Dickerson Josie, Bird Philippa K, McEachan Rosemary R C, Pickett Kate E, Waiblinger Dagmar, Uphoff Eleonora, Mason Dan, Bryant Maria, Bywater Tracey, Bowyer-Crane Claudine, Sahota Pinki, Small Neil, Howell Michaela, Thornton Gill, Astin Melanie, Lawlor Debbie A, Wright John
Born in Bradford, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.
Department of Health Sciences, The University of York, York, UK.
BMC Public Health. 2016 Aug 4;15(1):711. doi: 10.1186/s12889-016-3318-0.
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.
早期干预被认为是改善儿童生活机遇、减少健康和福祉方面不平等现象的关键，然而，针对改善儿童健康和发展成果的干预措施有效性的高质量研究却很匮乏。针对多种单独的干预措施开展独立的随机对照试验既缓慢、繁琐又昂贵。本文描述了一项创新的实验性出生队列研究方案：布拉德福德更好开端出生队列研究（BiBBS），该研究将采用高效的研究设计同时评估多种早期生活干预措施的影响。布拉德福德更好开端计划（BSB）已从大乐透基金获得4900万英镑，用于实施22项干预措施，以改善0至3岁儿童在三个关键领域的成果：社会和情感发展；沟通和语言发展；营养与肥胖。这些干预措施将在布拉德福德三个贫困且种族多样的市中心地区实施。
BiBBS研究旨在从2016年1月至2020年12月的5年时间里招募5000名婴儿、他们的母亲及其母亲的伴侣。在孕期将收集人口统计学和社会经济信息、身心健康状况、生活方式因素以及生物样本。在孩子的整个成长过程中，父母和孩子将与他们的常规健康数据以及地方当局（包括教育）数据相链接。他们参与BSB干预措施的情况也将被跟踪。BiBBS将使用队列中的试验（TwiCs）方法以及在TwiCs不可行或不符合伦理时使用其他准实验设计来测试干预措施，以评估这些早期生活干预措施。将测量单一干预措施的效果，以及在关键的早期阶段叠加（多种）干预措施对健康和社会成果的累积影响。
BiBBS队列研究的重点是干预措施的影响而非观察。据我们所知，BiBBS是世界上首个此类实验性出生队列研究。虽然一些对健康和社会不良后果的风险因素已得到越来越多的描述，但解决这些问题的方法仍然难以捉摸。BiBBS的新颖设计可为政策制定者和从业者提供急需的证据，以了解改善后代健康和福祉的有效方法。
