Participants' perspectives of being recruited into a randomised trial of a weight loss intervention before colorectal cancer surgery: a qualitative interview study.

BACKGROUND: The period between cancer diagnosis and surgery presents an opportunity for trials to assess the feasibility of behaviour change interventions. However, this can be a worrying time for patients and may hinder recruitment. We describe the perspectives of patients with excess weight awaiting colorectal cancer surgery about their recruitment into a randomised trial of a prehabilitation weight loss intervention. METHODS: We interviewed the first 26 participants from the 8 recruitment sites across England in the 'CARE' feasibility trial. Participants were randomised into either usual care (n = 13) or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian (n = 13). The semi-structured interviews occurred shortly after recruitment and the questions focused on participants' recollections of being recruited into the trial. We analysed data rapidly and then used a mind-mapping technique to develop descriptive themes. Themes were agreed by all co-authors, including a person with lived-experience of colorectal surgery. RESULTS: Participants had a mean body mass index (± SD) of 38 kg/m2 (± 6), age of 50 years (± 12), and 42% were female. People who participated in the trial were motivated by the offer of structured weight loss support that could potentially help them improve their surgical outcomes. However, participants also had concerns around the potential unpalatability of the intervention diet and side effects. Positive attitudes of clinicians towards the trial facilitated recruitment but participants were disappointed when they were randomised to usual care due to clinical teams' overemphasis on the benefits of losing weight. CONCLUSIONS: Patients were motivated to take part by the prospect of improved surgical outcomes. However, the strong preference to be allocated to the intervention suggests that balanced communication of equipoise is crucial to minimise disappointment from randomisation to usual care and differential dropout from the trial. CLINICAL TRIAL REGISTRATION: ISRCTN39207707, Registration date 13/03/2023.

Association of gestational diabetes with long-term risk of premature mortality, and cardiovascular outcomes and risk factors: A retrospective cohort analysis in the UK Biobank.

AIM: To investigate the association of gestational diabetes mellitus (GDM) with premature mortality and cardiovascular (CVD) outcomes and risk factors. MATERIALS AND METHODS: Parous women recruited to the UK Biobank cohort during 2006-2010 were followed up from their first delivery until 31 October 2021. The data were linked to Hospital Episode Statistics and mortality registries. Multivariate Cox proportional hazard models investigated associations of GDM with all-cause mortality, CVD, diabetes, hypertension and dyslipidaemia. RESULTS: The maximum total analysis time at risk and under observation was 9 694 090 person-years. Among 220 726 women, 1225 self-reported or had a recorded diagnosis of GDM. After adjusting for confounders and behavioural factors, GDM was associated with increased risk for premature mortality [hazard ratio (HR): 1.44, 95% confidence interval (CI): 1.12-1.86], particularly CVD-related death (HR: 2.38, 95% CI: 1.63-3.48), as well as incident total CVD (HR: 1.50, 95% CI: 1.30-1.74), non-fatal CVD (HR: 1.41, 95% CI: 1.20-1.65), diabetes (HR: 14.37, 95% CI: 13.51-15.27), hypertension (HR: 1.49, 95% CI: 1.38-1.60), and dyslipidaemia (HR: 1.30, 95% CI: 1.22-1.39). The total CVD risk was greater in women with GDM who did not later develop diabetes than in those with GDM and diabetes. CONCLUSIONS: Women with GDM are at increased risk of premature death and have increased CV risk, emphasizing the importance of interventions to prevent GDM. If GDM develops, the diagnosis represents an opportunity for future surveillance and intervention to reduce CVD risk factors, prevent CVD and improve long-term health.

REduced-Carbohydrate intervention for managing Obesity and Reduction of gestational Diabetes (RECORD): A randomized controlled feasibility trial.

AIM: To test the feasibility and acceptability of a reduced-carbohydrate dietary program, intended to reduce the risk of gestational diabetes. MATERIALS AND METHODS: Fifty-one pregnant women at <20 weeks' gestation, with body mass index ≥30 kg/m2 , and a normal baseline oral glucose tolerance test (OGTT), were randomized 2:1 to an intervention or control group and followed-up until delivery. The dietary intervention aimed at providing 130-150 g carbohydrate/day. Feasibility outcomes assessed at 24-28 weeks' gestation, included adoption of the reduced-carbohydrate diet by the intervention group, and retention of all participants, assessed by completion of a second OGTT. Changes in glycemia, weight gain and dietary intake, and the maternal and neonatal outcomes were also assessed. Participants were interviewed about their experience of the intervention and the study. RESULTS: Forty-nine of 51 participants attended the follow-up OGTT, a retention rate of 96% (95% confidence interval [CI] 86.8%-98.9%). In the intervention group, carbohydrate intake at follow-up was 190.4 (95% CI 162.5-215.6) g/day, a reduction of -24.6 (95% CI -51.5-2.4) g/day from baseline. Potentially favourable effects of the intervention on glucose control, weight gain and blood pressure were observed, but the study was not powered to detect significant differences in these. Participants found the intervention acceptable, and were content with the study processes, but some reported barriers to sustained adherence, mainly pertaining to competing priorities. CONCLUSIONS: Retention was high, suggesting the study processes are feasible, but the carbohydrate reduction in the intervention group was small, and did not meet progression criteria, limiting the likelihood of achieving the desired goal to prevent gestational diabetes. TRIAL REGISTRATION NUMBER: ISRCTN16235884.

Do promotions of healthier or more sustainable foods increase sales? Findings from three natural experiments in UK supermarkets.

BACKGROUND: Dietary changes are necessary to improve population health and meet environmental sustainability targets. Here we analyse the impact of promotional activities implemented in UK supermarkets on purchases of healthier and more sustainable foods. METHODS: Three natural experiments examined the impact of promotional activities on sales of a) no-added-sugar (NAS) plant-based milk (in 199 stores), b) products promoted during 'Veganuary' (in 96 stores), and c) seasonal fruit (in 100 non-randomised intervention and 100 matched control stores). Data were provided on store-level product sales, in units sold and monetary value (£), aggregated weekly. Predominant socioeconomic position (SEP) of the store population was provided by the retailer. Analyses used interrupted time series and multivariable hierarchical mixed-effects models. RESULTS: Sales of both promoted and total NAS plant-based milks increased significantly during the promotional period (Promoted:+126 units, 95%CI: 105-148; Overall:+307 units, 95%CI: 264-349). The increase was greater in stores with predominately low SEP shoppers. During Veganuary, sales increased significantly for plant-based foods on promotion (+60 units, 95%CI: 37-84), but not for sales of plant-based foods overall (dairy alternatives: -1131 units, 95%CI: -5821-3559; meat alternatives: 1403 units, 95%CI: -749-3554). There was no evidence of a change in weekly sales of promoted seasonal fruit products (assessed via ratio change in units sold: 0.01, 95%CI: 0.00-0.02), and overall fruit category sales slightly decreased in intervention stores relative to control (ratio change in units sold: -0.01, 95%CI: -0.01-0.00). CONCLUSION: During promotional campaigns there was evidence that sales of plant-based products increased, but not seasonal fruits. There was no evidence for any sustained change beyond the intervention period.

Changing the availability and positioning of more vs. less environmentally sustainable products: A randomised controlled trial in an online experimental supermarket.

Food purchasing behaviours are shaped by the choices available to shoppers and the way they are offered for sale. This study tested whether prominent positioning of more sustainable food items online and increasing their relative availability might reduce the environmental impact of foods selected in a 2x2 (availability x position) factorial randomised controlled trial. Participants (n = 1179) selected items in a shopping task in an experimental online supermarket. The availability intervention added lower-impact products to the regular range. The positioning intervention biased product order to give prominence to lower-impact products. The primary outcome was the environmental impact score (ranging from 1 "least impact" to 5 "most impact", of each item in shopping baskets) analysed using Welch's ANOVA. Secondary outcomes included interactions (analysed via linear regression) by gender, age group, education, income and meat consumption and we assessed intervention acceptability (using different frames) in a post-experiment questionnaire. Compared to control (mean = 21.6), mean eco quintile score was significantly reduced when availability & order was altered (-2.30; 95%CI: 3.04; -1.56) and when order only was changed (-1.67; 95%CI: 2.42; -0.92). No significant difference between availability only (-0.02; 95%CI: 0.73; 0.69) and control was found. There were no significant interactions between interventions or by demographic characteristics. Both interventions were acceptable under certain frames (positioning emphasising lower-impact products: 70.3% support; increasing lower-impact items: 74.3% support). Prominent positioning of more sustainable products may be an effective strategy to encourage more sustainable food purchasing. Increasing availability of more sustainable products alone did not significantly alter the environment impact of products selected.

Ethnic differences in meat consumption attitudes, norms and behaviors: A survey of White, South Asian and Black ethnic groups in the UK.

A reduction in meat consumption is necessary to mitigate negative impacts of climate change and adverse health outcomes. The UK has an increasingly multi-ethnic population, yet there is little research on meat consumption habits and attitudes among ethnic groups in the UK. We ran a survey (N = 1014) with quota samples for ethnic groups and analyzed attitudes, behaviors and norm perceptions of White, South Asian and Black British respondents. Most respondents believe overconsumption of red and processed meat has negative impacts on health (73.3%) and the environment (64.3%).South Asian respondents were statistically significantly less likely to be meat eaters than White respondents (OR = 0.44, 95% CIs: 0.30-0.65, t = -4.15, p = 0.000), while there was no significant difference between White and Black respondents (OR = 1.06, 95% CIs: 0.63-1.76, t = 0.21, p = 0.834). Both South Asian (OR = 2.76, 95% CIs: 1.89-4.03 t = 5.25, p = 0.000) and Black respondents (OR = 2.09, 95% CIs: 0.1.30-3.35, t = 3.06, p = 0.002) were significantly more likely to express being influenced by friends and family in their food choices than White respondents. South Asian (OR = 3.24,95% CIs: 2.17-4.84, t = 5.74, p = 0.000) and Black (OR = 2.02,95% CIs: 1.21-3.39, t = 2.69, p = 0.007) respondents were also both significantly more likely to report they would want to eat similarly to their friends and family than White respondents. Statistical analyses suggested some gender and socioeconomic differences across and among ethnic groups, which are reported and discussed. The differences in meat consumption behaviors and norm conformity between ethnic groups raises the prospect that interventions that leverage social norms may be more effective in South Asian groups than Black and White groups in the UK.

Meat consumption and risk of ischemic heart disease: A systematic review and meta-analysis.

There is uncertainty regarding the association between unprocessed red and processed meat consumption and the risk of ischemic heart disease (IHD), and little is known regarding the association with poultry intake. The aim of this systematic review and meta-analysis was to quantitatively assess the associations of unprocessed red, processed meat, and poultry intake and risk of IHD in published prospective studies. We systematically searched CAB Abstract, MEDLINE, EMBASE, Web of Science, bioRxiv and medRxiv, and reference lists of selected studies and previous systematic reviews up to June 4, 2021. All prospective cohort studies that assessed associations between 1(+) meat types and IHD risk (incidence and/or death) were selected. The meta-analysis was conducted using fixed-effects models. Thirteen published articles were included (ntotal = 1,427,989; ncases = 32,630). Higher consumption of unprocessed red meat was associated with a 9% (relative risk (RR) per 50 g/day higher intake, 1.09; 95% confidence intervals (CI), 1.06 to 1.12; nstudies = 12) and processed meat intake with an 18% higher risk of IHD (1.18; 95% CI, 1.12 to 1.25; nstudies = 10). There was no association with poultry intake (nstudies = 10). This study provides substantial evidence that unprocessed red and processed meat, though not poultry, might be risk factors for IHD.

Weight regain after behavioural weight management programmes and its impact on quality of life and cost effectiveness: Evidence synthesis and health economic analyses.

AIMS: We used data from a recent systematic review to investigate weight regain after behavioural weight management programmes (BWMPs, sometimes referred to as lifestyle modification programmes) and its impact on quality-of-life and cost-effectiveness. MATERIALS AND METHODS: Trial registries, databases and forward-citation searching (latest search December 2019) were used to identify randomized trials of BWMPs in adults with overweight/obesity reporting outcomes at ≥12 months, and after programme end. Two independent reviewers screened records. One reviewer extracted data and a second checked them. The differences between intervention and control groups were synthesized using mixed-effect, meta-regression and time-to-event models. We examined associations between weight difference and difference in quality-of-life. Cost-effectiveness was estimated from a health sector perspective. RESULTS: In total, 155 trials (n > 150 000) contributed to analyses. The longest follow-up was 23 years post-programme. At programme end, intervention groups achieved -2.8 kg (95%CI -3.2 to -2.4) greater weight loss than controls. Weight regain after programme end was 0.12-0.32 kg/year greater in intervention relative to control groups, with a between-group difference evident for at least 5 years. Quality-of-life increased in intervention groups relative to control at programme end and thereafter returned to control as the difference in weight between groups diminished. BWMPs with this initial weight loss and subsequent regain would be cost-effective if delivered for under £560 (£8.80-£3900) per person. CONCLUSIONS: Modest rates of weight regain, with persistent benefits for several years, should encourage health care practitioners and policymakers to offer obesity treatments that cost less than our suggested thresholds as a cost-effective intervention to improve long-term weight management. REGISTRATION: The review is registered on PROSPERO, CRD42018105744.

The impact of altering restaurant and menu option position on food selected from an experimental food delivery platform: a randomised controlled trial.

BACKGROUND: Overconsumption is one of the most serious public health challenges in the UK and has been linked to increased consumption of food ordered through delivery platforms. This study tested whether repositioning foods and/or restaurant options in a simulated food delivery platform could help to reduce the energy content of users' shopping basket. METHODS: UK adult food delivery platform users (N = 9,003) selected a meal in a simulated platform. Participants were randomly allocated to a control condition (choices listed randomly) or to one of four intervention groups, (1) food options listed in ascending order of energy content, (2) restaurant options listed in ascending order of average energy content per main meal, (3) interventions 1 and 2 combined (4) interventions 1 and 2 combined, but food and restaurant options repositioned based on a kcal/price index to display options lower in energy but higher in price at the top. Gamma regressions assessed the impact of interventions on total energy content of baskets at checkout. RESULTS: The energy content of participants' baskets in the control condition was 1382 kcals. All interventions significantly reduced energy content of baskets: Compared to control, repositioning both foods and restaurants purely based on energy content of options resulted in the greatest effect (-209kcal; 95%CIs: -248,-168), followed by repositioning restaurants (-161kcal; 95%CIs: -201,-121), repositioning restaurants and foods based on a kcal/price index (-117kcals; 95%CI: -158,-74) and repositioning foods based on energy content (-88kcals; 95%CI: -130,-45). All interventions reduced the basket price compared to the control, except for the intervention repositioning restaurants and foods based on a kcal/price index, which increased the basket price. CONCLUSIONS: This proof-of-concept study suggests repositioning lower-energy options more prominently may encourage lower energy food choices in online delivery platforms and can be implemented in a sustainable business model.

CARE: Protocol of a randomised trial evaluating the feasibility of preoperative intentional weight loss to support postoperative recovery in patients with excess weight and colorectal cancer.

AIM: Excess weight increases the risk of morbidity following colorectal cancer surgery. Weight loss may improve morbidity, but it is uncertain whether patients can follow an intensive weight loss intervention while waiting for surgery and there are concerns about muscle mass loss. The aim of this trial is to assess the feasibility of intentional weight loss in this setting and determine progression to a definitive trial. METHODS: CARE is a prospectively registered, multicentre, feasibility, parallel, randomised controlled trial with embedded evaluation and optimisation of the recruitment process. Participants with excess weight awaiting curative colorectal resection for cancer are randomised 1:1 to care as usual or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian. Progression criteria will be based on the recruitment, engagement, adherence, and retention rates. Data will be collected on the 30-day postoperative morbidity, the typical primary outcome of prehabilitation trials. Secondary outcomes will include, among others, length of hospital stay, health-related quality of life, and body composition. Qualitative interviews will be used to understand patients' experiences of and attitudes towards trial participation and intervention engagement and adherence. CONCLUSION: CARE will evaluate the feasibility of intensive intentional weight loss as prehabilitation before colorectal cancer surgery. The results will determine the planning of a definitive trial.

The impact of price promotions on confectionery and snacks on the energy content of shopping baskets: A randomised controlled trial in an experimental online supermarket.

Overconsumption of foods high in fat, sugars, and salt (HFSS) poses a significant risk to health. The government in England has passed legislation that would limit some price promotions of HFSS foods within supermarkets, but evidence regarding likely impacts of these policies, especially in online settings, is limited. This study aimed to determine whether there were any differences in the energy and nutrient content of shopping baskets after removing promotions on HFSS foods in an online experimental supermarket. UK adults (n = 511) were asked to select food from four categories with a £10 budget in an online experimental supermarket: confectionery; biscuits and crackers; crisps, nuts and snacking fruit; cakes and tarts. They were randomly allocated to one of two trial arms: (1) promotions present (matched to promotion frequency seen in a major UK retailer) (n = 257), or (2) all promotions removed from all products within the target food categories (n = 254). The primary outcome analysis used linear regression to compare total energy (kcal) of items placed in shopping baskets when promotions were present vs. absent, while secondary analyses investigated differences in nutrients and energy purchased from individual food categories. Mean energy in food selected without promotions was 5156 kcal per basket (SD 1620), compared to 5536 kcal (SD 1819) with promotions, a difference of -552kcal (95%CIs: -866, -238), equivalent to 10%. There were no significant differences in energy purchased for any individual category between groups. No evidence was found of other changes in nutritional composition of baskets or of significant interactions between the impact of promotions and participant characteristics (gender, age, ethnicity) on energy purchased. Removing promotions on HFSS foods resulted in significantly less total energy selected in an online experimental supermarket study.

Effects of environmental impact and nutrition labelling on food purchasing: An experimental online supermarket study.

Nutrition labels and ecolabels can support consumers to make healthier and more sustainable choices, and the former is now widespread. But there is no information on the impact of ecolabels in the presence of nutrition labels. The aims of this study were primarily to examine whether (1) ecolabels are effective at promoting sustainable purchasing behaviour if presented alongside nutrition labels; (2) and secondarily, whether nutrition labels are effective at promoting healthier purchasing if presented alongside ecolabels. Participants (N = 2730) visited an experimental online supermarket platform, and were randomised to see products with (1) environmental impact labels only; (2) nutrition (NutriScore) labels only; (3) both environmental and nutrition labels; (4) no labels. Linear regressions compared the mean environmental impact scores (EIS; primary outcome) and health scores of products in participants' shopping baskets across each condition. Compared to control (no labels) there were significant reductions in the EIS when environmental impact labels were presented: Alone (-1.3, 95%CI: -2.3 to -0.4) or With nutrition labels (-2.0, 95%CI: -2.9 to -1.0), with no evidence of differences in effectiveness between these two conditions. There was no evidence of an impact of nutrition labels on either the EIS or the healthiness of purchases, both when nutrition labels were shown alone and when ecolabels were also present. Environmental impact labels may be effective at encouraging more sustainable purchases alone or when used alongside nutrition labels. This adds to the evidence base on the feasibility and effectiveness of environmental impact labelling as an important measure to change dietary behaviour to improve planetary health.

Effectiveness of Motivational Interviewing in Managing Overweight and Obesity : A Systematic Review and Meta-analysis.

BACKGROUND: Motivational interviewing (MI) is potentially useful in management of overweight and obesity, but staff training and increased delivery time are barriers, and its effectiveness independent of other behavioral components is unclear. PURPOSE: To assess the independent contribution of MI as part of a behavioral weight management program (BWMP) in controlling weight and improving psychological well-being. DATA SOURCES: 6 electronic databases and 2 trial registries, searched from database inception through 24 September 2021. STUDY SELECTION: Randomized controlled trials in adults or adolescents aimed at weight loss or maintenance and comparing programs incorporating MI versus interventions without MI. DATA EXTRACTION: Two reviewers independently screened studies, extracted data, and assessed risk of bias. Outcomes included weight, anxiety, depression, quality of life, and other aspects of psychological well-being. Pooled mean differences or standardized mean differences were obtained using random- and fixed-effects meta-analyses. DATA SYNTHESIS: Forty-six studies involving 11 077 participants, predominantly with obesity, were included. At 6 months, BWMPs using MI were more effective than no/minimal intervention (-0.88 [95% CI, -1.27 to -0.48] kg; I 2 = 0%) but were not statistically significantly more effective than lower-intensity (-0.88 [CI, -2.39 to 0.62] kg; I 2 = 55.8%) or similar-intensity (-1.36 [CI, -2.80 to 0.07] kg; I 2 = 18.8%) BWMPs. At 1 year, data were too sparse to pool comparisons with no/minimal intervention, but MI did not produce statistically significantly greater weight change compared with lower-intensity (-1.16 [CI, -2.49 to 0.17] kg; I 2 = 88.7%) or similar-intensity (-0.18 [CI, -2.40 to 2.04] kg; I 2 = 72.7%) BWMPs without MI. Studies with 18-month follow-up were also sparse; MI did not produce statistically significant benefit in any of the comparator categories. There was no evidence of subgroup differences based on study, participant, or intervention characteristics. Too few studies assessed effects on psychological well-being to pool, but data did not suggest that MI was independently effective. LIMITATIONS: High statistical heterogeneity among studies, largely unexplained by sensitivity and subgroup analyses; stratification by comparator intensity and follow-up duration resulted in pooling of few studies. CONCLUSION: There is no evidence that MI increases effectiveness of BWMPs in controlling weight. Given the intensive training required for its delivery, MI may not be a worthwhile addition to BWMPs. PRIMARY FUNDING SOURCE: National Institute for Health Research Biomedical Research Centre. (PROSPERO: CRD42020177259).

Removing seasonal confectionery from prominent store locations and purchasing behaviour within a major UK supermarket: Evaluation of a nonrandomised controlled intervention study.

BACKGROUND: The proportion of energy from free sugars and saturated fat currently exceeds the UK-recommended intake across all age groups. Recognising the limits of reformulation programmes, the government in England has announced their intention to introduce legislation to restrict the promotion of foods high in free sugars, salt, and saturated fats in prominent store locations. Here, we evaluated a grocery store intervention to remove seasonal confectionery from prominent locations within a major UK supermarket. METHODS AND FINDINGS: A nonrandomised controlled intervention study with interrupted time series (ITS) analysis was used. Data were analysed from 34 intervention stores located in 2 London boroughs and 151 matched control stores located elsewhere in the UK owned by the same retailer. Stores were matched based on store size and overall sales during the previous year. Between 15 February 2019 and 3 April 2019 (before Easter), stores removed free-standing promotional display units of seasonal confectionery from prominent areas, although these products were available for purchase elsewhere in the store. Store-level weekly sales (units, weight (g), and value (£)) of seasonal chocolate confectionery products were used in primary analyses, with data from 1 January 2018 to 24 November 2019. Secondary outcomes included total energy, fat, saturated fat, and sugars from all in-store purchases. Multivariable hierarchical models were used to investigate pre/post differences in weekly sales of confectionery in intervention versus control stores. ITS analyses were used to evaluate differences in level and trends after intervention implementation. Over a preintervention baseline period (15 February 2018 to 3 April 2018), there were no significant differences in sales (units, weight, and value) of all chocolate confectionery between intervention versus control stores. After intervention implementation, there was an attenuation in the seasonal increase of confectionery sales (units) in intervention stores compared to control (+5% versus +18%; P < 0.001), with similar effects on weight (g) (+12% versus +31%; P < 0.001) and value (£) (-3% versus +10%; P < 0.001). ITS analyses generally showed statistically significant differences in the level at the point of intervention (P ranges 0.010 to 0.067) but also in the trend afterwards (P ranges 0.024 to 0.053), indicating that the initial difference between intervention and control stores reduced over time. There was a significant difference in level change in total energy sold, adjusted for the total weight of food and drink (kcal/g, P = 0.002), and total fat (fat/g) (P = 0.023), but no significant changes in saturated fat or sugars from total sales in ITS models. There was no evidence that the main results varied across store deprivation index. The limitations of this study include the lack of randomisation, residual confounding from unmeasured variables, absolute differences in trends and sales between intervention versus control stores, and no independent measures of intervention fidelity. CONCLUSIONS: Removal of chocolate confectionery from prominent locations was associated with reduced purchases of these products, of sufficient magnitude to observe a reduction in the energy content of total food purchases. These results from a "real-world" intervention provide promising evidence that the proposed legislation in England to restrict promotions of less healthy items in prominent locations may help reduce overconsumption. TRIAL REGISTRATION: https://osf.io/br96f/.

Testing availability, positioning, promotions, and signage of healthier food options and purchasing behaviour within major UK supermarkets: Evaluation of 6 nonrandomised controlled intervention studies.

BACKGROUND: Governments are increasingly looking for policies to change supermarket environments to support healthier food purchasing. We evaluated 6 interventions within major United Kingdom grocery stores, including availability, positioning, promotions, and signage strategies to encourage selection of healthier products. METHODS AND FINDINGS: Nonrandomised controlled study designs were used, except for one intervention that was rolled out nationwide using a pre/post within-store design. Store-level weekly sales (units, weight (g), and value (£)) of products targeted in the interventions were used in primary analyses using multivariable hierarchical models and interrupted time series (ITS) analyses. Stocking low fat chips next to regular chips was associated with decreases in sales of regular chips (units) in intervention versus control stores (-23% versus -4%; P = 0.001) with a significant level change in ITS models (P = 0.001). Increasing availability of lower energy packs of biscuits was associated with increased sales but reduced sales of regular biscuits in intervention versus control stores (lower energy biscuits +18% versus -2%; P = 0.245; regular biscuits -4% versus +7%; P = 0.386), although not significantly, though there was a significant level change in ITS models (P = 0.004 for regular biscuits). There was no evidence that a positioning intervention, placing higher fibre breakfast cereals at eye level was associated with increased sales of healthier cereal or reduced sales of regular cereal. A price promotion on seasonal fruits and vegetables showed no evidence of any greater increases in sales of items on promotion in intervention versus control stores (+10% versus +8%; P = 0.101) but a significant level change in ITS models (P < 0.001). A nationwide promotion using Disney characters was associated with increased sales of nonsugar baked beans (+54%) and selected fruits (+305%), with a significant level change in ITS models (P < 0.001 for both). Shelf labels to highlight lower sugar beverages showed no evidence of changes in purchasing of lower or higher sugar drinks. These were all retailer-led interventions that present limitations regarding the lack of randomisation, residual confounding from unmeasured variables, absolute differences in trends and sales between intervention versus control stores, and no independent measures of intervention fidelity. CONCLUSIONS: Increasing availability and promotions of healthier alternatives in grocery stores may be promising interventions to encourage purchasing of healthier products instead of less healthy ones. There was no evidence that altering positioning within an aisle or adding shelf edge labelling is associated with changes in purchasing behaviours. TRIAL REGISTRATION: https://osf.io/br96f/.

Changes in the salt content of packaged foods sold in supermarkets between 2015-2020 in the United Kingdom: A repeated cross-sectional study.

BACKGROUND: Excess consumption of salt is linked to an increased risk of hypertension and cardiovascular disease. The United Kingdom has had a comprehensive salt reduction programme since 2003, setting a series of progressively lower, product-specific reformulation targets for the food industry, combined with advice to consumers to reduce salt. The aim of this study was to assess the changes in the sales-weighted mean salt content of grocery foods sold through retail between 2015 and 2020 by category and company. METHODS AND FINDINGS: Information for products, including salt content (g/100 g), was collected online from retailer websites for 6 consecutive years (2015 to 2020) and was matched with brand-level retail sales data from Euromonitor for 395 brands. The sales-weighted mean salt content and total volume of salt sold were calculated by category and company. The mean salt content of included foods fell by 0.05 g/100 g, from 1.04 g/100 g in 2015 to 0.90 g/100 g in 2020, equivalent to -4.2% (p = 0.13). The categories with the highest salt content in 2020 were savoury snacks (1.6 g/100 g) and cheese (1.6 g/100 g), and the categories that saw the greatest reductions in mean salt content over time were breakfast cereals (-16.0%, p = 0.65); processed beans, potatoes, and vegetables (-10.6%, p = 0.11); and meat, seafood, and alternatives (-9.2%, p = 0.56). The total volume of salt sold fell from 2.41 g per person per day to 2.25 g per person per day, a reduction of 0.16 g or 6.7% (p = 0.54). The majority (63%) of this decrease was attributable to changes in mean salt content, with the remaining 37% accounted for by reductions in sales. Across the top 5 companies in each of 9 categories, the volume of salt sold decreased in 26 and increased in 19 cases. This study is limited by its exclusion of foods purchased out of the home, including at restaurants, cafes, and takeaways. It also does not include salt added at the table, or that naturally occurring in foods, meaning the findings underrepresent the population's total salt intake. The assumption was also made that the products matched with the sales data were entirely representative of the brand, which may not be the case if products are sold exclusively in convenience stores or markets, which are not included in this database. CONCLUSIONS: There has been a small decline in the salt content of foods and total volume of salt sold between 2015 and 2020, but observed changes were not statistically significant so could be due to random variations over time. We suggest that mandatory reporting of salt sales by large food companies would increase the transparency of how individual businesses are progressing towards the salt reduction targets.

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).

Association of Weight Changes With Changes in Histological Features and Blood Markers in Nonalcoholic Steatohepatitis.

BACKGROUND AND AIMS: Weight loss is recommended for patients with non-alcoholic steatohepatitis (NASH) but the impact of weight change on disease activity remains unclear. We examined the association between weight change (gain/loss) and changes in biochemical and histological features of NASH. METHODS: This was an analysis of the PIVENS and FLINT trials in adults with NASH who had liver biopsies at baseline and at either 1.5 years or 2 years. Multivariable regression models examined how weight change was associated with changes in (a) blood liver markers, (b) NASH resolution with no fibrosis worsening, (c) fibrosis improving with no NASH worsening, and (d) individual histological features. RESULTS: The BMI of the 421 participants was 34.3 kg/m2 (SD:6.5) and their mean weight change was +0.5 kg (SD:6.5). Weight change was independently and positively associated with changes in liver enzymes and the Fibrosis-4 score (all P < .001). Each kg of weight loss was associated with 7% (95% CI, 3%-10%; P < .001) increase in odds of achieving NASH resolution with no fibrosis worsening and with 5% (95% CI, 1%-8%; P = .01) increase in odds of achieving fibrosis improvement with no NASH worsening. Weight gain was associated with worsening of disease activity. For every kg of weight lost, the odds of fibrosis improving were 5% (95% CI, 2%-8%; P = .001). There was no evidence that the association between weight change and outcome depended upon pharmacological treatment, trial, body mass index, and baseline fibrosis. CONCLUSIONS: Weight change was independently and monotonically associated with changes in biochemical and histological features of NASH. Guidelines for NASH management should incorporate recommendations for both avoidance of weight gain and support to lose weight.

Obesity, metabolic risk and adherence to healthy lifestyle behaviours: prospective cohort study in the UK Biobank.

BACKGROUND: Contested evidence suggests that obesity confers no risk to health in people who have a healthy lifestyle, particularly if there are no metabolic complications of obesity. The aim was to examine the association between adherence to lifestyle recommendations and the absence of metabolic complications on the incident or fatal cardiovascular disease and all-cause mortality across different categories of body mass index (BMI). METHODS: This contemporary prospective cohort study included 339,902 adults without cardiovascular disease at baseline, recruited between 2006 and 2010 from the UK Biobank and followed until 2018-2020. The main exposures were four healthy lifestyle behaviours: never smoker, alcohol intake ≤ 112g/ week, 150 min moderate physical activity or 75 min vigorous activity/week, ≥ 5 servings of fruit or vegetables/day, and we assessed these overall and across the BMI groups. Metabolic complications of excess adiposity were hypertension, diabetes and hyperlipidaemia, and we examined whether obesity was associated with increased risk in the absence of these complications. The outcomes were all-cause mortality, death from, and incident cardiovascular disease (CVD). RESULTS: Individuals who met four lifestyle recommendations but had excess weight had higher all-cause mortality; for BMI 30-34.9 kg/m2, the hazard ratio (HR) was 1.42 (95% confidence interval 1.20 to 1.68), and for BMI ≥ 35 kg/m2, HR was 2.17 (95% CI 1.71 to 2.76). The risk was lower, but still increased for people with no metabolic complications; for all-cause mortality, BMI 30-34.9 kg/m2 had an HR of 1.09 (95% CI 0.99 to 1.21), and BMI ≥ 35 kg/m2 had an HR of 1.44 (95% CI 1.19 to 1.74) for all-cause mortality. Similar patterns were found for incident and fatal CVD. CONCLUSIONS: Meeting healthy lifestyle recommendations, or the absence of metabolic complications of obesity offsets some, but not all, of the risk of subsequent CVD, and premature mortality in people with overweight or obesity. Offering support to achieve and maintain a healthy weight and to adopt healthy behaviours are likely to be important components in effective preventative healthcare.

Associations between body composition, fat distribution and metabolic consequences of excess adiposity with severe COVID-19 outcomes: observational study and Mendelian randomisation analysis.

BACKGROUND: Higher body mass index (BMI) and metabolic consequences of excess weight are associated with increased risk of severe COVID-19, though their mediating pathway is unclear. METHODS: A prospective cohort study included 435,504 UK Biobank participants. A two-sample Mendelian randomisation (MR) study used the COVID-19 Host Genetics Initiative in 1.6 million participants. We examined associations of total adiposity, body composition, fat distribution and metabolic consequences of excess weight, particularly type 2 diabetes, with incidence and severity of COVID-19, assessed by test positivity, hospital admission, intensive care unit (ICU) admission and death. RESULTS: BMI and body fat were associated with COVID-19 in the observational and MR analyses but muscle mass was not. The observational study suggested the association with central fat distribution was stronger than for BMI, but there was little evidence from the MR analyses than this was causal. There was evidence that strong associations of metabolic consequences with COVID-19 outcomes in observational but not MR analyses. Type 2 diabetes was strongly associated with COVID-19 in observational but not MR analyses. In adjusted models, the observational analysis showed that the association of BMI with COVID-19 diminished, while central fat distribution and metabolic consequences of excess weight remained strongly associated. In contrast, MR showed the reverse, with only BMI retaining a direct effect on COVID-19. CONCLUSIONS: Excess total adiposity is probably casually associated with severe COVID-19. Mendelian randomisation data do not support causality for the observed associations of central fat distribution or metabolic consequences of excess adiposity with COVID-19.