Impact of an Integrated Community-Based Nutrition Intervention on the Growth of Under five children in Abia State

Last registered on May 08, 2024

Pre-Trial

Trial Information

General Information

Title
Impact of an Integrated Community-Based Nutrition Intervention on the Growth of Under five children in Abia State
RCT ID
AEARCTR-0013524
Initial registration date
April 30, 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 08, 2024, 5:01 PM EDT

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

Locations

Region

Primary Investigator

Affiliation
SCIDaR

Other Primary Investigator(s)

PI Affiliation
Solina Center for International Development and Research
PI Affiliation
Solina Center for International Development and Research
PI Affiliation
Solina Center for International Development and Research

Additional Trial Information

Status
Completed
Start date
2022-07-02
End date
2023-11-30
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
The "critical window" for obtaining optimal growth and development is from birth to two years old. Under-fives’ growth is significantly impacted by infection, poor child feeding techniques, and inadequate quality and quantity of supplemental foods. In underdeveloped nations, one-third of children under the age of five are stunted, and many of them are also micronutrient deficient. Ensuring appropriate supplementary feeding can reduce an estimated 6% of under-five mortalities. This study is a two-arm cluster randomized controlled trial that aim to improve maternal knowledge, attitudes and practice regarding child feeing practices through strategies such as mid-upper arm circumference (MUAC) measurement, food incentives and behaviour change communication (BCC).
In this community-based randomized controlled trial study, the participants were assigned to two arms; the control group (Arm 1) and the intervention group (Arm 2). The intervention group will receive a package of interventions that include, food incentives, micronutrient powder to fortify children’s food at home, child feeding counselling, behaviour change communication and the Basic package of Nutrition Services (BPNS) through a peer support group meeting activity. The control group receives routine Basic Packages of Nutrition services provided by the community Volunteers. A baseline survey is conducted before the intervention while an endline survey will be conducted after the intervention; Data collection is performed monthly on children’s MUAC status, food incentive utilization, child feeding and support meeting attendance. The intervention will be conducted over a period of 18 months, with data collected at baseline and endline.
This trial aims to explore whether an integrated nutrition intervention can mitigate childhood stunting during the critical window of opportunity in rural Umuahia South and Bende LGAs of Abia State Nigeria. The findings might offer solid support for efforts to increase children's linear growth in underdeveloped nations.
External Link(s)

Registration Citation

Citation
Aigbogun, Eric et al. 2024. "Impact of an Integrated Community-Based Nutrition Intervention on the Growth of Under five children in Abia State." AEA RCT Registry. May 08. https://doi.org/10.1257/rct.13524-1.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
Intervention (Hidden)
In the control group, Mother-child pairs are recruited into the control group and receive routine Basic Package of Nutrition Services (BPNS), while in the individuals (mothers) in the intervention arm are recruited into a peer support group where:1. Mothers are provided with basic information on food nutritive value and good nutritional dietary practices 2. Mothers will receive Micronutrient powder and other ANRiN BPNS Services 3. Mothers recruited into the intervention arms will be required to routinely monitor their children's nutritional status and record the results on the provided care card. 4. Information, Education, and Communication (IEC) materials will be produced and distributed to guide mothers and volunteers. 5. Mothers will be expected to promptly refer malnourished children to the community-based volunteer and will be incentivized with select commodities that will be useful to the mother and her child 6.The volunteers will facilitate monthly support group meetings in line with COVID19 guidelines with all the women and their children where they will counsel the women on nutrition, retrain the women on the use of MUAC tapes, review the care cards of all the children and validate the nutritional status of the children.
Intervention Start Date
2022-07-14
Intervention End Date
2023-11-30

Primary Outcomes

Primary Outcomes (end points)
Reduction in the GAM prevalence
Primary Outcomes (explanation)
Changes in knowledge, attitude and practice regarding child feeding practices among mothers in the intervention and control groups.

Secondary Outcomes

Secondary Outcomes (end points)
Reduced prevalence of stunting, wasting, and underweight among under-five children in the study area
Secondary Outcomes (explanation)
1. Improved maternal knowledge of nutrition and health seeking behavior
2. Increased percentage of mothers aware of food nutritive value and good nutritional dietary practices
3. Increased percentage of mothers who know how to track the nutritional status of their children using MUAC tapes
4. Reduced prevalence of stunted, wasted and underweight children in the study area.

Experimental Design

Experimental Design
The study employs a two-arm cluster randomized controlled trial design, investigating the impact of an integrated community-based nutrition intervention on knowledge, attitudes, and practices regarding child feeding among mothers of children aged 6-59 months in Abia State, Nigeria. The study aims to assess the effectiveness of the intervention in reducing malnutrition rates, improving child health outcomes, and enhancing overall well-being. The control group (Arm 1) receives the Basic Package of Nutrition Services (BPNS), while the intervention group (Arm 2) undergoes a comprehensive strategy involving MUAC measurement training, food incentives, behavior change communication sessions, and nutritional supplementation. The study explores changes in maternal knowledge and practices, monitoring MUAC measurements, administration of nutrition supplements, and nutritional indicators among children as primary outcomes.
Experimental Design Details
The study employs a two-arm cluster randomized controlled trial design, investigating the impact of an integrated community-based nutrition intervention on knowledge, attitudes, and practices regarding child feeding among mothers of children aged 6-59 months in Abia State, Nigeria. The study aims to assess the effectiveness of the intervention in reducing malnutrition rates, improving child health outcomes, and enhancing overall well-being. The control group (Arm 1) receives the Basic Package of Nutrition Services (BPNS), while the intervention group (Arm 2) undergoes a comprehensive strategy involving MUAC measurement training, food incentives, behavior change communication sessions, and nutritional supplementation. The study explores changes in maternal knowledge and practices, monitoring MUAC measurements, administration of nutrition supplements, and nutritional indicators among children as primary outcomes.
Randomization Method
The randomization method used in the document is a coin tossing technique.
Randomization Unit
Cluster Randomized Control Trial (Community-based)
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
The study has set out 30 clusters per Local Government Area (LGA)
Sample size: planned number of observations
817
Sample size (or number of clusters) by treatment arms
408 individuals for control and 409 individuals for treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The estimated sample size using the Hemming et al. (2011) and online sample size calculator for multi-arm randomized trial, (GIGAcalculator, 2022: https://www.gigacalculator.com/) is 328 respondents per arm. Considering a 10% attrition rate the sample size increases to 360 respondents per am for a total sample size of 720.
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
Government of Abia State of Nigeria Ministry of Health, Umuahia
IRB Approval Date
2022-06-15
IRB Approval Number
ASMH/EC/23/019

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
November 30, 2023, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
November 30, 2022, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
30 clusters per LGA, 6 Wards per LGA, five villages per Ward
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
720
Final Sample Size (or Number of Clusters) by Treatment Arms
360 individuals for control and 360 individuals for intervention
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