Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia

NCT05073562 — Not applicable, Withdrawn, Boston Children's Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05073562
Status	Withdrawn - Change in funding availability
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, health services research
Sponsor	Boston Children's Hospital (Other); collaborators: UNICEF, Ministry of Health, Liberia, Liberia Institute of Statistics and Geo-Information Services
Conditions	Nutritional Anemia, Nutritional Deficiency, Iron Deficiency Anemia Treatment, Folic Acid Deficiency Anemia, Dietary, Adolescent Development, Knowledge, Attitudes, Practice, Food Habits
Interventions	Iron and folic acid (IFA) supplementation, Targeted nutrition education, Mebendazole Pill, Standard nutrition services (Dietary supplement, behavioral, drug, other)
Dates	start 2021-10-01 (estimated), primary completion 2021-12-01 (estimated), completion 2021-12-01 (estimated), first posted 2021-10-11, last updated 2021-11-22

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Nutrition+ Intervention	Experimental	Dietary Supplement: Iron and folic acid (IFA) supplementation; Behavioral: Targeted nutrition education; Drug: 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	Active comparator	Other: 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.

Iron and folic acid (IFA) supplementation (Dietary supplement): Weekly IFA supplementation for duration of the study.
Targeted nutrition education (Behavioral): Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)
Mebendazole Pill (Drug): One-time deworming treatment with mebendazole.
Standard nutrition services (Other): Basic nutrition services currently provided at the health facility and at community level in Liberia

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: Female, ages: 10 Years to 19 Years, accepts healthy volunteers

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

+Investigators

Julia Rubin-Smith, MD, MSPH, Principal investigator, Boston Children's Hospital