- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721197
Hens Hatching Hope
September 8, 2026 updated by: Ana Palacios, Georgia Southern University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- 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 Contact
- Name: Ana Palacios, MD, PhD
- Phone Number: 4193244643
- Email: anapalac@iu.edu
Study Locations
-
-
Intibucá Department
-
Concepción, Intibucá Department, Honduras
- Recruiting
- Clinica medica Roy and Melaney Sanders
-
Contact:
- Laura Manship
- Phone Number: +5049829-0262
- Email: paulandlaura@shouldertoshoulder.org
-
-
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
Ages Eligible for Study
6 months to 2 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children from families that are considering leaving the region within the next 12 months
- Known egg allergy
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: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
30-day egg vouchers, in addition to the standard of care.
|
30-day egg vouchers will be provided monthly, in addition to standard of care.
Participants will continue to receive the standard of care.
No egg vouchers.
|
|
Active Comparator: Control group
Standard of care.
|
Participants will continue to receive the standard of care.
No egg vouchers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
|
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
|
Change from baseline zHAZ at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the prevalence of stunting from baseline at 6 months
Time Frame: 6 months
|
Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ <-2)
|
6 months
|
|
Changes in the prevalence of stunting from baseline at 12 months
Time Frame: 12 months
|
Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ <-2)
|
12 months
|
|
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 6 months
Time Frame: 6 months
|
Calculated using the 2006 World Health Organization Child Growth Standards
|
6 months
|
|
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 12 months
Time Frame: 12 months
|
Calculated using the 2006 World Health Organization Child Growth Standards
|
12 months
|
|
Assessment of rapid weight gain after 6 months of intervention
Time Frame: 6 months
|
Defined as a zBMI upward percentile crossing (>+0.67
SD) Calculated using the 2006 World Health Organization Child Growth Standards
|
6 months
|
|
Assessment of rapid weight gain after 12 months of intervention
Time Frame: 12 months
|
Defined as a zBMI upward percentile crossing (>+0.67
SD) Calculated using the 2006 World Health Organization Child Growth Standards
|
12 months
|
|
Changes in the prevalence of diarrhea from baseline at 12 months
Time Frame: 12 months
|
Defined as three or more liquid or semisolid stools in 24 hours
|
12 months
|
|
Changes in the prevalence of Respiratory symptoms from baseline at 12 months
Time Frame: 12 months
|
Defined as reported presence of cough, or nasal congestion, or ear ache, or sore throat in the last 7 days.
|
12 months
|
|
Changes in the prevalence of Respiratory infections from baseline at 12 months
Time Frame: baseline and 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
|
baseline and 12 months
|
|
Changes in the food insecurity scores from baseline at 6 months
Time Frame: 6 months
|
Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
|
6 months
|
|
Changes in the food insecurity scores from baseline at 12 months
Time Frame: 12 months
|
Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
|
12 months
|
|
Changes in the dietary diversity scores from baseline at 6 months
Time Frame: 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)
|
6 months
|
|
Changes in the dietary diversity scores from baseline at 12 months
Time Frame: 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)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Palacios, MD, PhD, Indiana University, Bloomington
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)
January 23, 2021
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Study Registration Dates
First Submitted
January 18, 2021
First Submitted That Met QC Criteria
January 21, 2021
First Posted (Actual)
January 22, 2021
Study Record Updates
Last Update Posted (Actual)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 8, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nutrition Disorders
- Signs and Symptoms, Digestive
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Child Nutrition Disorders
- Diarrhea
- Growth Disorders
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- 2012965659
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.