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Clinical Trials/NCT06815315
NCT06815315CompletedNot Applicable

A Formative, Mixed-Methods Evaluation Assessing the Acceptability, Feasibility, and Effectiveness of Micronutrient Interventions Among Adolescents in Mozambique

World Vision US1 site in 1 country490 target enrollmentStarted: January 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
490
Locations
1
Primary Endpoint
Anemia Status

Study Overview

Brief Summary

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status and the impact of a nutrition curriculum on diet diversity and anemia knowledge among adolescent girls.

Detailed Description

This study aimed to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health, and education in Mozambique. In conjunction with the Mozambique Ministries of Health, Education and Culture, we conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm). Each club was comprised of around 18 girls aged 13 to 20 years. Using constrained sampling to balance for age and school, clubs were randomly assigned to one of two intervention groups: 1) Multiple Micronutrient Supplementation (MMS) for five months plus a Nutrition Curriculum, or 2) Iron and Folic Acid Supplementation (IFAS) plus a Nutrition Curriculum. Girls enrolled in the MMS arm consumed supplements daily for 4 months at home and weekly nutrition messages delivered through the clubs. Girls enrolled in the IFAS arm consumed supplements once a week for 4 months at school (the standard of care) and weekly nutrition messages delivered through the clubs. The study evaluated the effects of MMS and IFAS on anemia status and the impact of the nutrition curriculum on diet diversity and anemia knowledge.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
13 Years to 20 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Adolescents aged 13-20 years Enrolled in secondary school at study initiation Member of an IMPACT+ Girls Club at one of the participating schools Consent provided by the parent Assent provided by the adolescent

Exclusion Criteria

  • •No informed consent from parent or assent from adolescent Self-reported pregnancy

Arms & Interventions

Multiple Micronutrient Supplementation (MMS) Arm

Active Comparator

The adolescent girls randomly assigned to the MMS arm consumed MMS for four months and participated in girls' clubs where they received nutrition messages.

Intervention: Multiple micronutrient supplementation (Dietary Supplement)

Multiple Micronutrient Supplementation (MMS) Arm

Active Comparator

The adolescent girls randomly assigned to the MMS arm consumed MMS for four months and participated in girls' clubs where they received nutrition messages.

Intervention: Adolescent Nutrition Curriculum (Behavioral)

Iron Folic Acid Supplementation (IFAS) Arm

Active Comparator

The adolescent girls randomly assigned to the IFAS arm consumed IFAS for four months and participated in girls' clubs where they received nutrition messages

Intervention: Iron Folic Acid Supplementation (Dietary Supplement)

Iron Folic Acid Supplementation (IFAS) Arm

Active Comparator

The adolescent girls randomly assigned to the IFAS arm consumed IFAS for four months and participated in girls' clubs where they received nutrition messages

Intervention: Adolescent Nutrition Curriculum (Behavioral)

Outcomes

Primary Outcomes

Anemia Status

Time Frame: 6 months

Anemia is defined as hemoglobin level \<10 g/dL

Secondary Outcomes

  • Anemia Knowledge(6 months)
  • Minimum Dietary Diversity Score(6 months)

Investigators

Sponsor
World Vision US
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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