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| Name | Class |
|---|---|
| Addis Continental Institute of Public Health | OTHER |
| Institut de Recherche en Sciences de la Sante, Burkina Faso | OTHER_GOV |
| Bill and Melinda Gates Foundation | OTHER |
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Adolescents' diets are key to breaking the intergenerational cycle of malnutrition. This study will guide policies and programs on the adequacy, acceptability, and feasibility of implementing balanced energy protein and multiple micronutrient supplementations to fill nutrient gaps in adolescent girls. Using a trial, the study will assess dietary intake and nutrient gaps, acceptability of balanced energy protein and multiple micronutrient supplementations. In addition to the trial, the study will the assess willingness to pay for the supplements and the most effective delivery platform and model to reach vulnerable adolescent girls. The most effective delivery platform and model to reach vulnerable adolescent girls cost-effectively will also be assessed through interviews with (inter)national experts, producers, and the donor community.
In low- and middle-income countries, it is estimated that each year, 21 million adolescent girls become mothers. Infants of adolescent mothers are at increased risk of delivering babies preterm, with low birth weight or length. Targeting nutrition interventions to improve adolescent girls' diet and nutrition is crucial to breaking the intergenerational cycle of poor growth and development. There is a specific need to assess how a balanced energy protein (BEP) and multiple micronutrient (MMN) supplement interventions can be tailored to adolescent girls and women of reproductive age.
This study aims to assess the adequacy, acceptability, and feasibility of implementing nutritional supplementations to fill nutrient gaps in adolescent girls in resource-limited settings. A trial will specifically:
Using a qualitative component, the study explores the food agency of adolescents and the most effective delivery platform to reach vulnerable adolescent girls cost-effectively. The overall aim is to guide policies and programs on new formulations of nutritional supplements for adolescent girls in resource-limited settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced Energy Protein Supplement | Experimental | Fortified lipid-based nutrient supplement |
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| Multiple Micronutrient Supplement | Active Comparator | The United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEP supplement | Dietary Supplement | The BEP supplement used in Burkina Faso is a fortified medium-quantity lipid-based nutrient supplement called Plumpy'Doz. The product is a peanut and milk-based ready-to-use nutritional formulation produced by Nutriset. A peanut-based BEP formulation with a trademark Plumpy'Sup produced by Hilina Enriched Foods PLC will be used in Ethiopia. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the supplement | Acceptability to the nutritional supplements, as measured using a 9-item scale (1 "Dislike extremely" up to 9 "Like extremely") | Day 8 (after 7 days of consumption) |
| Nutritional adequacy | Mean nutrient adequacy ratio of adolescent diets, using 24 h recall | Day 8 (after 7 days of consumption) |
| Measure | Description | Time Frame |
|---|---|---|
| Willingness to pay for the supplement | Mean household head's willingness to pay values elicited through their bids | Day 8 (after 7 days of consumption) |
| Reported consumption of the supplement | Percent of the recommended nutritional supplement consumed during the intervention period, self-reported |
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Eligibility criteria are all based on self-reported information
Inclusion criteria:
Exclusion criteria:
Only females are recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Yemane Berhane, Prof | Addis Continental Institute of Public Health | Principal Investigator |
| Firehiwot Workneh, dr. | Addis Continental Institute of Public Health | Study Director |
| Moustapha Drabo, Dr | University Ghent | Study Director |
| Carl Lachat, Prof | University Ghent | Study Chair |
| Laeticia Céline Toé, MD | Institute de Recherche en Sciences de la Santé, Bobo Dioulasso | Principal Investigator |
| Hans De Steur, Prof | University Ghent | Principal Investigator |
| Alemayehu Alemayehu, Dr | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté) | Bobo-Dioulasso | Burkina Faso | ||||
The data will be transferred to the donor in a pseudo-anonymised way. After preparing a data-sharing agreement, the investigators will also share food intake data with the Food and Agriculture Organization and World Health Organization (FAO/WHO) of the United Nations Global Individual Food Consumption Data Tool. All research output generated by the project is open access as part of the Grant Agreement with the funder. Given the personal nature of the data, individual data will only be shared after a data transfer agreement with third parties. The informed consent form mentions that data can be shared outside the study team.
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Individual participant data will be shared after data cleaning and quality checks are completed. All study other study materials will be shared after the finalization of the data collection.
Personal data will only be shared under a data sharing agreement, subject to approval by the relevant authorities. The transfer will only be performed in the public interest, which means that it will increase knowledge and insight to society's direct or indirect benefit.
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| AfricSanté, Burkina Faso |
| UNKNOWN |
200 adolescent girls will be enrolled in Ethiopia and 200 adolescent girls will be enrolled in Burkina Faso.
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| Multiple Micronutrient supplement | Dietary Supplement | The MMN formulation is based on the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). The formulation contains 15 minerals and vitamins and is administered as a tablet. |
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| Day 8 (average of 7-day intervention) |
| Substitution of food and nutrient intake | Substitution of food and nutrition intake at group level, using 24 h recall | Day 8 (after 7 days of consumption) |
| Nutrient intake | Mean energy, macronutrient and micronutrient intake between the BEP and MMN group, using 24 h recall | Day 8 (after 7 days of consumption) |
| Addis Continental Institute of Public Health |
| Addis Ababa |
| Ethiopia |