Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique

NCT06815315 | Completed

• 2 other identifiers: WorldVision218961
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

Vitamins; Supplements; Iron; Folic Acid; Mozambique; Micronutrients; Adolescents

Outcome Measures

Primary Outcomes (1)

• Anemia Status

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

  6 months

Secondary Outcomes (2)

• Anemia Knowledge

  6 months

• Minimum Dietary Diversity Score

  6 months

Study Arms (2)

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.

Dietary Supplement: Multiple micronutrient supplementation; Behavioral: Adolescent Nutrition Curriculum

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

Dietary Supplement: Iron Folic Acid Supplementation; Behavioral: Adolescent Nutrition Curriculum

Interventions

Multiple micronutrient supplementation DIETARY_SUPPLEMENT

The multiple micronutrient supplementation composition follows the United Nations International Multiple Micronutrient Antenatal Preparation. Each MMS tablet contains 15 micronutrients, including iron (30mg), folic acid (400 mcg), Vit A, Retinol (800 RE), vit D (200 IU), vit E (10 mg), vit C (70 mg), vit B1 (1.4 mg), vit B2 (1.4 mg), vit B6 (1.9 mg), vit B12 (2.6 mcg), niacin (18 mg), zinc (15 mg), copper (2 mg), iodine (150 mcg), selenium (65 mcg) and is consumed daily.

Multiple Micronutrient Supplementation (MMS) Arm

Iron Folic Acid Supplementation DIETARY_SUPPLEMENT

One IFAS tablet contains Iron (60 mg) and Folic Acid (2800 μg) and is taken weekly.

Iron Folic Acid Supplementation (IFAS) Arm

Adolescent Nutrition Curriculum BEHAVIORAL

The Adolescent Nutrition Curriculum includes five modules focused on promoting healthy behaviors to enhance nutrition, with an emphasis on consuming iron-rich foods.

Iron Folic Acid Supplementation (IFAS) Arm; Multiple Micronutrient Supplementation (MMS) Arm

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• World Vision US: lead

Study Sites (1)

World Vision Monapo Field Office

Monapo, Nampula, Mozambique

Location

Related Links

• The paper on photovoice published in the Emergency Nutrition Action Field Exchange describes the methodology and findings we used to develop and refine the Nutrition Curriculum. The Nutrition Curriculum is one of the interventions tested in this CRT.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sarah A Bauler, DrPH(c)

  World Vision International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm), with each club consisting of approximately 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.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: January 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

MO (1)