Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique

February 3, 2025 updated by: World Vision US

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
490

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anemia Status
Time Frame: 6 months
Anemia is defined as hemoglobin level <10 g/dL
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anemia Knowledge
Time Frame: 6 months
Changes in knowledge from baseline to endline around anemia causes and strategies to prevent anemia.
6 months
Minimum Dietary Diversity Score
Time Frame: 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
World Vision US

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah A Bauler, DrPH(c), World Vision International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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