Adolescent Nutrition in Girls in Burkina Faso and Ethiopia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2024-07-05

Brief Summary

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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.

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Detailed Description

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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:

1. assess the short-term acceptability of BEP and MMN supplements
2. assess how nutrition supplements increase nutrient adequacy of diets adolescent girls in resources-limited settings;

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.

Conditions

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Nutrition Deficiency Due to Insufficient Food

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

200 adolescent girls will be enrolled in Ethiopia and 200 adolescent girls will be enrolled in Burkina Faso.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Balanced Energy Protein Supplement

Fortified lipid-based nutrient supplement

Group Type EXPERIMENTAL

BEP supplement

Intervention Type 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.

Multiple Micronutrient Supplement

The United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP).

Group Type ACTIVE_COMPARATOR

Multiple Micronutrient supplement

Intervention Type 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.

Interventions

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BEP 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.

Intervention Type DIETARY_SUPPLEMENT

Multiple Micronutrient 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Balanced energy protein supplement UNIMAPP

Eligibility Criteria

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Inclusion Criteria

* Non-pregnant and non-lactating women
* Without any known chronic illness or acute illness affecting appetite
* Permanent residents of the study area