NutritionNCT04135625
Improving Nutrition in Children Under Two Through Increased Egg Consumption in Burkina Faso
A study testing Integrated nutrition and agricultural (INA) trainings and Ceremonial Gifting of Livestock in people with Nutrition, run by University of Florida at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- What is being tested?
- Integrated nutrition and agricultural (INA) trainings and Ceremonial Gifting of Livestock
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 5 Jul 2018to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Living within the identified areas of the study population
Who cannot join
- history of egg allergies
- severe malnutrition
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Institut de l'Environnement et Recherches Agricoles (INERA)
Ouagadougou
About this study
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.
Read the 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.
- Conditions
- Nutrition
- Being tested
- Integrated nutrition and agricultural (INA) trainings, Ceremonial Gifting of Livestock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated nutrition and agricultural (INA) trainingsBehavioural
Monthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level.
Ceremonial Gifting of LivestockBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrated nutrition and agricultural (INA) trainings; Behavioral: 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. Receives: Behavioral: Integrated nutrition and agricultural (INA) trainings |
| Control | No intervention | The control group will receive no chickens gifted and no INA training sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: Baseline up to 12 months
Secondary outcomes (1)
Improve growth in children under two living in Kaya, Burkina Faso.
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.
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start5 Jul 2018
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Sarah McKune, PhD, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135625
- Sponsor's protocol ID
- IRB201702810
- Other IDs
- AID-OAA-L-15-00003
- Status last verified
- Jun 2021
- First submitted
- 11 Oct 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared on a USAID data development library and DataVerse.
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.
PubMed 33239474Stark 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.
PubMed 32770664
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Nutrition in Children Under Two Through Increased Egg Consumption in Burkina Faso
- ClinicalTrials.gov ID
- NCT04135625
- Acronym / sponsor ID
- IRB201702810
- Conditions
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full Intervention | Active comparator | Behavioral: Integrated nutrition and agricultural (INA) trainings, Behavioral: Ceremonial Gifting of LivestockThe 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. |
| Education Only | Active comparator | Behavioral: Integrated nutrition and agricultural (INA) trainingsThe education only intervention group will receive 3 chickens given in manner similar to animal distribution programs and the INA training sessions. |
| Control | No intervention | –The control group will receive no chickens gifted and no INA training sessions. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Living within the identified areas of the study population
Key exclusion criteria (2 listed)
- history of egg allergies
- severe malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated nutrition and agricultural (INA) trainingsMonthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level. | Behavioural | Education Only, Full Intervention |
| Ceremonial Gifting of LivestockEgg 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 | Behavioural | Full Intervention |
Primary outcome
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.
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 .
1 secondary outcome
Improve growth in children under two living in Kaya, Burkina Faso.
Time frame: Baseline up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 33239474McKune 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.
- Derived from this study: PubMed 32770664Stark 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.
- Individual participant dataSharing planned: Yes. All IPD will be shared on a USAID data development library and DataVerse.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah McKune, PhD, MPH principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated nutrition and agricultural (INA) trainings and Ceremonial Gifting of Livestock in people with Nutrition, run by University of Florida at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase egg consumption in children under two living in Kaya, Burkina Faso (time frame: Baseline up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04135625, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.