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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
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.
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.
Optimising a digitally delivered behavioural weight loss programme: study protocol for a factorial cluster randomised controlled trial
Background: Digitally delivered weight loss programmes can provide a convenient, potentially cheaper, and scalable treatment option for people who may need to lose weight. However, outcomes are often inferior to in-person interventions in the long-term. This trial will use principles from the Multiphase Optimisation Strategy (MOST) framework to test whether it can enhance the effectiveness of a commercial digital behavioural weight loss programme. This trial aims to identify an optimised combination of four intervention components to enhance weight loss over a 24-week period. We will also explore which components contribute to improvements in participant retention and engagement with the programme. Methods: Approximately 1400 adults with a BMI > 21 kg/m2 will be enrolled and randomised to one of 16 experimental conditions in a 24 factorial cluster design. The trial will test four intervention components: an introductory video call with the health coach, drop-in webchat sessions with the health coach, goal setting statements, and food diary review and feedback. All participants will receive the core digital behavioural weight loss programme and up to four new intervention components. Participation in the trial will last for 24 weeks. The primary outcome will be weight change at 16 weeks. Other outcomes, measured at 4, 16, and 24 weeks, include programme drop-out and engagement (number of interactions with the three main app functions). Fidelity and acceptability will be assessed using data on component adherence and self-report questionnaires. Decision-making for the enhanced programme will be based on components that contribute to at least a minimal improvement in weight loss, defined as ≥ 0.75kg, alone or in combination with other components. Discussion: The factorial design is an efficient way to test the efficacy of behavioural components alone, or in combination, to improve the effectiveness of digital weight loss programmes. This trial will test the implementation of the MOST framework in an industry setting, using routinely collected data, which may provide a better way to refine and evaluate these types of interventions in a model of continuous service improvement. Trial registration: Trial registration: ISRCTN, ISRCTN14407868. Registered 5 January 2024, 10.1186/ISRCTN14407868.
What is the effect of bariatric surgery on health-related quality of life in people with obesity? Observational cohort analysis of the United Kingdom National Bariatric Surgery Registry
BACKGROUND: Previous small studies investigating health-related quality of life (HRQoL) following bariatric surgery have demonstrated heterogenous effects. This study aimed to use National Bariatric Surgery Registry (NBSR) records to investigate the relationship between weight and HRQoL in people undergoing bariatric surgery in the UK. MATERIALS AND METHODS: In this observational study using United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022, patients undergoing primary bariatric surgery with one baseline and at least one follow-up visit within 1 year from surgery were eligible for inclusion. Models estimated the relationship between EuroQol Five Dimension 5-level (EQ-5D) and BMI at baseline and longitudinally. Further analyses were stratified by type 2 diabetes, type of operation (adjustable gastric band, sleeve, or bypass), and domain of EQ-5D. RESULTS: Five thousand five hundred eighty-seven observations of 2160 patients were analysed. At baseline, the mean BMI was 45.7±7.8 kg/m 2 and the mean EQ-5D was 0.78±0.22. A 1 kg/m 2 higher BMI was associated with 0.005 (95% CI [-0.006 to -0.004]) lower EQ-5D. In the month following surgery, EQ-5D increased to 0.91±0.2 while BMI decreased to 39.8±7.1 kg/m 2 ( P <0.001 for both); subsequently, EQ-5D plateaued (0.90±0.17 at 12 months) while BMI continued to decrease (31.5±6.2 kg/m 2 at 12 months, P <0.001). Each 1 kg/m 2 decrease in BMI was associated with a 0.006 (95% CI [-0.007 to -0.005]) increase in EQ-5D. Remission of T2D was independently associated with increase in EQ-5D (0.037, 95% CI [0.015-0.059]); type of operation was not. Decreases in BMI were associated with improvements in all five domains of EQ-5D. CONCLUSIONS: In this large dataset, greater weight loss and T2D remission were independently associated with greater improvements in HRQoL following bariatric surgery. The HRQoL-BMI relationship for people undergoing bariatric surgery differs to that which has previously been estimated following behavioural interventions. The use of the estimates generated here will be important for clinical and political decision-making.
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.
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.
Early findings from the NHS Type 2 Diabetes Path to Remission Programme: a prospective evaluation of real-world implementation
Background: Randomised controlled trials have shown that total diet replacement (TDR) can lead to remission of type 2 diabetes. In 2019, the English National Health Service (NHS) committed to establishing a TDR-based interventional programme delivered at scale within real-world environments; development followed of the NHS Type 2 Diabetes Path to Remission (T2DR) programme, a 12-month behavioural intervention to support weight loss involving an initial 3-month period of TDR. We assessed remission of type 2 diabetes for programme participants. Methods: In this national prospective service evaluation of programme implementation, people in England aged 18–65 years and diagnosed with type 2 diabetes in the last 6 years were referred to the programme between programme launch on Sept 1, 2020, and Dec 31, 2022. Programme data were linked to the National Diabetes Audit to ascertain HbA1c measurements and glucose-lowering medication prescriptions. The primary outcome was remission of type 2 diabetes at 1 year, defined as two HbA1c measurements of less than 48 mmol/mol recorded at least 3 months apart with no glucose-lowering medications prescribed from 3 months before the first HbA1c measurement, and the second HbA1c measurement recorded 11–15 months after the programme start date. Outcomes were assessed in two ways: for all participants who started TDR on the 12-month programme before January, 2022, for whom there were no missing data; and for all participants who started TDR on the 12-month programme before January, 2022, and had completed the programme (ie, had a valid weight recorded at month 12) by Dec 31, 2022, for whom there were no missing data. Findings: Between Sept 1, 2020, and Dec 31, 2022, 7540 people were referred to the programme; of those, 1740 started TDR before January, 2022, and therefore had a full 12-month opportunity to undertake the programme by the time of data extraction at the end of December, 2022. Of those who started TDR before January, 2022, 960 (55%) completed the programme (defined as having a weight recorded at 12 months). The mean weight loss for the 1710 participants who started the programme before January, 2022 and had no missing data was 8·3% (95% CI 7·9–8·6) or 9·4 kg (8·9–9·8), and the mean weight loss for the 945 participants who completed the programme and had no missing data was 9·3% (8·8–9·8) or 10·3 kg (9·7–10·9). For the subgroup of 710 (42%) of 1710 participants who started the programme before January, 2022, and also had two HbA1c measurements recorded, 190 (27%) had remission, with mean weight loss of 13·4% (12·3–14·5) or 14·8 kg (13·4–16·3). Of the 945 participants who completed the programme, 450 (48%) had two HbA1c measurements recorded; of these, 145 (32%) had remission, with mean weight loss of 14·4% (13·2–15·5) or 15·9 kg (14·3–17·4). Interpretation: Findings from the NHS T2DR programme show that remission of type 2 diabetes is possible outside of research settings, through at-scale service delivery. However, the rate of remission achieved is lower and the ascertainment of data is more limited with implementation in the real world than in randomised controlled trial settings. Funding: None.
Calorie (energy) labelling for changing selection and consumption of food or alcohol
Background: Overconsumption of food and consumption of any amount of alcohol increases the risk of non-communicable diseases. Calorie (energy) labelling is advocated as a means to reduce energy intake from food and alcoholic drinks. However, there is continued uncertainty about these potential impacts, with a 2018 Cochrane review identifying only a small body of low-certainty evidence. This review updates and extends the 2018 Cochrane review to provide a timely reassessment of evidence for the effects of calorie labelling on people's selection and consumption of food or alcoholic drinks. Objectives: – To estimate the effect of calorie labelling for food (including non-alcoholic drinks) and alcoholic drinks on selection (with or without purchasing) and consumption. – To assess possible modifiers – label type, setting, and socioeconomic status – of the effect of calorie labelling on selection (with or without purchasing) and consumption of food and alcohol. Search methods: We searched CENTRAL, MEDLINE, Embase, PsycINFO, five other published or grey literature databases, trial registries, and key websites, followed by backwards and forwards citation searches. Using a semi-automated workflow, we searched for and selected records and corresponding reports of eligible studies, with these searches current to 2 August 2021. Updated searches were conducted in September 2023 but their results are not fully integrated into this version of the review. Selection criteria: Eligible studies were randomised controlled trials (RCTs) or quasi-RCTs with between-subjects (parallel group) or within-subjects (cross-over) designs, interrupted time series studies, or controlled before-after studies comparing calorie labelling with no calorie labelling, applied to food (including non-alcoholic drinks) or alcoholic drinks. Eligible studies also needed to objectively measure participants' selection (with or without purchasing) or consumption, in real-world, naturalistic laboratory, or laboratory settings. Data collection and analysis: Two review authors independently selected studies for inclusion and extracted study data. We applied the Cochrane RoB 2 tool and ROBINS-I to assess risk of bias in included studies. Where possible, we used (random-effects) meta-analyses to estimate summary effect sizes as standardised mean differences (SMDs) with 95% confidence intervals (CIs), and subgroup analyses to investigate potential effect modifiers, including study, intervention, and participant characteristics. We synthesised data from other studies in a narrative summary. We rated the certainty of evidence using GRADE. Main results: We included 25 studies (23 food, 2 alcohol and food), comprising 18 RCTs, one quasi-RCT, two interrupted time series studies, and four controlled before-after studies. Most studies were conducted in real-world field settings (16/25, with 13 of these in restaurants or cafeterias and three in supermarkets); six studies were conducted in naturalistic laboratories that attempted to mimic a real-world setting; and three studies were conducted in laboratory settings. Most studies assessed the impact of calorie labelling on menus or menu boards (18/25); six studies assessed the impact of calorie labelling directly on, or placed adjacent to, products or their packaging; and one study assessed labels on both menus and on product packaging. The most frequently assessed labelling type was simple calorie labelling (20/25), with other studies assessing calorie labelling with information about at least one other nutrient, or calories with physical activity calorie equivalent (PACE) labelling (or both). Twenty-four studies were conducted in high-income countries, with 15 in the USA, six in the UK, one in Ireland, one in France, and one in Canada. Most studies (18/25) were conducted in high socioeconomic status populations, while six studies included both low and high socioeconomic groups, and one study included only participants from low socioeconomic groups. Twenty-four studies included a measure of selection of food (with or without purchasing), most of which measured selection with purchasing (17/24), and eight studies included a measure of consumption of food. Calorie labelling of food led to a small reduction in energy selected (SMD −0.06, 95% CI −0.08 to −0.03; 16 randomised studies, 19 comparisons, 9850 participants; high-certainty evidence), with near-identical effects when including only studies at low risk of bias, and when including only studies of selection with purchasing. There may be a larger reduction in consumption (SMD −0.19, 95% CI −0.33 to −0.05; 8 randomised studies, 10 comparisons, 2134 participants; low-certainty evidence). These effect sizes suggest that, for an average meal of 600 kcal, adults exposed to calorie labelling would select 11 kcal less (equivalent to a 1.8% reduction), and consume 35 kcal less (equivalent to a 5.9% reduction). The direction of effect observed in the six non-randomised studies was broadly consistent with that observed in the 16 randomised studies. Only two studies focused on alcoholic drinks, and these studies also included a measure of selection of food (including non-alcoholic drinks). Their results were inconclusive, with inconsistent effects and wide 95% CIs encompassing both harm and benefit, and the evidence was of very low certainty. Authors' conclusions: Current evidence suggests that calorie labelling of food (including non-alcoholic drinks) on menus, products, and packaging leads to small reductions in energy selected and purchased, with potentially meaningful impacts on population health when applied at scale. The evidence assessing the impact of calorie labelling of food on consumption suggests a similar effect to that observed for selection and purchasing, although there is less evidence and it is of lower certainty. There is insufficient evidence to estimate the effect of calorie labelling of alcoholic drinks, and more high-quality studies are needed. Further research is needed to assess potential moderators of the intervention effect observed for food, particularly socioeconomic status. Wider potential effects of implementation that are not assessed by this review also merit further examination, including systemic impacts of calorie labelling on industry actions, and potential individual harms and benefits.
Adolescent and parental views on weight and weight management: A qualitative study
Objective: To examine the views of adolescents with excess weight and parents of adolescents with excess weight towards weight and weight management. Design: A qualitative study design using semi-structured phone interviews. The interviews were recorded, transcribed verbatim and analysed using reflexive thematic analysis to interpret the data. Settings: Parents and adolescents based in the UK and recruited through schools, social media and youth centres. Participants: Ten parents and 16 adolescents, including four linked parent-child dyads. Results: Both parents and adolescents reported that adolescents felt societal pressure to achieve an 'ideal body' and that this pressure was the primary motivator for weight loss. All interviewed parents perceived themselves as overweight; however, those who had minimal weight-based shame were more likely to normalise weight discussions, reducing weight shame in their children. Adolescents preferred parents to display healthy behaviours rather than initiate weight-based discussions; however, they wanted to feel supported if the conversations were self-initiated. Conclusion: Weight is a sensitive issue in intergenerational relationships, primarily driven by feelings of shame. Adolescents feel supported by a 'show not tell' approach from parents, which is more likely in families with less shame. While guidelines encourage clinicians to initiate weight-related conversations, this may not be welcomed by adolescents, although they do want confidence that they could access weight management support if they choose to seek help.