Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia

Not Applicable

Withdrawn

• Conditions: Nutritional Deficiency; Iron Deficiency Anemia Treatment; Adolescent Development; Folic Acid Deficiency Anemia, Dietary; Knowledge, Attitudes, Practice; Nutritional Anemia; Food Habits
• Interventions: Dietary Supplement: Iron and folic acid (IFA) supplementation; Other: Standard nutrition services; Behavioral: Targeted nutrition education; Drug: Mebendazole Pill

• Registration Number: NCT05073562
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-01
• Study First Submitted QC: 2021-09-28
• Study Start: 2021-10
• Study First Posted: 2021-10-11
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-13
• Last Update Posted: 2021-11-22
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition+ Intervention	Iron and folic acid (IFA) supplementation	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.
Nutrition+ Intervention	Targeted nutrition education	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.
Nutrition+ Intervention	Mebendazole Pill	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.
Control group - standard services only	Standard nutrition services	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.