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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
| ACDI/VOCA | OTHER |
| Save the Children | OTHER |
| Institut de Recherche en Sciences de la Sante, Burkina Faso |
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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:
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSB14 | Active Comparator | Isocaloric amount and cost-effectiveness of CSB14 (with whey protein concentrate and enhanced micronutrient profile), prepared with fortified vegetable oil (FVO). |
|
| RUSF1 | Active Comparator | Isocaloric amount and cost-effectiveness of Ready-to Use Supplementary Food 1(RUSF1), USAID's Lipid-Based Nutrient Supplement (LNS) product |
|
| SC+ | Active Comparator | Isocaloric amount and cost-effectiveness of Supercereal Plus (SC+), the FBF used by WFP, which has an enhanced nutrient profile, dairy ingredient (non-fat dry milk), and oil already embedded into the flour |
|
| CSB+ | No Intervention | Isocaloric amount and cost-effectiveness of Supercereal/CSB+ prepared with FVO. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSB14 | Dietary Supplement |
| ||
| RUSF1 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MAM and Stunting | Primary outcomes to be measured are incidence of MAM and incidence of stunting during the 18 months of preventive supplementation (age 6 months to 23 months). Stunting will be defined as less than -2 SD of Height-for-Age Z-score and MAM will be defined as less than -2 SD Weight-for-Height (length) Z-score | Monthly for 18 months |
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The subjects are as follows:
Beneficiary Children that are weighed and measured Beneficiary Mothers/Caretakers that participate in interviews, focus group discussions, and in-home observations Health and Nutrition Promoters (HNP) that participate in individual interviews and FGD Community Health Agents that participate in individual interviews PVO staff members that participate in individual interviews Village Elders/Headmen Store owners/Market Vendors that participate in individual interviews
Beneficiary Children (Children 6 -23 months old)
Inclusion Criteria
• Child enrolled in the ViM program to receive ration from a Food Distribution Point
Exclusion Criteria
Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 -23 months old)
Inclusion Criteria
Exclusion Criteria • Beneficiary Mothers/Caretakers who participate in an interview, observation or FGD once for this study will not be eligible again for participation
Health and Nutrition Promoters (HNP) Inclusion Criteria
Community Health Agents (CHA) Inclusion Criteria
PVO Staff Members Inclusion Criteria
Village Elders/Headmen Inclusion Criteria
Store Owners/Market Vendor Inclusion Criteria
The withdrawal/termination criterion for this study is not applicable as the subject's participation will not be terminated by the investigator, and there are no necessary precautions applied to those who withdraw.
Study subjects may not participate in another research study that provides supplementary food as a food ration to children between 6-23 months.
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice L Rogers, PhD | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaya | Sanmatenga | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38309828 | Derived | Cliffer IR, Naumova EN, Masters WA, Perumal N, Garanet F, Rogers BL. Peak timing of slowest growth velocity among young children coincides with highest ambient temperatures in Burkina Faso: a longitudinal study. Am J Clin Nutr. 2024 Feb;119(2):393-405. doi: 10.1016/j.ajcnut.2023.09.021. Epub 2023 Dec 29. | |
| 34637506 | Derived |
| Label | URL |
|---|---|
| Food Aid Quality Review | View source |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER_GOV |
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| SC+ | Dietary Supplement |
|
| Cliffer IR, Masters WA, Perumal N, Naumova EN, Zeba AN, Garanet F, Rogers BL. Monthly measurement of child lengths between 6 and 27 months of age in Burkina Faso reveals both chronic and episodic growth faltering. Am J Clin Nutr. 2022 Jan 11;115(1):94-104. doi: 10.1093/ajcn/nqab309. |
| 32106840 | Derived | Shen Y, Cliffer IR, Suri DJ, Langlois BK, Vosti SA, Webb P, Rogers BL. Impact of stakeholder perspectives on cost-effectiveness estimates of four specialized nutritious foods for preventing stunting and wasting in children 6-23 months in Burkina Faso. Nutr J. 2020 Feb 27;19(1):20. doi: 10.1186/s12937-020-00535-x. |
| 32072130 | Derived | Cliffer IR, Nikiema L, Langlois BK, Zeba AN, Shen Y, Lanou HB, Suri DJ, Garanet F, Chui K, Vosti S, Walton S, Rosenberg I, Webb P, Rogers BL. Cost-Effectiveness of 4 Specialized Nutritious Foods in the Prevention of Stunting and Wasting in Children Aged 6-23 Months in Burkina Faso: A Geographically Randomized Trial. Curr Dev Nutr. 2020 Jan 23;4(2):nzaa006. doi: 10.1093/cdn/nzaa006. eCollection 2020 Feb. |
| 31998858 | Derived | Langlois BK, Cliffer IR, Nikiema L, Suri DJ, Garanet F, Shen Y, Zeba AN, Walton SM, Lanou HB, Webb P, Rogers BL. Factors that May Influence the Effectiveness of 4 Specialized Nutritious Foods in the Prevention of Stunting and Wasting in Children Aged 6-23 Months in Burkina Faso. Curr Dev Nutr. 2020 Jan 6;4(2):nzaa002. doi: 10.1093/cdn/nzaa002. eCollection 2020 Feb. |