Objective To test the effectiveness of a postpartum behavioural intervention delivered by automated text messaging in reducing weight. Design Two parallel group, multicentre, randomised controlled trial. Setting Recruitment from five areas across the United Kingdom (Belfast, Bradford, Stirling, London and Cardiff) through healthcare and community pathways, including social media. Participants A diverse sample of 892 women between 6 weeks and 24 months postpartum, aged 18 years or more and with a body mass index of 25 kg/m2 or more, enrolled between May 2022 and May 2023: 445 were randomised to the intervention and 447 to an active control (comparator). Interventions Twelve months of fully automated text messages with embedded behaviour change techniques and two-way messaging components to support weight loss and maintenance of weight loss in the postpartum period by targeting dietary, physical activity and weight management behaviours. The comparator group received 12 months of text messages on child health and development tailored to child age. Main outcome measures Primary outcome: weight in kilograms at 12 months (end of intervention). Secondary outcomes recorded at 6 and 12 months were changes in weight (at 6 months), body mass index, proportions of women with weight gain or loss of 5 kg or more, waist circumference, self-reported dietary intake, physical activity and infant feeding practices. Results 674 (75.6%) participants were included in the primary analysis. There was no statistically significant difference found in the adjusted mean weight change between the intervention and active control groups (-0.1 kg (95% confidence interval -1.0 to 0.8, P= 0.84). Sensitivity analyses did not change these results. There was a small statistically significant improvement in Fat and Fibre Barometer scores at 12 months in the intervention compared with control group (adjusted mean difference 0.09, 95% CI: 0.04 to 0.14; P <0.001) and a statistically significant increase in physical activity scores (International Physical Activity Questionnaire Short Form) at 12 months in the intervention group compared with the control group (adjusted mean difference 405.3 total MET minutes/week, 95% CI: 141.3 to 669.3; P= 0.003). Conclusions A 12 month automated, interactive behavioural weight management intervention delivered by text message did not support weight loss for postpartum women but did have a positive impact on diet and physical activity behaviours. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN16299220 ### Clinical Protocols ### Funding Statement This work was funded by the National Institute for Health and Care Research (NIHR) Public Health Research Programme (NIHR131509) (https://fundingawards.nihr.ac.uk/award/NIHR131509) undergoing external peer review at application. Intervention costs were provided by the HSC Research and Development Division of the Public Health Agency Northern Ireland. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee of the West of Scotland Research Ethics Service REC 4 (22/WS/0003; IRAS- 305557) gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors

OBJECTIVES:To evaluate the efficacy and safety of low concentration atropine eye drops for reducing progression of myopia in children in the UK. DESIGN:Multicentre, double masked, superiority, placebo controlled, randomised trial. SETTING:National Health Service hospital eye services and academic institutions at five UK centres. PARTICIPANTS:289 children aged 6-12 years with myopia between -0.50 and -10.0 dioptres (D). Participants were allocated in ratio of 2:1 to atropine or placebo. INTERVENTIONS:One eye drop of preserved atropine 0.01% or placebo daily for two years. MAIN OUTCOME MEASURES:The primary outcome was spherical equivalent refractive error of both eyes measured by autorefractor under cycloplegia after two years. Secondary outcomes included change in axial length, best corrected distance and near visual acuity, reading speed, pupil diameter, spectacle correction, adverse event rates, quality of life, and tolerability. Outcomes were collected every six months. An electronic monitoring system was used to assess adherence. RESULTS:192 participants were included in the atropine group and 97 in the placebo group, with an average age of 9.3 years (standard deviation (SD) 1.7 years). 207 (72%) reported white ethnicity, 161 (56%) were girls, and the mean level of myopia was -2.87 D (SD 1.71 D). A total of 235 (81%) participants completed the study, with primary outcome data available for 230 (80%) participants: 151 (79%) in the atropine group and 79 (81%) in the placebo group. Atropine eye drops were more effective than placebo in reducing myopia progression (mean difference 0.33 D, 95% confidence interval (CI) 0.17 to 0.49 D, P<0.001). Prespecified subgroup analyses did not show differences according to age, ethnicity, sex, or severity of myopia. Changes in central axial length were significantly less in the atropine group versus placebo group: mean difference 0.14 mm (95% CI 0.07 to 0.21, P<0.001). There were no differences in other secondary outcomes, except pupil diameter, which was greater in the atropine group (0.36 mm, 95% CI 0.17, 0.55, P<0.001), and no differences in frequency of adverse events or in tolerability measures. No serious adverse events were related to the trial drugs. CONCLUSIONS:Low concentration atropine (0.01%) eye drops significantly reduced progression of myopia and were well tolerated compared with placebo in children in the UK. TRIAL REGISTRATION:ISRCTN registry ISRCTN99883695, ClinicalTrials.gov NCT03690089.

BACKGROUND:Acute respiratory distress syndrome (ARDS) is a clinically defined, biologically heterogeneous condition with no proven disease-modifying therapies. Retrospective analyses have identified two biologically distinct subphenotypes (hyperinflammatory and hypoinflammatory) of ARDS, with differing outcomes and responses to therapy. Rapid identification of these subphenotypes in an actionable timeframe has previously not been possible. The PHIND study aimed to prospectively identify these subphenotypes and to demonstrate differing 60-day mortality. METHODS:The PHIND study was a prospective, multicentre, observational cohort study conducted in intensive care units (ICUs) within the National Health Service in the UK and the Health Service Executive in Ireland. Adult patients aged 18 years and older with ARDS or acute hypoxaemic respiratory failure (AHRF) were enrolled within 72 h of onset of the syndrome. Eligible patients were required to be receiving invasive mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen. Plasma interleukin (IL-6) and soluble TNF receptor-1 (TNFR1) were quantified at enrolment using a near-patient benchtop immunoanalyser (Randox multiSTAT) with a run time of approximately 1 h. Together with plasma bicarbonate measured from an arterial blood sample, these values were used to prospectively determine subphenotypes on an individual patient basis using a validated parsimonious logistic regression model. The primary outcome was 60-day mortality. The study was registered on ClinicalTrials.gov, NCT04009330. FINDINGS:Between Nov 22, 2019, and Sept 28, 2023, 1853 patients from 30 centres were screened for eligibility. Of these, 1328 were excluded and 525 were recruited into the study, with 512 individuals included. 308 (60%) patients were male, 204 (40%) were female, and mean age was 57·0 years (SD 15·1). 443 (87%) patients were white, 18 (4%) were Black, and 16 (3%) were Asian. 490 were subphenotyped using the near-patient assay: 89 (18%) were classified as hyperinflammatory and 401 (82%) as hypoinflammatory. The primary outcome of 60-day mortality was measured in 486 patients after four patients withdrew consent for confirmation of vital status. 60-day mortality was significantly higher in the hyperinflammatory group (45 [51%] of 88) than in the hypoinflammatory group (111 [28%] of 398; risk ratio 1·8 [95% CI 1·4-2·4], p<0·0001). After adjustment, hyperinflammatory patients had increased odds of 60-day mortality (adjusted odds ratio 2·7 [95% CI 1·6-4·4], p=0·0002). INTERPRETATION:Rapid identification of ARDS inflammatory subphenotypes using a near-patient assay was feasible and associated with many clinical characteristics and outcomes consistent with those described in earlier retrospective studies, including mortality, prevalence of sepsis, and incidence of metabolic acidosis. These findings support the implementation of precision medicine approaches in ARDS and the urgent need for prospective, subphenotype-stratified interventional trials. FUNDING:Innovate UK, Randox Laboratories, and Belfast Health & Social Care Trust.

Background Mucoactives such as hypertonic saline (HTS) and carbocisteine are widely used in the treatment of bronchiectasis, though there is insufficient evidence to support their use. The aim of this mechanistic sub-study, embedded within the CLEAR trial, was to characterise the properties of sputum from patients with bronchiectasis and to assess whether treatment with HTS and/or carbocisteine altered these properties. Methods In CLEAR, patients were randomised to receive HTS, carbocisteine, HTS plus carbocisteine or standard care, and sputum samples were collected at randomisation (baseline) and at 2 and 8 weeks post-randomisation. Sputum viscoelasticity was determined by rotational plate rheometry. Biomarkers were quantified by ELISA and microbiome composition was assessed by next-generation sequencing. The primary outcome was differences in sputum viscoelasticity between groups at 2 weeks following the commencement of treatment. Results Sputum viscoelastic properties were not reduced by 2 or 8 weeks of treatment with HTS and/or carbocisteine (n=6–15 per group). Sputum biomarker levels and bacterial community composition were similar across groups at 2 or 8 weeks. At baseline, viscoelasticity (crossover point σc) was positively correlated with IL-8 (r=0.49, p=0.012) and greater relative bacterial dominance (r=0.35, p=0.041). Conclusions These data do not support the use of HTS or carbocisteine to alter sputum viscoelasticity, inflammatory marker levels or bacterial community composition in patients with bronchiectasis.

RATIONALE: In patients with acute respiratory distress syndrome (ARDS), the hyperinflammatory and hypoinflammatory phenotypes have been reported to have different outcomes and treatment effects in retrospective analyses of completed clinical trials. We tested the hypothesis that real-time identification of inflammatory phenotypes at the bedside with a point-of-care assay and a validated parsimonious classifier model was feasible. METHODS: Patients with ARDS (defined using identical criteria to the 2024 global definition), were recruited in 30 intensive care units in the United Kingdom and Ireland within 72 hours of ARDS onset. Clinical data were collected at baseline. Freshly collected plasma samples were quantitatively analyzed for interleukin-6 (IL-6) and soluble tumour necrosis factor receptor-1 (sTNFR-1) using an Evidence MultiSTAT point-of-care analyzer (Randox Laboratories Ltd). These values were used along with an arterial bicarbonate measurement in the validated parsimonious regression classifier model to calculate the probability of belonging to the hyperinflammatory phenotype, with a cut-off > 0.5 indicating allocation to the hyperinflammatory phenotype. The primary outcome was difference in mortality at 60 days between the hyperinflammatory and hypoinflammatory ARDS phenotypes (NCT04009330). RESULTS: 512 patients were recruited and consented to data usage. For 22 of these patients (4.2%), phenotype allocation was not possible due to assay failure. The prevalence of the hyperinflammatory phenotype was 18% (89/490). Despite the phenotypes having similar age ranges and pulmonary dysfunction as measured by the PaO2/FiO2 ratio and lung injury score, patients with the hyperinflammatory phenotype were more severely ill as measured by APACHE II and SOFA scores. In patients on high-flow nasal oxygen (HFNO) at enrolment, progression to intubation was more frequent in the hyperinflammatory phenotype (7/89 [63.6%] compared to 27/401 [31.0%]). In the hyperinflammatory phenotype, mortality was higher (51.1% vs. 27.9%; 23.2% difference [95% CI 11.9-34.6]; adjusted OR 2.6 [95% CI 1.6-4.4, p<0.001]) and successful extubation was lower (Figure 1). CONCLUSION: Our large multicenter study indicates that real-time classification of ARDS inflammatory phenotypes is feasible in a real-world setting and that the identified phenotypes have distinct clinical characteristics and outcomes. Our findings advance the field by enabling precision medicine clinical trials, such as the PANTHER trial, to test differential pharmacological treatment effects in these phenotypes.

Background:In patients who require mechanical ventilation for acute hypoxaemic respiratory failure, further reduction in tidal volumes, compared with conventional low tidal volume ventilation, may improve outcomes. Objective:To determine whether using extracorporeal carbon dioxide removal improves outcomes in patients with acute hypoxaemic respiratory failure and is cost-effective. Design:A multicentre, randomised, allocation-concealed, open-label, pragmatic clinical trial. Setting:Fifty-one intensive care units across the United Kingdom. Participants:Four hundred and twelve adult patients receiving mechanical ventilation for acute hypoxaemic respiratory failure, of a planned sample size of 1120. Interventions:Lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal for at least 48 hours (n = 202) or standard care with conventional low tidal volume ventilation (n = 210). Main outcome measures:All-cause mortality 90 days. Secondary outcomes included ventilator-free days; adverse events; extracorporeal membrane oxygenation use; long-term mortality; health-related quality of life; health service costs; long-term respiratory morbidity. Results:The trial was stopped early because of futility and feasibility. The 90-day mortality rate was 41.5% in the extracorporeal carbon dioxide removal group versus 39.5% in the standard care group (risk ratio 1.05, 95% confidence interval 0.83 to 1.33; difference 2.0%, 95% confidence interval  - 7.6% to 11.5%; p = 0.68). There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1, 95% confidence interval 5.9 to 8.3) versus (9.2, 95% confidence interval 7.9 to 10.4) days; mean difference, -2.1 (95% confidence interval -3.8 to -0.3; p = 0.02). Serious adverse events were reported for 62 patients (31%) in extracorporeal carbon dioxide removal group and 18 (9%) in the standard care group, including intracranial haemorrhage in 9 patients (4.5%) versus 0 (0%) and bleeding at other sites in 6 (3.0%) versus 1 (0.5%) in the extracorporeal carbon dioxide removal group versus the control group. Two-year mortality data were available for 95% of patients. There was no difference in the time to death between groups (hazard ratio 1.08, 95% confidence interval 0.81 to 1.44; log-rank test p = 0.61). There was no difference in long-term outcomes between groups. There was no difference in quality-adjusted life-years at 12 months (mean difference -0.01, 95% confidence interval -0.06 to 0.05). Total 12-month costs were statistically significantly higher in the extracorporeal carbon dioxide removal group (mean difference £7668.76, 95% confidence interval £159.75 to £15,177.77). Secondary analyses indicated there may be heterogeneity of treatment effect based on physiological characteristics of the patients. A systematic review supported these findings. Limitations:Only 6% of screened patients were included in the study; most sites were naive to the intervention before the study commenced; other aspects of care were not standardised in each group, because this was a pragmatic trial; the trial may have been underpowered to detect a clinically important difference, because the trial was stopped early; blinding to the clinicians or patients was not possible. Conclusions:There were no short- or long-term benefits found, and the device was associated with higher cost and potentially significant complications. We would advise against using this device in addition to standard care for the treatment of patients with hypoxaemic respiratory failure, outside of future clinical trials. Future work:Future studies could further explore whether different patient populations receiving a larger 'dose' of from extracorporeal carbon dioxide removal might benefit, use core outcome sets and collect broader long-term outcomes and consider measuring patients' health-related quality of life at the soonest opportunity after regaining capacity. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 13/143/02.

OBJECTIVE:The Sedation and Weaning in Children (SANDWICH) trial of a sedation weaning and ventilator liberation bundle had a primary outcome of time to successful extubation, and showed significant but small difference. We explored the impact of the intervention on infants with bronchiolitis.DESIGN:Post hoc subgroup analysis of a cluster-randomized trial, 2018 to 2019 (ISRCTN16998143).PATIENTS:Surviving patients with bronchiolitis under 1 year of age in the SANDWICH trial (n = 784).INTERVENTIONS:Nil.MEASUREMENTS AND MAIN RESULTS:Time to successful extubation, and rates of unplanned and failed extubation were compared in patients exposed and not exposed to the intervention. To explore a site-level effect, we tested the correlation between the rate of unplanned and failed extubation at each trial site with the median time to successful extubation at that site. Of 784 patients (48%), 376 were exposed to the intervention. Median (interquartile range [IQR]) time to successful extubation was 69.6 (IQR 50.4-110.4) hours in patients exposed to the intervention and 86.4 (IQR 60-124.8) hours in non-exposed. Exposure to the SANDWICH intervention was associated with a 13% (95% CI, 1%-26%) reduction in time to extubation following adjustment for confounders. Thirty (3.8%) patients experienced unplanned extubation and 112 (14%) failed extubation. Patients who experienced failed extubation had an increased time to successful extubation, which remained significant after adjustment for confounders. At the site level, there was a negative correlation between failed extubation rate and median time to successful extubation (Spearman rho -0.53 [95% CI, -0.8 to -0.08], p = 0.02).CONCLUSIONS:In a secondary analysis of the SANDWICH trial, the subgroup of bronchiolitis patients showed that exposure to the intervention was associated with a clinically significant reduction in time to successful extubation. Although failed extubation was associated with increased duration of ventilation in an individual, sites with higher rates of failed extubation had a lower median duration of ventilation.

Chronic cough is a common clinical problem which is burdensome for patients and can be difficult to treat. Individual centres of cough expertise have been set up in countries across Europe but to date there has been no means to collate and analyse clinical data from such sites to gain a more comprehensive understanding of cough phenotypes, disease burden and the natural history of this condition. The NEw Understanding in the tReatment Of COUGH (NEuroCOUGH) registry is the first pan-European prospective observational study of adult patients referred for evaluation of chronic cough. Patients (≥18 years old) with a cough lasting more than 8 weeks with no chest radiology findings to explain the cough will be recruited. Key exclusion criteria include current or recent (<12 months) smoking, significant smoking history (≥20 pack-years) and obstructive spirometry (forced expiratory volume in 1 s/forced vital capacity ratio <0.6). The study aims to recruit 2500 patients across 13 European sites by 2026 and participants will be followed up at 12-monthly intervals for 36 months. The registry comprises comprehensive clinical, physiological and biological data on chronic cough, along with data on the impact and longitudinal outcome of chronic cough. The NEuroCOUGH registry has been established at a time of considerable advance in the field of cough. It will serve as a valuable clinical and research resource which will extend our current understanding of this difficult to treat condition. The initiative is also intended to encourage the establishment of new specialist cough clinics, thus creating much needed clinical trial infrastructure throughout Europe to ultimately improve patient care.

Background International guidelines recommend structured diabetes education to empower individuals with type 2 diabetes (T2D). While DESMOND is an effective programme for T2D management, it is often inaccessible to people with intellectual disabilities (ID) due to their unique needs. There is limited evidence on the effectiveness of adapted T2D education for this group, despite the importance of tailored support in preventing complications and early mortality. We previously adapted the DESMOND programme for adults with ID, creating DESMOND-ID. A feasibility study showed it is possible to recruit and deliver the programme to adults with ID and their carers, who found it valuable. Initial findings suggest DESMOND-ID may improve blood glucose control, warranting further investigation through a large-scale randomised controlled trial (RCT). Methods The "My Diabetes & Me" study will be conducted in two stages: an internal pilot and a main RCT. The pilot will recruit 108 participants over 10 months to assess recruitment and retention, using glycated haemoglobin (HbA1c, mmol/mol) at six months as the primary outcome. This will inform the design of the main study. Across both stages, 450 participants will be randomly assigned to receive either the DESMOND-ID intervention or treatment as usual (TAU). The intervention group, with their carers, will attend weekly sessions for seven weeks, plus two booster sessions at one and three months post-programme. Primary outcome is HbA1c at six months. Secondary outcomes include HbA1c at 12 and 18 months (pilot only), anthropometric data, self-reported outcomes, and other risk factors. A process evaluation will explore barriers and facilitators to implementation using qualitative and quantitative methods. Conclusion DESMOND-ID is the first structured T2D education programme tailored for adults with ID, and this RCT is the first to evaluate its clinical and cost-effectiveness. Trial Registration 09/11/2022 ISRCTN83150600 (https://doi.org/10.1186/ISRCTN83150600)

Background Urinary tract infections (UTI) are the second most common serious bacterial infection in children. When healthcare practitioners are unsure if an infant, child, or young person has a UTI they perform a urine test. A midstream sample is recommended by the National Institute for Health and Care Excellence (NICE) for obtaining urine for testing. However, collecting urine from children who are unable to provide a midstream urine sample is challenging. Samples can be collected either by non-invasive (clean catch) or invasive methods (trans-urethral bladder catheter or suprapubic aspirate). Non-invasive methods are slow and prone to contamination but are painless. Invasive methods are less prone to contamination and are quick but can cause pain and distress. Methods This is a mixed methods feasibility study comprising of three parts. Part 1 is a pragmatic multicentre randomised controlled feasibility trial. The trial aims to evaluate the feasibility of conducting an RCT comparing invasive and non-invasive sampling methods for infants, children and young people (N = 100). Resource use will be assessed by parent reported questionnaire and mixed methods descriptors reported by healthcare professionals (n = 24). A cost analysis will assess the urine collection methods, informing a future cost-effectiveness analysis. Part 2 is an embedded mixed methods perspectives’ study including interviews with parents (n = 15-20) and children (n = 10-15), five focus groups (n = 6-8 per group) and interviews (n = 10) with healthcare professionals aiming to assess feasibility and acceptability of the trial. Part 3 is a stakeholder (n = 40) consensus meeting determining a final definitive study design. Discussion The results of the study will inform a recommendation and decision on progression and design of a definitive RCT for infants, children and young people who have a suspected urine infection but cannot provide a midstream urine sample. Trial registration International Standard Randomised Controlled Trial Number (ISRCTN) 84676764: Feasibility of conducting a randomised controlled trial (RCT) comparing invasive and non-invasive urine sampling techniques in children under 16 years old with a suspected urinary tract infection 1 .

OBJECTIVES:. Lower tidal volume ventilation (targeting 3 mL/kg predicted body weight, PBW) facilitated by extracorporeal carbon dioxide removal (ECCO2R) has been investigated as a potential therapy for acute hypoxemic respiratory failure (AHRF) in the pRotective vEntilation with veno-venouS lung assisT in respiratory failure (REST) trial. We investigated the effect of this strategy on cardiac function, and in particular the right ventricle. DESIGN:. Substudy of the REST trial. SETTING:. Nine U.K. ICUs. PATIENTS:. Patients with AHRF (Pao2/Fio2 < 150 mm Hg [20 kPa]). INTERVENTION:. Transthoracic echocardiography and N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurements were collected at baseline and postrandomization in patients randomized to ECCO2R or usual care. MEASUREMENTS:. The primary outcome measures were a difference in tricuspid annular plane systolic excursion (TAPSE) on postrandomization echocardiogram and difference in NT-proBNP postrandomization. RESULTS:. There were 21 patients included in the echocardiography cohort (ECCO2R, n = 13; usual care, n = 8). Patient characteristics were similar in both groups at baseline. Median (interquartile range) tidal volumes were lower in the ECCO2R group compared with the usual care group postrandomization; 3.6 (3.1–4.2) mL/kg PBW versus 5.2 (4.9–5.7) mL/kg PBW, respectively (p = 0.01). There was no difference in the primary outcome measure of mean (sd) TAPSE in the ECCO2R and usual care groups postrandomization; 21.3 (5.4) mm versus 20.1 (3.2) mm, respectively (p = 0.60). There were 75 patients included in the NT-proBNP cohort (ECCO2R, n = 36; usual care, n = 39). Patient characteristics were similar in both groups at baseline. Median (interquartile range [IQR]) tidal volumes were lower in the ECCO2R group than the usual care group postrandomization; 3.8 (3.3–4.2) mL/kg PBW versus 6.7 (5.8–8.1) mL/kg PBW, respectively (p < 0.0001). There was no difference in median (IQR) NT-proBNP postrandomization; 1121 (241–5370) pg/mL versus 1393 (723–4332) pg/mL in the ECCO2R and usual care groups, respectively (p = 0.30). CONCLUSIONS:. In patients with AHRF, a reduction in tidal volume facilitated by ECCO2R, did not modify cardiac function.

Introduction The reproductive years can increase women’s weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development.Methods and analysis Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost–utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants’ experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation.Ethics and dissemination Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences.Trial registration number ISRCTN16299220.

Abstract Background Traffic crashes are the leading cause of death globally for people aged 5–29 years, with 90% of mortality occurring in low- and middle-income countries (LMICs). The STABLE (Slashing Two-wheeled Accidents by Leveraging Eyecare) trial was designed to determine whether providing spectacles could reduce risk among young myopic motorcycle users in Vietnam. Methods This investigator-masked, stepped-wedge, cluster randomised naturalistic driving trial will recruit 625 students aged 18–23 years, driving ≥ 50 km/week, with ≥ 1-year driving experience and using motorcycles as their primary means of transport, in 25 clusters of 25 students in Ho Chi Minh City, Vietnam. Motorcycles of consenting students who have failed self-testing on the WHOeyes app will be fitted with Data Acquisition Systems (DAS) with video cameras and accelerometers. Video clips (± 30 s) of events flagged by the accelerometer will be reviewed for crash and near-crash events per 1000 km driven (main outcome). Five clusters of 25 students will be randomly selected every 12 weeks to undergo ocular examination and an estimated 40% of these will have bilateral spherical equivalent < − 0.5 D, and better-eye presenting distance visual acuity < 6/12, correctable bilaterally to ≥ 6/7.5. They will be given free distance spectacles and their driving data before receiving spectacles will be analysed as the control condition and subsequent data as the intervention condition. Secondary outcomes include visual function, cost-effectiveness and self-reported crash events. Discussion STABLE will be the first randomised trial of vision interventions and driving safety in a LMIC. Trial registration ClinicalTrials.gov, NCT05466955. Initial registration: 20 July 2022, most recent update: 9 July 2024.

Background: The proportion of the population aged 65 years or older is increasing. Typically, physical activity and health decline with age, which is why action to promote active ageing is a major public health priority, particularly due to health inequalities in older adults. The aim of this study is to assess the effectiveness and cost-effectiveness of the Walk with Me peer-led walking intervention for older adults. Methods: This study is a two-arm, assessor-blind, randomised controlled trial. The intervention is a 12-week peer-led walking intervention based on social cognitive theory. Participants in the control group will receive information on active ageing and healthy nutrition. The study will target 348 community-dwelling older adults, aged 60 years or over living in areas of socio-economic disadvantage communities. Trained peer mentors will deliver the intervention. The primary outcome will be a mean between-group change in moderate-to-vigorous physical activity at 12 months from baseline, measured using an Actigraph accelerometer. Secondary outcomes will include quality of life, mental wellbeing, blood pressure, BMI and waist circumference. An embedded process evaluation will involve focus groups and participant diaries. Discussion: Evidence-based, cost-effective interventions to promote physical activity in older adults living in socio-economically disadvantaged communities are needed to address health inequalities.

Background:The need to engage boys in gender-transformative relationships and sexuality education (RSE) to reduce adolescent pregnancy is endorsed by the World Health Organization and the United Nations Educational, Scientific and Cultural Organization.Objectives:To evaluate the effects of If I Were Jack on the avoidance of unprotected sex and other sexual health outcomes.Design:A cluster randomised trial, incorporating health economics and process evaluations.Setting:Sixty-six schools across the four nations of the UK.Participants:Students aged 13-14 years.Intervention:A school-based, teacher-delivered, gender-transformative RSE intervention (If I Were Jack) versus standard RSE.Main outcome measures:Self-reported avoidance of unprotected sex (sexual abstinence or reliable contraceptive use at last sex) after 12-14 months. Secondary outcomes included knowledge, attitudes, skills, intentions and sexual behaviours.Results:The analysis population comprised 6556 students: 86.6% of students in the intervention group avoided unprotected sex, compared with 86.4% in the control group {adjusted odds ratio 0.85 [95% confidence interval (CI) 0.58 to 1.26], p = 0.42}. An exploratory post hoc analysis showed no difference for sexual abstinence [78.30% intervention group vs. 78.25% control group; adjusted odds ratio 0.85 (95% CI 0.58 to 1.24), p = 0.39], but more intervention group students than control group students used reliable contraception at last sex [39.62% vs. 26.36%; adjusted odds ratio 0.52 (95% CI 0.29 to 0.920), p = 0.025]. Students in schools allocated to receive the intervention had significantly higher scores on knowledge [adjusted mean difference 0.18 (95% CI 0.024 to 0.34), p = 0.02], gender-equitable attitudes and intentions to avoid unintended pregnancy [adjusted mean difference 0.61 (95% CI 0.16 to 1.07), p = 0.01] than students in schools allocated to receive the control. There were positive but non-significant differences in sexual self-efficacy and communication skills. The total mean incremental cost of the intervention compared with standard RSE was £2.83 (95% CI -£2.64 to £8.29) per student. Over a 20-year time horizon, the intervention is likely to be cost-effective owing to its impact on unprotected sex because it would result in 379 (95% CI 231 to 477) fewer unintended pregnancies, 680 (95% CI 189 to 1467) fewer sexually transmitted infections and a gain of 10 (95% CI 5 to 16) quality-adjusted life-years per 100,000 students for a cost saving of £9.89 (95% CI -£15.60 to -£3.83).Limitations:The trial is underpowered to detect some effects because four schools withdrew and the intraclass correlation coefficient (0.12) was larger than that in sample size calculation (0.01).Conclusions:We present, to our knowledge, the first evidence from a randomised trial that a school-based, male engagement gender-transformative RSE intervention, although not effective in increasing avoidance of unprotected sex (defined as sexual abstinence or use of reliable contraception at last sex) among all students, did increase the use of reliable contraception at last sex among students who were, or became, sexually active by 12-14 months after the intervention. The trial demonstrated that engaging all adolescents early through RSE is important so that, as they become sexually active, rates of unprotected sex are reduced, and that doing so is likely to be cost-effective.Future work:Future studies should consider the longer-term effects of gender-transformative RSE as students become sexually active. Gender-transformative RSE could be adapted to address broader sexual health and other settings.Trial registration:This trial is registered as ISRCTN10751359.Funding:This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (PHR 15/181/01) and will be published in full in Public Health Research; Vol. 11, No. 8. See the NIHR Journals Library website for further project information.

Supplementary Figures S1-S2 and Supplementary Tables S1-S3.