Ringing up about breastfeeding: a randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY) - trial protocol

BACKGROUND: The risks of not breastfeeding for mother and infant are well established, yet in Australia, although most women initiate breastfeeding many discontinue breastfeeding altogether and few women exclusively breastfeed to six months as recommended by the World Health Organization and Australian health authorities. We aim to determine whether proactive telephone peer support during the postnatal period increases the proportion of infants who are breastfed at six months, replicating a trial previously found to be effective in Canada. DESIGN/METHODS: A two arm randomised controlled trial will be conducted, recruiting primiparous women who have recently given birth to a live baby, are proficient in English and are breastfeeding or intending to breastfeed. Women will be recruited in the postnatal wards of three hospitals in Melbourne, Australia and will be randomised to peer support or to 'usual' care. All women recruited to the trial will receive usual hospital postnatal care and infant feeding support. For the intervention group, peers will make two telephone calls within the first ten days postpartum, then weekly telephone calls until week twelve, with continued contact until six months postpartum. Primary aim: to determine whether postnatal telephone peer support increases the proportion of infants who are breastfed for at least six months. HYPOTHESIS: that telephone peer support in the postnatal period will increase the proportion of infants receiving any breast milk at six months by 10% compared with usual care (from 46% to 56%).Outcome data will be analysed by intention to treat. A supplementary multivariate analysis will be undertaken if there are any baseline differences in the characteristics of women in the two groups which might be associated with the primary outcomes. DISCUSSION: The costs and health burdens of not breastfeeding fall disproportionately and increasingly on disadvantaged groups. We have therefore deliberately chosen trial sites which have a high proportion of women from disadvantaged backgrounds. This will be the first Australian randomised controlled trial to test the effectiveness and cost effectiveness of proactive peer telephone support for breastfeeding. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612001024831

Proactive Peer (Mother-to-Mother) Breastfeeding Support by Telephone (Ringing up About Breastfeeding Early [RUBY]):A Multicentre, Unblinded, Randomised Controlled Trial

Background: Breastfeeding rates are suboptimal internationally, and many infants are not receiving any breast milk at all by six months of age. Few interventions increase breastfeeding duration, particularly where there is relatively high initiation. The effect of proactive peer (mother-to-mother) support has been found to increase breastfeeding in some contexts but not others, but if it is shown to be effective would be a potentially sustainable model in many settings. We aimed to determine whether proactive telephone-based peer support during the postnatal period increases the proportion of infants being breastfed at six months of age. Methods: RUBY (Ringing Up about Breastfeeding earlY) was a multicentre, two-arm un-blinded randomised controlled trial conducted in three hospitals in Victoria, Australia. First-time mothers intending to breastfeed were recruited after birth and prior to hospital discharge, and randomly assigned (1:1) to usual care or usual care plus proactive telephone-based breastfeeding support from a trained peer volunteer for up to six months postpartum. A computerised random number program generated block sizes of four or six distributed randomly, with stratification by site. Research midwives were masked to block size, but masking of allocation was not possible. The primary outcome was the proportion of infants receiving any breast milk at six months of age. Analyses were by intention to treat; data were collected and analysed masked to group. The trial is registered with ACTRN, number 12612001024831. Findings: Women were recruited between Feb 14, 2013 and Dec 15, 2015 and randomly assigned to peer support (n = 574) or usual care (n = 578). Five were not in the primary analysis [5 post-randomisation exclusions]. Infants of women allocated to telephone-based peer support were more likely than those allocated to usual care to be receiving breast milk at six months of age (intervention 75%, usual care 69%; Adj. RR 1·10; 95% CI 1·02, 1·18). There were no adverse events. Interpretation: Providing first time mothers with telephone-based support from a peer with at least six months personal breastfeeding experience is an effective intervention for increasing breastfeeding maintenance in settings with high breastfeeding initiation. Funding: The Felton Bequest, Australia, philanthropic donation and La Trobe University grant. Keywords: Breastfeeding, Clinical trial, Peer support, Telephone intervention, Peer volunteer, Community-base