Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia

November 13, 2021 updated by: Julia Rubin-Smith, Boston Children's Hospital

A Study on the Effectiveness of IFA Supplementation, Deworming, and Nutrition Education in Addressing Anemia Among Adolescent Girls in Two Counties in Liberia

The purpose of this study is to evaluate the feasibility and effectiveness of weekly iron and folic acid (IFA) supplementation and one-time deworming treatment at the community level in improving hemoglobin levels among adolescent girls in Liberia, West Africa, and to assess the feasibility and effectiveness of a targeted nutrition education program in improving nutrition knowledge, attitudes, and practices in the same population.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

Ages Eligible for Study

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adolescent girl aged 10 - 19 years at the time of enrollment
  • Lives within the selected study communities in Montserrado or Margibi counties
  • Caregiver/adolescent consents to participate in the study

Exclusion Criteria:

  • Currently pregnant
  • Active malaria infection as defined by positive rapid diagnostic test (RDT)
  • Severe acute malnutrition at the time of enrollment
  • Known malignancy
  • Known sickle cell disease

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition+ Intervention
This group will receive a structured nutrition education package provided by Community Health Assistants (CHAs) based on a handbook on nutrition education developed by UNICEF with collaboration from the Liberia Ministry of Health. The structured nutrition education package will focus on four key areas: causes and prevention of anemia, healthy eating and food choices, hand washing, and physical exercise. Participants in the intervention group will also receive IFA supplementation on a weekly basis for the duration of the study, and a one-time oral deworming treatment (mebendazole), which will be administered once at the beginning of the study.
Dietary supplement: Iron and folic acid (IFA) supplementation
Weekly IFA supplementation for duration of the study.
Behavioral: Targeted nutrition education
Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)
Drug: Mebendazole Pill
One-time deworming treatment with mebendazole.
Active Comparator: Control group - standard services only
This group will receive only the current package of basic nutrition services provided at the health facility and at community level by health workers and CHAs, respectively.
Other: Standard nutrition services
Basic nutrition services currently provided at the health facility and at community level in Liberia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participants' hemoglobin level from enrollment to completion of the study
Time Frame: Baseline and Week 12
Point of care hemoglobin testing will be conducted at enrollment and at the conclusion of the study.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in responses to questions in the Nutrition Knowledge, Attitudes, and Practice (KAP) survey from baseline to follow up evaluation
Time Frame: Baseline and Week 12
Increase in nutrition-related knowledge, and improvements in nutrition practices as evidenced by changes in responses to the KAP survey, which is based on validated measures of nutrition-related knowledge, attitudes, and practices, and has been modified for appropriateness to the target population of this study.
Baseline and Week 12
Feasibility of targeted intervention for scale-up to country-wide enhanced nutrition services
Time Frame: 12 weeks
Successful completion of study visits by Community Health Assistants, specifically ability to conduct every scheduled visit without skipping visits or households, within the timeframe of scheduled work day.
12 weeks

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

Collaborators

UNICEF
Ministry of Health, Liberia
Liberia Institute of Statistics and Geo-Information Services

Investigators

  • Principal Investigator: Julia Rubin-Smith, MD, MSPH, Boston Children's Hospital

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 (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 1, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 13, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00036604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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