Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Department of Kinesiology, University of New Brunswick Fredericton, Fredericton, New Brunswick, Canada.
BMJ Open. 2023 Nov 15;13(11):e075460. doi: 10.1136/bmjopen-2023-075460.
Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.
A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become 'infant feeding helpers' in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle.
The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences.
ISRCTN17395671.
母乳喂养对婴儿和母亲都有健康益处，但英国的母乳喂养率很低，且存在显著的社会不平等。基于资产的母乳喂养支持产前和产后（ABA）可行性研究表明，一种积极主动、以资产为基础、以妇女为中心的同伴支持干预措施是可以接受的，包括所有喂养方式，适用于母亲、同伴支持者和产妇服务。ABA-feed 研究旨在评估与常规护理相比，ABA-feed 干预在初次生育的母亲中的临床和成本效益，这是一项全面的试验。
这是一项多中心随机对照试验，结合经济评估，以探索临床和成本效益，并嵌入过程评估，以探索不同地点之间实施的差异。我们旨在招募 2730 名初产妇，无论其喂养意图如何。妇女将在 17 个地点通过产前诊所和各种远程方法招募，包括社交媒体以及从中助产士和健康访视员处获得的邀请。妇女将以 1.43:1 的比例随机分配接受 ABA-feed 干预或常规护理。将使用培训师培训模型来培训当地的婴儿喂养协调员，培训现有的同伴支持者成为 ABA-feed 干预中的“婴儿喂养助手”。婴儿喂养结果将在产后 3 天以及 8、16 和 24 周收集。主要结局将是产后 8 周的任何母乳喂养。次要结局将包括母乳喂养开始、任何和纯母乳喂养、配方奶喂养实践、焦虑、社会支持和医疗保健利用。所有分析都将基于意向治疗原则。
该研究方案已获得苏格兰东部研究伦理委员会的批准。试验结果将通过同行评审期刊的开放获取出版物提供，并在相关会议和会议上展示。
ISRCTN81454644。
