 year (n = 321). Linear regression was used to quantify the associations between baseline demographic, clinical, psychosocial and behavioural variables and change in PAEE over 12 months. This study is registered as ISRCTN61323766., Results: ProActive participants significantly increased their PAEE by 0.6 kj/min (SD 4.2, p = 0.006) over one year, the equivalent of around 20 minutes brisk walking/day. Male sex and higher fitness at baseline predicted increase in PAEE. No significant associations were found for any other variables. Very few baseline demographic, clinical, psychosocial and behavioural predictors were associated with change in objectively measured physical activity., Conclusions: Traditional baseline determinants of self-reported physical activity targeted by behavioural interventions may be relatively weak predictors of change in objectively measured physical activity. Further research is needed to improve our understanding of factors influencing change in physical activity to inform the development and targeting of interventions.

Background: In the ProActive Trial an intensive theory-based intervention program was no more effective than theory-based brief advice in increasing objectively measured physical activity among adults at risk of Type 2 diabetes. We aimed to illuminate these findings by assessing whether the intervention program changed cognitions about increasing activity, defined by the Theory of Planned Behaviour, in ways consistent with the theory., Methods: N = 365 sedentary participants aged 30-50 years with a parental history of Type 2 diabetes were randomised to brief advice alone or to brief advice plus the intervention program delivered face-to-face or by telephone. Questionnaires at baseline, 6 and 12 months assessed cognitions about becoming more physically active. Analysis of covariance was used to test intervention impact. Bootstrapping was used to test multiple mediation of intervention impact., Results: At 6 months, combined intervention groups (face-to-face and telephone) reported that they found increasing activity more enjoyable (affective attitude, d = .25), and they perceived more instrumental benefits (e.g., improving health) (d = .23) and more control (d = .32) over increasing activity than participants receiving brief advice alone. Stronger intentions (d = .50) in the intervention groups than the brief advice group at 6 months were partially explained by affective attitude and perceived control. At 12 months, intervention groups perceived more positive instrumental (d = .21) and affective benefits (d = .29) than brief advice participants. The intervention did not change perceived social pressure to increase activity., Conclusion: Lack of effect of the intervention program on physical activity over and above brief advice was consistent with limited and mostly small short-term effects on cognitions. Targeting affective benefits (e.g., enjoyment, social interaction) and addressing barriers to physical activity may strengthen intentions, but stronger intentions did not result in more behaviour change. More powerful interventions which induce large changes in TPB cognitions may be needed. Other interventions deserving further evaluation include theory-based brief advice, intensive measurement of physical and psychological factors, and monitoring of physical activity. Future research should consider a wider range of mediators of physical activity change, assess participants' use of self-regulatory strategies taught in the intervention, and conduct experimental studies or statistical modelling prior to trial evaluation. ISRCTN61323766.