Improving child nutrition status, maternal knowledge of nutrition, and uptake of nutritional services in Gombe State: A Cluster randomized controlled trial

Last registered on May 09, 2024
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Pre-Trial

Trial Information

General Information

Title
Improving child nutrition status, maternal knowledge of nutrition, and uptake of nutritional services in Gombe State: A Cluster randomized controlled trial
RCT ID
AEARCTR-0013498
Initial registration date
April 26, 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
May 09, 2024, 1:06 PM EDT

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

Locations

Country
Nigeria
Region
Africa

Primary Investigator

Name
Eric Aigbogun
Affiliation
SCIDaR
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Other Primary Investigator(s)

PI Name
Abdulateef Salisu
PI Affiliation
Solina Center for International Development and Research (SCIDaR)
Contact Investigator
PI Name
Eric Aigbogun
PI Affiliation
Solina Center for International Development and Research (SCIDaR)
Contact Investigator
PI Name
Oluwademilade Osoteku
PI Affiliation
Solina Center for International Development and Research (SCIDaR)
Contact Investigator

Additional Trial Information

Status
Completed
Start date
2022-12-17
End date
2023-12-16
Keywords
Behavior, Welfare
Additional Keywords
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Malnutrition is a pressing public health issue in Nigeria, particularly affecting children under five in hard-to-reach communities. The Gombe ANRiN project addresses this challenge through a comprehensive approach involving the delivery of a Basic Package of Nutrition Services (BPNS) and innovative mobile-nutrition units. These units aim to overcome geographical barriers and provide essential nutrition services, awareness, and education to underserved populations. The project employs a cluster randomized controlled trial (RCT) design to evaluate the effectiveness of the intervention. Communities in Gombe State are randomized into intervention and control arms, with data collected through structured questionnaires, anthropometric measurements, and qualitative interviews. Trained field enumerators administer surveys, while mobile units deliver services and collect data electronically using the Open Data Kit (ODK) tool.
External Link(s)

Registration Citation

Citation
Aigbogun, Eric et al. 2024. "Improving child nutrition status, maternal knowledge of nutrition, and uptake of nutritional services in Gombe State: A Cluster randomized controlled trial." AEA RCT Registry. May 09. https://doi.org/10.1257/rct.13498-1.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2022-12-17
Intervention End Date
2023-12-16

Primary Outcomes

Primary Outcomes (end points)
Reduction in the GAM rates between the intervention and control group
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Reduced prevalence of stunting, wasting, and underweight among under-five children in the study area
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The Gombe ANRiN innovation study is a two-arm cluster randomized controlled trial with a control group (Arm 1) and an intervention group (Arm 2). Participants in the intervention arm will have access to the mobile nutrition promotion units that visit their community. The women in attendance will be counseled by the trained personnel and can share concerns and/or experiences regarding their children’s health, they will also be given essential medication such as zinc, vitamin A and other micronutrients distributed for their children.
During the visit the participants will also be trained on home-based food fortification methods to improve the value of their diet, incentivized non-monetarily for demonstrating active participation during visits, bringing their children for treatment and showing commitment to monitoring their child's status, and empowered to transfer all the new information about food fortification and complementary feeding to other women in their immediate neighborhood.
The control group will not be visited by the mobile unit but will have access to nutritional services by visiting health facilities near their community or when the regular ANRiN community health workers make a deliberate effort to visit these communities.
Experimental Design Details
Randomization Method
The randomization method used in the document is a **coin tossing technique**. This method is employed to randomly assign communities in Gombe State into intervention and control arms for the cluster randomized controlled trial (RCT) described in the study. The coin toss is conducted by the Project Coordinator of the Gombe ANRiN Partner Implementation Unit, with representatives of the Non-State Actors (NSAs) present to ensure transparency and fairness in the randomization process.
Randomization Unit
Community based Cluster Randomized Control Trial
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
The planned number of clusters for the study is 36 settlements. These are divided between 18 settlements from Dukku LGA and 18 settlements from Nafada LGA, with each LGA having 6 wards contributing to the selection of settlements. The study aims to enroll a minimum of 36 women with their children per settlement for the baseline study.
Sample size: planned number of observations
The planned number of observations for the study is 1,200.
Sample size (or number of clusters) by treatment arms
Estimated sample size is 600 respondents per arm, resulting in a total sample size of 1,200 for the study
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The sample size calculation is based on detecting a 5%-point change in Global Acute Malnutrition (GAM) with 80% power and a significance level of 5%. Considering a 10% dropout rate, the estimated sample size is 600 respondents per arm, resulting in a total sample size of 1,200 for the study. This includes both the intervention and control groups in the targeted Hard-To-Reach (HTR) settlements.
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
Gombe State of Nigeria Ministry of Health
IRB Approval Date
2022-07-01
IRB Approval Number
MOH/ADM/621/V.1/494
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
December 16, 2023, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
December 16, 2023, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
The final sample size for the clusters in the randomized controlled trial (RCT) is 600 respondents per arm, resulting in a total sample size of 1,200 respondents.
Was attrition correlated with treatment status?
Yes
Final Sample Size: Total Number of Observations
1200 particiapants
Final Sample Size (or Number of Clusters) by Treatment Arms
600 participants in control arm and 600 participants in intervention arm
Data Publication

Data Publication

Is public data available?
No

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Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials