Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso
Condition: Child Malnutrition
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): CSB14; RUSF1; SC+
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention