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A paradigm shift in cystic fibrosis nutritional care: Clinicians' views on the management of patients with overweight and obesity
Background: Overweight and obesity among people with cystic fibrosis (pwCF) has become more prevalent since the widespread adoption of CF transmembrane conductance regulator (CFTR) modulator therapies and presents a new challenge for nutritional care. We aimed to explore how clinicians working in CF care approach the management of adults with overweight and obesity. Methods: We conducted semi-structured interviews with n = 20 clinicians (n = 6 physiotherapists, n = 6 doctors and n = 8 dietitians) working in 15 adult CF centres in the United Kingdom. The interviews explored their perspectives and current practices caring for people with CF and overweight/obesity. Data were analysed using reflexive thematic analysis. Results: Four main themes were identified: 1) challenges of raising the topic of overweight and obesity in the CF clinic (e.g., clinician-patient rapport and concerns around weight stigma); 2) the changing landscape of assessment due to CF-specific causes of weight gain: (e.g., impact of CFTR modulators and CF legacy diet) 3) presence of clinical equipoise for weight management due to the lack of CF-specific evidence on the consequences of obesity and intentional weight loss (e.g., unclear consequences on respiratory outcomes and risk of weight related co-morbidities) and 4) opportunities for a safe, effective, and acceptable weight management treatment for people with CF (e.g., working collaboratively with current multidisciplinary CF care). Conclusions: Approaching weight management in the CF setting is complex. Trials are needed to assess the equipoise of weight management interventions in this group and CF-specific issues should be considered when developing such interventions.
Effect of the National Enhanced Service for weight management on the content of annual review consultations for patients living with obesity and hypertension and/or diabetes
Guidelines specify that clinicians should support patients living with obesity by referring to weight management programmes (WMPs), but clinicians do so infrequently. To provide additional support to patients living with obesity and weight-related conditions, the UK government instated the National Enhanced Service (NES) for weight management in England, including a reimbursement to general practices for referring eligible patients to WMPs. To assess the impact of the NES on conversations regarding weight and relevant behavioural risk factors in primary care consultations we recruited 11 medical practices in England where the NES was operating and six comparator practices from Scotland and Wales where the NES was not implemented. Clinicians audio-recorded annual review appointments of patients living with obesity and hypertension and/or diabetes. The content of these consultations was synthesised using quantitative content analysis. Consultations with 92 patients were analysed: 58 in England and 34 in Scotland and Wales. No difference was found between the NES sites (England) and non-NES sites (Scotland and Wales) in the proportion of referrals made to WMPs. Clinicians in England weighed patients and took other body measurements more often, mentioned body mass index more often, and had more detailed discussions about patients' diets, but there was no evidence that they differed in their discussion of WMPs or other modifiable risk factors. We found no strong evidence that the NES affected how clinicians addressed weight management or related behavioural risk factors within annual review consultations for patients living with obesity and hypertension and/or diabetes.
Antiphospholipid antibody positivity in early systemic lupus erythematosus is associated with subsequent vascular events
Abstract Objective aPL are found in the blood of 20–30% of patients with SLE. Although aPL cause vascular thrombosis in the antiphospholipid syndrome, it is not clear whether positive aPL levels in early SLE increase risk of subsequent vascular events (VE). In a previous analysis of 276 patients with SLE, we found that early positivity for ≥2 of IgG anti-cardiolipin (anti-CL), IgG anti-β2-glycoprotein I (anti-β2GPI) and anti-domain I of β2-glycoprotein I (anti-DI) showed a possible association with VE. Here we have extended that analysis. Methods Serum samples taken from 501 patients with SLE early in their disease had been tested for IgG anti-CL, anti-β2GPI and anti-DI by ELISA. Complete VE history was available for 423 patients of whom 23 were excluded because VE occurred before the diagnosis of SLE. For the remaining 400 patients we carried out Kaplan–Meier survival analysis to define groups at higher risk of VE. Results Of 400 patients, 154 (38.5%) were positive for one or more aPL, 27 (6.8%) were double/triple-positive and 127 (31.8%) were single-positive. There were 91 VE in 77 patients, of whom 42 were aPL-positive in early disease. VE were significantly increased in aPL-positive vs aPL-negative patients (P = 0.041) and in double/triple-positive vs single-positive vs aPL-negative patients (P = 0.0057). Omission of the IgG anti-DI assay would have missed 14 double/triple-positive patients of whom six had VE. Conclusion Double/triple-positivity for IgG anti-CL, anti-β2GPI and anti-DI in early SLE identifies a population at higher risk of subsequent VE.
The role of masks and respirators in preventing respiratory infections in healthcare and community settings
Abstract The covid-19 pandemic saw frequent changes and conflicts in mask policies and politicization of masks. On reviewing the evidence, including studies published after the pandemic, the data suggest respirators are more effective than masks in healthcare, but must be continuously worn to be protective. Healthcare and aged care settings amplify outbreaks, so protection of patients and staff is paramount. Most guidelines assume risk is only present during close contact or aerosol generating procedures, but studies show intermittent use of respirators is not protective. New research in aerosol science confirms the risk of infection is widespread in health facilities. In community settings, any mask use is protective during epidemics, especially if used early, when combined with hand hygiene, and if wearers are compliant. Community use of N95 respirators is more protective than surgical masks, which are more protective than cloth masks, but even cloth masks provide some protection. Mask guidelines should be adaptable to the specific context and should account for rising epidemic activity, and whether a pathogen has asymptomatic transmission. The main rationale for universal masking during pandemics is asymptomatic transmission, which means risk of transmission cannot be self-identified. The precautionary principle should be applied during serious emerging infections or pandemics when transmission mode is not fully understood, or vaccines and drugs are not available. If respirators are not available, medical or cloth masks could be used as a last resort. Data exist to support extended use and reuse of masks and respirators during short supply. In summary, extensive evidence generated during the covid-19 pandemic confirms the superiority of respirators and supports the use of masks and respirators in the community during periods of high epidemic activity. Some gaps in research remain, including economic analyses, research in special population groups for whom masking is challenging, and research on countering disinformation.
Doxycycline for community treatment of suspected COVID-19 in people at high risk of adverse outcomes in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial
Background: Doxycycline is often used for treating COVID-19 respiratory symptoms in the community despite an absence of evidence from clinical trials to support its use. We aimed to assess the efficacy of doxycycline to treat suspected COVID-19 in the community among people at high risk of adverse outcomes. Methods: We did a national, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in older people (PRINCIPLE) across primary care centres in the UK. We included people aged 65 years or older, or 50 years or older with comorbidities (weakened immune system, heart disease, hypertension, asthma or lung disease, diabetes, mild hepatic impairment, stroke or neurological problem, and self-reported obesity or body-mass index of 35 kg/m2 or greater), who had been unwell (for ≤14 days) with suspected COVID-19 or a positive PCR test for SARS-CoV-2 infection in the community. Participants were randomly assigned using response adaptive randomisation to usual care only, usual care plus oral doxycycline (200 mg on day 1, then 100 mg once daily for the following 6 days), or usual care plus other interventions. The interventions reported in this manuscript are usual care plus doxycycline and usual care only; evaluations of other interventions in this platform trial are ongoing. The coprimary endpoints were time to first self-reported recovery, and hospitalisation or death related to COVID-19, both measured over 28 days from randomisation and analysed by intention to treat. This trial is ongoing and is registered with ISRCTN, 86534580. Findings: The trial opened on April 2, 2020. Randomisation to doxycycline began on July 24, 2020, and was stopped on Dec 14, 2020, because the prespecified futility criterion was met; 2689 participants were enrolled and randomised between these dates. Of these, 2508 (93·3%) participants contributed follow-up data and were included in the primary analysis: 780 (31·1%) in the usual care plus doxycycline group, 948 in the usual care only group (37·8%), and 780 (31·1%) in the usual care plus other interventions group. Among the 1792 participants randomly assigned to the usual care plus doxycycline and usual care only groups, the mean age was 61·1 years (SD 7·9); 999 (55·7%) participants were female and 790 (44·1%) were male. In the primary analysis model, there was little evidence of difference in median time to first self-reported recovery between the usual care plus doxycycline group and the usual care only group (9·6 [95% Bayesian Credible Interval [BCI] 8·3 to 11·0] days vs 10·1 [8·7 to 11·7] days, hazard ratio 1·04 [95% BCI 0·93 to 1·17]). The estimated benefit in median time to first self-reported recovery was 0·5 days [95% BCI −0·99 to 2·04] and the probability of a clinically meaningful benefit (defined as ≥1·5 days) was 0·10. Hospitalisation or death related to COVID-19 occurred in 41 (crude percentage 5·3%) participants in the usual care plus doxycycline group and 43 (4·5%) in the usual care only group (estimated absolute percentage difference −0·5% [95% BCI −2·6 to 1·4]); there were five deaths (0·6%) in the usual care plus doxycycline group and two (0·2%) in the usual care only group. Interpretation: In patients with suspected COVID-19 in the community in the UK, who were at high risk of adverse outcomes, treatment with doxycycline was not associated with clinically meaningful reductions in time to recovery or hospital admissions or deaths related to COVID-19, and should not be used as a routine treatment for COVID-19. Funding: UK Research and Innovation, Department of Health and Social Care, National Institute for Health Research.
Favipiravir for COVID-19 in adults in the community in PRINCIPLE, an open-label, randomised, controlled, adaptive platform trial of short- and longer-term outcomes
Background: Evidence for the effect of favipiravir treatment of acute COVID-19 on recovery, hospital admissions and longer-term outcomes in community settings is limited. Methods: In this multicentre. open-label, multi-arm, adaptive platform randomised controlled trial participants aged ≥18 years in the community with a positive test for SARS-CoV-2 and symptoms lasting ≤14 days were randomised to: usual care; usual care plus favipiravir tablets (loading dose of 3600 mg in divided doses on day one, then 800 mg twice a day for four days); or, usual care plus other interventions. Co-primary endpoints were time to first self-reported recovery and hospitalisation/death related to COVID-19, within 28 days, analysed using Bayesian models. Recovery at six months was the primary longer-term outcome. Trial registration: ISRCTN86534580. Findings: The primary analysis model included 8811 SARS-CoV-2 positive mostly COVID vaccinated participants, randomised to favipiravir (n = 1829), usual care (n = 3256), and other treatments (n = 3726). Time to self-reported recovery was shorter in the favipiravir group than usual care (estimated hazard ratio 1·23 [95% credible interval 1·14 to 1·33]), a reduction of 2·98 days [1·99 to 3·94] from 16 days in median time to self-reported recovery for favipiravir versus usual care alone. COVID-19 related hospitalisations/deaths were similar (estimated odds ratio 0·99 [0·61 to 1·61]; estimated difference 0% [−0·9% to 0·6%]). 14 serious adverse events occurred in the favipiravir group and 4 in usual care. By six months, the proportion feeling fully recovered was 74·9% for favipiravir versus 71·3% for usual care (RR = 1·05, [1·02 to 1·08]). Interpretation: In this open-label trial in a largely vaccinated population with COVID-19 in the community, favipiravir did not reduce hospital admissions, but shortened time to recovery and had a marginal positive impact on long term outcomes.
Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes
Background: The evidence for whether ivermectin impacts recovery, hospital admissions, and longer-term outcomes in COVID-19 is contested. The WHO recommends its use only in the context of clinical trials. Methods: In this multicentre, open-label, multi-arm, adaptive platform randomised controlled trial, we included participants aged ≥18 years in the community, with a positive SARS-CoV-2 test, and symptoms lasting ≤14 days. Participants were randomised to usual care, usual care plus ivermectin tablets (target 300–400 μg/kg per dose, once daily for 3 days), or usual care plus other interventions. Co-primary endpoints were time to first self-reported recovery, and COVID-19 related hospitalisation/death within 28 days, analysed using Bayesian models. Recovery at 6 months was the primary, longer term outcome. Trial registration: ISRCTN86534580. Findings: The primary analysis included 8811 SARS-CoV-2 positive participants (median symptom duration 5 days), randomised to ivermectin (n = 2157), usual care (n = 3256), and other treatments (n = 3398) from June 23, 2021 to July 1, 2022. Time to self-reported recovery was shorter in the ivermectin group compared with usual care (hazard ratio 1·15 [95% Bayesian credible interval, 1·07 to 1·23], median decrease 2.06 days [1·00 to 3·06]), probability of meaningful effect (pre-specified hazard ratio ≥1.2) 0·192). COVID-19-related hospitalisations/deaths (odds ratio 1·02 [0·63 to 1·62]; estimated percentage difference 0% [−1% to 0·6%]), serious adverse events (three and five respectively), and the proportion feeling fully recovered were similar in both groups at 6 months (74·3% and 71·2% respectively (RR = 1·05, [1·02 to 1·08]) and also at 3 and 12 months. Interpretation: Ivermectin for COVID-19 is unlikely to provide clinically meaningful improvement in recovery, hospital admissions, or longer-term outcomes. Further trials of ivermectin for SARS-Cov-2 infection in vaccinated community populations appear unwarranted. Funding: UKRI/National Institute of Health Research (MC_PC_19079).
Platform adaptive trial of novel antivirals for early treatment of COVID-19 in the community (PANORAMIC): Protocol for a randomised, controlled, open-label, adaptive platform trial of community novel antiviral treatment of COVID-19 in people at increased risk of more severe disease
Introduction There is an urgent need to determine the safety, effectiveness and cost-effectiveness of novel antiviral treatments for COVID-19 in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. Methods and analysis PANORAMIC is a UK-wide, open-label, prospective, adaptive, multiarm platform, randomised clinical trial that evaluates antiviral treatments for COVID-19 in the community. A master protocol governs the addition of new antiviral treatments as they become available, and the introduction and cessation of existing interventions via interim analyses. The first two interventions to be evaluated are molnupiravir (Lagevrio) and nirmatrelvir/ritonavir (Paxlovid). Eligibility criteria: community-dwelling within 5 days of onset of symptomatic COVID-19 (confirmed by PCR or lateral flow test), and either (1) aged 50 years and over, or (2) aged 18-49 years with qualifying comorbidities. Registration occurs via the trial website and by telephone. Recruitment occurs remotely through the central trial team, or in person through clinical sites. Participants are randomised to receive either usual care or a trial drug plus usual care. Outcomes are collected via a participant-completed daily electronic symptom diary for 28 days post randomisation. Participants and/or their Trial Partner are contacted by the research team after days 7, 14 and 28 if the diary is not completed, or if the participant is unable to access the diary. The primary efficacy endpoint is all-cause, non-elective hospitalisation and/or death within 28 days of randomisation. Multiple prespecified interim analyses allow interventions to be stopped for futility or superiority based on prespecified decision criteria. A prospective economic evaluation is embedded within the trial. Ethics and dissemination Ethical approval granted by South Central-Berkshire REC number: 21/SC/0393; IRAS project ID: 1004274. Results will be presented to policymakers and at conferences, and published in peer-reviewed journals. Trial registration number ISRCTN30448031; EudraCT number: 2021-005748-31.
Vitamin B12 prescribing from 2015 to 2024 in English general practice: an observational study to investigate the switch from injections to tablets
Background Traditionally, intramuscular vitamin B12 injections were considered by patients and clinicians the most effective treatment option for B12 deficiency. The improving understanding of the condition paired with the restricted National Health Service (NHS) resources, resulted in a shift from injections towards tablets. The COVID-19 pandemic accelerated this change, while healthcare services were adapted to reduce COVID-19 transmission. This included new guidelines on vitamin B12 prescribing where injections were substituted by tablets. Objective We investigated changes between 2015 and 2024 in prescribing B12 injections and tablets including the effect of the COVID-19 pandemic. Design, population and setting This was an observational study of general practice in England covering 100% of the population. Methods We used prescribing data published by the NHS Business Service Authority. Monthly prescription counts and rates per 100 000 patients were visualised in longitudinal plots from 1 January 2015 to 30 September 2024. We stratified the analysis by regions in England. Changes in yearly counts and rates were summarised using descriptive statistics. Linear regression and data from before the COVID-19 pandemic were used to model trends from 2020 to 2024 as if the pandemic had not occurred. The predicted values and their 95% CI were used to assess the effect of the pandemic. Results The number of prescriptions for B12 formulations doubled in the last 10 years from 2.5 million to 5 million per year. The prescriptions for tablets increased from half a million in 2015 to 2 million in 2024. While the prescriptions for injections increased from 2 million to 3 million. In 2020, there was a sharp drop in prescriptions for injections and a simultaneous rapid increase in prescriptions for tablets coinciding with the onset of the pandemic. There were 806 031 (27%) less than expected prescriptions for injections (2 171 924 observed vs 2 977 956 predicted, 95% CI 2 905 348 to 3 050 565) and 299 834 (27%) more prescriptions for tablets (1 415 315 observed vs 1 115 481 predicted, 95% CI 1 094 350 to 1 136 612). After the 2020 drop, by 2024, injections returned to the prepandemic levels of 3 million prescriptions per year and tablets doubled from 1 million in 2019 to 2 million prescriptions in 2024. Conclusions In this study, we document important changes to vitamin B12 prescribing in England over the last 10 years. Before the pandemic, injections were the medication of choice for B12 deficiency but there had been an ongoing debate about the benefits and cost of injections over tablets. The pandemic accelerated the switch from injections to tablets. However, these changes in the pandemic were driven by the availability of resources and not necessarily clinical evidence or patient preference. To establish best practices, more evidence is needed comparing the safety and effectiveness of injections and tablets specific to the condition being treated.
The impact of the English calorie labelling policy on the energy content of food offered and purchased in worksite cafeterias: a natural experiment
Background: On 6 April 2022, legislation came into effect in England requiring calorie labels to be applied to food items on menus of larger food businesses. This study aimed to assess the impact of calorie labelling on (a) food purchased and (b) energy content of menu options in worksite cafeterias. Methods: Product-level sales data and energy content of available items was obtained from 142 worksite cafeterias from January 2022-October 2022. Interrupted-time-series (ITS) analysis with level and slope change evaluated daily energy (kcal) purchased per item, and ITS with level change assessed mean energy per option available on menus before and after calorie labelling. Each analysis was conducted 6 weeks and 6 months from implementation. A post-hoc ITS examined weekly energy purchased per item over a longer period (March 2021-October 2022; 135 sites). Results: There was no evidence calorie labelling changed the energy content of foods purchased (6-week: + 0.60 cal/product, 95%CI:-2.54, + 3.75; 6-month: + 1.59 cal/product, 95%CI:-0.96, + 4.16). Post-hoc analyses suggested calorie labels were associated with a reduction in mean energy of items purchased over time (-0.65 kcal/week, 95%CI:-0.81,-0.49), but a significant increase (+ 3 kcal, 95%CI: + 0.43, + 5.60) at the point of implementation. There was a reduction in the mean energy content of menu options at each seasonal menu change (April 2022:-1.79 kcal, 95%CI:-3.42,-0.15; July 2022:-4.18 kcal, 95% CI:-7.65,-0.73). Conclusion: This large observational study in worksite cafeterias found no evidence to indicate the introduction of calorie labelling led to any immediate reduction in energy purchased by customers. There was some evidence of increasing impact over time, possibly associated with changes in menu offerings, but this effect was small and cannot be directly attributed to calorie labelling.
The impact of weight loss interventions on disordered eating symptoms in people with overweight and obesity: a systematic review & meta-analysis
Background: It is unclear whether weight loss interventions worsen disordered eating in people living with overweight/obesity. We aimed to systematically evaluate the association between weight loss interventions and disordered eating. Methods: Six databases were searched from inception until September 2024. Trials of weight loss interventions in people with overweight/obesity were included if they reported a validated score for disordered eating on either the Eating Disorder Examination Interview or the Eating Disorder Examination Questionnaire pre- and post-intervention. Interventions included behavioural weight loss programmes (BWL) and pharmacotherapy licenced for weight loss, with or without concurrent psychological support, provided for at least 4 weeks. Pooled standardised mean differences (SMD) in scores of disordered eating were calculated using random effects meta-analyses. Risk of bias (RoB) was assessed using the Cochrane RoB 2 tool and the Newcastle–Ottawa scale for randomised and single-arm trials, respectively (PROSPERO ID: CRD42023404792). Findings: Thirty-eight studies with 66 eligible arms (61 interventions: 29 BWL, 11 BWL + pharmacotherapy, 20 BWL + psychological intervention, 1 pharmacotherapy + psychological intervention) and 3364 participants in total were included. The mean weight change was −4.7 kg (95% CI: −5.7, −3.7). Compared with baseline, disordered eating scores improved by −1.47 SMD units (95% CI: −1.67, −1.27, p < 0.001, I2 = 94%) at intervention completion (median of 4 months). Seven randomised trials that directly compared a weight loss intervention to no/minimal intervention reported an improvement of −0.49 SMD units (95% CI, −0.93, −0.04, p = 0.0035, I2 = 73%). Sub-group analyses showed: (a) disordered eating scores improved more in people with an eating disorder at baseline compared with people without high scores, (b) no clear evidence that the association depended upon intervention type, and (c) disordered eating scores improved more in trials rated at low overall RoB. Interpretation: Despite heterogeneity in effect size, weight loss interventions consistently improved disordered eating scores. These findings provide reassurance that weight loss interventions might not worsen disordered eating and may improve it. Funding: Novo Nordisk UK Research Foundation Doctoral Fellowship in Clinical Diabetes.
Healthy eating interventions conducted in small, local restaurants and hot food takeaways: A systematic review
Objective: This systematic review investigates the characteristics, effectiveness, and acceptability of interventions to encourage healthier eating in small, independent restaurants and takeaways. Design: We searched five databases (CENTRAL, Medline, Embase, CINAHL, and Science Citation Index & Social Science Citation Index) in June 2022. Eligible studies had to measure changes in sales, availability, nutritional quality, portion sizes, or dietary intake of interventions targeting customer behaviour or restaurant environments. We evaluated study quality using the Mixed Methods Appraisal Tool (MMAT). Results are synthesised narratively and interventions’ impact on personal autonomy is assessed using the Nuffield intervention ladder. Setting: Small, independent or local restaurants or hot food takeaway outlets, with no restrictions by year or country. Participants: Anyone selling or purchasing food in intervention settings (e.g. restaurant staff/owners, customers). Results: We screened 4,624 records and included 12 studies describing 13 interventions in 351 businesses. Most studies were of poor quality. Customer-level intervention components mostly operated on the lower rungs of the Nuffield ladder and most had limited positive effects on increasing demand, measured as sales or orders of healthy options. Whilst rare, most interventions measuring business outcomes operated on higher ladder rungs and showed small positive results. There was insufficient evidence to investigate differences in impact by intervention intrusiveness. Acceptability was greater for interventions that were low-effort, inexpensive, and perceived as not negatively impacting on customer satisfaction. Conclusions: Despite some evidence of small positive effects of healthy eating interventions on healthier purchases or restaurant/hot food takeaway practices, a weak evidence base hinders robust inference.
Testing the effect of ecolabels on the environmental impact of food purchases in worksite cafeterias: a randomised controlled trial
BACKGROUND: Reducing the environmental impact of foods consumed is important for meeting climate goals. We aimed to conduct a randomised controlled trial to test whether ecolabels reduce the environmental impact of food selected in worksite cafeterias, alone or in combination with increased availability of more sustainable meal options. METHODS: Worksite cafeterias (n = 96) were randomised to one of three study groups, with 54 included for final analysis. One group was intended to increase the availability of meat-free options, but no change was implemented. Therefore, this group was treated as part of the control, creating two groups: (1) control (no ecolabels) (n = 35), and (2) ecolabels (n = 19). Regression analysis assessed the primary outcome of total environmental impact of hot meals sold over a 6-week period. Secondary outcome analyses explored the individual environmental indicators that composed the total environmental impact score (i.e., greenhouse gas emissions, biodiversity loss, eutrophication, and water scarcity). The mean weekly environmental impact scores of hot meal options over the full 12-week trial period were assessed using hierarchical mixed effects models. RESULTS: There was no significant effect of the intervention on the environmental impact scores of meals sold (mean difference between control and intervention sites: -1.4%, 95%CI: -33.6%, + 30.8%). There was no evidence of an effect in mean weekly environmental impact score (-5.4%, 95%CI: -12.6%, + 2.5%), nor in any of the four individual environmental indicators (greenhouse gas emissions: -3.6%, 95%CI: -30.7%, 34.3%; biodiversity loss: 2.0%, 95%CI: -25.8%, 40.2%; eutrophication: -2.4%, 95%CI: -29.3%, 34.7%; water scarcity: -0.4%, 95%CI: -28.7%, 39.1%). CONCLUSIONS: Ecolabels may not be an effective tool to shift consumer behaviour in worksite cafeterias towards meals with lower environmental impact. TRIAL REGISTRATION: The study was pre-registered prospectively on ISRCTN ( https://www.isrctn.com/ISRCTN10268258 ; 06/01/2022).
Do calorie labels change energy purchased in a simulated online food delivery platform? A multi-arm randomised controlled trial
Background: As rates of obesity and overweight continue to increase in the UK, calorie labels have been introduced on menus as a policy option to provide information to consumers on the energy content of foods and to enable informed choices. This study tested whether the addition of calorie labels to items in a simulated food delivery platform may reduce the energy content of items selected. Methods: UK adults (n = 8,780) who used food delivery platforms were asked to use the simulated platform as they would in real life to order a meal for themselves. Participants were randomly allocated to a control condition (no calorie labels) or to one of seven intervention groups: (1) large size calorie labels adjacent to the price (LP), (2) large size label adjacent to the product name (LN), (3) small label adjacent to price (SP), (4) small label adjacent to product name (SN), (5) LP with a calorie label switch-off filter (LP + Off), (6) LP with a switch-on filter (LP + On), or, (7) LP with a summary label of the total basket energy content (LP + Sum). Regression analysis assessed the impact of calorie labels on energy content of foods selected compared to the control condition. Results: The mean energy selected in the control condition was 1408 kcal (95%CI: 93, 2719). There was a statistically significant reduction in mean energy selected in five of the seven intervention trial arms (LN labels (-60 kcal, 95%CI: -111, -6), SN (-73, 95%CI: -125, -19), LP + Off (-110, 95%CI: -161, -57), LP + On (-109, 95%CI: -159, -57), LP + Sum (-85 kcal, 95%CI: -137, -30). There was no evidence the other two conditions (LP (-33, 95%CI: -88, 24) and SP (-52, 95%CI: -105, 2)) differed from control. There was no evidence of an effect of any intervention when the analysis was restricted to participants who were overweight or obese. Conclusion: Adding calorie labels to food items in a simulated online food delivery platform reduced the energy content of foods selected in five out of seven labelling scenarios. This study provides useful information to inform the implementation of these labels in a food delivery platform context.
Effects of environmental impact labels on the sustainability of food purchases: A randomised controlled trial in an experimental online supermarket
Providing consumers with product-specific environmental impact information for food products (ecolabels) may promote more sustainable purchasing, needed to meet global environmental targets. This UK study (N = 1051 participants) investigated the effectiveness of different ecolabels using an experimental online supermarket platform, comparing three labels against control (no label). Significant reductions were found in the environmental impact score (EIS) for all labels compared to control (labels presented: values for four environmental indicators [-3.9 percentiles, 95%CIs: -5.3, -2.6]; a composite score [taking values from A to E; -3.9, 95%CIs: -5.2,-2.5]; or both together [-3.2, 95%CIs: -4.5, -1.9]). Providing ecolabels is a promising intervention to promote the selection of more sustainable products.
Erratum Identifying Preferred Features of Weight Loss Programs for Adults With or at Risk of Type 2 Diabetes: A Discrete Choice Experiment With 3,960 Adults in the U.K. (Diabetes Care, (2024) 47, 4, (739–746), 10.2337/dc23-2019)
Erratum. Identifying Preferred Features of Weight Loss Programs for Adults With or at Risk of Type 2 Diabetes: A Discrete Choice Experiment With 3,960 Adults in the U.K. Diabetes Care 2024;47:739–746 https://doi.org/10.2337/dc24-er07b In the article cited above, funding information was inadvertently omitted for authors Paul Aveyard and Susan A. Jebb. The following text has been added: “P.A. is an NIHR senior investigator. P.A. and S.A.J. are funded by NIHR Oxford Biomedical Research Centre, NIHR Oxford Health Biomedical Research Centre, and NIHR Oxford and Thames Valley Applied Research Collaboration.” The authors apologize for the omission. The online version of the article (https://doi.org/10.2337/dc23-2019) has been updated to correct the error.
A feasibility study using motivational interviewing and a smartphone application to promote physical activity (+Stay-Active) for women with gestational diabetes
Background: Physical activity (PA) interventions have an encouraging role in gestational diabetes mellitus (GDM) management. Digital technologies can potentially be used at scale to support PA. The aim of this study was to assess the feasibility and acceptability of + Stay-Active: a complex intervention which combines motivational interviewing with a smartphone application to promote PA levels in women with GDM. Methods: This non-randomised feasibility study used a mixed methods approach. Participants were recruited from the GDM antenatal clinic at Oxford University Hospitals. Following baseline assessments (visit 1) including self-reported and device determined PA measurements (wrist worn accelerometer), women participated in an online motivational interview, and then downloaded (visit 2) and used the Stay-Active app (Android or iOS). Women had access to Stay-Active until 36 weeks’ gestation, when acceptability and PA levels were reassessed (visit 3). The primary outcome measures were recruitment and retention rates, participant engagement, and acceptability and fidelity of the intervention. Secondary outcome measures included PA levels, app usage, blood glucose and perinatal outcomes. Descriptive statistics were performed for assessments at study visits. Statistics software package Stata 14 and R were used. Results: Over the recruitment period (46 weeks), 114 of 285 women met inclusion criteria and 67 (58%) enrolled in the study. Mean recruitment rate of 1.5 participants/clinic with 2.5 women/clinic meeting inclusion criteria. Fifty-six (83%) received the intervention at visit 2 and 53 (79%) completed the study. Compliance to accelerometer measurement protocols were sufficient in 78% of participants (52/67); wearing the device for more than 10 h on 5 or more days at baseline and 61% (41/67) at 36 weeks. There was high engagement with Stay-Active; 82% (55/67) of participants set goals on Stay-Active. Sustained engagement was evident, participants regularly accessed and logged multiples activities on Stay-Active. The intervention was deemed acceptable; 85% of women rated their care was satisfactory or above, supported by written feedback. Conclusions: This combined intervention was feasible and accepted. Recruitment rates were lower than expected. However, retention rates remained satisfactory and participant compliance with PA measurements and engagement was a high. Future work will explore the intervention’s efficacy to increase PA and impact on clinical outcomes. Trial registration: The study has received a favourable opinion from South Central—Hampshire B Research Ethics Committee; REC reference: 20/SC/0342. ISRCTN11366562.
Retraction notice to “Effects of environmental impact and nutrition labelling on food purchasing: An experimental online supermarket study” [Appetite 180 (2023) 106312] (Appetite (2023) 180, (S0195666322004032), (10.1016/j.appet.2022.106312))
This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/locate/withdrawalpolicy). This article has been retracted at the request of Authors. It was determined post-publication that errors had been made with the labelling of products in the experimental supermarket. The labels on some products were inaccurate. As a result, the findings in the paper are now in question.