Effectiveness of Local Food Solutions for the Prevention of Acute Malnutrition in Tigray, Northern Ethiopia (ELOFSAM) (ELOFSAM)

October 22, 2023 updated by: Afework Mulugeta, Mekelle University

Acceptability and Effectiveness of Local Food Solutions for the Prevention of Acute Malnutrition in Tigray, Northern Ethiopia (ELOFSAM)

The lack of diversified and enriched complementary foods is one of the key causes of the high burden of acute malnutrition among 6-23 months old children in Ethiopia. Thus, a new innovative way of diversifying and enriching complementary foods is essential in communities where vulnerable populations are likely to have nutrient gaps in their typical diets and multiple micronutrient deficiencies. The purpose of this project is to investigate the acceptability and effectiveness of locally produced cereal based foods (LP-CBFs) and small quantity lipid based nutrient supplements (SQ-LNS) as preventive interventions to effectively reduce the burden of acute malnutrition among 6-23 months old children in the post conflict settings of Tigray, Northern Ethiopia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7530

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ethiopia
    • Tigray
      • Mek'ele, Tigray, Ethiopia, 1547
        • Recruiting
        • Tigray Health Research Institute
        • Contact:
        • Principal Investigator:
          • Afework Mulugeta, PhD
        • Sub-Investigator:
          • Gebretsadkan Gebremdhin, MSc
        • Sub-Investigator:
          • Hadush Gebre egziabher, MPH
        • Sub-Investigator:
          • Mulugeta Woldu, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All 6-23 months old children

Exclusion Criteria:

  • 6-23 months old children with severe acute malnutrition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bahgina group
The Bahgina treatment group will be supplemented with Bahgina, a locally produced cereal based product for a maximum of six months at 200g/day.
Dietary supplement: Bahgina
Bahgina, a locally produced cereal based food, will be provided at 200g/day/child for a duration of six months on top of the routine nutrition services provided by the local government and nutrition partners.
Experimental: SQLNS group
The small quantity lipid based nutrient supplements (SQLNS) group will be provided with 20g of SQLNS/day for a maximum of six months.
Dietary supplement: SQLNS
Small quantity lipid based nutrient supplement (SQ-LNS) will be provided at 20g/day/child for a duration of six months on top of the routine nutrition services provided by the local government and nutrition partners.
No Intervention: Control
The control group will get nothing except the routine nutrition services and products provided by the local government sectors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Malnutrition
Time Frame: six months
The burden or prevalence of acute malnutrition among 6-23 months old children.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mekelle University

Collaborators

Tigray Development Association
Mums for Mums
Tigray Health Research Institute
Tigray Health Bureau
UNICEF Tigray Office

Investigators

  • Study Chair: Hayelom Kahsay, MD, Tigray Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUCHS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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