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Improving Nutrition in Children Under Two Through Increased Egg Consumption in Burkina Faso

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135625
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nutrition Behavioral: Integrated nutrition and agricultural (INA) trainings Behavioral: Ceremonial Gifting of Livestock Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Control Group - with no chickens gifted and no INA training sessions
Primary Purpose: Health Services Research
Official Title: Improving Nutrition in Children Under Two Through Increased Egg Consumption in Burkina Faso
Actual Study Start Date : July 5, 2018
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : September 20, 2019

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.
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.



Primary Outcome Measures :
  1. 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.

  2. 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 .


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135625


Locations
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Burkina Faso
Institut de l'Environnement et Recherches Agricoles (INERA)
Ouagadougou, Burkina Faso
Sponsors and Collaborators
University of Florida
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Sarah McKune, PhD, MPH University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04135625    
Other Study ID Numbers: IRB201702810
AID-OAA-L-15-00003 ( Other Grant/Funding Number: US AGCY INTL DEV )
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD will be shared on a USAID data development library and DataVerse.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame:

IPD will be shared with six months time completion. USAID will review and determine the level of access.

IPD uploaded to Dataverse.

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.
URL: https://dataverse.harvard.edu/dataverse/livestock-lab-burkina-egg-consumption .

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No