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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
267

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Institut de l'Environnement et Recherches Agricoles (INERA)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Integrated nutrition and agricultural (INA) trainings
Monthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level.
Behavioral: Ceremonial Gifting of Livestock
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
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.
Behavioral: Integrated nutrition and agricultural (INA) trainings
Monthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level.
No Intervention: Control
The control group will receive no chickens gifted and no INA training sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
Baseline up to 12 months
Increase egg consumption frequency in children under two living in Kaya, Burkina Faso
Time Frame: Baseline up to 12 months
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 .
Baseline up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline up to 12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Agency for International Development (USAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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