Abstract
BACKGROUND: Breast milk is the primary source of nutrition for newborns, containing both macro- and micronutrients. However, breastfeeding practices vary from setting to setting and have an effect on a newborn's growth and development. Ethiopian women frequently demonstrate poor breastfeeding practices due to cultural norms and limited access to health information. Null-parous pregnant women have no previous experience of breastfeeding, so they can easily be influenced by others, such as their mother-in-law, who are influential people in the family. Evidence from interventional studies regarding whether involving influential people like mothers-in-law in breastfeeding education interventions in addition to educating pregnant women alone improves breastfeeding practices or not is limited in the study areas. Therefore, this study aimed to evaluate the effect of breastfeeding education interventions on breastfeeding practices in rural South Ethiopia. METHODS: A community-based, three-arm, parallel, cluster randomized controlled trial design will be conducted among 510 pregnant women who will be enrolled between the end of the first trimester and the early second trimester (< 16 weeks) of their pregnancy. The three arms are: pregnant woman alone, pregnant woman with her mother-in-law (paired), and pregnant woman in control arm (routine care). The study includes 51 non-adjacent clusters (kebeles) for the three arms. This helps minimize information contamination. We implement a simple randomization technique to allocate interventions and control clusters. Interventions will be given at home in eight phases: six times during pregnancy (monthly starting from the 4th month up to the 9th month), and two times after delivery (within one week and the last week of the 3rd month). The outcomes are pre-lacteal feeding, colostrum feeding, early initiation of breastfeeding, and exclusive breastfeeding. DISCUSSION: Recruitment is ongoing, and the final trial is expected to be completed on May 20, 2025. The trial results will have implications for the future involvement of influential family members, such as mothers-in-law, in breastfeeding education, which may improve good breastfeeding practices to enhance child health and survival. PROTOCOL REGISTRATION: ClinicalTrials.gov identifier (NCT number): NCT06236412, January 23, 2024.