Food Aid Quality Review: Feasibility and Acceptability Study of Corn Soy Blend and Fortified Vegetable Oil in Malawi — FAQR-Malawi  

Child Malnutrition Clinical Trial

Official title: Food Aid Quality Review: Feasibility and Acceptability Study of Corn Soy Blend and Fortified Vegetable Oil in Malawi

Status Completed

Clinical Trial Summary

This research will test alternative methods of ensuring compliance with recommended preparation and targeting of supplementary foods for malnourished children under five years of age.

The hypotheses that the proposed study intends to test are as follows:

1. With appropriate behavior change communication (BCC) and social support, and with provision of CSB and FVO in the correct proportions, it is possible to get women to prepare CSB with oil in the recommended ratio of 100:30, and in quantities just sufficient for the target child.

2. Providing CSB to Beneficiary Mothers/Caretakers pre-packaged bags of 2 kg with appropriate messaging and with instructions to direct the food to children and to prepare the CSB with oil in the recommended ratio and feed as instructed will result in better compliance.

Clinical Trial Description

The first stage of the study involves working with the procurement and program staff to ensure that oil and CSB will be available at the same time in sufficient quantities and can be distributed together. We will work with program staff and outside consultants (if needed) to develop locally acceptable recipes for CSB plus oil. A sample of communities with MCHN programs will be chosen, and the intervention (consistent provision of CSB with oil, teaching of recipes using CSB with oil, appropriate behavioral support) implemented. Tufts and locally contracted researchers will interview program staff involved in procurement and supply chain management as well as program staff, and beneficiaries, to assess the feasibility and acceptability of the provision of CSB with oil, and identify barriers and problems. This stage is expected to take six months.

In the second stage of the study, the CSB will be distributed in new, smaller packages in half the sample communities, with the other half continuing with their normal distribution. In preparation for this stage, during the first stage, Tufts researchers will arrange for the production/packaging of a sufficient supply of CSB in the new packages, and will contract with local communications specialists to develop appropriate messages, so these will be available in time for the second stage of the study. Tufts and locally contracted researchers will collect information from program staff on their perception of the feasibility and impact of the change, and will interview beneficiaries to determine how they use the CSB and whether their use changes with the change in packaging/messaging. We may track the effect on intrahousehold sharing through self report of consumption among family members. This stage will last about six months, with data collection from beneficiaries conducted before and up to six months after the start of the intervention.

In addition to interviews and focus group discussions, we will collect samples of porridge as prepared in order to assess the proportion of oil, and we will conduct market observations to determine whether increased distribution of oil affects availability and price in the market, and whether market access affects beneficiary mothers' compliance with recommended preparation method. We will conduct a small number of in-home observations to observe beneficiary mothers' practices with respect to storage, preparation, and feeding of children, of which they might not be aware.

The key outcomes of the study are the proportion of oil in the CSB porridge as prepared, and the percent of beneficiary mothers who meet the standard for the oil : CSB ratio. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Child Malnutrition
• Malnutrition

• NCT number: NCT01873196
• Study type: Interventional
• Source: Tufts University
• Status: Completed
• Phase: N/A
• Start date: July 2013