title: Breastfeeding booklet and proactive phone calls for increasing exclusive breastfeeding rates: RCT protocol.
abstract: Breastfeeding is associated with infant and maternal health benefits and considerable potential savings to health services. Despite this, only 37% of infants globally are exclusively breastfed for 6 months. 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 3 months compared with general birth-related 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 2 weeks later, and 2, 6 and 10 weeks after birth. The primary outcome will be the proportion of women exclusively breastfeeding at 3 months. 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 6 months 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.
authors.affiliation: University of Split School of Medicine, Split, Croatia.
authors.forename: Irena
authors.initials: I
authors.lastname: Zakarija-Grković
authors.affiliation: University of Split School of Medicine, Split, Croatia.
authors.forename: Drita
authors.initials: D
authors.lastname: Puharić
authors.affiliation: University of Split School of Medicine, Split, Croatia.
authors.forename: Mario
authors.initials: M
authors.lastname: Malički
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, UK.
authors.forename: Pat
authors.initials: P
authors.lastname: Hoddinott
mesh_terms: D001294:Attitude to Health; D001942:Breast Feeding; D017523:Croatia; D005260:Female; D005500:Follow-Up Studies; D006266:Health Education; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D007223:Infant; D008297:Male; D009035:Mothers / Q000193:education; D010174:Pamphlets; D018743:Perinatal Care; D011181:Postnatal Care; D012107:Research Design; D018401:Sample Size; D012944:Social Support; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D013689:Telephone
keywords: exclusive breastfeeding; pregnancy; proactive support; protocol; randomised controlled trial