Adolescent Nutrition in Girls in Burkina Faso and Ethiopia

NCT06444555 | Completed

• 1 other identifier: ONZ-2024-0038
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Nutrition Deficiency Due to Insufficient Food

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Willingness to pay for the supplement

  Day 8 (after 7 days of consumption)

• Reported consumption of the supplement

  Day 8 (average of 7-day intervention)

• Substitution of food and nutrient intake

  Day 8 (after 7 days of consumption)

• Nutrient intake

  Day 8 (after 7 days of consumption)

Study Arms (2)

Balanced Energy Protein Supplement

EXPERIMENTAL

Fortified lipid-based nutrient supplement

Dietary Supplement: BEP supplement

Multiple Micronutrient Supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Multiple Micronutrient supplement

Interventions

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.

Also known as: Balanced energy protein supplement

Balanced Energy Protein Supplement

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.

Also known as: UNIMAPP

Multiple Micronutrient Supplement

Eligibility Criteria

• Age: 15 Years - 19 Years
• Gender Eligibility Details: Only females are recruited.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Being allergic to peanuts
• Eating disorders or dietary restrictions

Sponsors & Collaborators

• University Ghent: lead
• Addis Continental Institute of Public Health: collaborator
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• Bill and Melinda Gates Foundation: collaborator
• AfricSanté, Burkina Faso: collaborator

Study Sites (2)

Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)

Bobo-Dioulasso, Burkina Faso

Location

Addis Continental Institute of Public Health

Addis Ababa, Ethiopia

Location

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 5, 2024
• Study Start: May 28, 2024
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

BU (1); ET (1)