Breastfeeding booklet and proactive phone calls for increasing exclusive breastfeeding rates: RCT protocol

Breastfeeding is associated with infant andmaternal health benefits and considerable potential savings to health services. Despite this, only 37%of infants globally are exclusively breastfed for 6months. Interventions are needed to improve breastfeeding rates. The aim of this study is to determine whether written breastfeeding information in pregnancy and proactive breastfeeding-focused support phone calls, provided by a health professional educated in breastfeeding management, increase exclusive breastfeeding rates at 3months compared with general birthrelated information with proactive support calls or standard care. This is a single-centre, randomised, controlled, three-arm, superiority study with blind outcome assessment. Eligible participants will include primigravidae with singleton pregnancies who speak Croatian, attending six primary care obstetric practices. We estimate a total sample size of 459, with computer generated stratified randomisation of 153 women per arm. Participants in the intervention and active control groups will receive booklets in pregnancy, phone calls 2weeks later, and 2, 6 and 10weeks after birth. The primary outcome will be the proportion of women exclusively breastfeeding at 3months. Secondary outcomes will compare: infant feeding practices and attitudes, social support, breastfeeding difficulties, breastfeeding self efficacy and utilisation of breastfeeding support services. Follow-up at 6months will compare exclusive and any breastfeeding and utilised support services. Analysis will be by intention to treat. This trial will contribute to future evidence syntheses identifying the most effective forms of breastfeeding support