A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial

BACKGROUND Breastfeeding has countless benefits to mothers, children and community at large, especially in developing countries. Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates. Evidence reveals that antenatal breastfeeding education, professional lactation support, and peer lay support are individually effective at increasing breastfeeding duration and exclusivity, particularly in low-income settings. Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon, we hypothesize that a complex breastfeeding support intervention, which is centered on the three components mentioned above, would significantly increase breastfeeding rates. METHODS/DESIGN A multi-center randomized controlled trial. STUDY POPULATION 443 healthy pregnant women in their first trimester will be randomized to control or intervention group. INTERVENTION A "prenatal/postnatal" professional and peer breastfeeding support package continuing till 6 months postpartum, guided by the Social Network and Social Support Theory. Control group will receive standard prenatal and postnatal care. Mothers will be followed up from early pregnancy till five years after delivery. OUTCOME MEASURES Total and exclusive breastfeeding rates, quality of life at 1, 3 and 6 months postpartum, maternal breastfeeding knowledge and attitudes at 6 months postpartum, maternal exclusive breastfeeding rates of future infants up to five years from baseline, cost-benefit and cost-effectiveness analyses of the intervention. STATISTICAL ANALYSIS Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS. DISCUSSION Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality. In a country with limited healthcare resources like Lebanon, developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority. If positive, the results of this study would provide a generalizable model to bolster breastfeeding promotion efforts and contribute to improved child health in Lebanon and the Middle East and North Africa (MENA) region. TRIAL REGISTRATION Current Controlled Trials ISRCTN17875591.