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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

Abstract 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.

Background: The Born in Bradford’s Better Start (BiBBS) interventional birth cohort study was designed as an innovative cohort platform for efficient evaluation of early life interventions delivered through the Better Start Bradford programme. There are a growing number of interventional cohorts being implemented internationally. This paper provides an interim analysis of BiBBS in order to share learning about the feasibility and value of this method. Methods: Recruitment began in January 2016 and will complete in December 2023 with a target sample of 5,000 pregnancies. An interim analysis was completed for all pregnancies recruited between January 2016 and November 2019 with an expected due date between 1st April 2016 and 8th March 2020. Descriptive statistics were completed on the data. Results: Of 4,823 eligible pregnancies, 2,626 (54%) pregnancies were recruited, resulting in 2,392 mothers and 2,501 children. The sample are representative of the pregnant population (61% Pakistani heritage; 12% White British; 8% other South Asian and 6% Central and Eastern European ethnicity). The majority of participants (84%) live in the lowest decile of the Index of Multiple Deprivation, and many live in vulnerable circumstances. A high proportion (85%) of BiBBS families have engaged in one or more of the Better Start Bradford interventions. Levels of participation varied by the characteristics of the interventions, such as the requirement for active participation and the length of commitment to a programme. Conclusions: We have demonstrated the feasibility of recruiting an interventional cohort that includes seldom heard families from ethnic minority and deprived backgrounds. The high level of uptake of interventions is encouraging for the goal of evaluating the process and outcomes of multiple early life interventions using the innovative interventional cohort approach. BiBBS covers a period before, during and after the coronavirus disease 2019 (COVID-19) pandemic which adds scientific value to the cohort.

The context of the COVID-19 pandemic has amplified the need to increase co-production activities to empower communities. The pandemic has further highlighted systemic health and socioeconomic inequities, especially for those from ethnic minority communities and in areas of economic deprivation. This research article presents a complex, collaborative process of co-production we undertook as part of the service design of Community Engagement work within the Better Start Bradford Programme; a program of projects for pregnant women and families with children aged 0–4 years living in an ethnically diverse area. Using theory of change as our underpinning theoretical framework, we co-produced a community engagement logic model or ‘strategy’. Our approach involved nine 90-minute workshops with a range of community stakeholders. We used the seven Scottish National Standards for Community Engagement and Communities’ self-identified key concepts of ‘voice’, ‘choice’ and ‘power’ to structure the partnership activity. Workshop discussions were analysed using qualitative framework analysis, and we developed a comprehensive, multi-faceted community engagement logic model with the community. Discussions with the community highlighted that (1) the COVID-19 pandemic had opened new avenues of community engagement, primarily virtual ones, and a blended offer of face-to-face and online activities; (2) vital support for community readiness to engage, facilitated through culturally sensitive engagement delivered by trusted sources, transparent governance processes and informal consultation, combined with a flexible approach to adapting to the community’s needs; (3) the need for a continuous reflective process of recruitment to key governance roles to include a range of diverse voices to ensure power is given to community voices. A strong two-way feedback loop is at the core of our community engagement strategy, with both the community and the organisation playing equal roles.

Despite a recent increase in community engagement in health initiatives during the COVID-19 pandemic, health inequalities and health inequities remain a serious problem for society, often affecting those in underserved communities the most. Often individualised incentives such as payment for vaccinations have been used to increase involvement in health initiatives but evidence suggests that these do not always work and can be ineffective. This paper addresses the real world problem of a lack of involvement of communities in health programmes and subsequent health inequalities. Using data from nine workshops with community members evaluating a large community health programme, we develop a socio-ecological model [SEM] of influences on community engagement in health programmes to identify holistic and systemic barriers and enablers to such engagement. To date SEM has not been used to develop solutions to improve community engagement in health programmes. Such an approach holds the potential to look beyond individualised conceptualisations of behaviour and instead consider a multitude of social and cultural influences. This knowledge can then be used to develop multi-faceted and multi-layered solutions to tackle the barriers to community engagement in health programmes. Our SEM highlights the overarching importance of the socio-cultural environment in influencing community engagement. Within the socio-cultural environment were factors such as trust, social support and community mindedness. We also found that other factors affecting community engagement fall within individual, economic, technological, political and physical environments. Such factors include engagement in community organisation governance and processes, access to and ability to use technology and access to safe outdoor spaces. We propose further testing our socioecological model in other communities.

Abstract Many interventions that are delivered within public health services have little evidence of effect. Evaluating interventions that are being delivered as a part of usual practice offers opportunities to improve the evidence base of public health. However, such evaluation is challenging and requires the integration of research into system-wide practice. The Born in Bradford’s Better Start experimental birth cohort offers an opportunity to efficiently evaluate multiple complex community interventions to improve the health, wellbeing and development of children aged 0–3 years. Based on the learning from this programme, this paper offers a pragmatic and practical guide to researchers, public health commissioners and service providers to enable them to integrate research into their everyday practice, thus enabling relevant and robust evaluations within a complex and changing system. Using the principles of co-production the key challenges of integrating research and practice were identified, and appropriate strategies to overcome these, developed across five key stages: 1) Community and stakeholder engagement; 2) Intervention design; 3) Optimising routinely collected data; 4) Monitoring implementation; and 5) Evaluation. As a result of our learning we have developed comprehensive toolkits (https://borninbradford.nhs.uk/what-we-do/pregnancy-early-years/toolkit/) including: an operational guide through the service design process; an implementation and monitoring guide; and an evaluation framework. The evaluation framework incorporates implementation evaluations to enable understanding of intervention performance in practice, and quasi experimental approaches to infer causal effects in a timely manner. We also offer strategies to harness routinely collected data to enhance the efficiency and affordability of evaluations that are directly relevant to policy and practice. These strategies and tools will help researchers, commissioners and service providers to work together to evaluate interventions delivered in real-life settings. More importantly, however, we hope that they will support the development of a connected system that empowers practitioners and commissioners to embed innovation and improvement into their own practice, thus enabling them to learn, evaluate and improve their own services.

Introduction Implementation evaluations are integral to understanding whether, how and why interventions work. However, unpicking the mechanisms of complex interventions is often challenging in usual service settings where multiple services are delivered concurrently. Furthermore, many locally developed and/or adapted interventions have not undergone any evaluation, thus limiting the evidence base available. Born in Bradford’s Better Start cohort is evaluating the impact of multiple early life interventions being delivered as part of the Big Lottery Fund’s ‘A Better Start’ programme to improve the health and well-being of children living in one of the most socially and ethnically diverse areas of the UK. In this paper, we outline our evaluation framework and protocol for embedding pragmatic implementation evaluation across multiple early years interventions and services.Methods and analysis The evaluation framework is based on a modified version of The Conceptual Framework for Implementation Fidelity. Using qualitative and quantitative methods, our evaluation framework incorporates semistructured interviews, focus groups, routinely collected data and questionnaires. We will explore factors related to content, delivery and reach of interventions at both individual and wider community levels. Potential moderating factors impacting intervention success such as participants’ satisfaction, strategies to facilitate implementation, quality of delivery and context will also be examined. Interview and focus guides will be based on the Theoretical Domains Framework to further explore the barriers and facilitators of implementation. Descriptive statistics will be employed to analyse the routinely collected quantitative data and thematic analysis will be used to analyse qualitative data.Ethics and dissemination The Health Research Authority (HRA) has confirmed our implementation evaluations do not require review by an NHS Research Ethics Committee (HRA decision 60/88/81). Findings will be shared widely to aid commissioning decisions and will also be disseminated through peer-reviewed journals, summary reports, conferences and community newsletters.