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NCT Number: NCT06444555

Adolescent Nutrition in 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.

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Key information

Age range

15 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté), Bobo-Dioulasso, Burkina Faso

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About this study

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:

  • assess the short-term acceptability of BEP and MMN supplements
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: UNIMAPP

Primary outcomes

  1. Acceptability of the supplement

    Time frame: Day 8 (after 7 days of consumption)

    Acceptability to the nutritional supplements, as measured using a 9-item scale (1 "Dislike extremely" up to 9 "Like extremely")

  2. Nutritional adequacy

    Time frame: Day 8 (after 7 days of consumption)

    Mean nutrient adequacy ratio of adolescent diets, using 24 h recall

Secondary outcomes

  1. Willingness to pay for the supplement

    Time frame: Day 8 (after 7 days of consumption)

    Mean household head's willingness to pay values elicited through their bids

  2. Reported consumption of the supplement

    Time frame: Day 8 (average of 7-day intervention)

    Percent of the recommended nutritional supplement consumed during the intervention period, self-reported

  3. Substitution of food and nutrient intake

    Time frame: Day 8 (after 7 days of consumption)

    Substitution of food and nutrition intake at group level, using 24 h recall

  4. Nutrient intake

    Time frame: Day 8 (after 7 days of consumption)

    Mean energy, macronutrient and micronutrient intake between the BEP and MMN group, using 24 h recall

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Adonut

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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