Effectiveness of Complementary Food Based on Foodrecipe Locally Produced in Malnutrition Prevention of Child 6–23, Katanga DRC: Randomized Controlled Trial of MASO31 Recipe

Abstract

Abstract Objectives This study aims to assess the effectiveness of the local additional food-recipe MASO 31 to increase weight gain (or z-score WHZ, WAZ, HAZ) in preventing malnutrition. The Null Hypothesis: “MASO31” recipe is not effective in preventing malnutrition or the z-score index (WHZ, WAZ, HAZ) gain averages in the two groups (intervention and control groups) are equal. The alternative Hypothesis: the “MASO31” recipe is effective in preventing malnutrition or the z-score index (WHZ, WAZ, HAZ) gain average is increased in the intervention children group than in the comparison children group. Methods In Kapolowe health zone, double-blind RCT is undertaken to assess the effectiveness of the MASO31 recipe to increase z-score (WHZ, WAZ, HAZ) in preventing malnutrition. P-S Power and sample size calculation software version 3.1.2. and the sample size calculation formula n = 2(Zα+Z[1-β])2 × SD2/d2 were used to obtain the sample size, where α = 0.01, Zα = 2.58, β = 0.10, Z(1-β) = 1.28; SD = 1z-score (within each subject group), d(effect size) = 0.55 z-score. So, n = 2(2.58 + 1.28)2 × (1)2/(0.55)2 = 99. Sample size with attrition rate (10%) = NR = n/(1-R) = 99/(1–0,90) = 110 intervention and 110 control children groups 12–20 months old. A total of 220 study children simply randomized are receiving daily 200g of MASO31 or MASO30 porridge-based. Standardized anthropometric equipment, trained investigators, and SPSS 23 are used before and will be used after implementation. A paired t-test will compare matched z-score (WHZ, WAZ, HAZ) averages within each children group. Two-sample t-test will compare the real difference of the difference of z-score (WHZ, WAZ, HAZ) gain averages in intervention and comparison children groups to reject the null hypothesis of the equality of the z-score (WHZ, WAZ, HAZ) gain averages in the two groups. Results The results are not yet available because it is a protocol whose study is being implemented. Conclusions Waiting for the end of the implementation study, we hope that this study will provide evidence about the effectiveness of local complementary food-recipe in DR Congo and serve the Health Ministry to make nutrition policy. Funding Sources Grant application to Nestle Foundation