Transferability of the NHS low-calorie diet programme: A qualitative exploration of factors influencing the programme's transfer ahead of wide-scale adoption.

INTRODUCTION: Although behavioural interventions have been found to help control type 2 diabetes (T2D), it is important to understand how the delivery context can influence implementation and outcomes. The NHS committed to testing a low-calorie diet (LCD) programme designed to support people living with excess weight and T2D to lose weight and improve diabetes outcomes. Understanding what influenced implementation during the programme pilot is important in optimising rollout. This study explored the transferability of the NHS LCD Programme prior to wider adoption. METHODS: Twenty-five interviews were undertaken with stakeholders involved in implementing the LCD programme in pilot sites (health service leads, referring health professionals and programme deliverers). Interviews with programme participants (people living with T2D) were undertaken within a larger programme of work, exploring what worked, for whom and why, which is reported separately. The conceptual Population-Intervention-Environment-Transfer Model of Transferability (PIET-T) guided study design and data collection. Constructs of the model were also used as a deductive coding frame during data analysis. Key themes were identified which informed recommendations to optimise programme transfer. RESULTS: Population: Referral strategies in some areas lacked consideration of population characteristics. Many believed that offering a choice of delivery model would promote acceptability and accessibility of the eligible population. INTERVENTION: Overall, stakeholders had confidence in the LCD programme due to the robust evidence base along with anecdotal evidence, but some felt the complex referral process hindered engagement from GP practices. ENVIRONMENT: Stakeholders described barriers to accessing the programme, including language and learning difficulties. Transferability: Multidisciplinary working and effective communication supported successful implementation. CONCLUSION: Referral strategies to reach underrepresented groups should be considered during programme transfer, along with timely data from service providers on access and programme benefits. A choice of delivery models may optimise uptake. Knowledge sharing between sites on good working practices is encouraged, including increasing engagement with key stakeholders.

Aquaponics in schools: Hands-on learning about healthy eating and a healthy planet.

Our food system is giving rise to a growing social, health and environmental crisis. Much of the food consumed in the United Kingdom is cheap, nutrient-poor and highly processed, leading to under-consumption of essential foods such as grains, beans, vegetables and fruit. This has contributed to a rise in diet-related diseases, with approximately 22% of primary school leavers being overweight or obese. Food production is unsustainable with agriculture responsible for 10% of the UK's greenhouse gas emissions and intensive farming practices have led to a significant loss of soil carbon and a decline in biodiversity. COVID-19 increased inequalities in our food system. Therefore, there is an urgent need for interventions to counteract these adverse social, health and environmental impacts. Education can play a crucial role as an intervention to address challenges in the food system. We tested an innovative school initiative using portable aquaponic pods and aligned to the national curriculum, to engage pupils in food production and foster learning about sustainability, climate change and healthy eating. The evaluation, based on teacher surveys, aquapod chart data, student blogs and postcards and feedback from the development team, revealed positive impacts on students' environmental awareness, as well as sustainability and practical food production knowledge. However, the programme encountered logistical challenges and we therefore highlight future improvements to produce a curriculum programme that can be delivered at scale to enhance food education and empower pupils to drive the agenda on tackling food sustainability and climate change.

Childhood obesity prevention trials: A systematic review and meta-analysis on trial design and the impact of type 1 error.

Effect sizes from previously reported trials are often used to determine the meaningful change in weight in childhood obesity prevention interventions because information on clinically meaningful differences is lacking. Estimates from previous trials may be influenced by statistical significance; therefore, it is important that they have a low risk of type 1 error. A systematic review and meta-analysis were conducted to report on the design of child obesity prevention randomized controlled trials and effectiveness according to risk of type 1 error. Eighty-four randomized controlled trials were identified. A large range of assumptions were applied in the sample size calculations. The most common primary outcome was BMI, with detectable effect size differences used in sample size calculations ranging from 0.25 kg/m2 (followed up at 2 years) to 1.1 kg/m2 (at 9 months) and BMI z-score ranging from 0.1 (at 4 years) to 0.67 (at 3 years). There was no consistent relationship between low risk of type 1 error and reports of higher or lower effectiveness. Further clarity of the size of a meaningful difference in weight in childhood obesity prevention trials is required to support evaluation design and decision-making for intervention and policy. Type 1 error risk does not appear to impact effect sizes in a consistent direction.

Effectiveness and cost-effectiveness of a sustainable obesity prevention programme for preschool children delivered at scale 'HENRY' (Health, Exercise, Nutrition for the Really Young): protocol for the HENRY III cluster randomised controlled trial.

INTRODUCTION: One-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas. Social, environmental and biological factors contribute to excess weight gain and programmes delivered in early years settings aim to support families to navigate these in order to prevent obesity. One of these programmes (Health, Exercise and Nutrition for the Really Young, HENRY) has been delivered in UK community venues (hereon named 'centres') in high deprivation areas since 2008 and aims to help families to provide a healthy start for their preschool children. We aim to establish the effectiveness and cost-effectiveness of HENRY, including its potential role from a wider systems perspective. METHODS AND ANALYSIS: This is a multicentre, open-labelled, two-group, prospective, cluster randomised controlled trial, with cost-effectiveness analysis, systems-based process evaluation and internal pilot. Primary analysis will compare body mass index (BMI) z-score at 12 months in children (n=984) whose parents have attended HENRY to those who have not attended. Secondary outcomes include parent and staff BMI and waist circumference, parenting efficacy, feeding, eating habits, quality of life, resource use and medium term (3 years) BMI z-scores (child and siblings). 82 centres in ~14 local authority areas will be randomised (1:1) to receive HENRY or continue with standard practice. Intention-to-treat analysis will compare outcomes using mixed effects linear regression. Economic evaluation will estimate a within-trial calculation of cost-per unit change in BMI z-score and longer-term trajectories to determine lifelong cost savings (long-term outcomes). A systems process evaluation will explore whether (and how) implementation of HENRY impacts (and is impacted by) the early years obesity system. An established parent advisory group will support delivery and dissemination. ETHICS AND DISSEMINATION: Ethical approval has been granted by the University of York, Health Sciences' Research Governance Committee (HSRGC/2022/537/E). Dissemination includes policy reports, community resources, social media and academic outputs. TRIAL REGISTRATION NUMBER: ISRCTN16529380.

Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis.

INTRODUCTION: Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population. METHODS AND ANALYSIS: An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives' and women's perspectives. ETHICS AND DISSEMINATION: Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings. TRIAL REGISTRATION NUMBER: IsRCTNhttps://doi.org/10.1186/ISRCTN31836167.

A randomised controlled feasibility trial of an early years language development intervention: results of the 'outcomes of Talking Together evaluation and results' (oTTer) project.

BACKGROUND: Early language difficulties are associated with poor school readiness and can impact lifelong attainment. The quality of the early home language environment is linked to language outcomes. However, few home-based language interventions have sufficient evidence of effectiveness in improving preschool children's language abilities. This study reports the first stage in the evaluation of a theory-based programme, Talking Together (developed and delivered by BHT Early Education and Training) given over 6 weeks to families in the home setting. We aimed to test the feasibility and acceptability of delivering Talking Together in the Better Start Bradford community prior to a definitive trial, using a two-armed randomised controlled feasibility study. METHODS: Families from a single site within the Better Start Bradford reach area were randomly allocated (1:1) to the Talking Together intervention or a wait list control group. Child language and parent-level outcome measures were administered before randomisation (baseline), pre-intervention (pre-test), 2 months post-intervention start (post-test), and 6 months post-intervention start (follow-up). Routine monitoring data from families and practitioners were also collected for eligibility, consent, protocol adherence, and attrition rates. Descriptive statistics on the feasibility and reliability of potential outcome measures were analysed alongside qualitative feedback on trial design acceptability. Pre-defined progression-to-trial criteria using a traffic light system were assessed using routine monitoring data. RESULTS: Two-hundred and twenty-two families were assessed for eligibility; of these, 164 were eligible. A total of 102 families consented and were randomised (intervention: 52, waitlist control: 50); 68% of families completed outcome measures at 6-month follow-up. Recruitment (eligibility and consent) reached 'green' progression criteria; however, adherence reached 'amber' and attrition reached 'red' criteria. Child- and parent-level data were successfully measured, and the Oxford-CDI was identified as a suitable primary outcome measure for a definitive trial. Qualitative data not only indicated that the procedures were largely acceptable to practitioners and families but also identified areas for improvement in adherence and attrition rates. CONCLUSIONS: Referral rates indicate that Talking Together is a much-needed service and was positively received by the community. A full trial is feasible with adaptations to improve adherence and reduce attrition. TRIAL REGISTRATION: ISRCTN registry ISRCTN13251954. Retrospectively registered 21 February 2019.

Interventions to Strengthen Environmental Sustainability of School Food Systems: Narrative Scoping Review.

School food systems play a role in the wider food system, but there is a scarcity of literature exploring interventions that aim to improve the environmental sustainability of school food systems. The present review aimed to understand and describe the types of interventions that have previously been explored to strengthen the sustainability of school food systems along with their impact. We applied a scoping review methodology guided by Arksey and O'Malley, which included a review of the online database Scopus and the grey literature. Information relating to intervention design, study population, evaluation method and impact were extracted. In total, 6016 records were screened for eligibility, 24 of which were eligible for inclusion. The most common types of interventions were school lunch menus designed to be more sustainable; school food waste reduction; sustainable food system education using school gardens; and dietary interventions with added environmental components. This review highlights a range of interventions which could positively influence the environmental sustainability of school food systems. Further research is needed to explore the effectiveness of such interventions.

Meta-evaluation of a whole systems programme, ActEarly: A study protocol.

INTRODUCTION: Living in an area with high levels of child poverty predisposes children to poorer mental and physical health. ActEarly is a 5-year research programme that comprises a large number of interventions (>20) with citizen science and co-production embedded. It aims to improve the health and well-being of children and families living in two areas of the UK with high levels of deprivation; Bradford in West Yorkshire, and the London Borough of Tower Hamlets. This protocol outlines the meta-evaluation (an evaluation of evaluations) of the ActEarly programme from a systems perspective, where individual interventions are viewed as events in the wider policy system across the two geographical areas. It includes investigating the programme's impact on early life health and well-being outcomes, interdisciplinary prevention research collaboration and capacity building, and local and national decision making. METHODS: The ActEarly meta-evaluation will follow and adapt the five iterative stages of the 'Evaluation of Programmes in Complex Adaptive Systems' (ENCOMPASS) framework for evaluation of public health programmes in complex adaptive systems. Theory-based and mixed-methods approaches will be used to investigate the fidelity of the ActEarly research programme, and whether, why and how ActEarly contributes to changes in the policy system, and whether alternative explanations can be ruled out. Ripple effects and systems mapping will be used to explore the relationships between interventions and their outcomes, and the degree to which the ActEarly programme encouraged interdisciplinary and prevention research collaboration as intended. A computer simulation model ("LifeSim") will also be used to evaluate the scale of the potential long-term benefits of cross-sectoral action to tackle the financial, educational and health disadvantages faced by children in Bradford and Tower Hamlets. Together, these approaches will be used to evaluate ActEarly's dynamic programme outputs at different system levels and measure the programme's system changes on early life health and well-being. DISCUSSION: This meta-evaluation protocol presents our plans for using and adapting the ENCOMPASS framework to evaluate the system-wide impact of the early life health and well-being programme, ActEarly. Due to the collaborative and non-linear nature of the work, we reserve the option to change and query some of our evaluation choices based on the feedback we receive from stakeholders to ensure that our evaluation remains relevant and fit for purpose.

Inflammatory Arthritis in a 19-month-old with Von Hippel-Lindau Disease.

Von Hippel-Lindau disease (VHL) is a rare autosomal dominant disease characterized by progressive development of cysts and tumors. Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disorder and the most common arthritis in children. Although the mechanism of pathogenesis is not fully understood, JIA is thought to be a polygenic, autoimmune-mediated disease. Inherited or acquired disorders resulting in immune dysregulation can lead to neoplastic and autoimmune disease, but very few cases of patients with VHL and concomitant autoimmune disease are reported in the literature. Herein, we describe, to the best of our knowledge, the first reported case of a child with VHL and inflammatory arthritis, and we discuss three possible pathophysiologic mechanisms that could link VHL and JIA. Understanding the shared pathophysiology and genetics of both diseases may help guide future direction of targeted therapies and lead to improved clinical outcomes.

The implications of defining obesity as a disease: a report from the Association for the Study of Obesity 2021 annual conference.

Unlike various countries and organisations, including the World Health Organisation and the European Parliament, the United Kingdom does not formally recognise obesity as a disease. This report presents the discussion on the potential impact of defining obesity as a disease on the patient, the healthcare system, the economy, and the wider society. A group of speakers from a wide range of disciplines came together to debate the topic bringing their knowledge and expertise from backgrounds in medicine, psychology, economics, and politics as well as the experience of people living with obesity. The aim of their debate was not to decide whether obesity should be classified as a disease but rather to explore what the implications of doing so would be, what the gaps in the available data are, as well as to provide up-to-date information on the topic from experts in the field. There were four topics where speakers presented their viewpoints, each one including a question-and-answer section for debate. The first one focused on the impact that the recognition of obesity could have on people living with obesity regarding the change in their behaviour, either positive and empowering or more stigmatising. During the second one, the impact of defining obesity as a disease on the National Health Service and the wider economy was discussed. The primary outcome was the need for more robust data as the one available does not represent the actual cost of obesity. The third topic was related to the policy implications regarding treatment provision, focusing on the public's power to influence policy. Finally, the last issue discussed, included the implications of public health actions, highlighting the importance of the government's actions and private stakeholders. The speakers agreed that no matter where they stand on this debate, the goal is common: to provide a healthcare system that supports and protects the patients, strategies that protect the economy and broader society, and policies that reduce stigma and promote health equity. Many questions are left to be answered regarding how these goals can be achieved. However, this discussion has set a good foundation providing evidence that can be used by the public, clinicians, and policymakers to make that happen.

Understanding school food systems to support the development and implementation of food based policies and interventions.

BACKGROUND: Schools provide opportunities to improve the quality of children's diet, whilst reducing inequalities in childhood diet and health. Evidence supports whole school approaches, including consistency in food quality, eating culture and food education. However, such approaches are often poorly implemented due to the highly complex environments in which schools operate. We aimed to develop a school food systems map using a systems thinking approach to help identify the key factors influencing primary school children's dietary choice. METHODS: Eight workshops were conducted with 80 children (from schools from varying locations (region of England/UK; urban/rural), deprivation levels and prioritisation of school food policies)) and 11 workshops were held with 82 adult stakeholders across the UK (principals, teachers, caterers, school governors, parents, and local and voluntary sector organisations) to identify factors that influence food choice in children across a school day and their inter-relationships. Initial exploratory workshops started with a 'blank canvas' using a group model building approach. Later workshops consolidated findings and supported a wider discussion of factors, relationships and influences within the systems map. Strengths of the relationship between factors/nodes were agreed by stakeholders and individually depicted on the map. We facilitated an additional eight interactive, in-person workshops with children to map their activities across a whole school day to enable the production of a journey map which was shared with stakeholders in workshops to facilitate discussion. RESULTS: The final 'CONNECTS-Food' systems map included 202 factors that were grouped into 27 nodes. Thematic analysis identified four key themes: leadership and curriculum; child food preference; home environment; and school food environment. Network analysis highlighted key factors that influence child diet across a school day, which were largely in keeping with the thematic analysis; including: 'available funds/resources', 'awareness of initiatives and resources', 'child food preference and intake', 'eligibility of free school meals', 'family circumstances and eating behaviours', 'peer/social norms', 'priorities of head teachers and senior leaders'. CONCLUSIONS: Our systems map demonstrates the need to consider factors external to schools and their food environments. The map supports the identification of potential actions, interventions and policies to facilitate a systems-wide positive impact on children's diets.

Study Protocol. Evaluating the life-course health impact of a city-wide system approach to improve air quality in Bradford, UK: A quasi-experimental study with implementation and process evaluation.

BACKGROUND: Air quality is a major public health threat linked to poor birth outcomes, respiratory and cardiovascular disease, and premature mortality. Deprived groups and children are disproportionately affected. Bradford will implement a Clean Air Zone (CAZ) as part of the Bradford Clean Air Plan (B-CAP) in 2022 to reduce pollution, providing a natural experiment. The aim of the current study is to evaluate the impact of the B-CAP on health outcomes and air quality, inequalities and explore value for money. An embedded process and implementation evaluation will also explore barriers and facilitators to implementation, impact on attitudes and behaviours, and any adverse consequences. METHODS: The study is split into 4 work packages (WP). WP1A: 20 interviews with decision makers, 20 interviews with key stakeholders; 10 public focus groups and documentary analysis of key reports will assess implementation barriers, acceptability and adverse or unanticipated consequences at 1 year post-implementation (defined as point at which charging CAZ goes 'live'). WP1B: A population survey (n = 2000) will assess travel behaviour and attitudes at baseline and change at 1 year post-implementation). WP2: Routine air quality measurements will be supplemented with data from mobile pollution sensors in 12 schools collected by N = 240 pupil citizen scientists (4 within, 4 bordering and 4 distal to CAZ boundary). Pupils will carry sensors over four monitoring periods over a 12 month period (two pre, and two post-implementation). We will explore whether reductions in pollution vary by CAZ proximity. WP3A: We will conduct a quasi-experimental interrupted time series analysis using a longitudinal routine health dataset of > 530,000 Bradford residents comparing trends (3 years prior vs 3 years post) in respiratory health (assessed via emergency/GP attendances. WP3B: We will use the richly-characterised Born in Bradford cohort (13,500 children) to explore health inequalities in respiratory health using detailed socio-economic data. WP4: will entail a multi-sectoral health economic evaluation to determine value for money of the B-CAP. DISCUSSION: This will be first comprehensive quasi-experimental evaluation of a city-wide policy intervention to improve air quality. The findings will be of value for other areas implementing this type of approach. TRIAL REGISTRATION: ISRCTN67530835 https://doi.org/10.1186/ISRCTN67530835.

The art of Patient and Public Involvement: exploring ways to research and reduce air pollution through art-based community workshops - a reflective paper.

In this reflective paper we outline and discuss our art-based Patient and Public Involvement (PPI) approach.  This exercise held two broad objectives. Firstly, to assist policy makers in understanding the types of interventions communities will find acceptable to address the problem of poor air quality, and secondly, to ascertain community views about our research plans to explore the impact of the planned interventions on neighbourhoods.  We reflect on both our approach and the emergent conversations from the PPI activity.  Attendees contributed to the process and stressed the importance of not burdening poor neighbourhoods with costly charges as that would ameliorate one health problem but generate others as a consequence of additional financial burden.  Equally, they stressed the need to conduct research on matters which they could connect with such as the impact of clean air plans on young children and how information about air pollution is disseminated in their neighbourhoods as and when research findings emerge.  This paper offers a conceptual analysis of the art-based PPI method and uniquely draws a connection to the philosophical traditions of Ludwig Wittgenstein.  Specifically, we demonstrate how art is conducive to creating a dialogue which is specifically helpful for PPI purposes for both researchers and implementers, and conversely, why traditional conversational approaches may have fallen short of the adequacy mark in this regard.

Transformations to regenerative food systems-An outline of the FixOurFood project.

This paper provides an outline of a new interdisciplinary project called FixOurFood, funded through UKRI's 'Transforming UK food systems' programme. FixOurFood aims to transform the Yorkshire food system to a regenerative food system and will work to answer two main questions: (1) What do regenerative food systems look like? (2) How can transformations be enabled so that we can achieve a regenerative food system? To answer these questions, FixOurFood will work with diverse stakeholders to change the Yorkshire food system and use the learning to inform change efforts in other parts of the UK and beyond. Our work will focus on shifting trajectories towards regenerative dynamics in three inter-related systems of: healthy eating for young children, hybrid food economies and regenerative farming. We do this by a set of action-orientated interventions in schools and the food economy, metrics, policies and deliverables that can be applied in Yorkshire and across the UK. This article introduces the FixOurFood project and concludes by assessing the potential impact of these interventions and the importance we attach to working with stakeholders in government, business, third sector and civil society.

A case of ANCA-associated vasculitis in a 16-year-old female following SARS-COV-2 infection and a systematic review of the literature.

BACKGROUND: Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare form of vasculitis in children. SARS-CoV-2, the virus that causes COVID-19 infection, seems to trigger autoimmunity and new-onset autoimmune disease in pediatric and adult patients. We present a case of new-onset AAV following COVID-19 infection in an adolescent patient, and we review the literature of AAV following COVID-19 infection. CASE PRESENTATION: An adolescent female with a history of asthma was diagnosed with mild COVID-19 infection and subsequently developed persistent cough, wheezing, hearing loss, arthralgias, and rash. Her imaging and laboratory workup showed pulmonary nodules and cavitary lesions, elevated inflammatory markers, negative infectious testing, and positive ANCA. She was treated with glucocorticoids, rituximab, and mycophenolate mofetil. At six-month follow-up, she had improvement in her symptoms, pulmonary function tests, imaging findings, and laboratory markers. CONCLUSIONS: We report the second case of new-onset anti-PR3, C-ANCA vasculitis and the fourth case of pediatric-onset AAV following COVID-19 infection. A systematic review of the literature found 6 cases of new-onset AAV in adults after COVID-19 infection. Pediatric and adult patients who develop AAV post COVID-19 infection have few, if any, comorbidities, and show marked radiographic and symptomatic improvement after treatment. There is increasing evidence for COVID-19-induced autoimmunity in children and our case highlights the importance of considering AAV in a child following a recent COVID-19 infection because timely treatment may improve clinical outcomes.

Efficacy of a Commercial Weight Management Program Compared With a Do-It-Yourself Approach: A Randomized Clinical Trial.

Importance: Given the prevalence of obesity, accessible and effective treatment options are needed to manage obesity and its comorbid conditions. Commercial weight management programs are a potential solution to the lack of available treatment, providing greater access at lower cost than clinic-based approaches, but few commercial programs have been rigorously evaluated. Objective: To compare the differences in weight change between individuals randomly assigned to a commercial weight management program and those randomly assigned to a do-it-yourself (DIY) approach. Design, Setting, and Participants: This 1-year, randomized clinical trial conducted in the United States, Canada, and United Kingdom between June 19, 2018, and November 30, 2019, enrolled 373 adults aged 18 to 75 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45. Assessors were blinded to treatment conditions. Interventions: A widely available commercial weight management program that included reduced requirements for dietary self-monitoring and recommendations for a variety of DIY approaches to weight loss. Main Outcomes and Measures: The primary outcomes were the difference in weight change between the 2 groups at 3 and 12 months. The a priori hypothesis was that the commercial program would result in greater weight loss than the DIY approach at 3 and 12 months. Analyses were performed on an intention-to-treat basis. Results: The study include 373 participants (272 women [72.9%]; mean [SD] BMI, 33.8 [5.2]; 77 [20.6%] aged 18-34 years, 74 [19.8%] aged 35-43 years, 82 [22.0%] aged 44-52 years, and 140 [37.5%] aged 53-75 years). At 12 months, retention rates were 88.8% (166 of 187) for the commercial weight management program group and 95.7% (178 of 186) for the DIY group. At 3 months, participants in the commercial program had a mean (SD) weight loss of -3.8 (4.1) kg vs -1.8 (3.7) kg among those in the DIY group. At 12 months, participants in the commercial program had a mean (SD) weight loss of -4.4 (7.3) kg vs -1.7 (7.3) kg among those in the DIY group. The mean difference between groups was -2.0 kg (97.5% CI, -2.9 to -1.1 kg) at 3 months (P < .001) and -2.6 kg (97.5% CI, -4.3 to -0.8 kg) at 12 months (P < .001). A greater percentage of participants in the commercial program group than participants in the DIY group achieved loss of 5% of body weight at both 3 months (40.7% [72 of 177] vs 18.6% [34 of 183]) and 12 months (42.8% [71 of 166] vs 24.7% [44 of 178]). Conclusions and Relevance: Adults randomly assigned to a commercial weight management program with reduced requirements for dietary self-monitoring lost more weight and were more likely to achieve weight loss of 5% at 3 and 12 months than adults following a DIY approach. This study contributes data on the efficacy of commercial weight management programs and DIY weight management approaches. Trial Registration: ClinicalTrials.gov Identifier: NCT03571893.

Development of Public Health Core Outcome Sets for Systems-Wide Promotion of Early Life Health and Wellbeing.

We aimed to develop a core outcome set (COS) for systems-wide public health interventions seeking to promote early life health and wellbeing. Research was embedded within the existing systems-based intervention research programme 'ActEarly', located in two different areas with high rates of child poverty, Bradford (West Yorkshire) and the Borough of Tower Hamlets (London). 168 potential outcomes were derived from five local government outcome frameworks, a community-led survey and an ActEarly consortium workshop. Two rounds of a Delphi study (Round 1: 37 participants; Round 2: 56 participants) reduced the number of outcomes to 64. 199 members of the community then took part in consultations across ActEarly sites, resulting in a final COS for systems-based public health interventions of 40 outcomes. These were grouped into the domains of: Development & education (N = 6); Physical health & health behaviors (N = 6); Mental health (N = 5); Social environment (N = 4); Physical environment (N = 7); and Poverty & inequality (N = 7). This process has led to a COS with outcomes prioritized from the perspectives of local communities. It provides the means to increase standardization and guide the selection of outcome measures for systems-based evaluation of public health programmes and supports evaluation of individual interventions within system change approaches.

Are free school meals failing families? Exploring the relationship between child food insecurity, child mental health and free school meal status during COVID-19: national cross-sectional surveys.

OBJECTIVE: Food insecurity is linked to poor health and well-being in children and rising prevalence rates have been exacerbated by COVID-19. Free school meals (FSM) are considered a critical tool for reducing the adverse effects of poverty but apply a highly restrictive eligibility criteria. This study examined levels of food security and FSM status to support decision-making regarding increasing the current eligibility criteria. DESIGN: Two cross-sectional national surveys administered in August-September 2020 and January-February 2021 were used to examine the impact of COVID-19 on the food experiences of children and young people. SETTING: UK. PARTICIPANTS: 2166 children (aged 7-17 years) and parents/guardians. MAIN OUTCOME MEASURES: Participant characteristics were described by food security and FSM status; estimated marginal means were calculated to obtain the probability of poor mental health, expressed as children reporting feeling stressed or worried in the past month, by food security status and FSM status. RESULTS: We observed food insecurity among both children who did and did not receive of FSM: 23% of children not receiving FSM were food insecure. Children who were food insecure had a higher probability of poor mental health (31%, 95% CI: 23%, 40%) than children who were food secure (10%, 95% CI: 7%, 14%). Food insecure children receiving FSM had a higher probability of poor mental health (51%, 95% CI: 37%, 65%) than those who were food insecure and not receiving FSM (29%, 95% CI: 19%, 42%). CONCLUSION: Many children experienced food insecurity regardless of whether they received FSM, suggesting the eligibility criteria needs to be widened to prevent overlooking those in need.