Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia

NCT05073562 | Withdrawn

• 1 other identifier: P00036604
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nutritional Anemia; Nutritional Deficiency; Iron Deficiency Anemia Treatment; Folic Acid Deficiency Anemia, Dietary; Adolescent Development; Knowledge, Attitudes, Practice; Food Habits

Outcome Measures

Primary Outcomes (1)

• Change in participants' hemoglobin level from enrollment to completion of the study

  Point of care hemoglobin testing will be conducted at enrollment and at the conclusion of the study.

  Baseline and Week 12

Secondary Outcomes (2)

• Changes in responses to questions in the Nutrition Knowledge, Attitudes, and Practice (KAP) survey from baseline to follow up evaluation

  Baseline and Week 12

• Feasibility of targeted intervention for scale-up to country-wide enhanced nutrition services

  12 weeks

Study Arms (2)

Nutrition+ Intervention

EXPERIMENTAL

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; Behavioral: Targeted nutrition education; Drug: Mebendazole Pill

Control group - standard services only

ACTIVE COMPARATOR

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

Interventions

Iron and folic acid (IFA) supplementation DIETARY_SUPPLEMENT

Weekly IFA supplementation for duration of the study.

Nutrition+ Intervention

Targeted nutrition education BEHAVIORAL

Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)

Nutrition+ Intervention

Mebendazole Pill DRUG

One-time deworming treatment with mebendazole.

Nutrition+ Intervention

Standard nutrition services OTHER

Basic nutrition services currently provided at the health facility and at community level in Liberia

Control group - standard services only

Eligibility Criteria

• Age: 10 Years - 19 Years
• Gender Eligibility Details: Will enroll females, assessed by participant self-identification
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• UNICEF: collaborator
• Ministry of Health, Liberia: collaborator
• Liberia Institute of Statistics and Geo-Information Services: collaborator

MeSH Terms

Conditions

Malnutrition; Behavior; Feeding Behavior

Interventions

Iron; Folic Acid; Dietary Supplements; Mebendazole

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior, Animal

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles

Study Officials

• Julia Rubin-Smith, MD, MSPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Global Health Faculty/Assistant in Medicine

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: October 11, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share