Malnutrition, ChildNCT04721197
Hens Hatching Hope
A study testing Egg vouchers in people with Malnutrition, Child, run by Georgia Southern University at 1 site in Honduras.
Trial summary
The study is a prospective community-cluster non-randomized trial that will evaluate the effectiveness of a program that will provide 30-day egg vouchers to mothers of 6 to 24 month-old children living in rural areas of Intibucá, Honduras. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Egg vouchers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteHonduras
- Study dates
- 23 Jan 2021to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children ages 6 to 24 months at the time the study begins
- No cerebral palsy, birth defect or condition that may affect their growth or development.
- Children living in the department of Intibucá, Honduras
Who cannot join
- Children from families that are considering leaving the region within the next 12 months
- Known egg allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras1 site, 1 recruiting
- Recruiting
Clinica medica Roy and Melaney Sanders
Concepción, Intibucá Department
Laura Manship, +5049829-0262, paulandlaura@shouldertoshoulder.org
About this study
Official title: Program Evaluation: Eggs Hatching Hope. Providing Egg Vouchers to Women With Young Children in Rural Honduras.
The study is a prospective community-cluster non-randomized trial that will evaluate the effectiveness of a program that will provide 30-day egg vouchers to mothers of 6 to 24 month-old children living in rural areas of Intibucá, Honduras.
- Conditions
- Malnutrition, Child
- Being tested
- Egg vouchers, Standard of Care
- Keywords
- Stunting, Eggs, diarrhea, complementary foods
- Medical subject headings
- Child Nutrition Disorders, Growth Disorders, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg vouchersOther
30-day egg vouchers will be provided monthly, in addition to standard of care.
Standard of CareOther
Participants will continue to receive the standard of care. No egg vouchers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 30-day egg vouchers, in addition to the standard of care. Receives: Other: Egg vouchers; Other: Standard of Care |
| Control group | Active comparator | Standard of care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 6 months
Calculated using the 2006 World Health Organization Child Growth Standards
Measured: 6 months
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 12 months
Calculated using the 2006 World Health Organization Child Growth Standards
Measured: Change from baseline zHAZ at 12 months
Secondary outcomes (13)
Changes in the prevalence of stunting from baseline at 6 months
Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ <-2)
Measured: 6 months
Changes in the prevalence of stunting from baseline at 12 months
Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ <-2)
Measured: 12 months
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 6 months
Calculated using the 2006 World Health Organization Child Growth Standards
Measured: 6 months
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 12 months
Calculated using the 2006 World Health Organization Child Growth Standards
Measured: 12 months
Assessment of rapid weight gain after 6 months of intervention
Defined as a zBMI upward percentile crossing (>+0.67 SD) Calculated using the 2006 World Health Organization Child Growth Standards
Measured: 6 months
Assessment of rapid weight gain after 12 months of intervention
Defined as a zBMI upward percentile crossing (>+0.67 SD) Calculated using the 2006 World Health Organization Child Growth Standards
Measured: 12 months
Changes in the prevalence of diarrhea from baseline at 12 months
Defined as three or more liquid or semisolid stools in 24 hours
Measured: 12 months
Changes in the prevalence of Respiratory symptoms from baseline at 12 months
Defined as reported presence of cough, or nasal congestion, or ear ache, or sore throat in the last 7 days.
Measured: 12 months
Changes in the prevalence of Respiratory infections from baseline at 12 months
Defined as reported presence of fever + any of the following symptoms: cough, or nasal congestion, or ear ache, or sore throat in the last 7 days
Measured: baseline and 12 months
Changes in the food insecurity scores from baseline at 6 months
Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
Measured: 6 months
Changes in the food insecurity scores from baseline at 12 months
Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
Measured: 12 months
Changes in the dietary diversity scores from baseline at 6 months
Measured using the frequency of intake survey from the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
Measured: 6 months
Changes in the dietary diversity scores from baseline at 12 months
Measured using the frequency of intake survey from the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
Measured: 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 Jan 2021
- Study start23 Jan 2021
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia Southern University
- Sponsor type
- University, hospital or other
- Collaborators
- Shoulder to Shoulder
- Responsible party
- Principal investigator, Ana Palacios, Georgia Southern University
- Investigators
- Ana Palacios, MD, PhD, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721197
- Sponsor's protocol ID
- 2012965659
- Status last verified
- Sep 2026
- First submitted
- 18 Jan 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Evaluation: Eggs Hatching Hope. Providing Egg Vouchers to Women With Young Children in Rural Honduras.
- ClinicalTrials.gov ID
- NCT04721197
- Acronym / sponsor ID
- 2012965659
- Conditions
- Malnutrition, Child
- Keywords
- Stunting, Eggs, diarrhea, complementary foods
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Georgia Southern UniversityUniversity, hospital or other
- Collaborators
- Shoulder to Shoulder
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 22 Jan 2021 (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.
The study is a prospective community-cluster non-randomized trial that will evaluate the effectiveness of a program that will provide 30-day egg vouchers to mothers of 6 to 24 month-old children living in rural areas of Intibucá, Honduras.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Egg vouchers, Other: Standard of Care30-day egg vouchers, in addition to the standard of care. |
| Control group | Active comparator | Other: Standard of CareStandard of care. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children ages 6 to 24 months at the time the study begins
- No cerebral palsy, birth defect or condition that may affect their growth or development.
- Children living in the department of Intibucá, Honduras
Key exclusion criteria (2 listed)
- Children from families that are considering leaving the region within the next 12 months
- Known egg allergy
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 |
|---|---|---|
| Egg vouchers30-day egg vouchers will be provided monthly, in addition to standard of care. | Other | Intervention |
| Standard of CareParticipants will continue to receive the standard of care. No egg vouchers. | Other | Control group, Intervention |
Primary outcome
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 6 months
Time frame: 6 months
Calculated using the 2006 World Health Organization Child Growth Standards
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 12 months
Time frame: Change from baseline zHAZ at 12 months
Calculated using the 2006 World Health Organization Child Growth Standards
13 secondary outcomes
Changes in the prevalence of stunting from baseline at 6 months
Time frame: 6 months
Changes in the prevalence of stunting from baseline at 12 months
Time frame: 12 months
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 6 months
Time frame: 6 months
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 12 months
Time frame: 12 months
Assessment of rapid weight gain after 6 months of intervention
Time frame: 6 months
Assessment of rapid weight gain after 12 months of intervention
Time frame: 12 months
Changes in the prevalence of diarrhea from baseline at 12 months
Time frame: 12 months
Changes in the prevalence of Respiratory symptoms from baseline at 12 months
Time frame: 12 months
Changes in the prevalence of Respiratory infections from baseline at 12 months
Time frame: baseline and 12 months
Changes in the food insecurity scores from baseline at 6 months
Time frame: 6 months
Changes in the food insecurity scores from baseline at 12 months
Time frame: 12 months
Changes in the dietary diversity scores from baseline at 6 months
Time frame: 6 months
Changes in the dietary diversity scores from baseline at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
Ana Palacios, MD, PhD principal investigator
Indiana University, Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg vouchers in people with Malnutrition, Child, run by Georgia Southern University at 1 site in Honduras.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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 Honduras. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Palacios, MD, PhD (4193244643, anapalac@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 6 months (time frame: 6 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?
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 9 Sep 2026.