The impact of introducing alcohol-free beer options in bars and public houses on alcohol sales and revenue: A randomised crossover field trial.

AIMS: The study aimed to estimate the impact of introducing a draught alcohol-free beer, thereby increasing the relative availability of these products, on alcohol sales and monetary takings in bars and pubs in England. DESIGN: Randomised crossover field trial. SETTING: England. PARTICIPANTS: Fourteen venues that did not previously sell draught alcohol-free beer. INTERVENTION AND COMPARATOR: Venues completed two intervention periods and two control periods in a randomised order over 8 weeks. Intervention periods involved replacing one draught alcoholic beer with an alcohol-free beer. Control periods operated business as usual. MEASUREMENTS: The primary outcome was mean weekly volume (in litres) of draught alcoholic beer sold. The secondary outcome was mean weekly revenue [in GBP (£)] from all drinks. Analyses adjusted for randomised order, special events, season and busyness. FINDINGS: The adjusted mean difference in weekly sales of draught alcoholic beer was -20 L [95% confidence interval (CI) = -41 to +0.4], equivalent to a 4% reduction (95% CI = 8% reduction to 0.1% increase) in the volume of alcoholic draught beer sold when draught alcohol-free beer was available. Excluding venues that failed at least one fidelity check resulted in an adjusted mean difference of -29 L per week (95% CI = -53 to -5), equivalent to a 5% reduction (95% CI = 8% reduction to 0.8% reduction). The adjusted mean difference in weekly revenue was +61 GBP per week (95% CI = -328 to +450), equivalent to a 1% increase (95% CI = 5% decrease to 7% increase) when draught alcohol-free beer was available. CONCLUSIONS: Introducing a draught alcohol-free beer in bars and pubs in England reduced the volume of draught alcoholic beer sold by 4% to 5%, with no evidence of the intervention impacting net revenue.

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.

Medicines and Healthcare products Regulatory Agency's "Consultation on proposals for legislative changes for clinical trials": a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing.

In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals "to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines". The purpose of the consultation was to help finalise the proposals and contribute to the drafting of secondary legislation. We discussed these proposals as members of the Trials Methodology Research Partnership Adaptive Designs Working Group, which is jointly funded by the Medical Research Council and the National Institute for Health and Care Research. Two topics arose frequently in the discussion: the emphasis on legislation, and the absence of questions on data sharing. It is our opinion that the proposals rely heavily on legislation to change practice. However, clinical trials are heterogeneous, and as a result some trials will struggle to comply with all of the proposed legislation. Furthermore, adaptive design clinical trials are even more heterogeneous than their non-adaptive counterparts, and face more challenges. Consequently, it is possible that increased legislation could have a greater negative impact on adaptive designs than non-adaptive designs. Overall, we are sceptical that the introduction of legislation will achieve the desired outcomes, with some exceptions. Meanwhile the topic of data sharing - making anonymised individual-level clinical trial data available to other investigators for further use - is entirely absent from the proposals and the consultation in general. However, as an aspect of the wider concept of open science and reproducible research, data sharing is an increasingly important aspect of clinical trials. The benefits of data sharing include faster innovation, improved surveillance of drug safety and effectiveness and decreasing participant exposure to unnecessary risk. There are already a number of UK-focused documents that discuss and encourage data sharing, for example, the Concordat on Open Research Data and the Medical Research Council's Data Sharing Policy. We strongly suggest that data sharing should be the norm rather than the exception, and hope that the forthcoming proposals on clinical trials invite discussion on this important topic.

Impact of health warning labels and calorie labels on selection and purchasing of alcoholic and non-alcoholic drinks: A randomized controlled trial.

AIMS: To estimate the impact on selection and actual purchasing of (a) health warning labels (text-only and image-and-text) on alcoholic drinks and (b) calorie labels on alcoholic and non-alcoholic drinks. DESIGN: Parallel-groups randomised controlled trial. SETTING: Drinks were selected in a simulated online supermarket, before being purchased in an actual online supermarket. PARTICIPANTS: Adults in England and Wales who regularly consumed and purchased beer or wine online (n = 651). Six hundred and eight participants completed the study and were included in the primary analysis. INTERVENTIONS: Participants were randomized to one of six groups in a between-subjects three [health warning labels (HWLs) (i): image-and-text HWL; (ii) text-only HWL; (iii) no HWL] × 2 (calorie labels: present versus absent) factorial design (n per group 103-113). MEASUREMENTS: The primary outcome measure was the number of alcohol units selected (with intention to purchase); secondary outcomes included alcohol units purchased and calories selected and purchased. There was no time limit for selection. For purchasing, participants were directed to purchase their drinks immediately (although they were allowed up to 2 weeks to do so). FINDINGS: There was no evidence of main effects for either (a) HWLs or (b) calorie labels on the number of alcohol units selected (HWLs: F(2,599) = 0.406, P = 0.666; calorie labels: F(1,599) = 0.002, P = 0.961). There was also no evidence of an interaction between HWLs and calorie labels, and no evidence of an overall difference on any secondary outcomes. In pre-specified subgroup analyses comparing the 'calorie label only' group (n = 101) with the 'no label' group (n = 104) there was no evidence that calorie labels reduced the number of calories selected (unadjusted means: 1913 calories versus 2203, P = 0.643). Among the 75% of participants who went on to purchase drinks, those in the 'calorie label only' group (n = 74) purchased fewer calories than those in the 'no label' group (n = 79) (unadjusted means: 1532 versus 2090, P = 0.028). CONCLUSIONS: There was no evidence that health warning labels reduced the number of alcohol units selected or purchased in an online retail context. There was some evidence suggesting that calorie labels on alcoholic and non-alcoholic drinks may reduce calories purchased from both types of drinks.

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).

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.

Cigarette pack size and consumption: a randomized cross-over trial.

BACKGROUND AND AIMS: Smoking fewer cigarettes per day may increase the chances of stopping smoking. Capping the number of cigarettes per pack is a promising policy option, but the causal impact of such a change is unknown. This study aimed to test the hypothesis that lowering cigarette pack sizes from 25 to 20 reduces the number of cigarettes smoked. DESIGN: This randomized controlled cross-over trial had two 14-day intervention periods with an intervening 7-day period of usual behaviour. Participants purchased their own cigarettes. They were instructed to smoke their usual brand from either one of two sizes of pack in each of two 14-day intervention periods: (a) 25 cigarettes and (b) 20 cigarettes. Participants were randomized to the order in which they smoked from the two pack sizes (a-b; b-a). SETTING: Canada. PARTICIPANTS: Participants were adult smokers who smoked from pack sizes of 25, recruited between July 2020 and June 2021. Of 252 randomized, 240 (95%) completed the study and 236 (94%) provided sufficient data for the primary analysis. MEASUREMENTS: Cigarettes smoked per participant per day. FINDINGS: Participants smoked fewer cigarettes per day from packs of 20 cigarettes [n = 234, mean = 15.7 standard deviation (SD) = 7.1] than from packs of 25 (n = 235, mean = 16.9, SD = 7.1). After adjusting for pre-specified covariates (baseline consumption and heaviness of smoking), modelling estimated that participants smoked 1.3 fewer cigarettes per day [95% confidence interval (CI) = -1.7 to -0.9], equivalent to 7.6% fewer (95% CI = -10.1 to -5.2%) from packs of 20 cigarettes. CONCLUSIONS: Smoking from packs of 20 compared with 25 cigarettes reduced the number of cigarettes smoked per day.

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.

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.

Impact of wine bottle and glass sizes on wine consumption at home: a within- and between- households randomized controlled trial.

BACKGROUND AND AIMS: Reducing alcohol consumption across populations would decrease the risk of a range of diseases, including many cancers, cardiovascular disease and Type 2 diabetes. The aim of the current study was to estimate the impact of using smaller bottles (37.5- versus 75-cl) and glasses (290 versus 370 ml) on consuming wine at home. DESIGN: Randomized controlled trial of households with cross-over randomization to bottle size and parallel randomization to glass size. SETTING: UK households. PARTICIPANTS: A total of 260 households consuming at least two 75-cl bottles of wine each week, recruited from the general population through a research agency. The majority consisted of adults who were white and of higher socio-economic position. INTERVENTION: Households were randomized to the order in which they purchased wine in 37.5- or 75-cl bottles, to consume during two 14-day intervention periods, and further randomized to receive smaller (290 ml) or larger (350 ml) glasses to use during both intervention periods. MEASUREMENTS: Volume (ml) of study wine consumed at the end of each 14-day intervention period, measured using photographs of purchased bottles, weighed on study scales. FINDINGS: Of the randomized households, 217 of 260 (83%) completed the study as per protocol and were included in the primary analysis. There was weak evidence that smaller bottles reduced consumption: after accounting for pre-specified covariates, households consumed on average 145.7 ml (3.6%) less wine when drinking from smaller bottles than from larger bottles [95% confidence intervals (CI) = -335.5 to 43. ml; -8.3 to 1.1%; P = 0.137; Bayes factor (BF) = 2.00]. The evidence for the effect of smaller glasses was stronger: households consumed on average 253.3 ml (6.5%) less wine when drinking from smaller glasses than from larger glasses (95% CI = -517 to 10 ml; -13.2 to 0.3%; P = 0.065; BF = 2.96). CONCLUSIONS: Using smaller glasses to drink wine at home may reduce consumption. Greater uncertainty remains around the possible effect of drinking from smaller bottles.

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.

Public support for policies to improve population and planetary health: A population-based online experiment assessing impact of communicating evidence of multiple versus single benefits.

BACKGROUND: Effective interventions for reducing the consumption of products that harm population and planetary health often lack public support, impeding implementation. Communicating evidence of policies' effectiveness can increase public support but there is uncertainty about the most effective ways of communicating this evidence. Some policies have multiple benefits such as both improving health and the environment. This study assesses whether communicating evidence of multiple versus single benefits of a policy increases its support. METHOD: Participants (n = 4616) nationally representative of the British population were randomised to one of 24 groups in an online experiment with a 4 × 3 × 2 between-subjects factorial design. The messages that participants viewed differed according to the evidence they communicated (no message, effectiveness for changing behaviour, effectiveness for changing behaviour + one policy benefit, effectiveness for changing behaviour + three policy benefits), type of policy (taxation, availability) and the target behaviour (consumption of energy-dense food, alcohol, or meat). The primary outcome was policy support. RESULTS: In a full factorial ANOVA, there was a significant main effect of communicating evidence of effectiveness on policy support, which was similar across policies and behaviours. Communicating three benefits increased support relative to communicating one benefit (d = 0.15; p = 0.01). Communicating one benefit increased support compared to providing evidence for changing behaviour alone (d = 0.13; p = 0.004) or no message (d = 0.11 p = 0.022). CONCLUSION: Communicating evidence of a policy's benefits increases support for policy action across different behaviours and policies. Presenting multiple benefits of policies enhances public support.

Communicating evidence about the environment's role in obesity and support for government policies to tackle obesity: a systematic review with meta-analysis.

Public support for many policies that tackle obesity by changing environments is low. This may reflect commonly held causal beliefs about obesity, namely that it is due to failures of self-control rather than environmental influences. Several studies have sought to increase public support by changing these and similar causal beliefs, with mixed results. The current review is the first systematic synthesis of these studies. Searches of PsycInfo, Medline, Web of Science, Scopus, and Open Grey yielded 20 eligible studies (N = 8977) from 11,776 abstracts. Eligible studies were controlled experiments with an intervention group that communicated information about the environment's role in obesity, and a measure of support for environment-based obesity policies. The protocol was prospectively registered on PROSPERO. Meta-analyses showed no evidence that communicating information about the environment's influence on obesity changed policy support or the belief that the environment influences obesity. A likely explanation for this null effect is the ineffectiveness of interventions that were designed to change the belief that the environment influences obesity. The possibility remains, however, that the association observed between beliefs about the causes of obesity and attitudes towards obesity policies is correlational and not causal.

Glassware design and drinking behaviours: a review of impact and mechanisms using a new typology of drinking behaviours.

Much of the global burden of disease is attributable to unhealthy behaviour, including excessive consumption of alcohol and sugar-sweetened beverages. Developing effective methods to change these drinking behaviours could inform policies to improve population health. In line with an increasing interest in environmental-level interventions - i.e., changing the environment in which a behaviour occurs in order to change the behaviour of interest - this review first describes the existing evidence of the impact of glassware design (including capacity and shape) on drinking behaviours (e.g., at the 'micro' level - including sip size, as well as at the macro level - including amount consumed). The roles of two sets of possible underlying mechanisms - perception and affordance - are also explored. Finally, this review sets out a provisional typology of drinking behaviours to enable more systematic approaches to the study of these behaviours. While there is a paucity of evidence - in particular on measures of consumption - this growing evidence base suggests promising targets for novel interventions involving glassware design to reduce the consumption of drinks that harm health.Trial registration: ISRCTN.org identifier: ISRCTN10456720.

Clinical and demographic correlates of accelerometer-measured physical activity in participants enrolled in the OPTIMISE HFpEF study.

AIMS: This study aimed to measure physical activity (PA) in participants with suspected heart failure with preserved ejection fraction (HFpEF) and assess associations between PA and participant characteristics. METHODS AND RESULTS: Adults with presumed HFpEF were recruited and received diagnostic evaluation and clinical assessment. Physical activity was objectively measured using accelerometers over 7 days. To examine predictors of PA, a best subset analysis was used, with the optimal model defined as that with the lowest Bayesian information criterion. One hundred and twenty-four participants with presumed HFpEF who had valid accelerometer data were included in this study. Seventy-six were confirmed by a cardiologist as meeting the European Society of Cardiology diagnosis criteria for HFpEF. The median age of all participants was 80.1 years, and 47.4% were female. Patients spent most of each 24-h period at low-intensity PA and few or no durations at high-intensity PA, with lower activity for those with HFpEF. Gait speed was the best univariate correlate of activity levels (adjusted R2 0.29). The optimal model using best subsets regression included six variables and improved adjusted R2 to 0.47. In the model, lower levels of PA were associated with slower gait speed, lower levels of anxiety, higher levels of depression, past smoking history, a confirmed HFpEF diagnosis, and higher body mass index. CONCLUSION: Participants demonstrated very low PA levels. The study has identified important patient characteristics associated with PA, which may help to identify those most in need of interventions. Notably, participants with confirmed HFpEF were more inactive than participants with other heart failure phenotypes.

Size and shape of plates and size of wine glasses and bottles: impact on self-serving of food and alcohol.

BACKGROUND: The physical properties of tableware could influence selection and consumption of food and alcohol. There is considerable uncertainty, however, around the potential effects of different sizes and shapes of tableware on how much food and alcohol people self-serve. These studies aimed to estimate the impact of: 1. Plate size and shape on amount of food self-served; 2.Wine glass and bottle size on amount of wine self-poured. METHODS: 140 adults participated in two laboratory studies-each using randomised within-subjects factorial designs-where they self-served food (Study 1) and wine (Study 2): Study 1: 3 plate sizes (small; medium; large) × 2 plate shapes (circular; square). Study 2: 3 wine glass sizes (small; medium; large) × 2 wine bottle sizes (75 cl; 50 cl). RESULTS: Study 1: There was a main effect of plate size: less was self-served on small (76 g less, p < 0.001) and medium (41 g less, p < 0.001) plates, compared to large plates. There was no evidence for a main effect of plate shape (p = 0.46) or a size and shape interaction (p = 0.47). Study 2: There was a main effect of glass size: less was self-served in small (34 ml less, p < 0.001) and medium (17 ml less, p < 0.001) glasses, compared to large glasses. There was no evidence of a main effect of bottle size (p = 0.20) or a glass and bottle size interaction (p = 0.18). CONCLUSIONS: Smaller tableware (i.e. plates and wine glasses) decreases the amount of food and wine self-served in an initial serving. Future studies are required to generate estimates on selection and consumption in real world settings when numerous servings are possible. Protocol registration information: OSF ( https://osf.io/dj3c6/ ) and ISRCTN ( https://doi.org/10.1186/ISRCTN66774780 ).

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.

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.