NCT04135625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

October 11, 2019

Last Update Submit

June 28, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Increase egg consumption in children under two living in Kaya, Burkina Faso

    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

    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 Outcomes (1)

  • Improve growth in children under two living in Kaya, Burkina Faso.

    Baseline up to 12 months

Study Arms (3)

Full Intervention

ACTIVE COMPARATOR

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) trainingsBehavioral: Ceremonial Gifting of Livestock

Education Only

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

The control group will receive no chickens gifted and no INA training sessions.

Interventions

Monthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level.

Education OnlyFull Intervention

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

Full Intervention

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Living within the identified areas of the study population

You may not qualify if:

  • history of egg allergies
  • severe malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de l'Environnement et Recherches Agricoles (INERA)

Ouagadougou, Burkina Faso

Location

Related Publications (2)

  • 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.

MeSH Terms

Interventions

alpha-internexin

Study Officials

  • Sarah McKune, PhD, MPH

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Control Group - with no chickens gifted and no INA training sessions
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 22, 2019

Study Start

July 5, 2018

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

All IPD will be shared on a USAID data development library and DataVerse.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.
More information

Locations