Motivational support intervention to reduce smoking and increase physical activity in smokers not ready to quit: the TARS RCT.

Background: Physical activity can support smoking cessation for smokers wanting to quit, but there have been no studies on supporting smokers wanting only to reduce. More broadly, the effect of motivational support for such smokers is unclear. Objectives: The objectives were to determine if motivational support to increase physical activity and reduce smoking for smokers not wanting to immediately quit helps reduce smoking and increase abstinence and physical activity, and to determine if this intervention is cost-effective. Design: This was a multicentred, two-arm, parallel-group, randomised (1 : 1) controlled superiority trial with accompanying trial-based and model-based economic evaluations, and a process evaluation. Setting and participants: Participants from health and other community settings in four English cities received either the intervention (n = 457) or usual support (n = 458). Intervention: The intervention consisted of up to eight face-to-face or telephone behavioural support sessions to reduce smoking and increase physical activity. Main outcome measures: The main outcome measures were carbon monoxide-verified 6- and 12-month floating prolonged abstinence (primary outcome), self-reported number of cigarettes smoked per day, number of quit attempts and carbon monoxide-verified abstinence at 3 and 9 months. Furthermore, self-reported (3 and 9 months) and accelerometer-recorded (3 months) physical activity data were gathered. Process items, intervention costs and cost-effectiveness were also assessed. Results: The average age of the sample was 49.8 years, and participants were predominantly from areas with socioeconomic deprivation and were moderately heavy smokers. The intervention was delivered with good fidelity. Few participants achieved carbon monoxide-verified 6-month prolonged abstinence [nine (2.0%) in the intervention group and four (0.9%) in the control group; adjusted odds ratio 2.30 (95% confidence interval 0.70 to 7.56)] or 12-month prolonged abstinence [six (1.3%) in the intervention group and one (0.2%) in the control group; adjusted odds ratio 6.33 (95% confidence interval 0.76 to 53.10)]. At 3 months, the intervention participants smoked fewer cigarettes than the control participants (21.1 vs. 26.8 per day). Intervention participants were more likely to reduce cigarettes by ≥ 50% by 3 months [18.9% vs. 10.5%; adjusted odds ratio 1.98 (95% confidence interval 1.35 to 2.90] and 9 months [14.4% vs. 10.0%; adjusted odds ratio 1.52 (95% confidence interval 1.01 to 2.29)], and reported more moderate-to-vigorous physical activity at 3 months [adjusted weekly mean difference of 81.61 minutes (95% confidence interval 28.75 to 134.47 minutes)], but not at 9 months. Increased physical activity did not mediate intervention effects on smoking. The intervention positively influenced most smoking and physical activity beliefs, with some intervention effects mediating changes in smoking and physical activity outcomes. The average intervention cost was estimated to be £239.18 per person, with an overall additional cost of £173.50 (95% confidence interval -£353.82 to £513.77) when considering intervention and health-care costs. The 1.1% absolute between-group difference in carbon monoxide-verified 6-month prolonged abstinence provided a small gain in lifetime quality-adjusted life-years (0.006), and a minimal saving in lifetime health-care costs (net saving £236). Conclusions: There was no evidence that behavioural support for smoking reduction and increased physical activity led to meaningful increases in prolonged abstinence among smokers with no immediate plans to quit smoking. The intervention is not cost-effective. Limitations: Prolonged abstinence rates were much lower than expected, meaning that the trial was underpowered to provide confidence that the intervention doubled prolonged abstinence. Future work: Further research should explore the effects of the present intervention to support smokers who want to reduce prior to quitting, and/or extend the support available for prolonged reduction and abstinence. Trial registration: This trial is registered as ISRCTN47776579. 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. 27, No. 4. See the NIHR Journals Library website for further project information.

NHS pharmacological and behavioural support helps smokers wanting to quit, and physical activity may also help. It is unclear if behavioural support for those not ready to quit may lead to more quit attempts and abstinence from smoking. A total of 915 smokers who wanted to reduce their smoking, but who had not yet quit, were recruited and randomised to receive an intervention or brief support as usual (brief advice to quit), in Plymouth, London, Oxford and Nottingham. The intervention involved up to eight sessions (by telephone or in person) of motivational support to reduce smoking and increase physical activity (and more sessions to support a quit attempt). Participants self-reported smoking and physical activity information at the start of the trial and after 3 and 9 months. Self-reported quitters confirmed their abstinence with a biochemical test of expired air or saliva. Our main interest was in whether or not the groups differed in the proportion who remained abstinent for at least 6 months. Overall, only 1­2% remained abstinent for 6 months. Although it appeared that a greater proportion did so after receiving the intervention, because few participants were abstinent, the results are not conclusive. However, the intervention had beneficial effects on less rigorous outcomes, including a reduction in the self-reported number of cigarettes smoked, and a greater proportion of intervention than control participants with self-reported and biochemically verified abstinence at 3 months. The intervention also helped participants to reduce, by at least half, the number of cigarettes they smoked at 3 and 9 months, and to report more physical activity, but only at 3 months. Despite reasonable intervention engagement and some short-term changes in smoking and physical activity, the trial does not provide evidence that this intervention would help smokers to quit for at least 6 months nor would it be cost-effective, with an average cost of £239 per smoker.

Effectiveness and cost-effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking (TARS).

AIMS: For smokers unmotivated to quit, we assessed the effectiveness and cost-effectiveness of behavioural support to reduce smoking and increase physical activity on prolonged abstinence and related outcomes. DESIGN: A multi-centred pragmatic two-arm parallel randomised controlled trial. SETTING: Primary care and the community across four United Kingdom sites. PARTICIPANTS: Nine hundred and fifteen adult smokers (55% female, 85% White), recruited via primary and secondary care and the community, who wished to reduce their smoking but not quit. INTERVENTIONS: Participants were randomised to support as usual (SAU) (n = 458) versus multi-component community-based behavioural support (n = 457), involving up to eight weekly person-centred face-to-face or phone sessions with additional 6-week support for those wishing to quit. MEASUREMENTS: Ideally, cessation follows smoking reduction so the primary pre-defined outcome was biochemically verified 6-month prolonged abstinence (from 3-9 months, with a secondary endpoint also considering abstinence between 9 and 15 months). Secondary outcomes included biochemically verified 12-month prolonged abstinence and point prevalent biochemically verified and self-reported abstinence, quit attempts, number of cigarettes smoked, pharmacological aids used, SF12, EQ-5D and moderate-to-vigorous physical activity (MVPA) at 3 and 9 months. Intervention costs were assessed for a cost-effectiveness analysis. FINDINGS: Assuming missing data at follow-up implied continued smoking, nine (2.0%) intervention participants and four (0.9%) SAU participants achieved the primary outcome (adjusted odds ratio, 2.30; 95% confidence interval [CI] = 0.70-7.56, P = 0.169). At 3 and 9 months, the proportions self-reporting reducing cigarettes smoked from baseline by ≥50%, for intervention versus SAU, were 18.9% versus 10.5% (P = 0.009) and 14.4% versus 10% (P = 0.044), respectively. Mean difference in weekly MVPA at 3 months was 81.6 minutes in favour of the intervention group (95% CI = 28.75, 134.47: P = 0.003), but there was no significant difference at 9 months (23.70, 95% CI = -33.07, 80.47: P = 0.143). Changes in MVPA did not mediate changes in smoking outcomes. The intervention cost was £239.18 per person, with no evidence of cost-effectiveness. CONCLUSIONS: For United Kingdom smokers wanting to reduce but not quit smoking, behavioural support to reduce smoking and increase physical activity improved some short-term smoking cessation and reduction outcomes and moderate-to-vigorous physical activity, but had no long-term effects on smoking cessation or physical activity.

A novel method for assessing design fidelity in web-based behavioral interventions.

OBJECTIVE: Delivery is one of the most common ways of assessing fidelity in behavioral interventions. However, there is a lack of research reporting on how well an intervention protocol reflects its proposed theoretical principles (design fidelity). This study presents a systematic method for assessing design fidelity and applies it to the eMotion web-based intervention targeting physical activity and depression. METHOD: The eMotion intervention comprises of 13 web-based modules, designed according to an underlying intervention map. An independent rater with expertise in behavior change coded the presence or absence of behavior change techniques (BCTs) in the content of eMotion. Results of coding were compared to the intervention designers' a priori specification for interrater reliability. RESULTS: After discussion, the independent rater and the intervention designer had a high agreement for the presence of BCTs relating to behavioral activation (AC1 = 0.91) with "demonstration of behavior" and "monitoring of emotional consequences" having the lowest agreement (AC1 < 0.4). There was also high agreement for the presence of BCTs targeting physical activity (AC1 = 0.88) with "demonstration of behavior" and "monitoring of emotional consequences" having the lowest agreement (AC1 < 0.4). The eMotion description was then amended to align the interrater agreement. CONCLUSIONS: This study presents a novel method for assessing design fidelity. Developers of behavioral (and other multicomponent) interventions are encouraged to develop and refine this method and assess design fidelity in future interventions to ensure BCTs are operationalized as intended. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Redesigning walking brochures using behaviour change theory: implications for walking intentions in natural environments.

Natural environments can be used to promote health through facilitating recreational walking. However, efforts to encourage this often neglect messages identified in psychological research that are effective at influencing intentions to walk. This is despite the National Institute for Health and Care Excellence stating that promotional efforts should utilize theoretical frameworks of behaviour change and be targeted towards less active adults. As an illustrative example, this experiment compared a prototypical recreational walking brochure with an "enhanced" version including such persuasive messages on people's intentions to walk for recreation in natural environments. The enhanced brochure heightened intentions for inexperienced recreational walkers through our hypothesized mechanisms, but appeared to dissuade already-experienced walkers. Optimal messaging strategies in recreational walking brochures require tailoring to more and less active readerships. Guidelines are provided for authors of recreational walking brochures, though the principles and techniques could easily be extended to other means of outdoor walking promotion.

Adding web-based behavioural support to exercise referral schemes for inactive adults with chronic health conditions: the e-coachER RCT.

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

When health-care professionals refer patients with chronic conditions to an exercise referral scheme, the effects on long-term increases in physical activity are limited. We therefore developed the e-coachER support package to add to usual exercise referral schemes and to prompt the use of skills such as self-monitoring and goal-setting. This package was also intended to empower patients to increase their levels of physical activity long term. The seven-step programme was delivered online (via an interactive website). As part of the package, we mailed participants a guide for accessing the online programme, a pedometer and a fridge magnet with a notepad to record physical activity. We aimed to determine whether or not adding the e-coachER support to usual exercise referral schemes resulted in lasting changes in moderate and vigorous physical activity and whether or not it offers good value for money compared with exercise referral schemes alone. A total of 450 inactive individuals were recruited across Plymouth, Birmingham and Glasgow and were referred to an exercise referral scheme for the following participant-reported main reasons: weight loss (50%), low mood (19%), osteoarthritis (12%), type 2 diabetes (10%) and high blood pressure (8%). Half of the individuals were given access to the e-coachER support and the other half were not. All individuals were mailed a wrist-worn movement sensor (accelerometer) to wear for 1 week and a survey to assess other outcomes at the start of the study as well as at 4 and 12 months post randomisation. At the start of the study, the participants were inactive and most had multiple health conditions. The participants had an average body mass index of 33 kg/m² and an average age of 50 years. Most (83%) were white. Participants with access to e-coachER support were only slightly more active at 12 months than those who did not have access, but we cannot be confident in the findings because we had data from fewer participants than planned. The lack of a clear effect may have been as a result of around one-third of participants not accessing the website, but otherwise there was reasonable engagement. The provision of the e-coachER support package led to an additional cost of £439 per participant over a 12-month period.

Modifiable risk factors for mortality in revision total hip arthroplasty for periprosthetic fracture.

AIMS: The aim of this study was to identify modifiable risk factors associated with mortality in patients requiring revision total hip arthroplasty (THA) for periprosthetic hip fracture. METHODS: The electronic records of consecutive patients undergoing revision THA for periprosthetic hip fracture between December 2011 and October 2018 were reviewed. The data which were collected included age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) classification, the preoperative serum level of haemoglobin, time to surgery, operating time, blood transfusion, length of hospital stay, and postoperative surgical and medical complications. Univariate and multivariate logistic regression analyses were used to determine independent modifiable factors associated with mortality at 90 days and one year postoperatively. RESULTS: A total of 203 patients were identified. Their mean age was 78 years (44 to 100), and 108 (53%) were female. The median time to surgery was three days (interquartile range (IQR) 2 to 5). The mortality rate at one year was 13.8% (n = 28). The commonest surgical complication was dislocation (n = 22, 10.8%) and the commonest medical complication within 90 days of surgery was hospital-acquired pneumonia (n = 25, 12%). Multivariate analysis showed that the rate of mortality one year postoperatively was five-fold higher in patients who sustained a dislocation (odds ratio (OR) 5.03 (95% confidence interval (CI) 1.60 to 15.83); p = 0.006). The rate of mortality was also four-fold higher in patients who developed hospital-acquired pneumonia within 90 days postoperatively (OR 4.43 (95% CI 1.55 to 12.67); p = 0.005). There was no evidence that the time to surgery was a risk factor for death at one year. CONCLUSION: Dislocation and hospital-acquired pneumonia following revision THA for a periprosthetic fracture are potentially modifiable risk factors for mortality. This study suggests that surgeons should consider increasing constraint to reduce the risk of dislocation, and the early involvement of a multidisciplinary team to reduce the risk of hospital-acquired pneumonia. We found no evidence that the time to surgery affected mortality, which may allow time for medical optimization, surgical planning, and resource allocation. Cite this article: Bone Joint J 2020;102-B(5):580-585.

Exercise interventions for smoking cessation.

BACKGROUND: Taking regular exercise, whether cardiovascular-type exercise or resistance exercise, may help people to give up smoking, particularly by reducing cigarette withdrawal symptoms and cravings, and by helping to manage weight gain. OBJECTIVES: To determine the effectiveness of exercise-based interventions alone, or combined with a smoking cessation programme, for achieving long-term smoking cessation, compared with a smoking cessation intervention alone or other non-exercise intervention. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialised Register for studies, using the term 'exercise' or 'physical activity' in the title, abstract or keywords. The date of the most recent search was May 2019. SELECTION CRITERIA: We included randomised controlled trials that compared an exercise programme alone, or an exercise programme as an adjunct to a cessation programme, with a cessation programme alone or another non-exercise control group. Trials were required to recruit smokers wishing to quit or recent quitters, to assess abstinence as an outcome and have follow-up of at least six months. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. Smoking cessation was measured after at least six months, using the most rigorous definition available, on an intention-to-treat basis. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for smoking cessation for each study, where possible. We grouped eligible studies according to the type of comparison, as either smoking cessation or relapse prevention. We carried out meta-analyses where appropriate, using Mantel-Haenszel random-effects models. MAIN RESULTS: We identified 24 eligible trials with a total of 7279 adult participants randomised. Two studies focused on relapse prevention among smokers who had recently stopped smoking, and the remaining 22 studies were concerned with smoking cessation for smokers who wished to quit. Eleven studies were with women only and one with men only. Most studies recruited fairly inactive people. Most of the trials employed supervised, group-based cardiovascular-type exercise supplemented by a home-based exercise programme and combined with a multi-session cognitive behavioural smoking cessation programme. The comparator in most cases was a multi-session cognitive behavioural smoking cessation programme alone. Overall, we judged two studies to be at low risk of bias, 11 at high risk of bias, and 11 at unclear risk of bias. Among the 21 studies analysed, we found low-certainty evidence, limited by potential publication bias and by imprecision, comparing the effect of exercise plus smoking cessation support with smoking cessation support alone on smoking cessation outcomes (RR 1.08, 95% CI 0.96 to 1.22; I2 = 0%; 6607 participants). We excluded one study from this analysis as smoking abstinence rates for the study groups were not reported. There was no evidence of subgroup differences according to the type of exercise promoted; the subgroups considered were: cardiovascular-type exercise alone (17 studies), resistance training alone (one study), combined cardiovascular-type and resistance exercise (one study) and type of exercise not specified (two studies). The results were not significantly altered when we excluded trials with high risk of bias, or those with special populations, or those where smoking cessation intervention support was not matched between the intervention and control arms. Among the two relapse prevention studies, we found very low-certainty evidence, limited by risk of bias and imprecision, that adding exercise to relapse prevention did not improve long-term abstinence compared with relapse prevention alone (RR 0.98, 95% CI 0.65 to 1.47; I2 = 0%; 453 participants). AUTHORS' CONCLUSIONS: There is no evidence that adding exercise to smoking cessation support improves abstinence compared with support alone, but the evidence is insufficient to assess whether there is a modest benefit. Estimates of treatment effect were of low or very low certainty, because of concerns about bias in the trials, imprecision and publication bias. Consequently, future trials may change these conclusions.

Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial.

INTRODUCTION: Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective. METHODS AND ANALYSIS: A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36-39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions. ETHICS AND DISSEMINATION: Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants. TRIAL REGISTRATION NUMBER: ISRCTN15644451; Pre-results.

Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial.

BACKGROUND: Physical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression. OBJECTIVE: The objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes. METHODS: Participants with elevated depressive symptoms were recruited from the community through various methods (eg, social media) and randomized to eMotion or a waiting list control group for 8 weeks. eMotion is an administratively supported weekly modular program that helps people use key behavior change techniques (eg, graded tasks, action planning, and self-monitoring) to re-engage in routine, pleasurable, and necessary activities, with a focus on physical activities. Feasibility data were collected that included the following: recruitment and trial retention rates; fidelity of intervention delivery, receipt, and enactment; and acceptability of the intervention and data collection procedures. Data were collected for the primary (depression) and secondary outcomes (eg, anxiety, physical activity, fidelity, and client satisfaction) at baseline and 2 months postrandomization using self-reported Web-based questionnaires and accelerometers. Delivery fidelity (logins, modules accessed, time spent) was tracked using Web usage statistics. Exploratory analyses were conducted on the primary and secondary outcomes. RESULTS: Of the 183 people who contacted the research team, 62 were recruited and randomized. The mean baseline score was 14.6 (SD 3.2) on the 8-item Patient Health Questionnaire depression scale (PHQ-8). Of those randomized, 52 participants provided accelerometer-recorded physical activity data at baseline that showed a median of 35.8 (interquartile range [IQR] 0.0-98.6) minutes of moderate-to-vigorous physical activity (MVPA) recorded in at least 10-minute bouts per week, with only 13% (7/52) people achieving guideline levels (150 minutes of MVPA per week). In total, 81% (50/62) of participants provided follow-up data for the primary outcome (PHQ-8), but only 39% (24/62) provided follow-up accelerometer data. Within the intervention group, the median number of logins, modules accessed, and total minutes spent on eMotion was 3 (IQR 2.0-8.0), 3 (IQR 2.0-5.0), and 41.3 (IQR 18.9-90.4), respectively. Acceptability was mixed. Exploratory data analysis showed that PHQ-8 levels were lower for the intervention group than for the control group at 2 months postrandomization (adjusted mean difference -3.6, 95% CI -6.1 to -1.1). CONCLUSIONS: It was feasible to deliver eMotion in UK communities to inactive populations. eMotion has the potential to be effective and is ready for testing in a full-scale trial. Further work is needed to improve engagement with both the intervention and data collection procedures. TRIAL REGISTRATION: ClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa).

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN).

INTRODUCTION: People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK. METHODS AND ANALYSIS: A multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial. ETHICS AND DISSEMINATION: The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants. TRIAL REGISTRATION NUMBERS: ISRCTN80475744; Pre-results.

Intervention delivery fidelity assessment of a counseling-based intervention for promoting smoking reduction and increasing physical activity.

OBJECTIVE: The aims of this study were to (1) develop an approach to assess the delivery fidelity of a complex intervention to simultaneously increase physical activity and reduce smoking and (2) use this approach to assess the variation of fidelity across the delivery of different intervention components of the intervention. METHOD: Audio recorded and transcribed sessions (90 in total) involving 30 participants and 3 health trainers delivering a one-to-one intervention were purposively sampled across health trainer (HT) and stage of treatment. The Dreyfus system for skill acquisition informed a scoring system based on 12 intervention processes and applied by three experts in health behavior change. Scores ranged from 0 to 2 (poor quality), 3 to 4 (reasonable quality), and 5 to 6 (expert level quality). Scores were averaged across coders and presented in relation to fidelity of both HT and the intervention component. RESULTS: The methods were successfully applied with recommendations for future application. Average scores for each item by each coder differed by up to +0.7 to -0.9 points indicating reasonable agreement. Mean scores for the three HTs were 2.9, 2.2, and 2.4, across all 12 intervention processes. The delivery of all intervention components for physical activity was scored lower (<3) than their respective counterparts for smoking reduction (>3; p < .001). CONCLUSIONS: Novel methods for assessing delivery fidelity were successfully applied and areas for improvement identified. Delivery fidelity was deemed to be of reasonable quality but was higher for smoking related intervention components over physical activity ones. (PsycINFO Database Record

Video-calls to reduce loneliness and social isolation within care environments for older people: an implementation study using collaborative action research.

BACKGROUND: Older people in care may be lonely with insufficient contact if families are unable to visit. Face-to-face contact through video-calls may help reduce loneliness, but little is known about the processes of engaging people in care environments in using video-calls. We aimed to identify the barriers to and facilitators of implementing video-calls for older people in care environments. METHODS: A collaborative action research (CAR) approach was taken to implement a video-call intervention in care environments. We undertook five steps of recruitment, planning, implementation, reflection and re-evaluation, in seven care homes and one hospital in the UK. The video-call intervention 'Skype on Wheels' (SoW) comprised a wheeled device that could hold an iPad and handset, and used Skype to provide a free video-call service. Care staff were collaborators who implemented the intervention within the care-setting by agreeing the intervention, recruiting older people and their family, and setting up video-calls. Field notes and reflective diaries on observations and conversations with staff, older people and family were maintained over 15 months, and analysed using thematic analysis. RESULTS: Four care homes implemented the intervention. Eight older people with their respective social contacts made use of video-calls. Older people were able to use SoW with assistance from staff, and enjoyed the use of video-calls to stay better connected with family. However five barriers towards implementation included staff turnover, risk averseness, the SoW design, lack of family commitment and staff attitudes regarding technology. CONCLUSIONS: The SoW intervention, or something similar, could aid older people to stay better connected with their families in care environments, but if implemented as part of a rigorous evaluation, then co-production of the intervention at each recruitment site may be needed to overcome barriers and maximise engagement.

Physical activity and the prevention, reduction, and treatment of alcohol and/or substance use across the lifespan (The PHASE review): protocol for a systematic review.

BACKGROUND: Alcohol and substance use results in significant human and economic cost globally and is associated with economic costs of £21 billion and £15billion within the UK, respectively, and trends for use are not improving. Pharmacological interventions are well researched, but relapse rates across interventions for substance and alcohol use disorders are as high as 60-90%. Physical activity may offer an alternative or adjunct approach to reducing rates of alcohol and substance use that is associated with few adverse side effects, is easily accessible, and is potentially cost-effective. Through psychological, behavioural, and physiological mechanisms, physical activity may offer benefits in the prevention, reduction, and treatment of alcohol and substance use across the lifespan. Whilst physical activity is widely advocated as offering benefit, no systematic review exists of physical activity (in all forms) and its effects on all levels of alcohol and substance use across all ages to help inform policymakers, service providers, and commissioners. METHODS: The objectives of this mixed methods systematic review are to describe and evaluate the quantitative and qualitative research obtained by a diverse search strategy on the impact of physical activity and its potential to: 1. Reduce the risk of progression to alcohol and/or substance use (PREVENTION) 2. Support individuals to reduce alcohol and/or substance use for harm reduction (REDUCTION), and 3. Promote abstinence and relapse prevention during and after treatment for an alcohol and/or substance use disorder (TREATMENT). With the input of key stakeholders, we aim to assess how what we know can be translated into policy and practice. Quantitative, qualitative, service evaluations, and economic analyses will be brought together in a final narrative synthesis that will describe the potential benefits of physical activity for whom, in what conditions, and in what form. DISCUSSION: This review will provide details of what is known about physical activity and the prevention, reduction, and treatment of alcohol and/or substance use. The synthesised findings will be disseminated to policymakers, service providers, and commissioners in the UK. SYSTEMATIC REVIEW REGISTRATION: PROSPERO number: CRD42017079322 .

How do brochures encourage walking in natural environments in the UK? A content analysis.

Although walking for leisure can support health, there has been little systematic attempt to consider how recreational walking is best promoted. In the UK, local authorities create promotional materials for walking networks, but little is known about whether they effectively encourage walking through persuasive messaging. Many of these materials pertain to walks in natural environments which evidence suggests are generally visited less frequently by physically inactive individuals. Consequently the present study explores whether and how recreational walking brochures use persuasive messages in their promotion of walks in natural environments. A coding taxonomy was developed to classify text in recreational walking brochures according to five behavioural content areas and 87 categories of potentially persuasive messages. Reliability of the taxonomy was ascertained and a quantitative content analysis was applied to 26 brochures collected from Devon, UK. Brochures often provided information about an advertised route, highlighted cultural and aesthetic points of interest, and provided directions. Brochures did not use many potentially effective messages. Text seldom prompted behaviour change or built confidence for walking. Social norm related information was rarely provided and there was a general lack of information on physical activity and its benefits for health and well-being. The limited range of message strategies used in recreational walking brochures may not optimally facilitate walking in natural environments for inactive people. Future research should examine the effects of theory-informed brochures on walking intentions and behaviour. The taxonomy could be adapted to suit different media and practices surrounding physical activity in natural environments.

Assessment of fidelity in individual level behaviour change interventions promoting physical activity among adults: a systematic review.

BACKGROUND: Behaviour change interventions that promote physical activity have major implications for health and well-being. Measuring intervention fidelity is crucial in determining the extent to which an intervention is delivered as intended, therefore increasing scientific confidence about effectiveness. However, we lack a clear overview of how well intervention fidelity is typically assessed in physical activity trials. METHODS: A systematic literature search was conducted to identify peer - reviewed physical activity promotion trials that explicitly measured intervention fidelity. Methods used to assess intervention fidelity were categorised, narratively synthesised and critiqued using assessment criteria from NIH Behaviour Change Consortium (BCC) Treatment Fidelity Framework (design, training, delivery, receipt and enactment). RESULTS: Twenty eight articles reporting of twenty one studies used a wide variety of approaches to measure intervention fidelity. Delivery was the most common domain of intervention fidelity measured. Approaches used to measure fidelity across all domains varied from researcher coding of observational data (using checklists or scales) to participant self-report measures. There was considerable heterogeneity of methodological approaches to data collection with respect to instruments used, attention to psychometric properties, rater-selection, observational method and sampling strategies. CONCLUSIONS: In the field of physical activity interventions, fidelity measurement is highly heterogeneous both conceptually and methodologically. Clearer articulation of the core domains of intervention fidelity, along with appropriate measurement approaches for each domain are needed to improve the methodological quality of fidelity assessment in physical activity interventions. Recommendations are provided on how this situation can be improved.

One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

BACKGROUND: Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. METHODS/DESIGN: INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. DISCUSSION: INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function and wellbeing in the long term. Patients state that these outcomes are more important than those that are clinically derived (such as re-infection) and have been commonly used in previous non-randomised studies. Results from the INFORM trial will also benefit clinicians and NHS managers by enabling the comparison of these key interventions in terms of patients' complication rates, health and social resource use and their overall cost-effectiveness. TRIAL REGISTRATION: Current controlled trials ISRCTN10956306 (registered on 29 January 2015); UKCRN ID 18159.

The London Exercise And Pregnant smokers (LEAP) trial: a randomised controlled trial of physical activity for smoking cessation in pregnancy with an economic evaluation.

BACKGROUND: Smoking during pregnancy is the main preventable cause of poor birth outcomes. Improved methods are needed to help women to stop smoking during pregnancy. Pregnancy provides a compelling rationale for physical activity (PA) interventions as cessation medication is contraindicated or ineffective, and an effective PA intervention could be highly cost-effective. OBJECTIVE: To examine the effectiveness and cost-effectiveness of a PA intervention plus standard behavioural support for smoking cessation relative to behavioural support alone for achieving smoking cessation at the end of pregnancy. DESIGN: Multicentre, two-group, pragmatic randomised controlled trial and economic evaluation with follow-up at the end of pregnancy and 6 months postnatally. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio. SETTING: 13 hospitals offering antenatal care in the UK. PARTICIPANTS: Women between 10 and 24 weeks' gestation smoking five or more cigarettes a day before pregnancy and one or more during pregnancy. INTERVENTIONS: Participants were randomised to behavioural support for smoking cessation (control) or behavioural support plus a PA intervention consisting of supervised treadmill exercise plus PA consultations. Neither participants nor researchers were blinded to treatment allocation. MAIN OUTCOME MEASURES: The primary outcome was self-reported, continuous smoking abstinence between a quit date and end of pregnancy, validated by expired carbon monoxide and/or salivary cotinine. Secondary outcomes were maternal weight, depression, birth outcomes, withdrawal symptoms and urges to smoke. The economic evaluation investigated the costs of the PA intervention compared with the control intervention. RESULTS: In total, 789 women were randomised (n = 394 PA, n = 395 control). Four were excluded post randomisation (two had been enrolled twice in sequential pregnancies and two were ineligible and randomised erroneously). The intention-to-treat analysis comprised 785 participants (n = 392 PA, n = 393 control). There was no significant difference in the rate of abstinence at the end of pregnancy between the PA group (7.7%) and the control group (6.4%) [odds ratio for PA group abstinence 1.21, 95% confidence interval (CI) 0.70 to 2.10]. For the PA group compared with the control group, there was a 33% (95% CI 14% to 56%), 28% (95% CI 7% to 52%) and 36% (95% CI 12% to 65%) significantly greater increase in self-reported minutes of moderate- and vigorous-intensity PA from baseline to 1 week, 4 weeks and 6 weeks respectively. Accelerometer data showed that there was no significant difference in PA levels between the groups. There were no significant differences between the groups for change in maternal weight, depression, withdrawal symptoms or urges to smoke. Adverse events and birth outcomes were similar between the groups except for there being significantly more caesarean births in the control group than in the PA group (28.7% vs. 21.3%; p < 0.023). The PA intervention was less costly than the control intervention by £35 per participant. This was mainly attributable to increased health-care usage in the control group. However, there was considerable statistical uncertainty around this estimate. CONCLUSIONS: During pregnancy, offering an intervention combining supervised exercise and PA counselling does not add to the effectiveness of behavioural support for smoking cessation. Only 10% of participants had PA levels accessed by accelerometer and it is, therefore, unclear whether or not the lack of an effect on the primary outcome is the result of insufficient increases in PA. Research is needed to identify the smoking populations most suitable for PA interventions and methods for increasing PA adherence. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48600346. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 84. See the NIHR Journals Library website for further project information.

Combining behavioural activation with physical activity promotion for adults with depression: findings of a parallel-group pilot randomised controlled trial (BAcPAc).

BACKGROUND: Depression is associated with physical inactivity, which may mediate the relationship between depression and a range of chronic physical health conditions. However, few interventions have combined a psychological intervention for depression with behaviour change techniques, such as behavioural activation (BA), to promote increased physical activity. METHODS: To determine procedural and clinical uncertainties to inform a definitive randomised controlled trial (RCT), a pilot parallel-group RCT was undertaken within two Improving Access to Psychological Therapies (IAPT) services in South West England. We aimed to recruit 80 adults with depression and randomise them to a supported, written self-help programme based on either BA or BA plus physical activity promotion (BAcPAc). Data were collected at baseline and 4 months post-randomisation to evaluate trial retention, intervention uptake and variance in outcomes to inform a sample size calculation. Qualitative data were collected from participants and psychological wellbeing practitioners (PWPs) to assess the acceptability and feasibility of the trial methods and the intervention. Routine data were collected to evaluate resource use and cost. RESULTS: Sixty people with depression were recruited, and a 73 % follow-up rate was achieved. Accelerometer physical activity data were collected for 64 % of those followed. Twenty participants (33 %) attended at least one treatment appointment. Interview data were analysed for 15 participants and 9 study PWPs. The study highlighted the challenges of conducting an RCT within existing IAPT services with high staff turnover and absences, participant scheduling issues, PWP and participant preferences for cognitive focussed treatment, and deviations from BA delivery protocols. The BAcPAc intervention was generally acceptable to patients and PWPs. CONCLUSIONS: Although recruitment procedures and data collection were challenging, participants generally engaged with the BAcPAc self-help booklets and reported willingness to increase their physical activity. A number of feasibility issues were identified, in particular the under-use of BA as a treatment for depression, the difficulty that PWPs had in adapting their existing procedures for study purposes and the instability of the IAPT PWP workforce. These problems would need to be better understood and resolved before proceeding to a full-scale RCT. TRIAL REGISTRATION: ISRCTN74390532 . Registered on 26 March 2013.

Energy expenditure on recreational visits to different natural environments.

Physical inactivity poses a significant challenge to physical and mental health. Environmental approaches to tackle physical inactivity have identified natural environments as potentially important public health resources. Despite this, little is known about characteristics of the activity involved when individuals visit different types of natural environment. Using Natural England's Monitor of Engagement with the Natural Environment Survey, we examined 71,603 English respondents' recreational visits to natural environments in the past week. Specifically, we examined the intensity of the activities they undertook on the visits (METs), the duration of their visit, and the associated total energy expenditure (MET minutes). Visits to countryside and urban greenspace environments were associated with more intense activities than visits to coastal environments. However, visits to coastal environments were associated with the most energy expenditure overall due to their relatively long duration. Results differed by the urbanity or rurality of the respondent's residence and also how far respondents travelled to their destination. Knowledge of what types of natural environment afford the highest volumes and intensities of physical activity could inform landscape architecture and exercise prescriptions. Isolating activity-supporting characteristics of natural environments that can be translated into urban design is important in providing physical activity opportunities for those less able to access expansive environments.

Lessons learned from recruiting socioeconomically disadvantaged smokers into a pilot randomized controlled trial to explore the role of Exercise Assisted Reduction then Stop (EARS) smoking.

BACKGROUND: Research is needed on what influences recruitment to smoking reduction trials, and how to increase their reach. The present study aimed to i) assess the feasibility of recruiting a disadvantaged population, ii) examine the effects of recruitment methods on participant characteristics, iii) identify resource requirements for different recruitment methods, and iv) to qualitatively assess the acceptability of recruitment. This was done as part of a pilot two-arm trial of the effectiveness of a novel behavioral support intervention focused on increasing physical activity and reducing smoking, among disadvantaged smokers not wishing to quit. METHODS: Smokers were recruited through mailed invitations from three primary care practices (62 participants) and one National Health Stop Smoking Service (SSS) database (31 participants). Six other participants were recruited via a variety of other community-based approaches. Data were collected through questionnaires, field notes, work sampling, and databases. Chi-squared and t-tests were used to compare baseline characteristics of participants. RESULTS: We randomized between 5.1 and 11.1% of those invited through primary care and SSS, with associated researcher time to recruit one participant varying from 18 to 157 minutes depending on time and intensity invested.Only six participants were recruited through a wide variety of other community-based approaches, with an associated researcher time of 469 minutes to recruit one participant. Targets for recruiting a disadvantaged population were met, with 91% of the sample in social classes C2 to E (NRS social grades, UK), and 41% indicating mental health problems. Those recruited from SSS were more likely to respond to an initial letter, had used cessation aids before, and had attempted to quit in the past year. Overall, initial responders were more likely to be physically active than those who were recruited via follow-up telephone calls. No other demographics or behaviour characteristics were associated with recruitment approach or intensity of effort. Qualitative feedback indicated that participants had been attracted by the prospect of support that focused on smoking reduction rather than abrupt quitting. CONCLUSIONS: Mailed invitations, and follow-up, from health professionals was an effective method of recruiting disadvantaged smokers into a trial of an exercise intervention to aid smoking reduction. Recruitment via community outreach approaches was largely ineffective. TRIAL REGISTRATION: ISRCTN identifier: 13837944 , registered on 6 July 2010.