Family MUAC Pilot Study: Empowering caregivers for the early detection and treatment of acute malnutrition in the Oromia and Amhara regions of rural Ethiopia

Last registered on October 19, 2024
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Pre-Trial

Trial Information

General Information

Title
Family MUAC Pilot Study: Empowering caregivers for the early detection and treatment of acute malnutrition in the Oromia and Amhara regions of rural Ethiopia
RCT ID
AEARCTR-0014497
Initial registration date
October 08, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 18, 2024, 4:38 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
October 19, 2024, 10:54 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

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Primary Investigator

Name
Beryl Oranga
Affiliation
World Vision United States
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Other Primary Investigator(s)

PI Name
Tigist Mamo
PI Affiliation
World Vision Ethiopia
Contact Investigator
PI Name
Elazar Tadesse
PI Affiliation
National Information Platform for Nutrition (NIPN), Ethiopian Public Health Institute
PI Name
Sarah Bauler
PI Affiliation
World Vision International
PI Name
Precious Mubanga
PI Affiliation
World Vision United States

Additional Trial Information

Status
On going
Start date
2024-06-24
End date
2025-11-30
Keywords
Behavior, Health
Additional Keywords
Health and Nutrition, Malnutrition, Food security
JEL code(s)
I10 General, I12 Health Behavior, I14 Health and Inequality
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Ethiopia has one of the highest rates of under-five child malnutrition globally, with a high prevalence of stunting, underweight, and wasting. The country's high prevalence of under-five child malnutrition limits better nutrition and health outcomes in children. Studies show that an innovative Family MUAC tape approach can significantly reduce the high malnutrition rates as mothers are empowered to screen their children for early detection and treatment instead of relying only on health workers. This innovative approach has also been shown to be cost-effective while increasing coverage. Ethiopia has adopted the approach as it strives to reduce malnutrition rates. While the approach has been shown to be effective, there is a lack of evidence on how training formats and supervision can lead to caregivers' knowledge retention, hence the sustainability of the approach in the long term. This pilot will be conducted within the SPIR II (Strengthen PSNP5 Institutions and Resilience) Program and aims to provide evidence on improving the early detection and prevention of acute malnutrition in rural Ethiopia as well as empowering caregivers and improving program coverage in the SPIR II Operational Woredas of Oromia and Amhara Regions. This will be a one-year study, where the caregivers will be randomly selected to participate in the program. The specific objectives are: 1) To investigate how periodic on-job Family MUAC training and supportive supervision impact the knowledge retention and accuracy of caregivers' detection skills of acute malnutrition; and 2) To assess the impact of Family MUAC on increasing early detection and self-referral of acute malnutrition.
External Link(s)

Registration Citation

Citation
Oranga, Beryl et al. 2024. "Family MUAC Pilot Study: Empowering caregivers for the early detection and treatment of acute malnutrition in the Oromia and Amhara regions of rural Ethiopia." AEA RCT Registry. October 19. https://doi.org/10.1257/rct.14497-2.0
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Experimental Details

Interventions

Intervention(s)
This is a three-arm group comparison study. The first arm (T1) will serve as the control group. The arm will continue to receive visits from the Health Extension Workers. However, it will not receive MUAC tape, training in family MUAC tape use, or any additional edema detection techniques (usual standard care). Arm T2 is designed to give minimal training and supervision, while T3 has been designed to give frequent support and training, which will contribute to the gap of whether frequent refresher training is needed for caregivers to accurately use MUAC tape and detect malnutrition in the early stages. At the time of recruitment, visitation, or data collection, if a child is found to be wasted (MUAC <12.5) regardless of the arm they are assigned to, they will be referred to the hospital (if severe <11.5) or to a feeding program (if moderate) and followed to assess the recovery rates and any relapse for the duration of the study.
Intervention Start Date
2024-08-26
Intervention End Date
2025-08-31

Primary Outcomes

Primary Outcomes (end points)
Ability of caregivers to correctly use the tape and measure MUAC accurately, validated by the health worker in health facilities or HEW in communities
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Early detection of malnutrition; confirmed wasting; median MUAC measurements for self-referred caregivers; the proportion of children admitted into a therapeutic feeding program and their recovery rates; caregivers' perception of malnutrition; and cost-effectiveness across the treatment arms.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
A three-arm group comparison design will be used to evaluate the effect of on-the-job periodic training and supervision on knowledge and skills retention and accurate and early detection of malnutrition in rural Ethiopia. The first arm (T1) will serve as the control group. The arm will continue to receive visits from the Health Extension Workers. However, it will not receive MUAC tape, training in family MUAC tape use, or any additional edema detection techniques (usual standard care). The second arm (T2) will receive only an initial basic training on the use of family MUAC with one follow-up visit three months after implementation. The third arm (T3) will receive the full package of family MUAC interventions, including the initial and with four follow-up on-the-job training and supervision visits for the rest of the study.
Experimental Design Details
Not available
Randomization Method
Randomization was done through a computer program
Randomization Unit
First the Kebeles were randomly allocated into the arms. Secondly, the household were randomly selected within the arms
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
The pilot is being implemented in nine Kebeles
Sample size: planned number of observations
Total sample size for is 1350 households of mother-child pairs. The sample size has been determined at the household level using Stata 17 power calculations, setting the significant levels of α=0.05, power at 80%, allowing for attrition at 10% and design effect at 2.0 to account for the differences across the Family MUAC program locations.
Sample size (or number of clusters) by treatment arms
450 households (mother-child pair) per arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Given the nature of the pilot study, power calculations were done at the household's level, catering to the main outcome of interest, with an MDE of 14%
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Ethiopian Public Health Association
IRB Approval Date
2024-05-08
IRB Approval Number
N/A
Analysis Plan