- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04135625
Improving Nutrition in Children Under Two Through Increased Egg Consumption in Burkina Faso
June 28, 2021 updated by: University of Florida
This project targets vulnerable populations of smallholders, women and children and should lead to increased poultry production, increased egg consumption of children, improved nutrition, and increased household level resilience.
This innovative intervention will be the gifting of chickens by religious leaders to children ages 6 to 12 months coupled with integrated nutrition and agricultural trainings.
Study Overview
Status
Completed
Conditions
Detailed Description
This study involves innovative behavioral change theoretical methodology to empower caregivers as smallholder poultry producers by improving their access to livestock production resources and agricultural extension services, providing tools for improved decision making, and enhancing nutrition based knowledge.
Smallholder production is important in eliminating food insecurities and building resilience to improve nutrition in children under 5. Based on the results of the Ethiopian egg project, through messaging and education, this study will foster favorable attitudes and consequent behavioral changes, including increased egg consumption.
Study Type
Interventional
Enrollment (Actual)
267
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 Locations
-
-
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Ouagadougou, Burkina Faso
- Institut de l'Environnement et Recherches Agricoles (INERA)
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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
6 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
The study population will be selected with the assistance of the OCADES Caritas Kaya and the CHWs who are actively involved and trusted within the targeted village communities.
Inclusion Criteria:
- Living within the identified areas of the study population
Exclusion Criteria:
- history of egg allergies
- severe 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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Full Intervention
The full intervention group will receive three egg laying chickens that will be presented as a gift to the child by their religious leader (imam or priest) during a gifting ceremony, as well as Integrated nutrition and agricultural (INA) education training sessions.
|
Monthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level.
Egg laying chickens will be presented as a gift to the child by a community champion (their religious leader or village chief)) during a gifting ceremony
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Active Comparator: Education Only
The education only intervention group will receive 3 chickens given in manner similar to animal distribution programs and the INA training sessions.
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Monthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level.
|
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No Intervention: Control
The control group will receive no chickens gifted and no INA training sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increase egg consumption in children under two living in Kaya, Burkina Faso
Time Frame: Baseline up to 12 months
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Dietary recall survey requesting caregiver/ parental recall of their child's dietary intake over the past week to include egg consumption embedded within the questionnaire The percentage of children consuming eggs will be calculated based on a yes response from the parent.The outcome measure will be described as the percentage of children consuming eggs with in the study population.
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Baseline up to 12 months
|
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Increase egg consumption frequency in children under two living in Kaya, Burkina Faso
Time Frame: Baseline up to 12 months
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Dietary recall survey requesting caregiver/ parental recall of their child's dietary intake over the past week to include frequency of eggs given embedded within the questionnaire.The outcome measure will be described as the mean number of eggs consumed in the past week by children enrolled in the study that consume eggs .
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Baseline up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improve growth in children under two living in Kaya, Burkina Faso.
Time Frame: Baseline up to 12 months
|
Anthropometric measurements to include weight in kilograms, height in centimeters of enrolled children.
Measurements will be aggregated to calculate z scores based on the child's age calculated in days and the wight and height of the anthropometric measurements.
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Baseline up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah McKune, PhD, MPH, University of Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McKune SL, Stark H, Sapp AC, Yang Y, Slanzi CM, Moore EV, Omer A, Wereme N'Diaye A. Behavior Change, Egg Consumption, and Child Nutrition: A Cluster Randomized Controlled Trial. Pediatrics. 2020 Dec;146(6):e2020007930. doi: 10.1542/peds.2020-007930.
- Stark H, Omer A, Wereme N'Diaye A, Sapp AC, Moore EV, McKune SL. The Un Oeuf study: Design, methods and baseline data from a cluster randomised controlled trial to increase child egg consumption in Burkina Faso. Matern Child Nutr. 2021 Jan;17(1):e13069. doi: 10.1111/mcn.13069. Epub 2020 Aug 8.
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)
July 5, 2018
Primary Completion (Actual)
September 20, 2019
Study Completion (Actual)
September 20, 2019
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
October 19, 2019
First Posted (Actual)
October 22, 2019
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 28, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- IRB201702810
- AID-OAA-L-15-00003 (Other Grant/Funding Number: US AGCY INTL DEV)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD will be shared on a USAID data development library and DataVerse.
IPD Sharing Time Frame
IPD will be shared with six months time completion. USAID will review and determine the level of access.
IPD uploaded to Dataverse.
IPD Sharing Access Criteria
USAID will review and determine the level of access and the time length the data is shared.
Data uploaded to DataVerse will be available indefinitely.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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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