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Clinical Trials/NCT06444555
NCT06444555
Recruiting
Not Applicable

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

University Ghent2 sites in 2 countries400 target enrollmentMay 28, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition Deficiency Due to Insufficient Food
Sponsor
University Ghent
Enrollment
400
Locations
2
Primary Endpoint
Nutritional adequacy
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 28, 2024
End Date
August 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Nutritional adequacy

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

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

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")

Secondary Outcomes

  • Willingness to pay for the supplement(Day 8 (after 7 days of consumption))
  • Nutrient intake(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))

Study Sites (2)

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