• Born in Bradford's Better Start: an experimental birth cohort study to evaluate the impact of early life interventions

      Dickerson, J.; Bird, P.K.; McEachan, Rosemary; Pickett, K.E.; Waiblinger, D.; Uphoff, E.P.; Mason, Dan; Bryant, M.; Bywater, T.; Bowyer-Crane, C.; et al. (2016-08-04)
      Background: Early interventions are recognised as key to improving life chances for children and reducing inequalities in health and well-being, however there is a paucity of high quality research into the effectiveness of interventions to address childhood health and development outcomes. Planning and implementing standalone RCTs for multiple, individual interventions would be slow, cumbersome and expensive. This paper describes the protocol for an innovative experimental birth cohort: Born in Bradford’s Better Start (BiBBS) that will simultaneously evaluate the impact of multiple early life interventions using efficient study designs. Better Start Bradford (BSB) has been allocated £49 million from the Big Lottery Fund to implement 22 interventions to improve outcomes for children aged 0–3 in three key areas: social and emotional development; communication and language development; and nutrition and obesity. The interventions will be implemented in three deprived and ethnically diverse inner city areas of Bradford. Method: The BiBBS study aims to recruit 5000 babies, their mothers and their mothers’ partners over 5 years from January 2016-December 2020. Demographic and socioeconomic information, physical and mental health, lifestyle factors and biological samples will be collected during pregnancy. Parents and children will be linked to their routine health and local authority (including education) data throughout the children’s lives. Their participation in BSB interventions will also be tracked. BiBBS will test interventions using the Trials within Cohorts (TwiCs) approach and other quasi-experimental designs where TwiCs are neither feasible nor ethical, to evaluate these early life interventions. The effects of single interventions, and the cumulative effects of stacked (multiple) interventions on health and social outcomes during the critical early years will be measured. Discussion: The focus of the BiBBS cohort is on intervention impact rather than observation. As far as we are aware BiBBS is the world’s first such experimental birth cohort study. While some risk factors for adverse health and social outcomes are increasingly well described, the solutions to tackling them remain elusive. The novel design of BiBBS can contribute much needed evidence to inform policy makers and practitioners about effective approaches to improve health and well-being for future generations.
    • Design and characteristics of a new birth cohort, to study the early origins and ethnic variation of childhood obesity: the BiB1000 study

      Bryant, M.; Santorelli, G.; Fairley, L.; West, Jane; Lawlor, D.A.; Bhopal, R.S.; Petherick, E.S.; Sahota, P.; Hill, A.; Cameron, N.; et al. (2013)
      Epidemiological evidence indicates that early life factors are important for obesity development but there are gaps in knowledge regarding the impact of exposures during pregnancy and early life, especially in South Asian children. There is a corresponding lack of evidence to guide development of culturally-appropriate, obesity prevention programmes. This paper describes the methodology and characteristics of participants in Born in Bradford 1000 (BiB1000), a nested cohort of the Born in Bradford prospective birth cohort. BiB1000 aims to enable a deep and extensive understanding of the predictors and influences of health-related behaviours to develop a culturally-specific obesity prevention intervention. 1,735 mothers agreed to take part in detailed assessments focused on risk factors of obesity. Of these, 1,707 had singleton births. Data were collected from the families during pregnancy, at birth and when the infant was aged 6, 12, 18, 24 and 36 months. Approximately half of the mothers (n=933) are of South Asian ethnicity; of which, just under half were born in the UK. Prevalence of obesity in BiB1000 is similar to the full BiB cohort and to UK national averages. In addition to pre-specified hypothesised targets for obesity prevention, (e.g. parental feeding styles, diet and activity), BiB1000 is exploring qualitative determinants of behaviours andother exposures with a lesser evidence base (e.g. food environments, sleep, parenting practices). These data will enable a rich understanding of the behaviours and their determinants in order to inform the development of a culturally-relevant, childhood obesity prevention intervention.
    • Development and evaluation of an intervention for the prevention of obesity in a multiethnic population : the Born in Bradford applied research porgramme

      West, Jane; Fairley, L.; McEachan, Rosemary; Bryant, M.; Petherick, E.S.; Sahota, P.; Santorelli, G.; Barber, Sally E.; Lawlor, D.A.; Taylor, N.; et al. (2016-05)
      Background: There is an absence of evidence about interventions to prevent or treat obesity in early childhood and in South Asian populations, in whom risk is higher. Objectives: To study patterns and the aetiology of childhood obesity in a multiethnic population and develop a prevention intervention. Design: A cohort of pregnant women and their infants was recruited. Measures to compare growth and identify targets for obesity prevention, sensitive to ethnic differences, were collected. A feasibility randomised controlled trial (RCT) was undertaken. Setting: Bradford, UK. Participants: A total of 1735 mothers, 933 of whom were of South Asian origin. Intervention: A feasibility trial of a group-based intervention aimed at overweight women, delivered ante- and postnatally, targeting key modifiable lifestyle behaviours to reduce infant obesity. Main outcome measures: The feasibility and acceptability of the pilot intervention. Data sources: Routine NHS data and additional bespoke research data. Review methods: A systematic review of diet and physical activity interventions to prevent or treat obesity in South Asian children and adults.
    • Ethnic differences in infant feeding practices and their relationship with body mass index at 3 years of age - results from the Born in Bradford birth cohort study.

      Santorelli, G.; Fairley, L.; Petherick, E.S.; Cabieses, B.; Sahota, P. (2014-05)
      The present study aimed to explore previously unreported ethnic differences in infant feeding practices during the introduction of solid foods, accounting for maternal and birth factors, and to determine whether these feeding patterns are associated with BMI at 3 years of age. An observational study using Poisson regression was carried out to investigate the relationship between ethnicity and infant feeding practices and linear regression was used to investigate the relationship between feeding practices and BMI at 3 years of age in a subsample of 1327 infants in Bradford. It was found that compared with White British mothers, mothers of Other ethnicities were less likely to replace breast milk with formula milk before introducing solid foods (adjusted relative risk (RR) – Pakistani: 0·76 (95 % CI 0·64, 0·91), Other South Asian: 0·58 (95 % CI 0·39, 0·86), and Other ethnicities: 0·50 (95 % CI 0·34, 0·73)). Pakistani and Other South Asian mothers were less likely to introduce solid foods early ( < 17 weeks) (adjusted RR – Pakistani: 0·92 (95 % CI 0·87, 0·96) and Other South Asian: 0·87 (95 % CI 0·81, 0·93)). Other South Asian mothers and mothers of Other ethnicities were more likely to continue breast-feeding after introducing solid foods (adjusted RR – 1·72 (95 % CI 1·29, 2·29) and 2·12 (95 % CI 1·60, 2·81), respectively). Pakistani and Other South Asian infants were more likely to be fed sweetened foods (adjusted RR – 1·18 (95 % CI 1·13, 1·23) and 1·19 (95 % CI 1·10, 1·28), respectively) and Pakistani infants were more likely to consume sweetened drinks (adjusted RR 1·72 (95 % CI 1·15, 2·57)). No association between infant feeding practices and BMI at 3 years was observed. Although ethnic differences in infant feeding practices were found, there was no association with BMI at 3 years of age. Interventions targeting infant feeding practices need to consider ethnicity to identify which populations are failing to follow recommendations.
    • The HAPPY (Healthy and Active Parenting Programme for Early Years) feasability randomised control trial: acceptability and feasability of an intervention to reduce infant Obesity

      McEachan, Rosemary; Santorelli, G.; Bryant, M.; Sahota, P.; Farrar, D.; Small, Neil A.; Akhtar, Shaheen; Sargent, J.; Barber, Sally E.; Taylor, N.; et al. (2016-03-01)
      prevent obesity at this age. This study tested the acceptability and feasibility of evaluating a theory-based intervention aimed at reducing risk of obesity in infants of overweight/obese women during and after pregnancy: the Healthy and Active Parenting Programme for Early Years (HAPPY). Methods: A feasibility randomised controlled trial was conducted in Bradford, England. One hundred twenty overweight/obese pregnant women (Body Mass Index [BMI] ≥25 kg/m2) were recruited between 10–26 weeks gestation. Consenting women were randomly allocated to HAPPY (6 antenatal, 6 postnatal sessions: N = 59) or usual care (N = 61). Appropriate outcome measures for a full trial were explored, including: infant’s length and weight, woman’s BMI, physical activity and dietary intake of the women and infants. Health economic data were collected. Measurement occurred before randomisation and when the infant was aged 6 months and 12 months. Feasibility outcomes were: recruitment/attrition rates, and acceptability of: randomisation, measurement, and intervention. Intra-class correlations for infant weight were calculated. Fidelity was assessed through observations and facilitator feedback. Focus groups and semi-structured interviews explored acceptability of methods, implementation, and intervention content. Results: Recruitment targets were met (~20 women/month) with a recruitment rate of 30 % of eligible women (120/396). There was 30 % attrition at 12 months; 66 % of recruited women failed to attend intervention sessions, but those who attended the first session were likely to continue to attend (mean 9.4/12 sessions, range 1–12). Reaction to intervention content was positive, and fidelity was high. Group clustering was minimal; an adjusted effect size of −0.25 standard deviation scores for infant weight at 12 months (95 % CI: −0.16–0.65) favouring the intervention was observed using intention to treat analyses. No adverse events were reported. Conclusions: The HAPPY intervention appeared feasible and acceptable to participants who attended and those delivering it, however attendance was low; adaptations to increase initial attendance are recommended. Whilst the study was not powered to detect a definitive effect, our results suggest a potential to reduce risk of infant obesity. The evidence reported provides valuable lessons to inform progression to a definitive trial.
    • Integrating research and system-wide practice in public health to enhance the evidence-base of interventions: lessons learnt from Better Start Bradford

      Dickerson, J.; Bird, P.K.; Bryant, M.; Dharni, N.; Bridges, S.; Willan, K.; Ahern, S.; Dunn, A.; Nielsen, D.; Uphoff, E.P.; et al. (2018-11)
    • Integrating research and system-wide practice in public health: lessons learnt from Better Start Bradford

      Dickerson, J.; Bird, P.K.; Bryant, M.; Dharni, N.; Bridges, S.; Willan, K.; Ahern, S.; Dunn, A.; Nielsen, D.; Uphoff, E.P.; et al. (2019-12)
      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/whatwe-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.