Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique

NCT ID: NCT06815315

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Multiple micronutrient supplementation

Intervention Type 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.

Adolescent Nutrition Curriculum

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Iron Folic Acid Supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Adolescent Nutrition Curriculum

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Iron Folic Acid Supplementation

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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World Vision US

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah A Bauler, DrPH(c)

Role: PRINCIPAL_INVESTIGATOR

World Vision International

Locations

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World Vision Monapo Field Office

Monapo, Nampula, Mozambique

Site Status

Countries

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Mozambique

Related Links

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https://www.ennonline.net/fex/74/photovoice-enhancing-health-and-nutrition-mozambiques

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.

Other Identifiers

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218961

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

WorldVision

Identifier Type: -

Identifier Source: org_study_id

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