Adolescent Nutrition in Girls in Burkina Faso and Ethiopia (Adonut)

Nutritional Needs and Food Supplement Intake of Adolescent Girls in Burkina Faso and Ethiopia

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.

Study Overview

• Status: Completed
• Conditions: Nutrition Deficiency Due to Insufficient Food
• Intervention / Treatment: Dietary supplement: BEP supplement; Dietary supplement: Multiple Micronutrient supplement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Burkina Faso
  • Bobo-Dioulasso, Burkina Faso
    • Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)
• Ethiopia
  • Addis Ababa, Ethiopia
    • Addis Continental Institute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Eligibility criteria are all based on self-reported information

Inclusion criteria:

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

Exclusion criteria:

• Being allergic to peanuts
• Eating disorders or dietary restrictions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balanced Energy Protein Supplement; Fortified lipid-based nutrient supplement	Dietary supplement: 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.; Other Names: Balanced energy protein supplement
Active Comparator: Multiple Micronutrient Supplement; The United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP).	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.; Other Names: UNIMAPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Bill and Melinda Gates Foundation; Institut de Recherche en Sciences de la Sante, Burkina Faso; Addis Continental Institute of Public Health; AfricSanté, Burkina Faso
• Investigators: Principal Investigator: Yemane Berhane, Prof, Addis Continental Institute of Public Health; Study Director: Firehiwot Workneh, dr., Addis Continental Institute of Public Health; Study Director: Moustapha Drabo, Dr, University Ghent; Study Chair: Carl Lachat, Prof, University Ghent; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): July 5, 2024
• Study Completion (Actual): July 5, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: ONZ-2024-0038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No