Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso — FAQR-Burkina  

Child Malnutrition Clinical Trial

Official title: Food Aid Quality Review Phase II Effectiveness Study: Preventing MAM and Stunting in Burkina Faso

Status Completed

Clinical Trial Summary

This research will serve as a follow-up on the review of Title II commodities performed by the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso will test the relative effectiveness and cost effectiveness of four supplementary foods in the prevention of MAM and stunting in normal programmatic settings.

The aims of this study are to:

1. To compare the effectiveness of four alternative supplementary food commodities in preventing stunting and wasting, and promoting linear growth in children 6 - 23 months in the context of a preventive supplementary feeding program in Burkina Faso.

2. To estimate the relative cost of implementing the supplementary feeding program using each commodity

3. To estimate the relative cost/effectiveness of implementing the program using each commodity.

Clinical Trial Description

Phase II of FAQR in Burkina Faso will assess the recommended improvements in the four arms of the study: CSB14 prepared with FVO, RUSF1, CSB+, and SC+.

The study will be a cluster-randomized, effectiveness trial. The study will use a mixed method technique of quantitative and qualitative data collection. The design of the study is quasi-experimental: food distribution sites (FDPs) (and the communities they serve) will be grouped into four clusters that are geographically contiguous with each other and sufficiently distant from each other so that the Beneficiaries are unlikely to have contact with each other. The four groups of food distribution points will be randomly assigned to one of four arms, defined by the specific food to be provided:

1. Corn Soy Blend 14 (CSB14) (with whey protein concentrate and enhanced micronutrient profile), prepared with fortified vegetable oil (FVO); 75g CSB14/day, 22.5g FVO/day

2. Ready-to use supplementary food 1 (RUSF1); 100g RUSF/day

3. Super Cereal Plus (SC+)( has an enhanced nutrient profile, non-fat dry milk, and oil already embedded into the CSB); 122g SC+/day

4. Corn Soy Blend Plus (CSB+) prepared with FVO; 75g CSB+/day, 22.5g FVO/day The CSB+ arm will act as a control

The intervention is implemented using the food distribution points providing supplementary food (CSB14, CSB+, RUSF, SC+) to children once they reach six months of age, and children from 6 to 23 months. This study will enroll all children as they turn six months of age and follow them through their 23rd month of age. Variables to be tracked include: age, sex, arm of study/commodity received ,Mid-Upper Arm Circumference (MUAC), height for age, weight for age, weight for height, month-to-month linear growth and weight gain, incidence of stunting (height for age below -2 Standard Deviations (SD)), incidence of wasting (weight for height below - 2 SD).

At 24 months, children stop receiving supplementary food. The study will continue to monitor these variables for at least an additional 6 months (through the age of 30 months).

The study will collect information on the following additional variables from Beneficiary Mothers/Caretakers, Health and Nutrition Promoters (HNPs), Community Health Agents (CHAs), store owners who sell products comparable to those distributed, and PVO staff members.

• Mothers' knowledge, attitude, and practices with respect to compliance with instructions about the preparation and use of the supplementary food

• Time and money costs to Beneficiary Mothers/Caretakers of participating in the feeding program

• Household Characteristics

• Environmental characteristics

• Community characteristics

• Perceived barriers and factors facilitating Title II program effectiveness

• Logistics and cost of procuring, warehousing and distributing the food to the food distribution point

Data Collection Time Points Data collection will be ongoing. It is expected that in order to reach our sample size, the study will need to enroll children on a rolling basis when they turn 6 months old for one year. All children will receive a food ration for 18 months, until they turn 2 years old. During this time period, the study will collect growth measurements (height, weight, MUAC) on every enrolled child at monthly intervals.

Throughout the study, qualitative and quantitative data will also be collected from Beneficiary Mothers/Caretakers, Health and Nutrition Promoters (HNPs), Community Health Agents (CHAs), and PVO staff members as described above. We will conduct qualitative open ended interviews with PVO staff members in their professional capacities, to learn of any challenges or strengths in implementing the procurement and distribution of new commodities.

We will also randomly select a small subsample of Beneficiary Mothers/Caretakers for in-home observations. The purpose of these observations is to observe aspects of the family's preparation and consumption of the ration that they would be unlikely to be able to report during focus groups or individual interviews, because respondents may not be conscious of their actions. Examples include: giving tastes of the ration to children while it is being cooked; how quickly the ration is covered after feeding; whether children are able to take tastes of leftover rations. We would follow a commonly used model of asking families to have a guest observer stay with them for up to a week during waking hours. The observer would collect information on these aspects of preparation and consumption methods and on other observable behavior (e.g. how many times a day the ration is made, whether covered while cooking, after cooking, after serving).

We will collect a small (2 tablespoon) sample of prepared ration from all individually interviewed Beneficiary Mothers/Caretakers. This will be used for laboratory assessment of the proportion of FVO in the porridge to validate our estimates of the CSB : Oil ratio as reported by the mother.

The objective of this study is to highlight which food product best prevents stunting and MAM, in the most cost effective way, thereby ultimately affecting future effective and efficient policy in food aid programs. ;

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition

• NCT number: NCT02071563
• Study type: Interventional
• Source: Tufts University
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: June 2017