The Philani MOVIE study: A cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa

Background: In South Africa, rates of exclusive breastfeeding remain low and breastfeeding promotion is a national health priority. Mobile health and narrative entertainment-education are recognized strategies for health promotion. In-home counseling by community health workers (CHWs) is a proven breastfeeding promotion strategy. This protocol outlines a cluster-randomized controlled trial with a nested mixed-methods evaluation of the MObile Video Intervention for Exclusive breastfeeding (MOVIE) program. The evaluation will quantify the causal effect of the MOVIE program and generate a detailed understanding of the context in which the intervention took place and the mechanisms through which it enacted change. Findings from the study will inform the anticipated scale-up of mobile video health interventions in South Africa and the wider sub-Saharan region. Methods: We will conduct a stratified cluster-randomized controlled trial in urban communities of the Western Cape, to measure the effect of the MOVIE intervention on exclusive breastfeeding and other infant feeding practices. Eighty-four mentor-mothers (CHWs employed by the Philani Maternal Child Health and Nutrition Trust) will be randomized 1:1 into intervention and control arms, stratified by neighborhood type. Mentor-mothers in the control arm will provide standard of care (SoC) perinatal in-home counseling. Mentor-mothers in the intervention arm will provide SoC plus the MOVIE intervention. At least 1008 pregnant participants will be enrolled in the study and mother-child pairs will be followed until 5 months post-delivery. The primary outcomes of the study are exclusive breastfeeding at 1 and 5 months of age. Secondary outcomes are other infant feeding practices and maternal knowledge. In order to capture human-centered underpinnings of the intervention, we will conduct interviews with stakeholders engaged in the intervention design. To contextualize quantitative findings and understand the mechanisms through which the intervention enacted change, end-line focus groups with mentor-mothers will be conducted. Discussion: This trial will be among the first to explore a video-based, entertainment-education intervention delivered by CHWs and created using a community-based, human-centered design approach. As such, it could inform health policy, with regards to both the routine adoption of this intervention and, more broadly, the development of other entertainment-education interventions for health promotion in under-resourced settings. Trial Registration: The study and its outcomes were registered at clinicaltrials.gov (#NCT03688217) on September 27th, 2018.