Exploring attitudes and variation by sociodemographic factors in consent provided for financial data linkage in an experimental birth cohort study.

BACKGROUND: Improving our understanding of household incomes and what constitutes financial insecurity can help us to better understand how financial insecurity is experienced and how this can change over time within and between individuals and populations. However, financial circumstances are often perceived as sensitive and stigmatising, particularly within some ethnic minority groups. This research aims to explore attitudes and variation by sociodemographic factors in consent provided for financial data linkage in an experimental birth cohort study, in order to obtain validated income and benefits data and to better understand the impact of community interventions on the financial security of its participants and their families. METHODS: This research utilises an observational study design to explore consent rates, attitudes and variation in sociodemographic factors between participants of an experimental birth cohort in a deprived and ethnically diverse setting who consent and do not consent to financial data linkage. RESULTS: Overall, participants were equally likely to consent and decline consent for financial data linkage. Measures of socioeconomic insecurity were associated with being more likely to provide consent for financial data linkage. Participants who were not employed (OR 1.49 95% CI 0.93, 2.40) and were more financially insecure (OR 1.85 95% CI 1.14, 3.93) were more likely to provide consent for financial data linkage. Where the participant's first language was a language other than English, participants were also less likely to provide consent for data linkage (OR 0.65 95% CI 0.39, 0.98). The choice of consent for financial data linkage was not associated with: ethnicity; relationship factors; employment status of the participant's partner; person present at time of recruitment; and measures of health, such as general health, mental health, wellbeing and health-related quality of life. CONCLUSIONS: This research sets out an approach to obtaining validated income and benefits data, as a proxy measure for financial security, within an experimental birth cohort study in a deprived and ethnically diverse setting. It achieves good consent rates and demonstrates greater input from those who report greater potential need for financial support. Further research should be conducted to further understand the interplay of language spoken in this context.

Exploring the feasibility of evaluating a community alliance welfare advice programme co-located in primary care in Bradford: an uncontrolled before and after study.

BACKGROUND: Welfare advice services co-located in health settings are known to improve financial security. However, little is known on how to effectively evaluate these services. This study aims to explore the feasibility of evaluating a welfare advice service co-located in a primary care setting in a deprived and ethnically diverse population. It seeks to investigate whether the proposed evaluation tools and processes are acceptable and feasible to implement and whether they are able to detect any evidence of promise for this intervention on the mental health, wellbeing and financial security of participants. METHODS: An uncontrolled before and after study design was utilised. Data on mental health, wellbeing, quality of life and financial outcomes were collected at baseline prior to receiving welfare advice and at three months follow-up. Multiple logistic and linear regression models were used to explore individual differences in self-reported financial security and changes to mental health, wellbeing and quality of life scores before and after the provision of welfare advice. RESULTS: Overall, the majority of key outcome measures were well completed, indicating participant acceptability of the mental health, wellbeing, quality of life and financial outcome measures used in this population. There was evidence suggestive of an improvement in participant financial security and evidence of promise for improvements in measured wellbeing and health-related quality of life for participants accessing services in a highly ethnically diverse population. Overall, the VCS Alliance welfare advice programme generated a total of £21,823.05 for all participants, with participants gaining an average of £389.70 per participant for participants with complete financial outcome data. CONCLUSIONS: This research demonstrates the feasibility of evaluating a welfare advice service co-located in primary care in a deprived and ethnically diverse setting utilising the ascribed mental health, wellbeing and quality of life and financial outcome tools. It provides evidence of promise to support the hypothesis that the implementation of a welfare advice service co-located in a health setting can improve health and wellbeing and reduce health inequalities.

Making ends meet - relating a self-reported indicator of financial hardship to health status.

BACKGROUND: Area-based index of multiple deprivation (IMD) indicators of financial hardship lack individual specificity and sensitivity. This study compared self-reports of hardship with area measures in relation to health status. METHODS: Interviews in one London Borough, reported financial hardship and health status. Associations of health status with most and least deprived quintiles of the IMD 2015 were compared with self-reported hardship; always or sometimes 'having difficulty making ends meet at the end of the month' in relation to never. RESULTS: 1024 interviews reported hardship status in 1001 (98%). 392 people (39%) reported they 'always' or 'sometimes' had hardship. In multivariate analysis, self-reported hardship was more strongly associated with smoking; odds ratio = 5.4 (95% CI: 2.8-10.4) compared with IMD, odds ratio = 1.9 (95% CI: 1.2-3.2). Health impairment was also more likely with self-reported hardship, odds ratio = 11.1 (95% CI: 4.9-25.4) compared with IMD; odds ratio = 2.7 (95% CI: 1.4-5.3). Depression was similarly related; odds ratio = 2.4 (95% CI: 1.0-5.6) and 2.7 (95% CI: 1.2-6.6), respectively. CONCLUSIONS: Self-reported hardship was more strongly related to health status than area-based indicators. Validity and implementation in routine health care settings remains to be established.

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.

Designing trials of Universal Basic Income for health impact: identifying interdisciplinary questions to address.

BACKGROUND: A large body of evidence indicates the importance of upstream determinants to health. Universal Basic Income (UBI) has been suggested as an upstream intervention capable of promoting health by affecting material, biopsychosocial and behavioural determinants. Calls are emerging across the political spectrum to introduce an emergency UBI to address socioeconomic insecurity. However, although existing studies indicate effects on health through cash transfers, UBI schemes have not previously been designed specifically to promote health. METHODS: In this article, we scope the existing literature to set out a set of interdisciplinary research challenges to address in designing a trial of the effectiveness of UBI as a population health measure. RESULTS: We present a theoretical model of impact that identifies three pathways to health impact, before identifying open questions related to regularity, size of payment, needs-based supplements, personality and behaviour, conditionality and duration. CONCLUSIONS: These results set, for the first time, a set of research activities required in order to maximize health impact in UBI programmes.

Covid-19 lockdown: Ethnic differences in children's self-reported physical activity and the importance of leaving the home environment; a longitudinal and cross-sectional study from the Born in Bradford birth cohort study.

BACKGROUND: In England, the onset of COVID-19 and a rapidly increasing infection rate resulted in a lockdown (March-June 2020) which placed strict restrictions on movement of the public, including children. Using data collected from children living in a multi-ethnic city with high levels of deprivation, this study aimed to: (1) report children's self-reported physical activity (PA) during the first COVID-19 UK lockdown and identify associated factors; (2) examine changes of children's self-reported PA prior to and during the first UK lockdown. METHODS: This study is part of the Born in Bradford (BiB) COVID-19 Research Study. PA (amended Youth Activity Profile), sleep, sedentary behaviours, daily frequency/time/destination/activity when leaving the home, were self-reported by 949 children (9-13 years). A sub-sample (n = 634) also self-reported PA (Physical Activity Questionnaire for Children) pre-pandemic (2017-February 2020). Univariate analysis assessed differences in PA between sex and ethnicity groups; multivariable logistic regression identified factors associated with children's PA. Differences in children's levels of being sufficiently active prior to and during the lockdown were examined using the McNemar test; and multivariable logistic regression was used to identify factors explaining change. RESULTS: During the pandemic, White British (WB) children were more sufficiently active (34.1%) compared to Pakistani Heritage children (PH) (22.8%) or 'Other' ethnicity children (O) (22.8%). WB children reported leaving the home more frequently and for longer periods than PH and O children. Modifiable variables related to being sufficiently active were frequency, duration, type of activity, and destination away from the home environment. There was a large reduction in children being sufficiently active during the first COVID-19 lockdown (28.9%) compared to pre-pandemic (69.4%). CONCLUSIONS: Promoting safe extended periods of PA everyday outdoors is important for all children, in particular for children from ethnic minority groups. Children's PA during the first COVID-19 UK lockdown has drastically reduced from before. Policy and decision makers, and practitioners should consider the findings in order to begin to understand the impact and consequences that COVID-19 has had upon children's PA which is a key and vital behaviour for health and development.

Understanding COVID-19 misinformation and vaccine hesitancy in context: Findings from a qualitative study involving citizens in Bradford, UK.

BACKGROUND: COVID-19 vaccines can offer a route out of the pandemic, yet initial research suggests that many are unwilling to be vaccinated. A rise in the spread of misinformation is thought to have played a significant role in vaccine hesitancy. To maximize uptake, it is important to understand why misinformation has been able to take hold at this time and why it may pose a more significant problem within certain contexts. OBJECTIVE: To understand people's COVID-19 beliefs, their interactions with (mis)information during COVID-19 and attitudes towards a COVID-19 vaccine. DESIGN AND PARTICIPANTS: Bradford, UK, was chosen as the study site to provide evidence to local decision makers. In-depth phone interviews were carried out with 20 people from different ethnic groups and areas of Bradford during Autumn 2020. Reflexive thematic analysis was conducted. RESULTS: Participants discussed a wide range of COVID-19 misinformation they had encountered, resulting in confusion, distress and mistrust. Vaccine hesitancy could be attributed to three prominent factors: safety concerns, negative stories and personal knowledge. The more confused, distressed and mistrusting participants felt about their social worlds during the pandemic, the less positive they were about a vaccine. CONCLUSIONS: COVID-19 vaccine hesitancy needs to be understood in the context of the relationship between the spread of misinformation and associated emotional reactions. Vaccine programmes should provide a focused, localized and empathetic response to counter misinformation. PATIENT OR PUBLIC CONTRIBUTION: A rapid community and stakeholder engagement process was undertaken to identify COVID-19 priority topics important to Bradford citizens and decision makers.

The Caregiver Health Effects of Caring for Young Children with Developmental Disabilities: A Meta-analysis.

OBJECTIVES: Mothers of school age and older children with developmental disabilities experience poorer health than mothers of typically developing children. This review assesses the evidence for the effect on mothers' health of caring for young children with developmental disabilities, and the influence of different disability diagnoses and socioeconomic status. METHODS: Medline, EMBASE, PsycINFO and CINAHL were searched. Studies measuring at least one symptom, using a quantitative scale, in mothers of preschool children (0-5 years) with and without a diagnosed developmental disability were selected. Random effects meta-analysis was performed, and predictive intervals reported due to high expected heterogeneity. RESULTS: The meta-analysis included 23 estimates of association from 14 retrospective studies for the outcomes of stress (n = 11), depressive symptoms (n = 9), general health (n = 2) and fatigue (n = 1). Caring for a child with a developmental disability was associated with greater ill health (standardised mean difference 0.87; 95% predictive interval - 0.47, 2.22). The largest association was for mixed developmental disabilities (1.36; - 0.64, 3.36) and smallest for Down syndrome (0.38; - 2.17, 2.92). There was insufficient socioeconomic information to perform subgroup analysis. The small number of studies and data heterogeneity limited the precision of the estimates of association and generalizability of the findings. CONCLUSIONS FOR PRACTICE: Mothers of young children with developmental disabilities may have poorer health than those with typically developing children. Research is needed to identify whether the relationship is causal and, if so, interventions that could reduce the negative effect of caregiving.

Using Birth Cohort Data to Assess the Impact of the UK 2008-2010 Economic Recession on Smoking During Pregnancy.

INTRODUCTION: Despite the well-known link between stress and smoking, evidence for associations between economic recession, financial stress, and smoking is contradictory. In this study, we assess whether women were more likely to continue smoking during pregnancy if they were exposed to the UK 2008-2010 economic recession during pregnancy than those who were unexposed, and whether this relationship is mediated by financial stress. METHODS: We used cross-sectional data on 2775 pregnant women who were regular smokers before pregnancy and who were enrolled in the UK Born in Bradford cohort study between March 2007 and December 2010. The cutoff date for exposure to recession was set as August 1, 2008, based on local and national economic data. Multivariable logistic regression analysis included potential confounders: maternal age, parity, cohabitation, ethnicity, and maternal age. The mediating role of financial stress was analyzed using "worse off financially" and a "difficult financial situation" as indicators of financial stress in Sobel-Goodman mediation tests with bootstrap resampling. RESULTS: After taking into account potential confounders, exposure to recession was associated with continued smoking during pregnancy (OR = 1.19, 95% CI = 1.01 to 1.41, p = 0.03). A worse financial situation and a difficult financial situation were identified as mediators, explaining 8.4% and 17.6%, respectively, of the relationship between exposure to recession and smoking during pregnancy. CONCLUSIONS: Smoking during pregnancy is associated with exposure to the UK 2008-2010 economic recession during pregnancy, and this relationship is partly mediated by financial stress. IMPLICATIONS: Health inequalities in smoking during pregnancy are affected by economic recession, as those who are most likely to smoke are also most likely to experience the financial stress resulting from economic recession. Socioeconomic conditions at the societal and individual level are important targets when aiming to reduce rates of smoking during pregnancy.

A Validation and Calibration Process for Self-reported Tobacco Use With Participants' Cotinine Levels: An Example From the Building Blocks Trial.

INTRODUCTION: Reducing smoking in pregnancy was a primary outcome in our Building Blocks trial of the Family Nurse Partnership. We calibrated maternal reports of smoking using cotinine values derived from urine samples to assess tobacco use. This involves identifying the extent to which an individual accurately reports smoking and requires complete and synchronized data collection over time. However, some urine samples may be missed or collected at a different time from self-report (non-synchronized. METHODS: We used statistical validation processes to address both non-synchronized and incomplete data. First, we examined consistency in reporting behaviors at baseline and follow-up for participants grouped by extent of non-synchronized time of collection. Second, we used data from complete cases to infer values for mothers with missing urine samples at follow-up. We then used Markov chain transition rate matrix constructed to assess the robustness of such inferences. RESULTS: Maternal underreporting and overreporting of smoking were consistent across the 870 participants grouped by different levels of noncontemporary data collection (Breslow-Day test: p = .24; chi-square test: p = .69). Using participants' baseline reporting behaviors to infer their follow-ups provided comparable smoking outcomes (4.5 cigarettes/day with SD of 5.5) to the simulated counterparts (4.5 cigarettes/day with SD of 6.0). CONCLUSION: We have demonstrated consistent reporting behavior over time and minimal impact due to nonaligned follow-up urine sample collection. For studies collecting smoking data, this proposed method provided a pragmatic solution to facilitate the calibration process of self-reported tobacco use and retain adequate power without introducing undue bias. IMPLICATIONS: Synchronized and completed data collection is essential but very often hard to achieve in smoking related studies. When violated, proper statistical validation process should be followed to minimize the potential bias and loss of power in trial analyses. For this purpose, we provided the Building Block trial as an example to demonstrate how to deal with the non-synchronization and incompleteness issues in data collection.

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.

Growing up in Bradford: protocol for the age 7-11 follow up of the Born in Bradford birth cohort.

BACKGROUND: Born in Bradford (BiB) is a prospective multi-ethnic pregnancy and birth cohort study that was established to examine determinants of health and development during childhood and, subsequently, adult life in a deprived multi-ethnic population in the north of England. Between 2007 and 2010, the BiB cohort recruited 12,453 women who experienced 13,776 pregnancies and 13,858 births, along with 3353 of their partners. Forty five percent of the cohort are of Pakistani origin. Now that children are at primary school, the first full follow-up of the cohort is taking place. The aims of the follow-up are to investigate the determinants of children's pre-pubertal health and development, including through understanding parents' health and wellbeing, and to obtain data on exposures in childhood that might influence future health. METHODS: We are employing a multi-method approach across three data collection arms (community-based family visits, school based physical assessment, and whole classroom cognitive, motor function and wellbeing measures) to follow-up over 9000 BiB children aged 7-11 years and their families between 2017 and 2021. We are collecting detailed parent and child questionnaires, cognitive and sensorimotor assessments, blood pressure, anthropometry and blood samples from parents and children. Dual x-ray absorptiometry body scans, accelerometry and urine samples are collected on subsamples. Informed consent is collected for continued routine data linkage to health, social care and education records. A range of engagement activities are being used to raise the profile of BiB and to disseminate findings. DISCUSSION: Our multi-method approach to recruitment and assessment provides an efficient method of collecting rich data on all family members. Data collected will enhance BiB as a resource for the international research community to study the interplay between ethnicity, socioeconomic circumstances and biology in relation to cardiometabolic health, mental health, education, cognitive and sensorimotor development and wellbeing.

Food insecurity and socio-demographic characteristics in two UK ethnic groups: an analysis of women in the Born in Bradford cohort.

Background: The use of foodbanks has risen sharply in the UK; however, the epidemiology of UK food insecurity is undeveloped. This study contributes to the field by analysing socio-demographic risk factors for food insecurity in a female, ethnically diverse population. Methods: Data from the Born in Bradford (BiB) cohort were matched with data on food insecurity from the nested BiB1000 study (N = 1280). Logistic regression was used to model food insecurity in relation to ethnicity and socio-demographic factors. Results: Food insecurity, reported by 13.98% of the sample, was more likely among White British than Pakistani women (crude Odds Ratio (OR) 1.94, 95% CI: 1.37; 2.74, adjusted OR 2.37, 95% CI: 1.57; 3.59). In fully adjusted analyses, food insecurity was associated with a range of socio-economic measures, particularly the receipt of mean-tested benefits (adjusted OR 2.11, 95% CI: 1.41; 3.15) and perception of financial insecurity (adjusted OR 8.91, 95% CI: 4.14; 19.16 for finding it difficult/very difficult compared to living comfortably). Conclusions: The finding that food insecurity prevalence may be higher than previously thought and that food insecurity is highly associated with socio-economic status, notably benefit receipt, is a cause for concern necessitating an urgent policy response.

Is food insecurity associated with maternal health among UK ethnic groups? An exploration of women in the BiB cohort.

Food insecurity is a determinant of maternal health; however, research on the health impact of food insecurity among mothers of varying ethnicities is under-developed. We assessed the association of food insecurity and health among white British and Pakistani mothers. Data from the Born in Bradford cohort were matched with data on food insecurity and self-reported health from the nested BiB1000 study (N = 1280). Food insecurity was associated with elevated odds of fair/poor health among white British mothers but not Pakistani mothers. Adjusting for financial security, the association between food insecurity and poor health was not significant among either white British or Pakistani mothers.

Hidden hunger? Experiences of food insecurity amongst Pakistani and white British women.

PURPOSE: Foodbank use in the UK is rising but, despite high levels of poverty, Pakistani women are less likely to use food banks than white British women. The purpose of this paper is to understand the lived experience of food in the context of poverty amongst Pakistani and white British women in Bradford, including perspectives on food aid. DESIGN/METHODOLOGY/APPROACH: A total of 16 Pakistani and white British women, recruited through community initiatives, participated in three focus groups (one interview was also held as a consequence of recruitment difficulties). Each group met for two hours aided by a moderator and professional interpreter. The transcripts were analysed thematically using a three-stage process. FINDINGS: Women in low-income households employed dual strategies to reconcile caring responsibilities and financial obligations: the first sought to make ends meet within household income; the second looked to outside sources of support. There was a reported near absence of food insecurity amongst Pakistani women which could be attributed to support from social/familial networks, resource management within the household, and cultural and religious frameworks. A minority of participants and no Pakistani respondents accessed charitable food aid. There were three reasons for the non-use of food aid: it was not required because of resource management strategies within the household and assistance from familial/social networks; it was avoided out of shame; and knowledge about its existence was poor. ORIGINALITY/VALUE: This case study is the first examination of varying experiences of food insecurity amongst UK white British and Pakistani women. Whilst the sample size is small, it presents new evidence on perceptions of food insecurity amongst Pakistani households and on why households of varying ethnicities do not use food aid.

Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial.

BACKGROUND: Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth. METHODS: We did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866. FINDINGS: Between June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64-1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI -47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99-1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77-1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother-child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention. INTERPRETATION: Adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge. FUNDING: Department of Health Policy Research Programme.

Does involvement in a cohort study improve health and affect health inequalities? A natural experiment.

BACKGROUND: Evidence suggests that the process of taking part in health research can improve participants' health, independent of any intended intervention. However, no research has yet explored whether these effects differ across socioeconomic groups. If the effect of mere participation in health research also has a social gradient this could increase health inequalities and bias research results. This study used the Born in Bradford family cohort (BIB) to explore whether simply taking part in BIB had improved participants' health and, if so, whether this effect was mediated by socioeconomic status. METHODS: Survey data on self-reported health behaviours were collected between 2007 and 2010 as part of BIB. These were augmented by clinical data on birth weight. Pregnant women on their second pregnancy, joining BIB for the first time formed the control group. Their health was compared to women on their second pregnancy who had both pregnancies within the study, who formed the exposed group. In order to limit the inherent bias in a non-randomised study, propensity score analysis was used, matching on age, ethnicity, education and date of questionnaire. The results were then compared according to mothers' education. RESULTS: Of six outcomes tested, only alcohol consumption showed a statistically significant reduction with exposure to BIB (OR: 0.35, 95% CIs 0.13, 0.92). Although effect estimates were larger for women with higher education compared to lower education, these effects were not statistically significant. CONCLUSIONS: Despite one significant finding, these results overall are insufficient to conclude that simply taking part in BIB affected participants' health. We recommend that socioeconomic status is considered in future studies testing effects of research participation, and that randomised studies with larger sample sizes are conducted.

Evaluation of ethnic disparities in detection of depression and anxiety in primary care during the maternal period: combined analysis of routine and cohort data.

BACKGROUND: There are limited data on detection disparities of common mental disorders in minority ethnic women. AIMS: Describe the natural history of common mental disorders in primary care in the maternal period, characterise women with, and explore ethnic disparities in, detected and potentially missed common mental disorders. METHOD: Secondary analyses of linked birth cohort and primary care data involving 8991 (39.4% White British) women in Bradford. Common mental disorders were characterised through indications in the electronic medical record. Potentially missed common mental disorders were defined as an elevated General Health Questionnaire (GHQ-28) score during pregnancy with no corresponding common mental disorder markers in the medical record. RESULTS: Estimated prevalence of pre-birth common mental disorders was 9.5%, rising to 14.0% 3 years postnatally. Up to half of cases were potentially missed. Compared with White British women, minority ethnic women were twice as likely to have potentially missed common mental disorders and half as likely to have a marker of screening for common mental disorders. CONCLUSIONS: Common mental disorder detection disparities exist for minority ethnic women in the maternal period.