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

University Ghent

Status: Completed

Conditions: Nutrition Deficiency Due to Insufficient Food

Treatments: Dietary Supplement: BEP supplement; Dietary Supplement: Multiple Micronutrient supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06444555

ONZ-2024-0038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 15 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Balanced Energy Protein Supplement

Experimental group

Description:

Fortified lipid-based nutrient supplement

Treatment:

Dietary Supplement: BEP supplement

Multiple Micronutrient Supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Multiple Micronutrient supplement