title: Born in Bradford's Better Start: an experimental birth cohort study to evaluate the impact of early life interventions.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK. Josie.dickerson@bthft.nhs.uk.
authors.forename: Josie
authors.initials: J
authors.lastname: Dickerson
authors.affiliation: Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.
authors.forename: Philippa K
authors.initials: PK
authors.lastname: Bird
authors.affiliation: Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.
authors.forename: Rosemary R C
authors.initials: RR
authors.lastname: McEachan
authors.affiliation: Department of Health Sciences, The University of York, York, UK.
authors.forename: Kate E
authors.initials: KE
authors.lastname: Pickett
authors.affiliation: Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.
authors.forename: Dagmar
authors.initials: D
authors.lastname: Waiblinger
authors.affiliation: Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Uphoff
authors.affiliation: Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.
authors.forename: Dan
authors.initials: D
authors.lastname: Mason
authors.affiliation: Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.|Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Bryant
authors.affiliation: Department of Health Sciences, The University of York, York, UK.
authors.forename: Tracey
authors.initials: T
authors.lastname: Bywater
authors.affiliation: Psychology in Education Research Centre, Department of Education, The University of York, York, UK.
authors.forename: Claudine
authors.initials: C
authors.lastname: Bowyer-Crane
authors.affiliation: School of Clinical and Applied Sciences, Leeds Beckett University, Leeds, UK.
authors.forename: Pinki
authors.initials: P
authors.lastname: Sahota
authors.affiliation: Faculty of Health Studies, University of Bradford, Bradford, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Small
authors.affiliation: Better Start Bradford, Bradford Trident, Bradford, UK.
authors.forename: Michaela
authors.initials: M
authors.lastname: Howell
authors.affiliation: Better Start Bradford, Bradford Trident, Bradford, UK.
authors.forename: Gill
authors.initials: G
authors.lastname: Thornton
authors.affiliation: BD4 Family, BD4 Community Trust, Bradford, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Astin
authors.affiliation: MRC Integrative Epidemiology Unit at the University of Bristol and School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Debbie A
authors.initials: DA
authors.lastname: Lawlor
authors.affiliation: Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.
authors.forename: John
authors.initials: J
authors.lastname: Wright
mesh_terms: D000328:Adult; D002657:Child Development; D002675:Child, Preschool; D015331:Cohort Studies; D004739:England; D005006:Ethnicity; D005260:Female; D006293:Health Promotion / Q000592:standards*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007804:Language Development; D008297:Male; D009035:Mothers; D009752:Nutritional Status; D009765:Obesity; D011203:Poverty; D011247:Pregnancy; D012107:Research Design; D012307:Risk Factors
keywords: Birth cohort; Child development; Child health; Communication; Early years interventions; Emotional; Inequalities; Language; Nutrition; Obesity; Quasi-experimental; Social; Trials within cohort