search
Back to results

Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia

Primary Purpose

Nutritional Anemia, Nutritional Deficiency, Iron Deficiency Anemia Treatment

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron and folic acid (IFA) supplementation
Targeted nutrition education
Mebendazole Pill
Standard nutrition services
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nutritional Anemia

Eligibility Criteria

10 Years - 19 Years (Child, Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Nutrition+ Intervention

    Control group - standard services only

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 1, 2021
    Last Updated
    November 13, 2021
    Sponsor
    Boston Children's Hospital
    Collaborators
    UNICEF, Ministry of Health, Liberia, Liberia Institute of Statistics and Geo-Information Services
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05073562
    Brief Title
    Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Change in funding availability
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Boston Children's Hospital
    Collaborators
    UNICEF, Ministry of Health, Liberia, Liberia Institute of Statistics and Geo-Information Services

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutritional Anemia, Nutritional Deficiency, Iron Deficiency Anemia Treatment, Folic Acid Deficiency Anemia, Dietary, Adolescent Development, Knowledge, Attitudes, Practice, Food Habits

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutrition+ Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group - standard services only
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Iron and folic acid (IFA) supplementation
    Intervention Description
    Weekly IFA supplementation for duration of the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Targeted nutrition education
    Intervention Description
    Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)
    Intervention Type
    Drug
    Intervention Name(s)
    Mebendazole Pill
    Intervention Description
    One-time deworming treatment with mebendazole.
    Intervention Type
    Other
    Intervention Name(s)
    Standard nutrition services
    Intervention Description
    Basic nutrition services currently provided at the health facility and at community level in Liberia
    Primary Outcome Measure Information:
    Title
    Change in participants' hemoglobin level from enrollment to completion of the study
    Description
    Point of care hemoglobin testing will be conducted at enrollment and at the conclusion of the study.
    Time Frame
    Baseline and Week 12
    Secondary Outcome Measure Information:
    Title
    Changes in responses to questions in the Nutrition Knowledge, Attitudes, and Practice (KAP) survey from baseline to follow up evaluation
    Description
    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.
    Time Frame
    Baseline and Week 12
    Title
    Feasibility of targeted intervention for scale-up to country-wide enhanced nutrition services
    Description
    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.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Will enroll females, assessed by participant self-identification
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julia Rubin-Smith, MD, MSPH
    Organizational Affiliation
    Boston Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia

    We'll reach out to this number within 24 hrs