Effect of nutritional education intervention to reduce anaemia during pregnancy in Dodoma City, Tanzania: Protocol for a cluster randomized controlled trial

Abstract

The objective of this study is to assess the effectiveness of community-based nutritional intervention in reducing the burden of anaemia during pregnancy. Study design will be a cluster-randomized controlled trial. Study setting will be peri-urban wards of Dodoma City. The study will have two arms (the interventional and the control arms). A total of 400 pregnant women at second trimester will be recruited. The study will consist of four phases in four months for both the interventional and the control arms namely: baseline, first and second follow-up and end-line surveys. During each phase, participants from both arms will be measured for haemoglobin concentration and assessed for gestational age, dietary practices and knowledge about anaemia. Furthermore, all participants will receive iron and folic acid supplements, sulphadoxinepyrimethamine and mebendazole tablets throughout the entire period of the study. Nutritional education will be provided to the interventional arm only during each phase. Main outcomes of the study will be changes in haemoglobin concentration, nutritional knowledge and dietary practices at each phase after the baseline survey in the interventional compared to the control arm. Descriptive statistics will be used to describe the participants. Independent and paired t-tests will be performed to make comparisons between and within groups. P-values less than 0.05 will be considered statistically significant. Trial registration PACTR Registry, PACTR202007617885299. Registered on 28 May 2020.