The effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation

BACKGROUND: Breastfeeding durations in the UK are amongst the shortest worldwide, despite considerable health benefits to both infant and mother associated with breastfeeding. The research team drew on best evidence and behavioural theory to develop the innovative ABA-feed intervention and tested it in a feasibility study. Criteria for progression to a full trial were met. RESEARCH QUESTION: To evaluate if the ABA-feed intervention compared with usual care increases any breastfeeding at 8 weeks post delivery, in first-time mothers regardless of their feeding intentions. SECONDARY AIMS: 1) To evaluate the effect of the ABA-feed intervention compared to usual feeding care on secondary outcomes including other feeding outcomes. 2) To explore the feasibility of i) modelling longer-term benefits ii) costs and outcomes for a lifetime horizon, using a within trial cost-consequence analysis over 16 weeks post-delivery. 3) To investigate how trial conduct and context varies across sites in order to understand any observed differences in outcomes and inform future implementation. METHODS: Randomised controlled trial with 2730 nulliparous women with singleton pregnancy, any feeding intention, recruited from scanning and antenatal clinics and randomised 1.4:1 to intervention or control group (usual feeding care with no proactive peer support). Intervention: Infant feeding helper service applying a proactive, assets-based, woman-centred approach, delivered antenatally and postnatally, tailored through face-to-face contacts, texts and telephone. A face-to-face contact at 30 weeks of pregnancy will be followed by texts/brief calls during pregnancy, daily for 2 weeks after birth, reducing until 8 weeks. Setting: 10-15 UK sites where usual feeding care does not include routine proactive peer supporter contact, including sites of low breastfeeding prevalence and socio-economically disadvantaged populations. Outcome measures: Primary outcome - any breastfeeding at 8 weeks. Secondary outcomes: breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and health care utilisation. Data collection: by text and online questionnaires at 3 days, 8 and 16 weeks postnatal. Mixed-methods process evaluation with more detailed case-studies in five sites to explore effect of context on implementation. Qualitative interviews with women, infant feeding helpers and maternity care professionals, fidelity of intervention delivery. Economic evaluation: will explore the feasibility of modelling longer-term benefits, and costs and outcomes for a lifetime horizon, using a within trial cost-consequence analysis over 16 weeks post delivery. TIMELINES FOR DELIVERY: Duration 36 months (M). Set-up and training (M1-6); recruitment of women (M7-20); follow-up (M9-30); process evaluation and case studies (M13-31); economic analysis and model (M22-36) and analysis of trial data and report writing (M31-36). ANTICIPATED IMPACT AND DISSEMINATION: The findings will address the effectiveness/cost-effectiveness of the ABA-feed intervention on breastfeeding. If effective, understanding how context impacts on implementation and observed outcomes will inform commissioning guidance and wider-scale roll out. Dissemination of findings will target key stakeholders including media, online forums, patient and public involvement, commissioners and health care professional events, and publications. Website: www.birmingham.ac.uk/ABA-feed