Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia

Sponsor

Boston Children's Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05073562

Collaborator

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

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Anemia Nutritional Deficiency Iron Deficiency Anemia Treatment Folic Acid Deficiency Anemia, Dietary Adolescent Development Knowledge, Attitudes, Practice Food Habits	Dietary Supplement: Iron and folic acid (IFA) supplementation Behavioral: Targeted nutrition education Drug: Mebendazole Pill Other: Standard nutrition services	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in participants' hemoglobin level from enrollment to completion of the study [Baseline and Week 12]
Point of care hemoglobin testing will be conducted at enrollment and at the conclusion of the study.

Secondary Outcome Measures

Changes in responses to questions in the Nutrition Knowledge, Attitudes, and Practice (KAP) survey from baseline to follow up evaluation [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.
Feasibility of targeted intervention for scale-up to country-wide enhanced nutrition services [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.