Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Dietary supplement: Multiple micronutrient supplementation; Behavioral: Adolescent Nutrition Curriculum; Dietary supplement: Iron Folic Acid Supplementation

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 Type: Interventional
• Enrollment (Actual): 490
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mozambique
  • Nampula Province
    • Monapo, Nampula Province, Mozambique
      • World Vision Monapo Field Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multiple Micronutrient Supplementation (MMS) Arm; 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; 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.; Behavioral: Adolescent Nutrition Curriculum; The Adolescent Nutrition Curriculum includes five modules focused on promoting healthy behaviors to enhance nutrition, with an emphasis on consuming iron-rich foods.
Active Comparator: Iron Folic Acid Supplementation (IFAS) Arm; The adolescent girls randomly assigned to the IFAS arm consumed IFAS for four months and participated in girls' clubs where they received nutrition messages	Behavioral: Adolescent Nutrition Curriculum; The Adolescent Nutrition Curriculum includes five modules focused on promoting healthy behaviors to enhance nutrition, with an emphasis on consuming iron-rich foods.; Dietary supplement: Iron Folic Acid Supplementation; One IFAS tablet contains Iron (60 mg) and Folic Acid (2800 μg) and is taken weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anemia Status	Anemia is defined as hemoglobin level <10 g/dL	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anemia Knowledge	Changes in knowledge from baseline to endline around anemia causes and strategies to prevent anemia.	6 months
Minimum Dietary Diversity Score	The minimum dietary diversity score measures girls and women who 10 possible food groups over a 24-hour recall period are classified as having minimally adequate diet diversity.	6 months

Collaborators and Investigators

• Sponsor: World Vision US
• Investigators: Principal Investigator: Sarah A Bauler, DrPH(c), World Vision International

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Micronutrients; Iron; Folic Acid; Mozambique; Supplements; Vitamins
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Vitamin B Complex; Vitamins; Hematinics; Folic Acid; Micronutrients; Trace Elements
• Other Study ID Numbers: WorldVision; 218961 (Other Grant/Funding Number: World Vision Canada)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: With permission from the Mozambique Ministry of Health Commitee for Bioethics, the quantitative dataset supporting the conclusions of this study can be found in the Humanitarian Data Exchange at https://data.humdata.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No