Clinical trial NCT06444555: Adolescent Nutrition in Girls in Burkina Faso and Ethiopia
Official title: Nutritional Needs and Food Supplement Intake of Adolescent Girls in Burkina Faso and Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Deficiency Due to Insufficient Food
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: Bill and Melinda Gates Foundation
name: AfricSanté, Burkina Faso
First posted: 2024-06-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 200 adolescent girls will be enrolled in Ethiopia and 200 adolescent girls will be enrolled in Burkina Faso.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the supplement
timeFrame: Day 8 (after 7 days of consumption)
measure: Nutritional adequacy
timeFrame: Day 8 (after 7 days of consumption)
Secondary outcomes:
measure: Willingness to pay for the supplement
timeFrame: Day 8 (after 7 days of consumption)
measure: Reported consumption of the supplement
timeFrame: Day 8 (average of 7-day intervention)
measure: Substitution of food and nutrient intake
timeFrame: Day 8 (after 7 days of consumption)
measure: Nutrient intake
timeFrame: Day 8 (after 7 days of consumption)
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)
city: Addis Ababa
country: Ethiopia
facility: Addis Continental Institute of Public Health
Study officials:
affiliation: Addis Continental Institute of Public Health
name: Yemane Berhane, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Continental Institute of Public Health
name: Firehiwot Workneh, dr.
role: STUDY_DIRECTOR
affiliation: University Ghent
name: Moustapha Drabo, Dr
role: STUDY_DIRECTOR
affiliation: University Ghent
name: Carl Lachat, Prof
role: STUDY_CHAIR
affiliation: Institute de Recherche en Sciences de la Santé, Bobo Dioulasso
name: Laeticia Céline Toé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Hans De Steur, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Alemayehu Alemayehu, Dr
role: PRINCIPAL_INVESTIGATOR
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