An evaluation of the feasibility of implementing the BeWEL lifestyle intervention programme for people at increased risk of colorectal cancer - from research to real life.

BACKGROUND: The BeWEL randomised controlled trial (RCT) of weight loss in people with colorectal adenomas demonstrated that a significant proportion of people are interested in lifestyle interventions (49%) and clinically relevant changes in body weight were achieved at 12-month follow-up. The current work aimed to assess the feasibility of the BeWEL programme invitation and delivery in a nonresearch setting to assess whether the original results could be replicated. METHODS: The original BeWel programme was modified through the provision of verbal introductions (vs. letter), requirement for people to contact BeWEL team (vs. BeWEL team contacting them), community delivery (vs. home), duration (12 weeks vs. 12 months) and two intervention visits (vs. 3) and inclusion of people with predisposition to colorectal cancer. Eligible people were informed about the BeWel programme from National Health Service (NHS) staff after colonoscopy procedures and invited to contact a dedicated Bowel Cancer UK lifestyle team. RESULTS: Findings demonstrated that programme uptake (10.6% vs. 33%) and retention (71% vs. 93%) was significantly lower than that obtained from the BeWEL RCT. For people who participated in the 3-month programme (n = 21), self-reported weight loss (mean: -7% body weight) was successful, and the programme was well received. CONCLUSIONS: The current approach to engaging clients with the BeWEL programme is unsustainable. Reliance on busy NHS staff to deliver invitations and the need for people to contact the delivery team (due to data protection) may have impacted on uptake. Alternative approaches to supporting weight management in this population should be explored further.

Response to a novel, weight self-awareness plan used in a multi-component lifestyle intervention programme to reduce breast cancer risk factors in older women-Secondary analysis from the ActWELL trial.

BACKGROUND: The ActWELL randomised controlled trial assessed the effectiveness of a weight management programme delivered by volunteer lifestyle coaches (LCs) in women attending breast clinics. The intervention focused on caloric intake and physical activity, utilising behavioural change techniques including a weight awareness plan (WAP). The current work is a secondary analysis of the ActWELL data and aims to examine the response to the weight self-awareness plan (used as part of the intervention programme). METHODS: The LCs invited participants (n = 279) to undertake an implementation intention discussion to formulate a self-weighing (SW) plan. Bodyweight scales were offered, and recording books provided. The physical activity component of the intervention focused on a walking plan assessed by accelerometers. The LCs contacted participants by telephone monthly and provided personalised feedback. Mann-Whitney tests and chi-squared analysis were used to examine the effect of SW on weight change. A qualitative evaluation utilising semi-structured interviews was also undertaken. RESULTS: Most participants (96.4%) agreed to set a weekly SW goal and 76 (27%) requested scales. At 12 months, 226 (81%) returned for follow up. The median (interquartile range) weight change for those who self- reported at least one weight (n = 211) was -2.3 kg (-5.0 to 0.0) compared to -1.2 kg (-5.0 to 0.03) in those who did not (n = 14). Participants who reported weights on more than eight occasions (39%) were significantly more likely (p = 0.012) to achieve 5% weight loss compared to those who weighed less often. Low numbers of accelerometers were returned that did not allow for significance testing. Qualitative data (n = 24) indicated that many participants found the WAP helpful and motivating. CONCLUSIONS: Greater adherence to the WAP initiated by volunteer coaches is associated with achieving 5% weight loss.

Applying Mendelian randomization to appraise causality in relationships between nutrition and cancer.

Dietary factors are assumed to play an important role in cancer risk, apparent in consensus recommendations for cancer prevention that promote nutritional changes. However, the evidence in this field has been generated predominantly through observational studies, which may result in biased effect estimates because of confounding, exposure misclassification, and reverse causality. With major geographical differences and rapid changes in cancer incidence over time, it is crucial to establish which of the observational associations reflect causality and to identify novel risk factors as these may be modified to prevent the onset of cancer and reduce its progression. Mendelian randomization (MR) uses the special properties of germline genetic variation to strengthen causal inference regarding potentially modifiable exposures and disease risk. MR can be implemented through instrumental variable (IV) analysis and, when robustly performed, is generally less prone to confounding, reverse causation and measurement error than conventional observational methods and has different sources of bias (discussed in detail below). It is increasingly used to facilitate causal inference in epidemiology and provides an opportunity to explore the effects of nutritional exposures on cancer incidence and progression in a cost-effective and timely manner. Here, we introduce the concept of MR and discuss its current application in understanding the impact of nutritional factors (e.g., any measure of diet and nutritional intake, circulating biomarkers, patterns, preference or behaviour) on cancer aetiology and, thus, opportunities for MR to contribute to the development of nutritional recommendations and policies for cancer prevention. We provide applied examples of MR studies examining the role of nutritional factors in cancer to illustrate how this method can be used to help prioritise or deprioritise the evaluation of specific nutritional factors as intervention targets in randomised controlled trials. We describe possible biases when using MR, and methodological developments aimed at investigating and potentially overcoming these biases when present. Lastly, we consider the use of MR in identifying causally relevant nutritional risk factors for various cancers in different regions across the world, given notable geographical differences in some cancers. We also discuss how MR results could be translated into further research and policy. We conclude that findings from MR studies, which corroborate those from other well-conducted studies with different and orthogonal biases, are poised to substantially improve our understanding of nutritional influences on cancer. For such corroboration, there is a requirement for an interdisciplinary and collaborative approach to investigate risk factors for cancer incidence and progression.

Influence of geographical latitude on vitamin D status: cross-sectional results from the BiomarCaRE consortium.

Even though sunlight is viewed as the most important determinant of 25-hydroxyvitamin D (25(OH)D) status, several European studies have observed higher 25(OH)D concentrations among north-Europeans than south-Europeans. We studied the association between geographical latitude (derived from ecological data) and 25(OH)D status in six European countries using harmonised immunoassay data from 81 084 participants in the Biomarkers for Cardiovascular Risk Assessment in Europe (BiomarCaRE) project (male sex 48·9 %; median age 50·8 years; examination period 1984-2014). Quantile regression models, adjusted for age, sex, decade and calendar week of sampling and time from sampling to analysis, were used for between-country comparisons. Up until the median percentile, the ordering of countries by 25(OH)D status (from highest to lowest) was as follows: Sweden (at 65·6-63·8°N), Germany (at 48·4°N), Finland (at 65·0-60·2°N), Italy (at 45·6-41·5°N), Scotland (at 58·2-55·1°N) and Spain (at 41·5°N). From the 75th percentile and upwards, Finland had higher values than Germany. As an example, using the Swedish cohort as a comparator, the median 25(OH)D concentration was 3·03, 3·28, 5·41, 6·54 and 9·28 ng/ml lower in the German, Finnish, Italian, Scottish and Spanish cohort, respectively (P-value < 0·001 for all comparisons). The ordering of countries was highly consistent in subgroup analyses by sex, age, and decade and season of sampling. In conclusion, we confirmed the previous observation of a north-to-south gradient of 25(OH)D status in Europe, with higher percentile values among north-Europeans than south-Europeans.

Prehabilitation services for people diagnosed with cancer in Scotland - Current practice, barriers and challenges to implementation.

BACKGROUND: Prehabilitation is the practice of enhancing a patient's functional and psychological capacity before treatment commences. It is of interest in the cancer context because of the impact of treatments on quality of life and cancer survivorship. This work aims to document current practice, barriers and challenges to implementing prehabilitation to inform the development of a national framework. METHODS: A mixed-methods approach was applied: an on-line survey was sent to stakeholders in cancer care across Scotland, supplemented by in-depth interviews. Key domains explored were the perceived importance of prehabilitation, availability, delivery and content of services, outcome measures, referral processes and funding. FINDINGS: A total of 295 survey responses were obtained and 11 interviews completed. Perceived importance of prehabilitation was rated highly. There was uncertainty over the definition of prehabilitation and most respondents did not know if local services were available. Where services were described, a range of health professionals were involved, different outcome measures were utilised and frequency of referrals varied. Respondents highlighted short time frames between referral and treatment, concerns about patient engagement, the evidence base for action and funding priorities. Respondents also commented on which context a referral should be made and to whom, and the need for equity of service across the country. CONCLUSIONS: The current work found clear evidence of the perceived importance of prehabilitation in cancer patients. However, issues and key gaps were identified within current services (including issues arising from COVID-19) which must be addressed to enable wide-spread development and implementation of equitable programmes.

Transition to quantitative faecal immunochemical testing from guaiac faecal occult blood testing in a fully rolled-out population-based national bowel screening programme.

OBJECTIVE: Faecal immunochemical tests (FIT) are replacing guaiac faecal occult blood tests (FOBT) in colorectal cancer (CRC) screening. Data from the first year of FIT screening were compared with those from FOBT screening and assumptions based on a pilot evaluation of FIT. DESIGN: Data on uptake, positivity, positive predictive value (PPV) for CRC and higher-risk adenoma from participants in the first year of the FIT-based Scottish Bowel Screening Programme (n=919 665), with a threshold of 80 µg Hb/g faeces, were compared with those from the penultimate year of the FOBT-based programme (n=862 165) and those from the FIT evaluation (n=66 225). RESULTS: Overall, uptake of FIT was 63.9% compared with 56.4% for FOBT. Positivity was 3.1% and 2.2% with FIT and FOBT; increases were seen in both sexes, and across age range and deprivation. More CRC and adenomas were detected by FIT, but the PPV for CRC was less (5.2% with FIT and 6.4% with FOBT). However, for higher-risk adenoma, PPV was greater with FIT (24.3% with FIT and 19.3% with FOBT). In the previous FIT evaluation, uptake was 58.5% with FIT compared with 54.0% with FOBT; positivity was 2.5% with FIT and 2.0% with FOBT. CONCLUSION: Transition to FIT from FOBT produced higher uptake and positivity with lower PPV for CRC and higher PPV for adenoma. The FIT pilot evaluation underestimated uptake and positivity. Introducing FIT at the same threshold as the evaluation caused a 67.2% increase in colonoscopy demand instead of a predicted 10%.

Cancer prevention through weight control-where are we in 2020?

Growing data from epidemiological studies highlight the association between excess body fat and cancer incidence, but good indicative evidence demonstrates that intentional weight loss, as well as increasing physical activity, offers much promise as a cost-effective approach for reducing the cancer burden. However, clear gaps remain in our understanding of how changes in body fat or levels of physical activity are mechanistically linked to cancer, and the magnitude of their impact on cancer risk. It is important to investigate the causal link between programmes that successfully achieve short-term modest weight loss followed by weight-loss maintenance and cancer incidence. The longer-term impact of weight loss and duration of overweight and obesity on risk reduction also need to be fully considered in trial design. These gaps in knowledge need to be urgently addressed to expedite the development and implementation of future cancer-control strategies. Comprehensive approaches to trial design, Mendelian randomisation studies and data-linkage opportunities offer real possibilities to tackle current research gaps. In this paper, we set out the case for why non-pharmacological weight-management trials are urgently needed to support cancer-risk reduction and help control the growing global burden of cancer.

Cancer survivorship, excess body fatness and weight-loss intervention-where are we in 2020?

Earlier diagnosis and more effective treatments mean that the estimated number of cancer survivors in the United Kingdom is expected to reach 4 million by 2030. However, there is an increasing realisation that excess body fatness (EBF) is likely to influence the quality of cancer survivorship and disease-free survival. For decades, the discussion of weight management in patients with cancer has been dominated by concerns about unintentional weight loss, low body weight and interventions to increase weight, often re-enforced by the existence of the obesity paradox, which indicates that high body weight is associated with survival benefits for some types of cancer. However, observational evidence provides strong grounds for testing the hypothesis that interventions for promoting intentional loss of body fat and maintaining skeletal muscle in overweight and obese cancer survivors would bring important health benefits in terms of survival outcomes and long-term impact on treatment-related side effects. In this paper, we outline the need for studies to improve our understanding of the health benefits of weight-loss interventions, such as hypocaloric healthy-eating plans combined with physical activity. In particular, complex intervention trials that are pragmatically designed are urgently needed to develop effective, clinically practical, evidence-based strategies for reducing EBF and optimising body composition in people living with and beyond common cancers.

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.

A novel approach to increasing community capacity for weight management a volunteer-delivered programme (ActWELL) initiated within breast screening clinics: a randomised controlled trial.

BACKGROUND: It is estimated that around 30% of breast cancers in post-menopausal women are related to lifestyle. The breast cancer-pooling project demonstrated that sustained weight loss of 2 to 4.5 kg is associated with an 18% lower risk of breast cancer, highlighting the importance of small changes in body weight. Our study aimed to assess the effectiveness a volunteer-delivered, community based, weight management programme (ActWELL) for women with a BMI > 25 kg/m2 attending NHS Scotland Breast Screening clinics. METHODS: A multicentre, 1:1 parallel group, randomised controlled trial was undertaken in 560 women aged 50 to 70 years with BMI > 25 kg/m2. On completion of baseline measures, all participants received a breast cancer prevention leaflet. Intervention group participants received the ActWELL intervention which focussed on personalised diet advice and pedometer walking plans. The programme was delivered in leisure centres by (the charity) Breast Cancer Now volunteer coaches. Primary outcomes were changes between groups at 12 months in body weight (kg) and physical activity (accelerometer measured step count). RESULTS: Two hundred seventy-nine women were allocated to the intervention group and 281 to the comparison group. Twelve-month data were available from 240 (81%) intervention and 227 (85%) comparison group participants. Coaches delivered 523 coaching sessions and 1915 support calls to 279 intervention participants. Mean weight change was - 2.5 kg (95% CI - 3.1 to - 1.9) in the intervention group and - 1.2 kg (- 1.8 to 0.6) in the comparison group. The adjusted mean difference was - 1.3 kg (95% CI - 2.2 to - 0.4, P = 0.003). The odds ratio for losing 5% weight was 2.20 (95% CI 1.4 to 3.4, p = 0.0005) in favour of the intervention. The adjusted mean difference in step counts between groups was 483 steps/day (95% CI - 635 to 1602) (NS). CONCLUSIONS: A community weight management intervention initiated at breast screening clinics and delivered by volunteer coaches doubled the likelihood of clinically significant weight loss at 12 months (compared with usual care) offering significant potential to decrease breast cancer risk. TRIAL REGISTRATION: Database of registration: ISCRTN. Registration number: 11057518 . Date trial registered:21.07.2017. Date of enrolment of first participant: 01.09.2017.

A qualitative evaluation of the impact of a training programme on colorectal cancer risk reduction for Specialist Screening Practitioners on health promotion, knowledge and practice.

OBJECTIVE: Colorectal cancer (CRC) is the fourth most common cancer in the UK. It is estimated that around 50% of the disease burden is caused by lifestyle factors. This paper evaluates the impact of a training programme for Specialist Screening Practitioners (SSPs) on knowledge of CRC risk reduction and subsequent health promotion activities. METHOD: Attendees (n = 21) were invited to participate in semi-structured qualitative telephone interviews developed in conjunction with programme organisers. An independent researcher undertook the interviews on the perceived impact of the training on knowledge about risk reduction, communicating health promotion messages and working practices. RESULTS: Ten interviews were conducted. The programme was perceived to be successful in increasing knowledge about CRC risk and methods to promote behavioural change. Participants questioned the suitability of the endoscopy setting to communicate health promotion messages given patient anxiety pre-investigation and post-investigation elation after negative results. Key barriers to health promotion activities were time, hesitancy over raising issues that could not be easily discussed and scepticism about the ability of older adults to change their lifestyle. CONCLUSIONS: Training on CRC risk reduction increased knowledge and behaviour change skills among SSPs. Further work is needed to explore opportunities to optimise the screening environment for health promotion activities.

Public Perceptions of Harm for Nine Popular Gambling Products.

Gambling causes significant levels of harm globally and is recognised as a serious public health issue. To reduce gambling-related harm, various strategies and policies have been recommended, including decreasing the availability of gambling products, restricting gambling advertising, and implementing public education campaigns. Government willingness to implement such strategies will be influenced by levels of public support, which in turn will be dependent on public perceptions of the harm caused by gambling products. The aim of the present study was to assess public perceptions of the harm associated with individual gambling products to inform future gambling reform. A sample of 2112 Australian adults provided perceived harm ratings for nine popular gambling products that are known to be associated with gambling-related harm: electronic gambling machines, casino table games, sports betting, bingo, scratch tickets, private betting, horse/dog races, keno, and the lottery. Binary logistic regressions were used to identify factors associated with harm perceptions. Only electronic gambling machines (70%), casino table games (64%), betting on horse/dog races (59%), and sports betting (53%) were perceived by a majority of respondents as being harmful. Less frequent gambling and experiencing greater levels of gambling-related harm were associated with higher harm perceptions. Many potentially harmful gambling products may not be recognised as such by the public, which is likely to reduce support for recommended harm-reduction strategies and policies. Efforts are needed to ensure Australians in general and gamblers in particular understand the levels of harm associated with popular gambling products.

Making hospital shops healthier: evaluating the implementation of a mandatory standard for limiting food products and promotions in hospital retail outlets.

BACKGROUND: The range of products stocked and their promotions in food retail outlets in healthcare settings can affect food choices by staff, patients and visitors. The innovative Scottish Healthcare Retail Standard (HRS) is a national mandatory scheme requiring all hospital food retail outlets to change the balance of food products stocked and their promotion to comply with nutritional criteria and promotional restrictions. The aim is to facilitate healthier food choices in healthcare settings. This study examined the implementation of HRS and the impact on foods stocked and promoted. METHODS: The study aimed to examine implementation process and changes to the retail environment in relation to food promotions and choice. A sample of hospital retail outlets (n = 17) including shops and trolley services were surveyed using a mixed methods design comprising: (a) structured observational audits of stock, layout and promotions (with a specific focus on chocolate and fruit product lines), and (b) face-to-face, semi-structured interviews with the shop manager or nominated members of staff (n = 32). Data were collected at Wave 1 (2016), at the beginning and during the early stages of HRS implementation; and Wave 2, 12 months later, after the HRS implementation deadline. RESULTS: All outlets, both commercial and not-for-profit, in the sample successfully implemented HRS. Implementation was reported to be more challenging by independent shop managers compared to chain store staff. Retail managers identified areas where more implementation guidance and support could have been provided. The number of chocolate product lines and promotions reduced substantially between Waves 1 and 2, but with no substantial increase in fruit product lines and promotions. Despite initial negative expectations of HRS's impact, managers identified some opportunities in the scheme and positive changes in the supply chain. CONCLUSIONS: Positive changes in food retail outlets occurred after hospital shops were required to implement HRS. By creating a consistent approach across hospital shops in Scotland, HRS changed the food retail environment for hospital staff, visitors and patients. HRS provides a regulatory template and implementation learning points for influencing retail environments in other jurisdictions and settings.

Acceptability of the "MOVEdiabetes" physical activity intervention in diabetes primary care settings in Oman: findings from participants and practitioners.

BACKGROUND: Adequate physical activity (PA) is considered essential in diabetes management. However, evidence on the best method of promoting PA within diabetes care is inconclusive. The current work identifies perceptions on the acceptability of Intervention Group Participants (IGP) and Project Officers (POs) about the "MOVEdiabetes" intervention programme aimed at increasing PA in adults with type 2 diabetes in Oman (a retrospectively registered trial). METHODS: The "MOVEdiabetes" programme (PA consultations, pedometers and WhatsApp messages) was delivered by the POs (primary health care practitioners) in four primary care centres within a one-year cluster randomised control trial. Recruitment and retention were measured from trial attendance records. Programme satisfaction, appropriateness, and content suitability were assessed using exit surveys for both the IGP (interview based) and POs (self-administered). Open text questions on perceptions to the study programme were also included. RESULTS: Participants were randomised to an intervention group (IG, n = 122) or comparison group (CG, n = 110). The overall retention rate at three and 12 months was 92.7% [110(90.2%) IG vs 105(95.5%) CG] and 75% [82(67.2%) IG vs 92(83.6%) CG] respectively. Most (n = 14, 87.5%) POs and more than half (n = 49, 59.8%) IGP perceived the programme as very appropriate and many reported that they were "quite/ very satisfied" with the programme (n = 16, 100% PO's and n = 71, 86.6% IGP). Two thirds (n = 55, 66.0%) of IGP were very/quite likely to recommend the programme to others. PA consultations, use of pedometers and Whatsapp messages were well perceived by all. Participants recommended the inclusion of dietary advice and PA promotion for the general public. Exploring PA facilities within the community was suggested by POs. CONCLUSIONS: The "MOVEdiabetes" programme achieved a high retention rate and was perceived as satisfactory and appropriate. Results from this study suggest that it is worthwhile exploring the use of the "MOVEdiabetes" programme in clinical practice and further community links. TRIAL REGISTRATION: International Standard Randomised Controlled Trials No: ISRCTN14425284. Registered retrospectively on 12th April 2016.

Symptom Management Among Cancer Survivors: Randomized Pilot Intervention Trial of Heart Rate Variability Biofeedback.

Chronic cancer-related symptoms (stress, fatigue, pain, depression, insomnia) may be linked with sympathetic nervous system over-activation and autonomic imbalance. Decreased heart rate variability (HRV) is an indicator of autonomic dysregulation that is commonly observed among cancer survivors. HRV biofeedback (HRVB) training induces HRV coherence, which maximizes HRV and facilitates autonomic and cardiorespiratory homeostasis. This randomized, wait-list-controlled, pilot intervention trial tested the hypothesis that HRVB can improve HRV coherence and alleviate cancer-related symptoms. The intervention group (n = 17) received 4-6 weekly HRVB training sessions until participants demonstrated skill acquisition. Controls (n = 17) received usual care. Outcomes assessed at baseline and follow-up included 15-min HRV recordings (HRV Coherence Ratio), and symptoms of: stress, distress, post-traumatic stress disorder (PTSD), pain, depression, fatigue, and sleep disturbance. Linear mixed models for repeated measures were used to assess Group-by-Time interactions, pre- versus post-treatment differences in mean symptom scores, and group differences at follow-up. Mean HRV Coherence Ratios (± standard error) improved in the HRVB group at follow-up (baseline: 0.37 ± 0.05, post-intervention: 0.84 ± 0.18, p = 0.01), indicating intervention validity. Statistically significant Group-by-Time interactions indicated treatment-related improvements in HRV Coherence Ratios (p = 0.03, Pre-vs. post-treatment effect size [Cohen's d]: 0.98), sleep symptoms (p = 0.001, d = 1.19), and sleep-related daytime impairment (p = 0.005, d = 0.86). Relative to controls, the intervention group experienced trends toward improvements in stress, distress, fatigue, PTSD, and depression, although no other statistically significant Group-by-Time interactions were observed. This pilot intervention found that HRVB training reduced symptoms of sleep disturbance among cancer survivors. Larger-scale interventions are warranted to further evaluate the role of HRVB for managing symptoms in this population. Registration: NCT03692624 www.clinicaltrials.gov.

Correction: The effect of a programme to improve men's sedentary time and physical activity: The European Fans in Training (EuroFIT) randomised controlled trial.

[This corrects the article DOI: 10.1371/journal.pmed.1002736.].

The effect of a programme to improve men's sedentary time and physical activity: The European Fans in Training (EuroFIT) randomised controlled trial.

BACKGROUND: Reducing sitting time as well as increasing physical activity in inactive people is beneficial for their health. This paper investigates the effectiveness of the European Fans in Training (EuroFIT) programme to improve physical activity and sedentary time in male football fans, delivered through the professional football setting. METHODS AND FINDINGS: A total of 1,113 men aged 30-65 with self-reported body mass index (BMI) ≥27 kg/m2 took part in a randomised controlled trial in 15 professional football clubs in England, the Netherlands, Norway, and Portugal. Recruitment was between September 19, 2015, and February 2, 2016. Participants consented to study procedures and provided usable activity monitor baseline data. They were randomised, stratified by club, to either the EuroFIT intervention or a 12-month waiting list comparison group. Follow-up measurement was post-programme and 12 months after baseline. EuroFIT is a 12-week, group-based programme delivered by coaches in football club stadia in 12 weekly 90-minute sessions. Weekly sessions aimed to improve physical activity, sedentary time, and diet and maintain changes long term. A pocket-worn device (SitFIT) allowed self-monitoring of sedentary time and daily steps, and a game-based app (MatchFIT) encouraged between-session social support. Primary outcome (objectively measured sedentary time and physical activity) measurements were obtained for 83% and 85% of intervention and comparison participants. Intention-to-treat analyses showed a baseline-adjusted mean difference in sedentary time at 12 months of -1.6 minutes/day (97.5% confidence interval [CI], -14.3-11.0; p = 0.77) and in step counts of 678 steps/day (97.5% CI, 309-1.048; p < 0.001) in favor of the intervention. There were significant improvements in diet, weight, well-being, self-esteem, vitality, and biomarkers of cardiometabolic health in favor of the intervention group, but not in quality of life. There was a 0.95 probability of EuroFIT being cost-effective compared with the comparison group if society is willing to pay £1.50 per extra step/day, a maximum probability of 0.61 if society is willing to pay £1,800 per minute less sedentary time/day, and 0.13 probability if society is willing to pay £30,000 per quality-adjusted life-year (QALY). It was not possible to blind participants to group allocation. Men attracted to the programme already had quite high levels of physical activity at baseline (8,372 steps/day), which may have limited room for improvement. Although participants came from across the socioeconomic spectrum, a majority were well educated and in paid work. There was an increase in recent injuries and in upper and lower joint pain scores post-programme. In addition, although the five-level EuroQoL questionnaire (EQ-5D-5L) is now the preferred measure for cost-effectiveness analyses across Europe, baseline scores were high (0.93), suggesting a ceiling effect for QALYs. CONCLUSION: Participation in EuroFIT led to improvements in physical activity, diet, body weight, and biomarkers of cardiometabolic health, but not in sedentary time at 12 months. Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life. Nevertheless, decision-makers may consider the incremental cost for increase in steps worth the investment. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN-81935608.

Alcohol use and breast cancer risk: A qualitative study of women's perspectives to inform the development of a preventative intervention in breast clinics.

OBJECTIVE: This study aimed to explore women's views about breast cancer risk and alcohol use, to inform the design of a prototype for an intervention in breast clinics about alcohol as a modifiable risk factor for breast cancer. METHODS: Women recruited in NHS breast screening and symptomatic clinics in Southampton, UK, were invited to take part in semi-structured telephone interviews or a focus group to discuss their perspectives of breast cancer risk, alcohol consumption and their information needs about these topics. Data were analysed thematically. Twenty-eight women took part in telephone interviews, and 16 attended one of three focus groups. RESULTS: While most women reported a personal responsibility for their health and were interested in advice about modifiable risk factors, few without (or prior to) experience of breast symptoms independently sought information. Many considered alcohol advice irrelevant as the association with breast cancer was largely unknown, and participants did not consider their drinking to be problematic. Women reported trusting information from health organisations like the NHS, but advice needs to be sensitive and non-blaming. CONCLUSION: NHS breast screening and symptomatic clinics offer a "teachable moment" to engage women with context-specific advice about alcohol and cancer risk that, if targeted correctly, may assist them in making informed lifestyle choices.

Metabolic syndrome in rural Australia: An opportunity for primary health care.

OBJECTIVE: To measure the impact of a 6-month home-based behaviour change intervention on reducing the risk of chronic disease as determined by metabolic syndrome status and cardiovascular risk score, and discuss implications for primary care in rural areas. DESIGN: A two-arm randomised controlled trial of rural adults. SETTING: The rural town of Albany in the Great Southern region of Western Australia. PARTICIPANTS: Participants (n = 401) aged 50-69 years who were classified with or at risk of metabolic syndrome and randomly assigned to intervention (n = 201) or waitlisted control (n = 200) group. INTERVENTIONS: A 6-month intervention program incorporating goal setting, self-monitoring and feedback, with motivational interviewing was conducted. MAIN OUTCOME MEASURES: Change in metabolic syndrome status and cardiovascular risk. RESULTS: Significant improvements in metabolic syndrome status and cardiovascular disease risk score (-0.82) were observed for the intervention group relative to control group from baseline to post-test. CONCLUSION: This home-based physical activity and nutrition intervention reduced participants' risk of experiencing a cardiovascular event in the next 5 years by 1%. Incorporating such prevention orientated approaches in primary care might assist in reducing the burden of long-term chronic diseases. However, for realistic application in this setting, hurdles such as current national health billing system and availability of resources will need to be considered.

Critical research gaps and recommendations to inform research prioritisation for more effective prevention and improved outcomes in colorectal cancer.

OBJECTIVE: Colorectal cancer (CRC) leads to significant morbidity/mortality worldwide. Defining critical research gaps (RG), their prioritisation and resolution, could improve patient outcomes. DESIGN: RG analysis was conducted by a multidisciplinary panel of patients, clinicians and researchers (n=71). Eight working groups (WG) were constituted: discovery science; risk; prevention; early diagnosis and screening; pathology; curative treatment; stage IV disease; and living with and beyond CRC. A series of discussions led to development of draft papers by each WG, which were evaluated by a 20-strong patient panel. A final list of RGs and research recommendations (RR) was endorsed by all participants. RESULTS: Fifteen critical RGs are summarised below: RG1: Lack of realistic models that recapitulate tumour/tumour micro/macroenvironment; RG2: Insufficient evidence on precise contributions of genetic/environmental/lifestyle factors to CRC risk; RG3: Pressing need for prevention trials; RG4: Lack of integration of different prevention approaches; RG5: Lack of optimal strategies for CRC screening; RG6: Lack of effective triage systems for invasive investigations; RG7: Imprecise pathological assessment of CRC; RG8: Lack of qualified personnel in genomics, data sciences and digital pathology; RG9: Inadequate assessment/communication of risk, benefit and uncertainty of treatment choices; RG10: Need for novel technologies/interventions to improve curative outcomes; RG11: Lack of approaches that recognise molecular interplay between metastasising tumours and their microenvironment; RG12: Lack of reliable biomarkers to guide stage IV treatment; RG13: Need to increase understanding of health related quality of life (HRQOL) and promote residual symptom resolution; RG14: Lack of coordination of CRC research/funding; RG15: Lack of effective communication between relevant stakeholders. CONCLUSION: Prioritising research activity and funding could have a significant impact on reducing CRC disease burden over the next 5 years.