Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial.

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.

Prioritising child health and maternity evidence-based interventions or service models: a stakeholder-driven process.

AIM: A UK programme, led by the National Institute for Health Research (NIHR) ( https://www.nihr.ac.uk ) and coordinated by Applied Research Collaborations (ARC), ( https://www.nihr.ac.uk/explore-nihr/support/collaborating-in-applied-health-research.htm ) aimed to identify and select evidence-based, implementation-ready service innovations for evaluation. The programme focused on seven areas of health provision. We report on a prioritisation process designed to identify and assess innovations in one of these areas: child and maternal health (CH&M). METHODS: We developed a three-stage, online, stakeholder driven process to 1) identify, 2) assess and prioritise and 3) select evidence-based interventions or service models, using crowdsourcing to identify projects and the APEASE criteria to assess and select projects. A brief evidence review was conducted for all initial suggestions to identify those with the largest evidence-base to take forward for ranking by stakeholders. Stakeholder workshops considered and ranked these suggestions using the APEASE criteria. We then conducted in-depth evidence reviews for the highest ranked suggestions. The Project Management Group and Advisory Board used these reviews and the APEASE criteria to select the final projects. RESULTS: We received 32 initial suggestions from a range of clinicians, practitioners and researchers. Fourteen of the most evidence-based suggestions were considered and ranked at four themed stakeholder workshops. Nine suggestions were ranked for further in-depth evidence review and a final four projects were selected for implementation evaluation using the APEASE criteria. These were: 1. Maternal Mental Health Services Multidisciplinary Teams 2. Early years tooth brushing programme 3. Trauma-focused CBT for young people in care and 4. Independent Domestic Violence Advisors in maternity settings. Feedback from participants suggested that having public representatives participating in all stakeholder meetings, rather than being consulted separately, focused discussions clearly on patient benefit rather than research aims. CONCLUSIONS: The stakeholder-driven process achieved its aim of identifying, prioritising and assessing and selecting, evidence-based projects for wider implementation and evaluation. The concurrent process could be adapted by other researchers or policy makers.

'When will this end? Will it end?' The impact of the March-June 2020 UK COVID-19 lockdown response on mental health: a longitudinal survey of mothers in the Born in Bradford study.

OBJECTIVES: To explore clinically important increases in depression/anxiety from before to during the first UK COVID-19 lockdown and factors related to this change, with a particular focus on ethnic differences. DESIGN: Pre-COVID-19 and lockdown surveys nested within two longitudinal Born in Bradford cohort studies. PARTICIPANTS: 1860 mothers with a child aged 0-5 or 9-13, 48% Pakistani heritage. MAIN OUTCOME MEASURES: ORs for a clinically important increase (5 points or more) in depression (eight item Patient Health Questionnaire (PHQ-8)) and anxiety (Generalised Anxiety Disorder Assessment (GAD-7)) in unadjusted regression analyses, repeated with exposures of interest separated by ethnicity to look for differences in magnitude of associations, and lived experience of mothers captured in open text questions. RESULTS: The number of women reporting clinically important depression/anxiety increased from 11% to 20% (95% CI 10%-13%; 18%-22%) and from 10% to 16% (95% CI 8%-11%; 15%-18%), respectively. Increases in depression/anxiety were associated with loneliness (OR=8.37, 95% CI 5.70 to 12.27; 8.50, 95% CI 5.71 to 12.65, respectively); financial (6.23, 95% CI 3.96 to 9.80; 6.03, 95% CI 3.82 to 9.51), food (3.33, 95% CI 2.09 to 5.28; 3.46, 95% CI 2.15 to 5.58) and housing insecurity (3.29, 95% CI 2.36 to 4.58; 3.0, 95% CI 2.11 to 4.25); a lack of physical activity (3.13, 95% CI 2.15 to 4.56; 2.55, 95% CI 1.72 to 3.78); and a poor partner relationship (3.6, 95% CI 2.44 to 5.43; 5.1, 95% CI 3.37 to 7.62). The magnitude of associations between key exposures and worsening mental health varied between ethnic groups.Responses to open text questions illustrated a complex interplay of challenges contributing to mental ill health including: acute health anxieties; the mental load of managing multiple responsibilities; loss of social support and coping strategies; pressures of financial and employment insecurity; and being unable to switch off from the pandemic. CONCLUSIONS: Mental ill health has worsened for many during the COVID-19 lockdown, particularly in those who are lonely and economically insecure. The magnitude of associations between key exposures and worsening mental health varied between ethnic groups. Mental health problems may have longer term consequences for public health and interventions that address the potential causes are needed.

Born in Bradford's Better Start (BiBBS) interventional birth cohort study: Interim cohort profile.

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 1 st April 2016 and 8 th 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.

Comparison of Experiences in Two Birth Cohorts Comprising Young Families with Children under Four Years during the Initial COVID-19 Lockdown in Australia and the UK: A Qualitative Study.

This study aims to understand the experience and impact of the initial COVID-19 lockdown in young families with children aged below 4 years. Free text questions were administered to participants in the ORIGINS (Australia) and Born in Bradford (UK) cohort studies to collect qualitative information on worries, concerns and enjoyable experiences during the pandemic. A total of 903 (400 for ORIGINS and 503 for BiB) participants completed the two surveys during April 2020. Despite varying in geography, levels of socio-economic disadvantage and their situational context during the pandemic, respondents from both cohorts reported similar worries and challenges during the lockdown period, including: employment/finances, health anxiety, mental health and social isolation, caring for children and child development. Families across the globe experienced both positive and negative immediate impacts of COVID-19. Population-based data can be used to inform the development of support services, public health campaigns and universal interventions to assist families in future health crises.

Developing a model for health determinants research within local government: lessons from a large, urban local authority.

Background: Socio-economic, cultural and environmental conditions strongly affect health across the life course. Local government plays a key role in influencing these wider determinants of health and levels of inequality within their communities. However, they lack the research infrastructure and culture that would enable them to develop an evidence-based approach to tackling the complex drivers of those conditions. Methods: We undertook a scoping project to explore the potential for, and what would be needed to develop a local authority research system for the City of Bradford, UK. This included identifying the current research landscape and any barriers and enablers to research activity within the local authority using qualitative individual and focus group interviews, a rapid review of existing local research system models, scoping of the use of evidence in decision making and training opportunities and existing support for local government research. Results: We identified four key themes important to developing and sustaining a research system: leadership, resource and capacity, culture, partnerships. Some use of research in decision making was evident but research training opportunities within the local authority were limited. Health research funders are slowly adapting to the local government environment, but this remains limited and more work is needed to shift the centre of gravity towards public health, local government and the community more generally.  Conclusions: We propose a model for a local authority research system that can guide the development of an exemplar whole system research framework that includes research infrastructure, data sharing, research training and skills, and co-production with local partners, to choose, use, generate, and deliver research in local government.

The Born in Bradford COVID-19 Research Study: Protocol for an adaptive mixed methods research study to gather actionable intelligence on the impact of COVID-19 on health inequalities amongst families living in Bradford.

The UK COVID-19 lockdown has included restricting social movement and interaction to slow the spread of disease and reduce demand on NHS acute services. It is likely that the impacts of restrictions will hit the least advantaged disproportionately and will worsen existing structural inequalities amongst deprived and ethnic minority groups. The aim of this study is to deliver rapid intelligence to enable an effective COVID-19 response, including co-production of interventions, that address key issues in the City of Bradford, UK, and nationally. In the longer term we aim to understand the impacts of the response on health trajectories and inequalities in these. In this paper we describe our approach and protocol. We plan an adaptive longitudinal mixed methods approach embedded with Born in Bradford (BiB) birth cohorts which have rich existing data (including questionnaire, routine health and biobank). All work packages (WP) interact and are ongoing. WP1 uses co-production and engagement methods with communities, decision-makers and researchers to continuously set (changing) research priorities and will, longer-term, co-produce interventions to aid the City's recovery. In WP2 repeated quantitative surveys will be administered during lockdown (April-June 2020), with three repeat surveys until 12 months post-lockdown with an ethnically diverse pool of BiB participants (parents, children aged 9-13 years, pregnant women: total sample pool N=7,652, N=5,154, N=1,800). A range of health, social, economic and education outcomes will be assessed. In WP3 priority topics identified in WP1 and WP2 will be explored qualitatively. Initial priority topics include children's mental wellbeing, health beliefs and the peri/post-natal period. Feedback loops will ensure findings are fed directly to decision-makers and communities (via WP1) to enable co-production of acceptable interventions and identify future priority topic areas. Findings will be used to aid development of local and national policy to support recovery from the pandemic and minimise health inequalities.

Experiences of lockdown during the Covid-19 pandemic: descriptive findings from a survey of families in the Born in Bradford study.

Background: Lockdown measures implemented to contain the Covid-19 virus may be increasing health inequalities, with families from deprived and ethnically diverse backgrounds most likely to be adversely affected. This paper presents findings of the experiences of the Covid-19 lockdown on families living in the multi-ethnic and deprived city of Bradford, England. Methods: Questionnaire surveys were sent during the Covid-19 UK lockdown (10th April to 30 th June 2020) to parents in two prospective birth cohort studies. Cross tabulations explored variation by ethnicity and employment status. Text from open questions were analysed using thematic analysis. Results: Of 7,652 families invited, 2,144 (28%) participated. Ethnicity of respondents was: 957 (47%) Pakistani heritage, 715 (35%) White British and 356 (18%) other. 971 (46%) live in the most deprived decile of material deprivation in England. 2,043 (95%) were mothers and 101 were partners. The results summarised below are based on the mothers' responses. Many families live in poor quality (N=574, 28%), and overcrowded (N=364, 19%) housing; this was more common in families of Pakistani heritage and other ethnicities. Financial (N=738 (37%), food (N=396, 20%), employment (N=728, 37%) and housing (N=204, 10%) insecurities were common, particularly in those who were furloughed, self-employed not working or unemployed. Clinically significant depression and anxiety symptoms were reported by 372 (19%) and 318 (16%) of the mothers and were more common in White British mothers and those with economic insecurity. Open text responses corroborated these findings and highlighted high levels of anxiety about becoming ill or dying from Covid-19. Conclusions: The experiences of the Covid-19 lockdown in this ethnically diverse and deprived population highlight a large number of families living in poor housing conditions, suffering from economic insecurity and poor mental health. There is a need for policy makers and commissioners to better support these families.

Assessing community readiness for early intervention programmes to promote social and emotional health in children.

OBJECTIVE: Evidence for early intervention and prevention-based approaches for improving social and emotional health in young children is robust. However, rates of participation in programmes are low. We explored the dynamics which affect levels of community readiness to address the issues of social and emotional health for pregnant women, young children (0-4 years) and their mothers. SETTING: A deprived inner-city housing estate in the north of England. The estate falls within the catchment area of a project that has been awarded long-term funding to address social and emotional health during pregnancy and early childhood. METHODS: We interviewed key respondents using the Community Readiness Model. This approach applies a mixed methodology, incorporating readiness scores and qualitative data. A mean community readiness score was calculated enabling the placement of the community in one of nine possible stages of readiness. Interview transcripts were analysed using a qualitative framework approach to generate contextual information to augment the numerical scores. RESULTS: An overall score consistent with vague awareness was achieved, indicating a low level of community readiness for social and emotional health interventions. This score suggests that there will be a low likelihood of participation in programmes that address these issues. CONCLUSION: Gauging community readiness offers a way of predicting how willing and prepared a community is to address an issue. Modifying implementation plans so that they first address community readiness may improve participation rates.

Integrating research and system-wide practice in public health: lessons learnt from Better Start Bradford.

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.

Comparison of the Physical Activity and Sedentary Behaviour Assessment Questionnaire and the Short-Form International Physical Activity Questionnaire: An Analysis of Health Survey for England Data.

BACKGROUND: The Physical Activity and Sedentary Behaviour Assessment Questionnaire (PASBAQ), used within the Health Survey for England (HSE) at 5-yearly intervals, is not included annually due to funding and interview-length constraints. Policy-makers and data-users are keen to consider shorter instruments such as the Short-form International Physical Activity Questionnaire (IPAQ) for the annual survey. Both questionnaires were administered in HSE 2012, enabling comparative assessment in a random sample of 1252 adults. METHODS: Relative agreement using prevalence-adjusted bias-adjusted Kappa (PABAK) statistics was estimated for: sufficient aerobic activity (moderate-to-vigorous physical activity [MVPA] ≥150 minutes/week); inactivity (MVPA<30 minutes/week); and excessive sitting (≥540 minutes/weekday). Cross-sectional associations with health outcomes were compared across tertiles of MVPA and tertiles of sitting time using logistic regression with tests for linear trend. RESULTS: Compared with PASBAQ data, IPAQ-assessed estimates of sufficient aerobic activity and inactivity were higher and lower, respectively; estimates of excessive sitting were higher. Demographic patterns in prevalence were similar. Agreement using PABAK statistics was fair-to-moderate for sufficient aerobic activity (0.32-0.49), moderate-to-substantial for inactivity (0.42-0.74), and moderate-to-substantial for excessive sitting (0.49-0.75). As with the PASBAQ, IPAQ-assessed MVPA and sitting each showed graded associations with mental well-being (women: P for trend = 0.003 and 0.004, respectively) and obesity (women: P for trend = 0.007 and 0.014, respectively). CONCLUSIONS: Capturing habitual physical activity and sedentary behaviour through brief questionnaires is complex. Differences in prevalence estimates can reflect differences in questionnaire structure and content rather than differences in reported behaviour. Treating all IPAQ-assessed walking as moderate-intensity contributed to the differences in prevalence estimates. PASBAQ data will be used for population surveillance every 4 to 5 years. The current version of the Short-form IPAQ was included in HSE 2013-14 to enable more frequent assessment of physical activity and sedentary behaviour; a modified version with different item-ordering and additional questions on walking-pace and effort was included in HSE 2015.