Rugby Fans in Training New Zealand (RUFIT NZ): a randomized controlled trial to assess the effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs.

BACKGROUND: A healthy lifestyle program that appeals to, and supports, overweight and obese New Zealand (NZ) European, Maori (indigenous) and Pasifika men to achieve weight loss is urgently needed. A pilot program inspired by the successful Football Fans in Training program but delivered via professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, adherence to healthy lifestyle behaviors, and cardiorespiratory fitness in overweight and obese men. A full effectiveness trial is now needed. AIMS: To determine the effectiveness and cost effectiveness of Rugby Fans In Training-NZ (RUFIT-NZ) on weight loss, fitness, blood pressure, lifestyle change, and health related quality of life (HRQoL) at 12- and 52-weeks. METHODS: We conducted a pragmatic, two-arm, multi-center, randomized controlled trial in NZ with 378 (target 308) overweight and obese men aged 30-65 years, randomized to an intervention group or wait-list control group. The 12-week RUFIT-NZ program was a gender-sensitised, healthy lifestyle intervention delivered through professional rugby clubs. Each intervention session included: i) a 1-h workshop-based education component focused on nutrition, physical activity, sleep, sedentary behavior, and learning evidence-based behavior change strategies for sustaining a healthier lifestyle; and 2) a 1-h group-based, but individually tailored, exercise training session. The control group were offered RUFIT-NZ after 52-weeks. The primary outcome was change in body weight from baseline to 52-weeks. Secondary outcomes included change in body weight at 12-weeks, waist circumference, blood pressure, fitness (cardiorespiratory and musculoskeletal), lifestyle behaviors (leisure-time physical activity, sleep, smoking status, and alcohol and dietary quality), and health-related quality of life at 12- and 52-weeks. RESULTS: Our final analysis included 200 participants (intervention n = 103; control n = 97) who were able to complete the RUFIT-NZ intervention prior to COVID-19 restrictions. At 52-weeks, the adjusted mean group difference in weight change (primary outcome) was -2.77 kg (95% CI -4.92 to -0.61), which favored the intervention group. The intervention also resulted in favorable significant differences in weight change and fruit and vegetable consumption at 12-weeks; and waist circumference, fitness outcomes, physical activity levels, and health-related quality of life at both 12 and 52 weeks. No significant intervention effects were observed for blood pressure, or sleep. Incremental cost-effective ratios estimated were $259 per kg lost, or $40,269 per quality adjusted life year (QALY) gained. CONCLUSION: RUFIT-NZ resulted in sustained positive changes in weight, waist circumference, physical fitness, self-reported physical activity, selected dietary outcomes, and health-related quality of life in overweight/obese men. As such, the program should be recommended for sustained delivery beyond this trial, involving other rugby clubs across NZ. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered 18 January 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376740 Universal Trial Number, U1111-1245-0645.

Contributions of changes in physical activity, sedentary time, diet and body weight to changes in cardiometabolic risk.

BACKGROUND: Increased physical activity (PA), reduced time spent sedentary (SED), healthier diet and reduced body weight may all have a positive impact on cardiometabolic risk. The relative importance of change in each of these variables on cardiometabolic risk, however, is unclear. We therefore sought to investigate the relative contributions of changes in PA, SED, diet and body weight on cardiometabolic risk. METHODS: This is a secondary analysis of data collected from the EuroFIT randomised controlled trial, which was a 12-week group-based lifestyle intervention for overweight middle-aged men delivered by coaches in football club stadia aiming to improve PA, SED, diet, and body weight. PA and SED were assessed by accelerometry, diet using the Dietary Instrument for Nutrition Education (DINE). An overall cardiometabolic risk score was derived from combining z-scores for glucose, HbA1c, insulin, lipids and blood pressure. In total, 707 men (from the overall cohort of 1113) with complete data for these variables at baseline and 12-month follow-up were included in the multivariable linear regression analyses. RESULTS: In multivariable analyses, change in number of steps (explaining 5.1% of R2) and dietary factors (less alcohol, fatty and sugary food, and more fruit and vegetables) (together explaining 4.5% of R2), but not changes in standing time or SED, were significantly associated with change in body weight. Changes in number of steps (R2 = 1.7%), fatty food score (R2 = 2.4%), and sugary food score (R2 = 0.4%) were significantly associated with change in cardiometabolic risk score in univariable models. However, in multivariable models which included changes in weight as well as changes in steps and dietary variables, change in weight explained a substantially larger proportion of the change in cardiometabolic risk score, explaining 14.1% of R2 (out of an overall model R2 of 19.0%). When baseline (as well as change) values were also included in the model, 38.8% of R2 for change in cardiometabolic risk score was explained overall, with 14.1% of R2 still explained by change in weight. CONCLUSION: Change in body weight, together with baseline cardiometabolic risk explained most of the change in cardiometabolic risk. Thus, the benefits of increasing physical activity and improving diet on cardiometabolic risk appear to act largely via an effect on changes in body weight. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN-81935608. Registered 06052015. https://www.isrctn.com/ISRCTN81935608?q=&filters=recruitmentCountry:Portugal&sort=&offset=7&totalResults=92&page=1&pageSize=10&searchType=basic-search.

Home-Based Intervention to Test and Start (HITS): a community-randomized controlled trial to increase HIV testing uptake among men in rural South Africa.

INTRODUCTION: The uptake of HIV testing and linkage to care remains low among men, contributing to high HIV incidence in women in South Africa. We conducted the "Home-Based Intervention to Test and Start" (HITS) in a 2x2 factorial cluster randomized controlled trial in one of the World's largest ongoing HIV cohorts in rural South Africa aimed at enhancing both intrinsic and extrinsic motivations for HIV testing. METHODS: Between February and December 2018, in the uMkhanyakude district of KwaZulu-Natal, we randomly assigned 45 communities (clusters) (n = 13,838 residents) to one of the four arms: (i) financial incentives for home-based HIV testing and linkage to care (R50 [$3] food voucher each); (ii) male-targeted HIV-specific decision support application, called EPIC-HIV; (iii) both financial incentives and male-targeted HIV-specific decision support application and (iv) standard of care (SoC). EPIC-HIV was developed to encourage and serve as an intrinsic motivator for HIV testing and linkage to care, and individually offered to men via a tablet device. Financial incentives were offered to both men and women. Here we report the effect of the interventions on uptake of home-based HIV testing among men. Intention-to-treat (ITT) analysis was performed using modified Poisson regression with adjustment for clustering of standard errors at the cluster levels. RESULTS: Among all 13,838 men ≥ 15 years living in the 45 communities, the overall population coverage during a single round of home-based HIV testing was 20.7%. The uptake of HIV testing was 27.5% (683/2481) in the financial incentives arm, 17.1% (433/2534) in the EPIC-HIV arm, 26.8% (568/2120) in the arm receiving both interventions and 17.8% in the SoC arm. The probability of HIV testing increased substantially by 55% in the financial incentives arm (risk ratio (RR)=1.55, 95% CI: 1.31 to 1.82, p < 0.001) and 51% in the arm receiving both interventions (RR = 1.51, 95% CI: 1.21 to 1.87 p < 0.001), compared to men in the SoC arm. The probability of HIV testing did not significantly differ in the EPIC-HIV arm (RR = 0.96, 95% CI: 0.76 to 1.20, p = 0.70). CONCLUSIONS: The provision of a small financial incentive acted as a powerful extrinsic motivator substantially increasing the uptake of home-based HIV testing among men in rural South Africa. In contrast, the counselling and testing application which was designed to encourage and serve as an intrinsic motivator to test for HIV did not increase the uptake of home-based testing.

Five-year cost-effectiveness analysis of the European Fans in Training (EuroFIT) physical activity intervention for men versus no intervention.

OBJECTIVES: Increasing physical activity reduces the risk of chronic illness including Type 2 diabetes, cardiovascular disease and certain types of cancer. Lifestyle interventions can increase physical activity but few successfully engage men. This study aims to investigate the 5 year cost-effectiveness of EuroFIT, a program to improve physical activity tailored specifically for male football (soccer) fans compared to a no intervention comparison group. METHODS: We developed a Markov cohort model in which the impact of improving physical activity on five chronic health conditions (colorectal cancer, Type 2 diabetes, coronary heart disease, stroke and depression) and mortality was modelled. We estimated costs from a societal perspective and expressed benefits as quality adjusted life years (QALYs). We obtained data from a 4-country (England, Netherlands, Portugal and Norway) pragmatic randomised controlled trial evaluating EuroFIT, epidemiological and cohort studies, and meta-analyses. We performed deterministic and probabilistic sensitivity analyses to assess the impact of uncertainty in the model's parameter values on the cost-effectiveness results. We used Monte Carlo simulations to estimate uncertainty and presented this using cost-effectiveness acceptability curves (CEACs). We tested the robustness of the base case analysis using five scenario analyses. RESULTS: Average costs over 5 years per person receiving EuroFIT were €14,663 and per person receiving no intervention €14,598. Mean QALYs over 5 years were 4.05 per person for EuroFIT and 4.04 for no intervention. Thus, the average incremental cost per person receiving EuroFIT was €65 compared to no intervention, while the average QALY gain was 0.01. This resulted in an ICER of €5206 per QALY gained. CEACs show that the probability of EuroFIT being cost-effective compared to no intervention is 0.53, 0.56 and 0.58 at thresholds of €10,000, €22,000 and €34,000 per QALY gained, respectively. When using a time horizon of 10 years, the results suggest that EuroFIT is more effective and less expensive compared to (i.e. dominant over) no intervention with a probability of cost-effectiveness of 0.63 at a threshold of €22,000 per QALY gained. CONCLUSIONS: We conclude the EuroFIT intervention is not cost-effective compared to no intervention over a period of 5 years from a societal perspective, but is more effective and less expensive (i.e. dominant) after 10 years. We thus suggest that EuroFIT can potentially improve public health in a cost-effective manner in the long term.

Scale-Up and Scale-Out of a Gender-Sensitized Weight Management and Healthy Living Program Delivered to Overweight Men via Professional Sports Clubs: The Wider Implementation of Football Fans in Training (FFIT).

Increasing prevalence of obesity poses challenges for public health. Men have been under-served by weight management programs, highlighting a need for gender-sensitized programs that can be embedded into routine practice or adapted for new settings/populations, to accelerate the process of implementing programs that are successful and cost-effective under research conditions. To address gaps in examples of how to bridge the research to practice gap, we describe the scale-up and scale-out of Football Fans in Training (FFIT), a weight management and healthy living program in relation to two implementation frameworks. The paper presents: the development, evaluation and scale-up of FFIT, mapped onto the PRACTIS guide; outcomes in scale-up deliveries; and the scale-out of FFIT through programs delivered in other contexts (other countries, professional sports, target groups, public health focus). FFIT has been scaled-up through a single-license franchise model in over 40 UK professional football clubs to 2019 (and 30 more from 2020) and scaled-out into football and other sporting contexts in Australia, Canada, New Zealand, England and other European countries. The successful scale-up and scale-out of FFIT demonstrates that, with attention to cultural constructions of masculinity, public health interventions can appeal to men and support them in sustainable lifestyle change.

Why colorectal screening fails to achieve the uptake rates of breast and cervical cancer screening: a comparative qualitative study.

BACKGROUND: In Scotland, the uptake of clinic-based breast (72%) and cervical (77%) screening is higher than home-based colorectal screening (~60%). To inform new approaches to increase uptake of colorectal screening, we compared the perceptions of colorectal screening among women with different screening histories. METHODS: We purposively sampled women with different screening histories to invite to semistructured interviews: (1) participated in all; (2) participated in breast and cervical but not colorectal ('colorectal-specific non-participants'); (3) participated in none. To identify the sample we linked the data for all women eligible for all three screening programmes in Glasgow, Scotland (aged 51-64 years; n=68 324). Interviews covered perceptions of cancer, screening and screening decisions. Framework method was used for analysis. RESULTS: Of the 2924 women invited, 86 expressed an interest, and 59 were interviewed. The three groups' perceptions differed, with the colorectal-specific non-participants expressing that: (1) treatment for colorectal cancer is more severe than for breast or cervical cancer; (2) colorectal symptoms are easier to self-detect than breast or cervical symptoms; (3) they worried about completing the test incorrectly; and (4) the colorectal test could be more easily delayed or forgotten than breast or cervical screening. CONCLUSION: Our comparative approach suggested targets for future interventions to increase colorectal screening uptake including: (1) reducing fear of colorectal cancer treatments; (2) increasing awareness that screening is for the asymptomatic; (3) increasing confidence to self-complete the test; and (4) providing a suggested deadline and/or additional reminders.

Comparing uptake across breast, cervical and bowel screening at an individual level: a retrospective cohort study.

BACKGROUND: We investigated demographic and clinical predictors of lower participation in bowel screening relative to breast and cervical screening. METHODS: Data linkage study of routinely collected clinical data from 430,591 women registered with general practices in the Greater Glasgow & Clyde Health Board. Participation in the screening programmes was measured by attendance at breast or cervical screening or the return of a bowel screening kit. RESULTS: 72.6% of 159,993 women invited attended breast screening, 80.7% of 309,899 women invited attended cervical screening and 61.7% of 180,408 women invited completed bowel screening. Of the 68,324 women invited to participate in all three screening programmes during the study period, 52.1% participated in all three while 7.2% participated in none. Women who participated in breast (OR = 3.34 (3.21, 3.47), p < 0.001) or cervical (OR = 3.48 (3.32, 3.65), p < 0.001) were more likely to participate in bowel screening. CONCLUSION: Participation in bowel screening was lower than breast or cervical for this population although the same demographic factors were associated with uptake, namely lower social deprivation, increasing age, low levels of comorbidity and prior non-malignant neoplasms. As women who complete breast and cervical are more likely to also complete bowel screening, interventions at these procedures to encourage bowel screening participation should be explored.

The Influence of Socio-economic Deprivation on Mobility, Participation, and Quality of Life Following Major Lower Extremity Amputation in the West of Scotland.

OBJECTIVE: Lower extremity amputation (LEA) is more common in people from lower socio-economic groups. This study examined this further by investigating the influence of socio-economic status on mobility, participation, and quality of life (QoL) after LEA. METHODS: Prospective data were gathered for all LEAs performed in one year in one Scottish Health Board, commencing March 2014. A postcode derived Scottish Index of Multiple Deprivation (SIMD) was applied by quintile (SIMD 1 = most deprived). Routine data were collected on the cohort of 171 patients; 101 participants consented and received postal questionnaires on QoL (EQ-5D-5L), participation (Reintegration to Normal Living Index [RNLI]), and mobility (Prosthetic Limb User Survey of Mobility), six (n = 67) and 12 months (n = 50) after LEA. RESULTS: The mean ± SD age of the cohort was 66.2 ± 11.4 years; 75% were male and 53% had diabetes. In total, 67% lived in SIMD 1 and 2 and 11.1% in SIMD 5. Sixty per cent had a transtibial amputation. Mortality was 6% at 30 days 17% at six, and 29% at 12 months. Those in SIMD 1 were significantly younger (62.9 years) than those in SIMD 5 (76.3 years). Significantly more participants with a transfemoral amputation (TFA) lived in SIMD 1 (44%) compared with SIMD 5 (11%) (p = .004). Participation was low (RNLI scores: 6 months = 55.7; 12 months = 56.6) and PLUS M scores suggested mobility was poor overall at six (39.1) and 12 months (38.9). Mean QoL was 0.37 at 6 months and 0.33 at 12 months. CONCLUSION: Although this study observed more LEAs in those from low socio-economic areas, it is impossible to conclude whether QoL after LEA is truly influenced by socio-economic status. There was an association between the disproportionately high rate of LEAs in SIMD groups 1 and 2 and the high prevalence of smoking, 61% vs. only 21% of those in the least deprived areas (SIMD 3, 4, and 5) being current smokers.

Lung cancer symptom appraisal among people with chronic obstructive pulmonary disease: A qualitative interview study.

OBJECTIVE: The incidence of lung cancer is four times higher in people with chronic obstructive pulmonary disease (COPD) compared with the general population. Promotion of a shorter time from symptom onset to presentation is one potential strategy for earlier lung cancer diagnosis, but distinguishing respiratory symptoms can be difficult. We investigated how the experience of COPD influences symptom appraisal and help seeking for potential lung cancer symptoms. METHODS: We conducted qualitative interviews with men (n = 17) and women (n = 23) aged 40 to 83 years with COPD. Topic guides drew on the integrated symptom-response framework and covered symptom experience, interpretation, action, recognition, help seeking, evaluation, and reevaluation. We used the framework method to analyse the data. RESULTS: Participants said that they attributed chest symptoms to their COPD; no other cause was considered. Participants said that family/friends noticed changes in their symptoms and encouraged help seeking. Others felt isolated by their COPD because they could not get out, were fatigued, or were embarrassed. Participants visited health professionals frequently, but increased risk of lung cancer was not discussed. CONCLUSIONS: Our study provides insight into different levels of influence on symptom appraisal and targets for intervention. Greater awareness of increased lung cancer risk and support to act on symptom changes is essential and could be achieved through a concerted information campaign. Health professionals working with people with COPD could also optimise appointments to support symptom appraisal of potential lung cancer symptoms.

The impact of lay counselors on HIV testing rates: quasi-experimental evidence from lay counselor redeployment in KwaZulu-Natal, South Africa.

OBJECTIVES: This study aimed to determine the causal effect of the number of lay counselors removed from a primary care clinic in rural South Africa on the number of clinic-based HIV tests performed. DESIGN: Fixed-effects panel analysis. METHODS: We collected monthly data on the number of lay counselors employed and HIV tests performed at nine primary care clinics in rural KwaZulu-Natal from January 2014 to December 2015. Using clinic-level and month-level fixed-effects regressions, we exploited the fact that lay counselors were removed from clinics at two quasi-random time points by a redeployment policy. RESULTS: A total of 24 526 HIV tests were conducted over the study period. Twenty-one of 27 lay counselors were removed across the nine clinics in the two redeployment waves. A 10% reduction in the number of lay counselors at a clinic was associated with a 4.9% [95% confidence interval (CI) 2.8-7.0, P < 0.001] decrease in the number of HIV tests performed. In absolute terms, losing one lay counselor from a clinic was associated with a mean of 29.7 (95% CI 21.2-38.2, P < 0.001) fewer HIV tests carried out at the clinic per month. CONCLUSION: This study provides some evidence that lay counselors play an important role in the HIV response in rural South Africa. More broadly, this analysis adds some empirical support to plans to increase the involvement of lay health workers in the HIV response.

Does gender matter? An analysis of men's and women's accounts of responding to symptoms of lung cancer.

Men are often portrayed - in research studies, 'common-sense' accounts and popular media - as reluctant users of health services. They are said to avoid going to the GP whenever possible, while women are portrayed, in presumed opposition, as consulting more readily, more frequently and with less serious complaints. Such stereotypes may inadvertently encourage doctors to pay greater heed to men's symptoms in 'routine' consultations. Although previous research has challenged this view with evidence, and suggested that links between gender identities and help-seeking are complex and fluid, gender comparative studies remain uncommon, and particularly few studies (either qualitative or quantitative) compare men and women with similar morbidity. We contribute here to gender comparative research on help-seeking by investigating men's and women's accounts of responding to symptoms later diagnosed as lung cancer. A secondary analysis of qualitative interviews with 27 men and 18 women attending Scottish cancer centres revealed striking similarities between men's and women's accounts. Participants were seen as negotiating a complex and delicate balance in constructing their moral integrity as, on the one hand, responsible service users who were conscious of the demands on health care professionals' time, and as patients who did not take undue risks with their health, in the context of an illness for which people are often held culpable, on the other. In accounting for their responses to symptoms, men and women drew equally on culturally-embedded moral frameworks of stoicism and responsible service use. Regardless of gender, the accounts portrayed participants as stoic in response to illness and responsible service users; and as people seeking explanations for bodily changes and taking appropriate and timely action. Our analysis challenges simplistic, 'common-sense' views of gendered help-seeking and highlights that both men and women need support to consult their doctor for investigation of significant or concerning bodily changes.

'It's like a personal motivator that you carried around wi' you': utilising self-determination theory to understand men's experiences of using pedometers to increase physical activity in a weight management programme.

BACKGROUND: Self-monitoring using pedometers is an effective behaviour change technique to support increased physical activity (PA). However, the ways in which pedometers operate as motivational tools in adoption and maintenance of PA is not well understood. This paper investigates men's experiences of pedometers as motivational tools both during and after their participation in a 12-week group-based, weight management programme for overweight/obese men, Football Fans in Training (FFIT). METHODS: Semi-structured telephone interviews were conducted with 28 men, purposively sampled to include men who did and did not achieve 5% weight loss during the programme. Data were analysed thematically utilising the framework approach, using Self-Determination Theory (SDT) - namely concepts of behavioural regulation and the basic needs of relatedness, competence and autonomy - as an analytical lens. RESULTS: During the programme, FFIT's context and fellow participants supported relatedness and encouraged use of the pedometer. The pedometer was seen to provide tangible proof of progress, thus increasing competence for change, whilst the ability to monitor one's own progress and take remedial action supported autonomy; these men portrayed the pedometer as an 'ally'. However, a minority found the pedometer 'dispiriting' or controlling when it evidenced their inability to meet their PA targets. After the programme, some men no longer used the device as they had fully internalised their motivations for increased PA. In contrast, others continued to use pedometers or progressed to other self-monitoring technologies because it was enjoyable and facilitated maintenance of their increased PA. However, the minority of men who experienced the pedometer as controlling no longer used it. They were less successful in achieving 5% weight loss and appeared reliant on external factors, including support from coach and group members, to maintain motivation. CONCLUSION: These findings show how self-monitoring using pedometers and associated goal setting supported the development of autonomous motivation for PA, during and after participation in a group-based programme. They also suggest that programmes could focus on early identification of participants who remain motivated by extrinsic factors or express negative experiences of self-monitoring tools, to offer greater support to identify the benefits of PA based on a person's own values.

Readiness for Delivering Digital Health at Scale: Lessons From a Longitudinal Qualitative Evaluation of a National Digital Health Innovation Program in the United Kingdom.

BACKGROUND: Digital health has the potential to support care delivery for chronic illness. Despite positive evidence from localized implementations, new technologies have proven slow to become accepted, integrated, and routinized at scale. OBJECTIVE: The aim of our study was to examine barriers and facilitators to implementation of digital health at scale through the evaluation of a £37m national digital health program: ?Delivering Assisted Living Lifestyles at Scale" (dallas) from 2012-2015. METHODS: The study was a longitudinal qualitative, multi-stakeholder, implementation study. The methods included interviews (n=125) with key implementers, focus groups with consumers and patients (n=7), project meetings (n=12), field work or observation in the communities (n=16), health professional survey responses (n=48), and cross program documentary evidence on implementation (n=215). We used a sociological theory called normalization process theory (NPT) and a longitudinal (3 years) qualitative framework analysis approach. This work did not study a single intervention or population. Instead, we evaluated the processes (of designing and delivering digital health), and our outcomes were the identified barriers and facilitators to delivering and mainstreaming services and products within the mixed sector digital health ecosystem. RESULTS: We identified three main levels of issues influencing readiness for digital health: macro (market, infrastructure, policy), meso (organizational), and micro (professional or public). Factors hindering implementation included: lack of information technology (IT) infrastructure, uncertainty around information governance, lack of incentives to prioritize interoperability, lack of precedence on accountability within the commercial sector, and a market perceived as difficult to navigate. Factors enabling implementation were: clinical endorsement, champions who promoted digital health, and public and professional willingness. CONCLUSIONS: Although there is receptiveness to digital health, barriers to mainstreaming remain. Our findings suggest greater investment in national and local infrastructure, implementation of guidelines for the safe and transparent use and assessment of digital health, incentivization of interoperability, and investment in upskilling of professionals and the public would help support the normalization of digital health. These findings will enable researchers, health care practitioners, and policy makers to understand the current landscape and the actions required in order to prepare the market and accelerate uptake, and use of digital health and wellness services in context and at scale.

Hockey Fans in Training (Hockey FIT) pilot study protocol: a gender-sensitized weight loss and healthy lifestyle program for overweight and obese male hockey fans.

BACKGROUND: Effective approaches that engage men in weight loss and lifestyle change are important because of worldwide increases, including in Canada, in obesity and chronic diseases. Football Fans in Training (FFIT), developed in Scotland, successfully tackled these problems by engaging overweight/obese male football fans in sustained weight loss and positive health behaviours, through program deliveries at professional football stadia. METHODS: Aims: 1) Adapt FFIT to hockey within the Canadian context and integrate with HealtheSteps™ (evidence-based lifestyle program) to develop Hockey Fans in Training (Hockey FIT); 2) Explore potential for Hockey FIT to help overweight/obese men lose weight and improve other outcomes by 12 weeks, and retain these improvements to 12 months; 3) Evaluate feasibility of recruiting and retaining overweight/obese men; 4) Evaluate acceptability of Hockey FIT; and 5) Conduct program optimization via a process evaluation. We conducted a two-arm pilot pragmatic randomized controlled trial (pRCT) whereby 80 overweight/obese male hockey fans (35-65 years; body-mass index ≥28 kg/m2) were recruited through their connection to two junior A hockey teams (London and Sarnia, ON) and randomized to Intervention (Hockey FIT) or Comparator (Wait-List Control). Hockey FIT includes a 12-week Active Phase (classroom instruction and exercise sessions delivered weekly by trained coaches) and a 40-week Maintenance Phase. Data collected at baseline and 12 weeks (both groups), and 12 months (Intervention only), will inform evaluation of the potential of Hockey FIT to help men lose weight and improve other health outcomes. Feasibility and acceptability will be assessed using data from self-reports at screening and baseline, program fidelity (program observations and coach reflections), participant focus group discussions, coach interviews, as well as program questionnaires and interviews with participants. This information will be analyzed to inform program optimization. DISCUSSION: Hockey FIT is a gender-sensitive program designed to engage overweight/obese male hockey fans to improve physical activity and healthy eating choices, thereby leading to weight loss and other positive changes in health outcomes. We expect this study to provide evidence for a full-scale confirmatory pRCT. TRIAL REGISTRATION: NCT02396524 (Clinicaltrials.gov). Date of registration: Feb 26, 2015.

Can a lifestyle intervention be offered through NHS breast cancer screening? Challenges and opportunities identified in a qualitative study of women attending screening.

BACKGROUND: Around one third of breast cancers in post-menopausal women could be prevented by decreasing body fatness and alcohol intake and increasing physical activity. This study aimed to explore views and attitudes on lifestyle intervention approaches in order to inform the proposed content of a lifestyle intervention programme amongst women attending breast cancer screening. METHODS: Women attending breast cancer screening clinics in Dundee and Glasgow, were invited to participate in focus group discussions (FGD) by clinic staff. The groups were convened out with the clinic setting and moderated by an experienced researcher who attained brief details on socio-demographic background and audio-recorded the discussions. Data analysis was guided by the framework approach. The main topics of enquiry were: Understanding of risk of breast cancer and its prevention, views on engaging with a lifestyle intervention programme offered through breast cancer screening and programme design and content. RESULTS: Thirty one women attended 5 focus groups. Participant ages ranged from 51 to 78 years and 38 % lived in the two most deprived quintiles of residential areas. Women were generally positive about being offered a programme at breast cancer screening but sceptical about lifestyle associated risk, citing genetics, bad luck and knowing women with breast cancer who led healthy lifestyles as reasons to query the importance of lifestyle. Engagement via clinic staff and delivery of the programme by lifestyle coaches out with the screening setting was viewed favourably. The importance of body weight, physical activity and alcohol consumption with disease was widely known although most were surprised at the association with breast cancer. They were particularly surprised about the role of alcohol and resistant to thinking about themselves having a problem. They expressed frustration that lifestyle guidance was often conflicting and divergent over time. The concept of focussing on small lifestyle changes, which were personalised, supported socially and appropriate to age and ability were welcomed. CONCLUSIONS: Offering access to a lifestyle programme through breast screening appears acceptable. Explaining the relevance of the target behaviours for breast cancer health, endorsing and utilising consistent messages and identifying personalised, mutually agreed, behaviour change goals provides a framework for programme development.

Details of development of the resource for adults with asthma in the RAISIN (randomized trial of an asthma internet self-management intervention) study.

BACKGROUND: Around 300 million people worldwide have asthma and prevalence is increasing. Self-management can be effective in improving a range of outcomes and is cost effective, but is underutilised as a treatment strategy. Supporting optimum self-management using digital technology shows promise, but how best to do this is not clear. We aimed to develop an evidence based, theory informed, online resource to support self-management in adults with asthma, called 'Living well with Asthma', as part of the RAISIN (Randomized Trial of an Asthma Internet Self-Management Intervention) study. METHODS: We developed Living well with Asthma in two phases. Phase 1: A low fidelity prototype (paper-based) version of the website was developed iteratively through input from a multidisciplinary expert panel, empirical evidence from the literature, and potential end users via focus groups (adults with asthma and practice nurses). Implementation and behaviour change theories informed this process. Phase 2: The paper-based designs were converted to a website through an iterative user centred process. Adults with asthma (n = 10) took part in think aloud studies, discussing the paper based version, then the web-based version. Participants considered contents, layout, and navigation. Development was agile using feedback from the think aloud sessions immediately to inform design and subsequent think aloud sessions. Think aloud transcripts were also thematically analysed, further informing resource development. RESULTS: The website asked users to aim to be symptom free. Key behaviours targeted to achieve this include: optimising medication use (including inhaler technique); attending primary care asthma reviews; using asthma action plans; increasing physical activity levels; and stopping smoking. The website had 11 sections, plus email reminders, which promoted these behaviours. Feedback on the contents of the resource was mainly positive with most changes focussing on clarification of language, order of pages and usability issues mainly relating to navigation difficulties. CONCLUSIONS: Our multifaceted approach to online intervention development underpinned by theory, using evidence from the literature, co-designed with end users and a multidisciplinary panel has resulted in a resource which end users find relevant to their needs and easy to use. Living well with Asthma is undergoing evaluation within a randomized controlled trial.

Breast cancer risk reduction--is it feasible to initiate a randomised controlled trial of a lifestyle intervention programme (ActWell) within a national breast screening programme?

BACKGROUND: Breast cancer is the most commonly diagnosed cancer and the second cause of cancer deaths amongst women in the UK. The incidence of the disease is increasing and is highest in women from least deprived areas. It is estimated that around 42% of the disease in post-menopausal women could be prevented by increased physical activity and reductions in alcohol intake and body fatness. Breast cancer control endeavours focus on national screening programmes but these do not include communications or interventions for risk reduction. This study aimed to assess the feasibility of delivery, indicative effects and acceptability of a lifestyle intervention programme initiated within the NHS Scottish Breast Screening Programme (NHSSBSP). METHODS: A 1:1 randomised controlled trial (RCT) of the 3 month ActWell programme (focussing on body weight, physical activity and alcohol) versus usual care conducted in two NHSSBSP sites between June 2013 and January 2014. Feasibility assessments included recruitment, retention, and fidelity to protocol. Indicative outcomes were measured at baseline and 3 month follow-up (body weight, waist circumference, eating and alcohol habits and physical activity). At study end, a questionnaire assessed participant satisfaction and qualitative interviews elicited women's, coaches, and radiographers' experiences. Statistical analysis used Chi squared tests for comparisons in proportions and paired t tests for comparisons of means. Linear regression analyses were performed, adjusted for baseline values, with group allocation as a fixed effect. RESULTS: A pre-set recruitment target of 80 women was achieved within 12 weeks and 65 (81%) participants (29 intervention, 36 control) completed 3 month assessments. Mean age was 58 ± 5.6 years, mean BMI was 29.2 ± 7.0 kg/m(2) and many (44%) reported a family history of breast cancer. The primary analysis (baseline body weight adjusted) showed a significant between group difference favouring the intervention group of 2.04 kg (95% CI -3.24 kg to -0.85 kg). Significant, favourable between group differences were also detected for BMI, waist circumference, physical activity and sitting time. Women rated the programme highly and 70% said they would recommend it to others. CONCLUSIONS: Recruitment, retention, indicative results and participant acceptability support the development of a definitive RCT to measure long term effects. TRIAL REGISTRATION: The trial was registered with Current Controlled Trials (ISRCTN56223933).

Treatment non-adherence in pediatric long-term medical conditions: systematic review and synthesis of qualitative studies of caregivers' views.

BACKGROUND: Non-adherence to prescribed treatments is the primary cause of treatment failure in pediatric long-term conditions. Greater understanding of parents and caregivers' reasons for non-adherence can help to address this problem and improve outcomes for children with long-term conditions. METHODS: We carried out a systematic review and thematic synthesis of qualitative studies. Medline, Embase, Cinahl and PsycInfo were searched for relevant studies published in English and German between 1996 and 2011. Papers were included if they contained qualitative data, for example from interviews or focus groups, reporting the views of parents and caregivers of children with a range of long-term conditions on their treatment adherence. Papers were quality assessed and analysed using thematic synthesis. RESULTS: Nineteen papers were included reporting 17 studies with caregivers from 423 households in five countries. Long-term conditions included; asthma, cystic fibrosis, HIV, diabetes and juvenile arthritis. Across all conditions caregivers were making on-going attempts to balance competing concerns about the treatment (such as perceived effectiveness or fear of side effects) with the condition itself (for instance perceived long-term threat to child). Although the barriers to implementing treatment regimens varied across the different conditions (including complexity and time-consuming nature of treatments, un-palatability and side-effects of medications), it was clear that caregivers worked hard to overcome these day-to-day challenges and to deal with child resistance to treatments. Yet, carers reported that strict treatment adherence, which is expected by health professionals, could threaten their priorities around preserving family relationships and providing a 'normal life' for their child and any siblings. CONCLUSIONS: Treatment adherence in long-term pediatric conditions is a complex issue which needs to be seen in the context of caregivers balancing the everyday needs of the child within everyday family life. Health professionals may be able to help caregivers respond positively to the challenge of treatment adherence for long-term conditions by simplifying treatment regimens to minimise impact on family life and being aware of difficulties around child resistance and supportive of strategies to attempt to overcome this. Caregivers would also welcome help with communicating with children about treatment goals.

Developing a community-based intervention to improve quality of life in people with colorectal cancer: a complex intervention development study.

OBJECTIVES: To develop and pilot a theory and evidence-based intervention to improve quality of life (QoL) in people with colorectal cancer. DESIGN: A complex intervention development study. SETTING: North East Scotland and Glasgow. PARTICIPANTS: Semistructured interviews with people with colorectal cancer (n=28), cancer specialists (n=16) and primary care health professionals (n=14) and pilot testing with patients (n=12). INTERVENTIONS: A single, 1 h nurse home visit 6-12 weeks after diagnosis, and telephone follow-up 1 week later (with a view to ongoing follow-up in future). PRIMARY AND SECONDARY OUTCOME MEASURES: Qualitative assessment of intervention feasibility and acceptability. RESULTS: Modifiable predictors of QoL identified previously were symptoms (fatigue, pain, diarrhoea, shortness of breath, insomnia, anorexia/cachexia, poor psychological well-being, sexual problems) and impaired activities. To modify these symptoms and activities, an intervention based on Control Theory was developed to help participants identify personally important symptoms and activities; set appropriate goals; use action planning to progress towards goals; self-monitor progress and identify (and tackle) barriers limiting progress. Interview responses were generally favourable and included recommendations about timing and style of delivery that were incorporated into the intervention. The pilot study demonstrated the feasibility of intervention delivery. CONCLUSIONS: Through multidisciplinary collaboration, a theory-based, acceptable and feasible intervention to improve QoL in colorectal cancer patients was developed, and can now be evaluated.

Football Fans in Training: the development and optimization of an intervention delivered through professional sports clubs to help men lose weight, become more active and adopt healthier eating habits.

BACKGROUND: The prevalence of obesity in men is rising, but they are less likely than women to engage in existing weight management programmes. The potential of professional sports club settings to engage men in health promotion activities is being increasingly recognised. This paper describes the development and optimization of the Football Fans in Training (FFIT) programme, which aims to help overweight men (many of them football supporters) lose weight through becoming more active and adopting healthier eating habits. METHODS: The MRC Framework for the design and evaluation of complex interventions was used to guide programme development in two phases. In Phase 1, a multidisciplinary working group developed the pilot programme (p-FFIT) and used a scoping review to summarize previous research and identify the target population. Phase 2 involved a process evaluation of p-FFIT in 11 Scottish Premier League (SPL) clubs. Participant and coach feedback, focus group discussions and interviews explored the utility/acceptability of programme components and suggestions for changes. Programme session observations identified examples of good practice and problems/issues with delivery. Together, these findings informed redevelopment of the optimized programme (FFIT), whose components were mapped onto specific behaviour change techniques using an evidence-based taxonomy. RESULTS: p-FFIT comprised 12, weekly, gender-sensitised, group-based weight management classroom and 'pitch-side' physical activity sessions. These in-stadia sessions were complemented by an incremental, pedometer-based walking programme. p-FFIT was targeted at men aged 35-65 years with body mass index ≥ 27 kg/m(2). Phase 2 demonstrated that participants in p-FFIT were enthusiastic about both the classroom and physical activity components, and valued the camaraderie and peer-support offered by the programme. Coaches appreciated the simplicity of the key healthy eating and physical activity messages. Suggestions for improvements that were incorporated into the optimized FFIT programme included: more varied in-stadia physical activity with football-related components; post-programme weight management support (emails and a reunion session); and additional training for coaches in SMART goal setting and the pedometer-based walking programme. CONCLUSIONS: The Football Fans in Training programme is highly acceptable to participants and SPL coaches, and is appropriate for evaluation in a randomised controlled trial.