Journal Article

Research protocol local ingredients-based supplementary food as an alternative to corn-soya blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: a randomized controlled non-inferiority trial in Wolaita

Lindtjørn, Bernt, Hatløy, Anne, Tadesse, Elazar, Nane, Debritu

2019

Overview

Background In Ethiopia, 12.5% of children below 5 years are wasted, and 9.7% are moderately wasted. The present strategy for the management of moderate acute malnutrition (MAM) is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. This randomized controlled non-inferiority trial examines if Local ingredients-based supplement (LIBS) is as effective as corn-soya blends plus (CSB+) in treating moderate acute malnutrition among children aged 6–59 months. Methods A randomized controlled non-inferiority trial will be conducted with moderately wasted children aged 6 to 59 months in Wolaita, Ethiopia. The calculated sample size is 324 (i.e. with 162 children in each of two arms, to be assigned by randomization). The daily ration will be: 100 g of LIBS plus 25.2 g of sugar with 8 ml oil in the intervention group, and 150 g of CSB+ with 16 ml of oil in the control group. These interventions will be provided for a maximum period of 12 weeks, with follow-up performed on a weekly basis. Data analysis will be done using SPSS and STATA software. Both intention-to-treat and per protocol analyses will be done. Hazard ratio and Kaplan-Meier (log rank) curves of survival analysis will be done to predict the probability of recovery rate. Logistic regression will be used to test for interactions between independent and dependent variables. Analysis of variances, t-tests, fisher’s exact test and chi-square tests will be used to assess baseline characteristics. Conclusions This paper will introduce to the existing research locally available nutritious foods which have the potential to enhance recovery from moderate acute malnutrition and to reduce the burden of malnutrition. The perceptions of mothers on feeding children with local ingredient-based supplementary food to assist recovery from moderate acute malnutrition will be the focus of in a qualitative study to follow; this will provide a further contribution in an evolving area of research. Trial registration Pan-African Clinical Trial Registration number: PACTR201809662822990 , retrospectively registered on 11/09/2018.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analysis / Biostatistics / Chi-square test / Child Nutrition Disorders - diet therapy / Child, Preschool / Children / Children & youth / Clinical trials / Control methods / Corn / Corn-soya blend plus / Counseling / Data analysis / Dependent variables / Dietary Supplements - statistics & numerical data / Edema / Effectiveness / Environmental Health / Epidemiology / Equivalence Trials as Topic / Ethiopia / Families & family life / Feeding / Food / Food availability / Food Ingredients - statistics & numerical data / Food security / Global health / Glycine max / Households / Humans / Independent variables / Infant / Infant Nutritional Physiological Phenomena / Information management / Ingredients / Local ingredients-based supplement / Malnutrition / Medicine / Medicine & Public Health / Mixtures / Moderate acute malnutrition / Nutrients / Nutrition / Population / Public Health / Qualitative research / Randomization / Randomized controlled non-inferiority trial / Randomized Controlled Trials as Topic / Recovery / Regression analysis / Research Design / Standard deviation / Statistical analysis / Statistical tests / Study Protocol / Vaccine / Zea mays