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

Abstract

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.

Keywords: Corn-soya blend plus; Effectiveness; Local ingredients-based supplement; Moderate acute malnutrition; Randomized controlled non-inferiority trial.

Fig. 1

Trial profile. Assessed for eligibility = Children aged 6 to 59 months who assessed for moderate acute malnutrition.. Randomized = Children aged 6 to 59 months who assessed for moderate acute malnutrition, fulfilled the inclusion criteria, recruited and randomly allocated. Loss to follow-up = Children who are randomly allocated to intervention and control groups and stop to participate in the study at any stage of the study. Discontinued = Children who are randomly allocated to intervention and control groups and discontinued from the study at any stage of the study. Analyzed at 12 weeks = Children aged 6 to 59 months whose information analyzed at 12 weeks

Fig. 2

Participants time line. Assessed for eligibility = Children aged 6 to 59 months who assessed for moderate acute malnutrition based on inclusion/exclusion criteria. Complete assessment = Completion of screening for moderate acute malnutrition. Confirm willingness to participate = be sure for the willingness of care givers of the subject to be included in the study / informed consent. Randomization = Process of randomizing the subjects/ children aged 6 to 59 months who assessed and claimed as moderately malnourished. Base line data collection = collection of data before starting food ration. Follow-up = Weekly as well as monthly anthropometric assessment and daily food ration. End line data collection = Collection of data after completion of the follow up. t = indicates time that the processes have done/completed