Impact on wine sales of removing the largest serving size by the glass: An A-B-A reversal trial in 21 pubs, bars, and restaurants in England.

BACKGROUND: Interventions that alter aspects of the physical environments in which unhealthy behaviours occur have the potential to change behaviour at scale, i.e., across populations, and thereby decrease the risk of several diseases. One set of such interventions involves reducing serving sizes, which could reduce alcohol consumption. The effect of modifying the available range of serving sizes of wine in a real-world setting is unknown. We aimed to assess the impact on the volume of wine sold of removing the largest serving size by the glass from the options available in licensed premises. METHODS AND FINDINGS: The study was conducted between September 2021 and May 2022 in 21 licensed premises in England that sold wine by the glass in serving sizes greater than 125 ml (i.e., 175 ml or 250 ml) and used an electronic point of sale till system. It used an A-B-A reversal design, set over 3 four-weekly periods. "A" represented the nonintervention periods during which standard serving sizes were served and "B" the intervention period when the largest serving size for a glass of wine was removed from the existing range in each establishment: 250 ml (18 premises) or 175 ml (3 premises). The primary outcome was the daily volume of wine sold, extracted from sales data. Twenty-one premises completed the study, 20 of which did so per protocol and were included in the primary analysis. After adjusting for prespecified covariates, the intervention resulted in -420·8 millilitres (ml) (95% confidence intervals (CIs) -681·4 to -160·2 p = 0·002) or -7·6% (95% CI -12·3%, -2·9%) less wine being sold per day. There was no evidence that sales of beer and cider or total daily revenues changed but the study was not powered to detect differences in these outcomes. The main study limitation is that we were unable to assess the sales of other alcoholic drinks apart from wine, beer, and cider, estimated to comprise approximately 30% of alcoholic drinks sold in participating premises. CONCLUSIONS: Removing the largest serving size of wine by the glass from those available reduced the volume of wine sold. This promising intervention for decreasing alcohol consumption across populations merits consideration as part of alcohol licensing regulations. TRIAL REGISTRATION: ISRCTN https://doi.org/10.1186/ISRCTN33169631; OSF https://osf.io/xkgdb.

Impact on alcohol selection and online purchasing of changing the proportion of available non-alcoholic versus alcoholic drinks: A randomised controlled trial.

BACKGROUND: Increasing the availability of non-alcoholic options is a promising population-level intervention to reduce alcohol consumption, currently unassessed in naturalistic settings. This study in an online retail context aimed to estimate the impact of increasing the proportion of non-alcoholic (relative to alcoholic) drinks, on selection and purchasing of alcohol. METHODS AND RESULTS: Adults (n = 737) residing in England and Wales who regularly purchased alcohol online were recruited between March and July 2021. Participants were randomly assigned to one of 3 groups: "25% non-alcoholic/75% alcoholic"; "50% non-alcoholic/50% alcoholic"; and "75% non-alcoholic/25% alcoholic," then selected drinks in a simulated online supermarket, before purchasing them in an actual online supermarket. The primary outcome was the number of alcohol units selected (with intention to purchase); secondary outcomes included actual purchasing. A total of 607 participants (60% female, mean age = 38 years [range: 18 to 76]) completed the study and were included in the primary analysis. In the first part of a hurdle model, a greater proportion of participants in the "75% non-alcoholic" group did not select any alcohol (13.1%) compared to the "25% non-alcoholic" group (3.4%; 95% confidence interval [CI] -2.09, -0.63; p < 0.001). There was no evidence of a difference between the "75% non-alcoholic" and the "50% non-alcoholic" (7.2%) groups (95% CI 0.10, 1.34; p = 0.022) or between the "50% non-alcoholic" and the "25% non-alcoholic" groups (95% CI -1.44, 0.17; p = 0.121). In the second part of a hurdle model in participants (559/607) selecting any drinks containing alcohol, the "75% non-alcoholic" group selected fewer alcohol units compared to the "50% non-alcoholic" (95% CI -0.44, -0.14; p < 0.001) and "25% non-alcoholic" (95% CI -0.54, -0.24; p < 0.001) groups, with no evidence of a difference between the "50% non-alcoholic" and "25% non-alcoholic" groups (95% CI -0.24, 0.05; p = 0.178). Overall, across all participants, 17.46 units (95% CI 15.24, 19.68) were selected in the "75% non-alcoholic" group; 25.51 units (95% CI 22.60, 28.43) in the "50% non-alcoholic" group; and 29.40 units (95% CI 26.39, 32.42) in the "25% non-alcoholic" group. This corresponds to 8.1 fewer units (a 32% reduction) in the "75% non-alcoholic" compared to the "50% non-alcoholic" group, and 11.9 fewer alcohol units (41% reduction) compared to the "25% non-alcoholic" group; 3.9 fewer units (13% reduction) were selected in the "50% non-alcoholic" group than in the "25% non-alcoholic" group. For all other outcomes, alcohol selection and purchasing were consistently lowest in the "75% non-alcoholic" group. Study limitations include the setting not being entirely naturalistic due to using a simulated online supermarket as well as an actual online supermarket, and that there was substantial dropout between selection and purchasing. CONCLUSIONS: This study provides evidence that substantially increasing the proportion of non-alcoholic drinks-from 25% to 50% or 75%-meaningfully reduces alcohol selection and purchasing. Further studies are warranted to assess whether these effects are realised in a range of real-world settings. TRIAL REGISTRATION: ISRCTN: 11004483; OSF: https://osf.io/qfupw.

Impact of e-cigarette retail displays on attitudes to smoking and vaping in children: an online experimental study.

OBJECTIVES: To estimate the impact of electronic cigarette (e-cigarette) retail display exposure on attitudes to smoking and vaping (susceptibility to tobacco smoking and using e-cigarettes, and perceptions of the harms of smoking and e-cigarette use). DESIGN: Between-subjects randomised experiment using a 2 (e-cigarette retail display visibility: high vs low)×2 (proportion of e-cigarette images: 75% vs 25%) factorial design. SETTING: Online via the Qualtrics survey platform. PARTICIPANTS: UK children aged 13-17 years (n=1034), recruited through a research agency. INTERVENTION: Participants viewed 12 images of retail displays that contained e-cigarette display images or unrelated product images. E-cigarette display images were either high or low visibility, based on a conspicuousness score. Participants were randomised to one of four groups, with e-cigarette display visibility and proportion of e-cigarette images, compared with images of unrelated products, manipulated: (1) 75% e-cigarettes, high visibility; (2) 25% e-cigarettes, high visibility; (3) 75% e-cigarettes, low visibility; (4) 25% e-cigarettes, low visibility. MAIN OUTCOME MEASURES: The primary outcome was susceptibility to smoking (among never smokers only). Secondary outcomes were susceptibility to using e-cigarettes (among never vapers only), and perceptions of smoking and e-cigarette harm (all participants). RESULTS: Neither e-cigarette retail display visibility, nor the proportion of e-cigarette images displayed, appeared to influence susceptibility to smoking (visibility: OR=0.84, 95% CI 0.62 to 1.13, p=0.24; proportion: OR=1.34, 95% CI 1.00 to 1.82, p=0.054 (reference: low visibility, not susceptible)).Planned subgroup analyses indicated that exposure to a higher proportion of e-cigarette images increased susceptibility to smoking among children who visited retail stores more regularly (n=524, OR=1.59, 95% CI 1.04 to 2.43, p=0.034), and those who passed the attention check (n=880, OR=1.43, 95% CI 1.03 to 1.98, p=0.031).In addition, neither e-cigarette retail display visibility nor the proportion of e-cigarette images displayed, appeared to influence susceptibility to using e-cigarettes (visibility: OR=1.07, 95% CI 0.80 to 1.43, p=0.65; proportion: OR=1.22, 95% CI 0.91 to 1.64, p=0.18).Greater visibility of e-cigarette retail displays reduced perceived harm of smoking (mean difference (MD)=-0.19, 95% CI -0.34 to -0.04, p=0.016). There was no evidence that the proportion of e-cigarette images displayed had an effect (MD=-0.07, 95% CI -0.22 to 0.09, p=0.40).Perceived harm of e-cigarette use did not appear to be affected by e-cigarette retail display visibility (MD=-0.12, 95% CI -0.28 to 0.05, p=0.16) or by the proportion of e-cigarette images displayed (MD=-0.10, 95% CI -0.26 to 0.07, p=0.24). CONCLUSIONS: There is no evidence in the full sample to suggest that children's susceptibility to smoking is increased by exposure to higher visibility e-cigarette retail displays, or to a higher proportion of e-cigarette images. However, for regular store visitors or those paying more attention, viewing a higher proportion of e-cigarette images increased susceptibility to smoking. In addition, viewing higher visibility e-cigarette images reduced perceived harm of smoking. A review of the current regulatory discrepancy between tobacco and e-cigarette point-of-sale marketing is warranted. TRIAL REGISTRATION NUMBER: ISRCTN18215632.

Impact on sales of adding a smaller serving size of beer and cider in licensed premises: an A-B-A reversal design.

BACKGROUND: Smaller serving sizes of alcoholic drinks could reduce alcohol consumption across populations thereby lowering the risk of many diseases. The effect of modifying the available range of serving sizes of beer and cider in a real-world setting has yet to be studied. The current study assessed the impact on beer and cider sales of adding a serving size of draught beer and cider (2/3 pint) that was between the current smallest (1/2 pint) and largest (1 pint) standard serving sizes. METHODS: Twenty-two licensed premises in England consented to taking part in the study. The study used an ABA reversal design, set over three 4-weekly periods, with A representing the non-intervention periods, during which standard serving sizes were served and B the intervention period when a 2/3 pint serving size of draught beer and cider was added to the existing range, along with smaller 1/2 pint and larger 1 pint serving sizes. The primary outcome was the daily volume of beer and cider sold, extracted from sales data. RESULTS: Fourteen premises started the study, of which thirteen completed it. Twelve of those did so per protocol and were included in the primary analysis. After adjusting for pre-specified covariates, the intervention did not have a significant effect on the volume of beer and cider sold per day (3.14 ml; 95%CIs -2.29 to 8.58; p = 0.257). CONCLUSIONS: In licensed premises, there was no evidence that adding a smaller serving size for draught beer and cider (2/3 pint) when the smallest (1/2 pint) and largest (1 pint) sizes were still available, affected the volume of beer and cider sold. Studies are warranted to assess the impact of removing the largest serving size. TRIAL REGISTRATION: ISRCTN: https://doi.org/10.1186/ISRCTN33169631 (08/09/2021), OSF: https://osf.io/xkgdb/ (08/09/2021).

Evaluation of physical activity calorie equivalent (PACE) labels' impact on energy purchased in cafeterias: A stepped-wedge randomised controlled trial.

BACKGROUND: A recent meta-analysis suggested that using physical activity calorie equivalent (PACE) labels results in people selecting and consuming less energy. However, the meta-analysis included only 1 study in a naturalistic setting, conducted in 4 convenience stores. We therefore aimed to estimate the effect of PACE labels on energy purchased in worksite cafeterias in the context of a randomised study design. METHODS AND FINDINGS: A stepped-wedge randomised controlled trial (RCT) was conducted to investigate the effect of PACE labels (which include kcal content and minutes of walking required to expend the energy content of the labelled food) on energy purchased. The setting was 10 worksite cafeterias in England, which were randomised to the order in which they introduced PACE labels on selected food and drinks following a baseline period. There were approximately 19,000 workers employed at the sites, 72% male, with an average age of 40. The study ran for 12 weeks (06 April 2021 to 28 June 2021) with over 250,000 transactions recorded on electronic tills. The primary outcome was total energy (kcal) purchased from intervention items per day. The secondary outcomes were: energy purchased from non-intervention items per day, total energy purchased per day, and revenue. Regression models showed no evidence of an overall effect on energy purchased from intervention items, -1,934 kcals per site per day (95% CI -5,131 to 1,262), p = 0.236, during the intervention relative to baseline, equivalent to -5 kcals per transaction (95% CI -14 to 4). There was also no evidence for an effect on energy purchased from non-intervention items, -5 kcals per site per day (95% CI -513 to 504), p = 0.986, equivalent to 0 kcals per transaction (95% CI -1 to 1), and no clear evidence for total energy purchased -2,899 kcals per site (95% CI -5,810 to 11), p = 0.051, equivalent to -8 kcals per transaction (95% CI -16 to 0). Study limitations include using energy purchased and not energy consumed as the primary outcome and access only to transaction-level sales, rather than individual-level data. CONCLUSION: Overall, the evidence was consistent with PACE labels not changing energy purchased in worksite cafeterias. There was considerable variation in effects between cafeterias, suggesting important unmeasured moderators. TRIAL REGISTRATION: The study was prospectively registered on ISRCTN (date: 30.03.21; ISRCTN31315776).

Practical guidance for planning resources required to support publicly-funded adaptive clinical trials.

Adaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent years, research suggests they are not used in many situations where they have potential to bring benefit. One barrier to their more widespread use is a lack of understanding about how the choice to use an adaptive design, rather than a traditional design, affects resources (staff and non-staff) required to set-up, conduct and report a trial. The Costing Adaptive Trials project investigated this issue using quantitative and qualitative research amongst UK Clinical Trials Units. Here, we present guidance that is informed by our research, on considering the appropriate resourcing of adaptive trials. We outline a five-step process to estimate the resources required and provide an accompanying costing tool. The process involves understanding the tasks required to undertake a trial, and how the adaptive design affects them. We identify barriers in the publicly funded landscape and provide recommendations to trial funders that would address them. Although our guidance and recommendations are most relevant to UK non-commercial trials, many aspects are relevant more widely.

Effect of health warning labels on motivation towards energy-dense snack foods: Two experimental studies.

Health warning labels (HWLs) show promise in reducing motivation towards energy-dense snack foods. Understanding the underlying mechanisms could optimise their effectiveness. In two experimental studies in general population samples (Study 1 n = 90; Study 2 n = 1382), we compared the effects of HWLs and irrelevant aversive labels (IALs) on implicit (approach) motivation towards unhealthy snacks, using an approach-avoidance task (Study 1), and a manikin task (Study 2). We also assessed explicit motivation towards unhealthy snacks using food selection tasks. We examined whether labelling effects on motivation arose from the creation of outcome-dependent associations between the food and its health consequences or from simple, non-specific aversive associations. Both label types reduced motivation towards snack foods but only when the label was physically present. HWLs and IALs showed similar effects on implicit motivation, although HWLs reduced explicit motivation more than IALs. Thus, aversive HWLs appear to act both through low level associative mechanisms affecting implicit motivation, and by additionally emphasizing explicit causal links to health outcomes thereby affecting explicitly motivated choice behaviours.

Impact of increasing vegetarian availability on meal selection and sales in cafeterias.

Shifting people in higher income countries toward more plant-based diets would protect the natural environment and improve population health. Research in other domains suggests altering the physical environments in which people make decisions ("nudging") holds promise for achieving socially desirable behavior change. Here, we examine the impact of attempting to nudge meal selection by increasing the proportion of vegetarian meals offered in a year-long large-scale series of observational and experimental field studies. Anonymized individual-level data from 94,644 meals purchased in 2017 were collected from 3 cafeterias at an English university. Doubling the proportion of vegetarian meals available from 25 to 50% (e.g., from 1 in 4 to 2 in 4 options) increased vegetarian meal sales (and decreased meat meal sales) by 14.9 and 14.5 percentage points in the observational study (2 cafeterias) and by 7.8 percentage points in the experimental study (1 cafeteria), equivalent to proportional increases in vegetarian meal sales of 61.8%, 78.8%, and 40.8%, respectively. Linking sales data to participants' previous meal purchases revealed that the largest effects were found in the quartile of diners with the lowest prior levels of vegetarian meal selection. Moreover, serving more vegetarian options had little impact on overall sales and did not lead to detectable rebound effects: Vegetarian sales were not lower at other mealtimes. These results provide robust evidence to support the potential for simple changes to catering practices to make an important contribution to achieving more sustainable diets at the population level.

Impact of decreasing the proportion of higher energy foods and reducing portion sizes on food purchased in worksite cafeterias: A stepped-wedge randomised controlled trial.

BACKGROUND: Overconsumption of energy from food is a major contributor to the high rates of overweight and obesity in many populations. There is growing evidence that interventions that target the food environment may be effective at reducing energy intake. The current study aimed to estimate the effect of decreasing the proportion of higher energy (kcal) foods, with and without reducing portion size, on energy purchased in worksite cafeterias. METHODS AND FINDINGS: This stepped-wedge randomised controlled trial (RCT) evaluated 2 interventions: (i) availability: replacing higher energy products with lower energy products; and (ii) size: reducing the portion size of higher energy products. A total of 19 cafeterias were randomised to the order in which they introduced the 2 interventions. Availability was implemented first and maintained. Size was added to the availability intervention. Intervention categories included main meals, sides, cold drinks, snacks, and desserts. The study setting was worksite cafeterias located in distribution centres for a major United Kingdom supermarket and lasted for 25 weeks (May to November 2019). These cafeterias were used by 20,327 employees, mainly (96%) in manual occupations. The primary outcome was total energy (kcal) purchased from intervention categories per day. The secondary outcomes were energy (kcal) purchased from nonintervention categories per day, total energy purchased per day, and revenue. Regression models showed an overall reduction in energy purchased from intervention categories of -4.8% (95% CI -7.0% to -2.7%), p < 0.001 during the availability intervention period and a reduction of -11.5% (95% CI -13.7% to -9.3%), p < 0.001 during the availability plus size intervention period, relative to the baseline. There was a reduction in energy purchased of -6.6% (95% CI -7.9% to -5.4%), p < 0.001 during the availability plus size period, relative to availability alone. Study limitations include using energy purchased as the primary outcome (and not energy consumed) and the availability only of transaction-level sales data per site (and not individual-level data). CONCLUSIONS: Decreasing the proportion of higher energy foods in cafeterias reduced the energy purchased. Decreasing portion sizes reduced this further. These interventions, particularly in combination, may be effective as part of broader strategies to reduce overconsumption of energy from food in out-of-home settings. TRIAL REGISTRATION: ISRCTN registry ISRCTN87225572.

Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project.

BACKGROUND: Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional resources are required to conduct a high-quality adaptive clinical trial, compared to a traditional fixed design. The Costing Adaptive Trials (CAT) project investigated which additional resources may be required to support adaptive trials. METHODS: We conducted a mock costing exercise amongst seven Clinical Trials Units (CTUs) in the UK. Five scenarios were developed, derived from funded clinical trials, where a non-adaptive version and an adaptive version were described. Each scenario represented a different type of adaptive design. CTU staff were asked to provide the costs and staff time they estimated would be needed to support the trial, categorised into specified areas (e.g. statistics, data management, trial management). This was calculated separately for the non-adaptive and adaptive version of the trial, allowing paired comparisons. Interviews with 10 CTU staff who had completed the costing exercise were conducted by qualitative researchers to explore reasons for similarities and differences. RESULTS: Estimated resources associated with conducting an adaptive trial were always (moderately) higher than for the non-adaptive equivalent. The median increase was between 2 and 4% for all scenarios, except for sample size re-estimation which was 26.5% (as the adaptive design could lead to a lengthened study period). The highest increase was for statistical staff, with lower increases for data management and trial management staff. The percentage increase in resources varied across different CTUs. The interviews identified possible explanations for differences, including (1) experience in adaptive trials, (2) the complexity of the non-adaptive and adaptive design, and (3) the extent of non-trial specific core infrastructure funding the CTU had. CONCLUSIONS: This work sheds light on additional resources required to adequately support a high-quality adaptive trial. The percentage increase in costs for supporting an adaptive trial was generally modest and should not be a barrier to adaptive designs being cost-effective to use in practice. Informed by the results of this research, guidance for investigators and funders will be developed on appropriately resourcing adaptive trials.

Cigarette pack size and consumption: an adaptive randomised controlled trial.

BACKGROUND: Observational evidence suggests that cigarette pack size - the number of cigarettes in a single pack - is associated with consumption but experimental evidence of a causal relationship is lacking. The tobacco industry is introducing increasingly large packs, in the absence of maximum cigarette pack size regulation. In Australia, the minimum pack size is 20 but packs of up to 50 cigarettes are available. We aimed to estimate the impact on smoking of reducing cigarette pack sizes from ≥25 to 20 cigarettes per pack. METHOD: A two-stage adaptive parallel group RCT in which Australian smokers who usually purchase packs containing ≥25 cigarettes were randomised to use only packs containing either 20 (intervention) or their usual packs (control) for four weeks. The primary outcome, the average number of cigarettes smoked per day, was measured through collecting all finished cigarette packs, labelled with the number of cigarettes participants smoked. An interim sample size re-estimation was used to evaluate the possibility of detecting a meaningful difference in the primary outcome. RESULTS: The interim analysis, conducted when 124 participants had been randomised, suggested 1122 additional participants needed to be randomised for sufficient power to detect a meaningful effect. This exceeded pre-specified criteria for feasible recruitment, and data collection was terminated accordingly. Analysis of complete data (n = 79) indicated that the mean cigarettes smoked per day was 15.9 (SD = 8.5) in the intervention arm and 16.8 (SD = 6.7) among controls (difference - 0.9: 95%CI = - 4.3, 2.6). CONCLUSION: It remains unclear whether reducing cigarette pack sizes from ≥25 to 20 cigarettes reduces cigarette consumption. Importantly, the results of this study provide no evidence that capping cigarette pack sizes would be ineffective at reducing smoking. The limitations identified in this study can inform a more efficient RCT, which is urgently required to address the dearth of experimental evidence on the impact of large cigarette pack sizes on smoking. TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN34202533.

Fear-of-falling and associated risk factors in persons with rheumatoid arthritis: a 1 year prospective study.

BACKGROUND: Falls, associated injuries and fear-of-falling are common in adults with RA. Fear-of-falling can be a major consequence of, and as debilitating as falling, resulting in a cycle of activity restriction, reduced quality of life, institutionalisation and potentially increase risk of falls. The objective of this study was to examine the relationship between fear-of-falling and risk factors associated with fear-of-falling in adults with rheumatoid arthritis (RA) over a 1 year period. METHODS: Five hundred fifty-nine patients with RA were recruited from four outpatient clinics in this prospective cohort study. Baseline assessments included socio-demographic, medical and lifestyle related risk factors. Fall incidence was prospectively obtained monthly using postal cards over a 1 year period. Fear-of-falling was assessed at baseline and 1 year using the Short Falls Efficacy Scale-International (Short FES-I). Logistic regression was used to determine the association between high fear-of-falling (Short FES-I > 11) at baseline (outcome) and a range of putative predictor variables including previous falls, and also baseline factors associated with a high fear-of-falling at follow-up. RESULTS: Five hundred thirty-five (ninety-six percent) participants (mean age 62.1 yrs.; 18-88 yrs) completed 1 year follow-up and of these, 254 (47%) completed the Short FES-I questionnaire at 1 year. In a multivariate model, a history of multiple falls (OR = 6.08) higher HAQ score (OR = 4.87) and increased time to complete the Chair Stand Test (OR = 1.11) were found to be independent predictors of high fear-of-falling and had an overall classification rate of 87.7%. There were no significant differences found in fear-of-falling at 1 year follow-up in those who reported falls during the study, participant's baseline fear appeared to predict future fear, regardless of further falls. CONCLUSIONS: Fear-of-falling is significantly associated with previous falls and predictive of future falls and fear. RA patients would benefit from fall prevention measures whether or not they have previously fallen.

Measurement of Muscle Mass and Sarcopenia Using Anthropometry, Bioelectrical Impedance, and Computed Tomography in Surgical Patients with Colorectal Malignancy: Comparison of Agreement Between Methods.

Background: Low skeletal muscle index (SMI) and sarcopenia adversely affect clinical outcomes in oncology patients. Study aims were to assess the agreement of bioelectrical impedance analysis (BIA), mid-arm muscle circumference (MAMC), and computed tomography (CT) at the third lumbar vertebra (L3), for the measurement of muscle mass and identification of sarcopenia, in patients with colorectal cancer (CRC).Method: A comparison study of low SMI and sarcopenia determined by BIA and MAMC, compared to CT. Sensitivity, specificity and area under the curve (AUC) were calculated.Results: CT scans were obtained for 100 participants. Low SMI was identified in 29%, 57%, and 20% of participants using CT at L3, BIA, and MAMC, respectively. For low muscle mass BIA showed 60% of participants were correctly classified (AUC 0.619, sensitivity 80%, specificity 52%, kappa 0.241, P = 0.009) and for MAMC, 73% of participants were correctly classified (AUC 0.625, sensitivity 38%, specificity 88%, kappa 0.286, P = 0.005). There were 14%, 31%, and 10% of participants identified as having sarcopenia from CT, BIA, and MAMC, respectively.Conclusions: Both BIA and MAMC show a poor level of agreement for measuring muscle mass compared to CT scans using L3 in patients with CRC.

The oral selective oestrogen receptor degrader (SERD) AZD9496 is comparable to fulvestrant in antagonising ER and circumventing endocrine resistance.

BACKGROUND: The oestrogen receptor (ER) is an important therapeutic target in ER-positive (ER+) breast cancer. The selective ER degrader (SERD), fulvestrant, is effective in patients with metastatic breast cancer, but its intramuscular route of administration and low bioavailability are major clinical limitations. METHODS: Here, we studied the pharmacology of a new oral SERD, AZD9496, in a panel of in vitro and in vivo endocrine-sensitive and -resistant breast cancer models. RESULTS: In endocrine-sensitive models, AZD9496 inhibited cell growth and blocked ER activity in the presence or absence of oestrogen. In vivo, in the presence of oestrogen, short-term AZD9496 treatment, like fulvestrant, resulted in tumour growth inhibition and reduced expression of ER-dependent genes. AZD9496 inhibited cell growth in oestrogen deprivation-resistant and tamoxifen-resistant cell lines and xenograft models that retain ER expression. AZD9496 effectively reduced ER levels and ER-induced transcription. Expression analysis of short-term treated tumours showed that AZD9496 potently inhibited classic oestrogen-induced gene transcription, while simultaneously increasing expression of genes negatively regulated by ER, including genes potentially involved in escape pathways of endocrine resistance. CONCLUSIONS: These data suggest that AZD9496 is a potent anti-oestrogen that antagonises and degrades ER with anti-tumour activity in both endocrine-sensitive and endocrine-resistant models.

Dietary interventions for adult cancer survivors.

BACKGROUND: International dietary recommendations include guidance on healthy eating and weight management for people who have survived cancer; however dietary interventions are not provided routinely for people living beyond cancer. OBJECTIVES: To assess the effects of dietary interventions for adult cancer survivors on morbidity and mortality, changes in dietary behaviour, body composition, health-related quality of life, and clinical measurements. SEARCH METHODS: We ran searches on 18 September 2019 and searched the Cochrane Central Register of Controlled trials (CENTRAL), in the Cochrane Library; MEDLINE via Ovid; Embase via Ovid; the Allied and Complementary Medicine Database (AMED); the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and the Database of Abstracts of Reviews of Effects (DARE). We searched other resources including reference lists of retrieved articles, other reviews on the topic, the International Trials Registry for ongoing trials, metaRegister, Physicians Data Query, and appropriate websites for ongoing trials. We searched conference abstracts and WorldCat for dissertations. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that recruited people following a cancer diagnosis. The intervention was any dietary advice provided by any method including group sessions, telephone instruction, written materials, or a web-based approach. We included comparisons that could be usual care or written information, and outcomes measured included overall survival, morbidities, secondary malignancies, dietary changes, anthropometry, quality of life (QoL), and biochemistry. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Two people independently assessed titles and full-text articles, extracted data, and assessed risk of bias. For analysis, we used a random-effects statistical model for all meta-analyses, and the GRADE approach to rate the certainty of evidence, considering limitations, indirectness, inconsistencies, imprecision, and bias. MAIN RESULTS: We included 25 RCTs involving 7259 participants including 977 (13.5%) men and 6282 (86.5%) women. Mean age reported ranged from 52.6 to 71 years, and range of age of included participants was 23 to 85 years. The trials reported 27 comparisons and included participants who had survived breast cancer (17 trials), colorectal cancer (2 trials), gynaecological cancer (1 trial), and cancer at mixed sites (5 trials). For overall survival, dietary intervention and control groups showed little or no difference in risk of mortality (hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.77 to 1.23; 1 study; 3107 participants; low-certainty evidence). For secondary malignancies, dietary interventions versus control trials reported little or no difference (risk ratio (RR) 0.99, 95% CI 0.84 to 1.15; 1 study; 3107 participants; low-certainty evidence). Co-morbidities were not measured in any included trials. Subsequent outcomes reported after 12 months found that dietary interventions versus control probably make little or no difference in energy intake at 12 months (mean difference (MD) -59.13 kcal, 95% CI -159.05 to 37.79; 5 studies; 3283 participants; moderate-certainty evidence). Dietary interventions versus control probably led to slight increases in fruit and vegetable servings (MD 0.41 servings, 95% CI 0.10 to 0.71; 5 studies; 834 participants; moderate-certainty evidence); mixed results for fibre intake overall (MD 5.12 g, 95% CI 0.66 to 10.9; 2 studies; 3127 participants; very low-certainty evidence); and likely improvement in Diet Quality Index (MD 3.46, 95% CI 1.54 to 5.38; 747 participants; moderate-certainty evidence). For anthropometry, dietary intervention versus control probably led to a slightly decreased body mass index (BMI) (MD -0.79 kg/m², 95% CI -1.50 to -0.07; 4 studies; 777 participants; moderate-certainty evidence). Dietary interventions versus control probably had little or no effect on waist-to-hip ratio (MD -0.01, 95% CI -0.04 to 0.02; 2 studies; 106 participants; low-certainty evidence). For QoL, there were mixed results; several different quality assessment tools were used and evidence was of low to very low-certainty. No adverse events were reported in any of the included studies. AUTHORS' CONCLUSIONS: Evidence demonstrated little effects of dietary interventions on overall mortality and secondary cancers. For comorbidities, no evidence was identified. For nutritional outcomes, there was probably little or no effect on energy intake, although probably a slight increase in fruit and vegetable intake and Diet Quality Index. Results were mixed for fibre. For anthropometry, there was probably a slight decrease in body mass index (BMI) but probably little or no effect on waist-to-hip ratio. For QoL, results were highly varied. Additional high-quality research is needed to examine the effects of dietary interventions for different cancer sites, and to evaluate important outcomes including comorbidities and body composition. Evidence on new technologies used to deliver dietary interventions was limited.

Increasing the proportion of healthier foods available with and without reducing portion sizes and energy purchased in worksite cafeterias: protocol for a stepped-wedge randomised controlled trial.

BACKGROUND: Overconsumption of energy from food contributes to high rates of overweight and obesity in many populations. A promising set of interventions tested in pilot studies in worksite cafeterias, suggests energy intake may be reduced by increasing the proportion of healthier - i.e. lower energy - food options available, and decreasing portion sizes. The current study aims to assess the impact on energy purchased of i. increasing the proportion of lower energy options available; ii. combining this with reducing portion sizes, in a full trial. METHODS: A stepped-wedge randomised controlled trial in 19 worksite cafeterias, where the proportion of lower energy options available in targeted food categories (including main meals, snacks, and cold drinks) will be increased; and combined with reduced portion sizes. The primary outcome is total energy (kcal) purchased from targeted food categories using a pooled estimate across all sites. Follow-up analyses will test whether the impact on energy purchased varies according to the extent of intervention implementation. DISCUSSION: This study will provide the most reliable estimate to date of the effect sizes of two promising interventions for reducing energy purchased in worksite cafeterias. TRIAL REGISTRATION: The study was prospectively registered on ISRCTN (date: 24.05.19; TRN: ISRCTN87225572; doi: https://doi.org/10.1186/ISRCTN87225572).

Impact of increasing the proportion of healthier foods available on energy purchased in worksite cafeterias: A stepped wedge randomized controlled pilot trial.

Increasing the proportion of healthier foods available could encourage healthier consumption, but evidence to date is limited in scope and quality. The current study aimed to: (a) examine the feasibility and acceptability of intervening to change product availability in worksite cafeterias; and (b) estimate the impact on energy purchased of increasing the proportion of healthier (i.e. lower energy) cooked meals, snacks, cold drinks and sandwiches. Six English worksite cafeterias increased the proportion of healthier foods available, aiming to keep the total number of options constant, in a stepped wedge randomized controlled pilot trial conducted between January and May 2017. The intervention was generally successfully implemented and acceptable to clientele. Generalized linear mixed models showed a reduction of 6.9% (95%CI: -11.7%, -1.7%, p = 0.044) in energy (kcal) purchased from targeted food categories across all sites. However, impact varied across sites, with energy purchased from targeted categories significantly reduced in two sites (-10.7% (95%CI: -18.1% to -2.6%, p = 0.046); -18.4% (95%CI: -26.9% to -8.8%, p = 0.013)), while no significant differences were seen in the other four sites. Overall, increasing the proportion of healthier options available in worksite cafeterias seems a promising intervention to reduce energy purchased but contextual effects merit further study.

What is the impact of increasing the prominence of calorie labelling? A stepped wedge randomised controlled pilot trial in worksite cafeterias.

BACKGROUND: Calorie labelling may help to reduce energy consumption, but few well-controlled experimental studies have been conducted in real world settings. In a previous randomised controlled pilot trial we did not observe an effect of calorie labelling on energy purchased in worksite cafeterias. In the present study we sought to enhance the effect by making the labels more prominent, and to address the operational challenges reported previously by worksites. METHODS: Three worksite cafeterias were randomised in a stepped wedge design to start the intervention at one of three fortnightly periods between March and July 2018. The intervention comprised introducing prominent calorie labelling for all cafeteria products for which calorie information was available (on average 87% of products offered across the three sites were labelled). Calorie content was displayed in bold capitalised Verdana typeface with a minimum font size of 14 e.g.120 CALORIES. Feasibility and acceptability were assessed using post-intervention surveys with cafeteria patrons and semi-structured interviews with managers. Effectiveness was assessed using total daily energy (kcal) purchased from intervention items across the three sites, analysed using semi-parametric GAMLSS models. RESULTS: Recruitment and retention of worksite cafeterias proved feasible: all three randomised sites successfully completed the study. Post-intervention feedback suggested high levels of intervention acceptability: 87% of responding patrons wanted calorie labelling to remain in place. No effect of the intervention on daily energy purchased was observed: -0.6% (95%CI -2.5 to 1.2, p = .487). By-site analyses showed similar null effects at each of the three sites, all ps > .110. CONCLUSIONS: There was no evidence that prominent calorie labelling changed daily energy purchased across three English-based worksite cafeterias. The intervention was feasible to implement and acceptable to patrons and managers.

Impact of reducing portion sizes in worksite cafeterias: a stepped wedge randomised controlled pilot trial.

BACKGROUND: Reducing the portion sizes of foods available in restaurants and cafeterias is one promising approach to reducing energy intake, but there is little evidence of its impact from randomised studies in field settings. This study aims to i. examine the feasibility and acceptability, and ii. estimate the impact on energy purchased, of reducing portion sizes in worksite cafeterias. METHODS: Nine worksites in England were recruited to reduce by at least 10% the portion sizes of foods available in their cafeterias from targeted categories (main meals, sides, desserts, cakes). In a stepped wedge randomised controlled pilot trial, each site was randomised to a date of implementation, staggered fortnightly, following a baseline period of four weeks. Impact on energy purchased was analysed using generalised linear mixed modelling. We also assessed feasibility, acceptability, and fidelity of intervention implementation. RESULTS: Data from six of the nine randomised sites were analysed, with three sites excluded for not providing sufficient data and/or not implementing the intervention. The extent to which the intervention was implemented varied by site, with between 6 and 49% of products altered within targeted categories. Feedback following the intervention suggested it was broadly acceptable to customers and cafeteria staff. For the primary outcome of daily energy (kcal) purchased from intervention categories, there was no statistically significant change when data from all six sites were pooled: percentage change - 8.9% (95% CI: -16.7, - 0.4; p = 0.081). Each of these six sites showed reductions in energy purchased, ranging from - 15.6 to - 0.3%, which were borderline statistically significant at two sites (respective percentage changes (95% CIs): - 15.6% (- 26.7, - 2.8); - 14.0% (- 25.0, - 1.2)). Secondary outcome data are suggestive of a compensatory increase in energy purchased from food categories not targeted by the intervention, with no overall effect observed on energy purchased across all categories. CONCLUSIONS: The results of this pilot trial suggest that reducing portion sizes could be effective in reducing energy purchased and consumed from targeted food categories, and merits investigation in a larger trial. Future studies will need to address factors that prevented optimal implementation including site dropout and application across a limited range of products. TRIAL REGISTRATION: ( ISRCTN52923504 ). Registered on 20th September 2016.

Impact of calorie labelling in worksite cafeterias: a stepped wedge randomised controlled pilot trial.

BACKGROUND: For working adults, about one-third of energy is consumed in the workplace making this an important context in which to reduce energy intake to tackle obesity. The aims of the current study were first, to identify barriers to the feasibility and acceptability of implementing calorie labelling in preparation for a larger trial, and second, to estimate the potential impact of calorie labelling on energy purchased in worksite cafeterias. METHODS: Six worksite cafeterias were randomised to the intervention starting at one of six fortnightly periods, using a stepped wedge design. The trial was conducted between August and December 2016, across 17 study weeks. The intervention comprised labelling all cafeteria products for which such information was available with their calorie content (e.g. "250 Calories") displayed in the same font style and size as for price. A post-intervention survey with cafeteria patrons and interviews with managers and caterers were used to assess the feasibility and acceptability of the intervention. Intervention impact was assessed using generalised linear mixed modelling. The primary outcome was the total energy (kcal) purchased from intervention items in each cafeteria each day. RESULTS: Recruitment and retention of worksite cafeterias proved feasible, with post-intervention feedback suggesting high levels of intervention acceptability. Several barriers to intervention implementation were identified, including chefs' discretion at implementing recipes and the manual recording of sales data. There was no overall effect of the intervention: -0.4% (95%CI -3.8 to 2.9, p = .803). One site showed a statistically significant effect of the intervention, with an estimated 6.6% reduction (95%CI -12.9 to - 0.3, p = .044) in energy purchased in the day following the introduction of calorie labelling, an effect that diminished over time. The remaining five sites did not show robust changes in energy purchased when calorie labelling was introduced. CONCLUSIONS: A calorie labelling intervention was acceptable to both cafeteria operators and customers. The predicted effect of labelling to reduce energy purchased was only evident at one out of six sites studied. Before progressing to a full trial, the calorie labelling intervention needs to be optimised, and a number of operational issues resolved. TRIAL REGISTRATION: ISRCTN52923504 ; Registered: 22/09/2016; retrospectively registered.