Hens Hatching Hope

• ClinicalTrials.gov Identifier: NCT04721197
• Recruitment Status: Active, not recruiting
• First Posted: January 22, 2021
• Last Update Posted: October 27, 2021
• Sponsor: Georgia Southern University
• Collaborator: Shoulder to Shoulder
• Information provided by (Responsible Party): Ana Palacios, Georgia Southern University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Malnutrition, Child	Other: Egg vouchers; Other: Standard of Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: The principal investigator and statistician will be blinded to the treatment group.
• Primary Purpose: Other
• Official Title: Program Evaluation: Eggs Hatching Hope. Providing Egg Vouchers to Women With Young Children in Rural Honduras.
• Actual Study Start Date: January 23, 2021
• Estimated Primary Completion Date: February 22, 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; 30-day egg vouchers, in addition to the standard of care.	Other: Egg vouchers; 30-day egg vouchers will be provided monthly, in addition to standard of care.; Other: Standard of Care; Participants will continue to receive the standard of care. No egg vouchers.
Active Comparator: Control group; Standard of care.	Other: Standard of Care; Participants will continue to receive the standard of care. No egg vouchers.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. 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)
2. 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)
3. 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
4. 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
5. 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. 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
7. 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
8. 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.
9. 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
10. 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)
11. 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. 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)
13. 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)

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 24 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Honduras

Clinica medica Roy and Melaney Sanders

Concepción, Intibucá, Honduras

Sponsors and Collaborators

Georgia Southern University

Shoulder to Shoulder

Investigators

• Principal Investigator: Ana Palacios, MD, PhD; Indiana University Bloomington

More Information

• Responsible Party: Ana Palacios, Assistant Professor, Georgia Southern University
• ClinicalTrials.gov Identifier: NCT04721197
• Other Study ID Numbers: 2012965659
• First Posted: January 22, 2021
• Last Update Posted: October 27, 2021
• Last Verified: October 2021

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

Keywords provided by Ana Palacios, Georgia Southern University:

Stunting; Eggs; diarrhea; complementary foods

Additional relevant MeSH terms:

Malnutrition; Child Nutrition Disorders; Nutrition Disorders