Hens Hatching Hope

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: Malnutrition, Child
• Intervention / Treatment: Other: Egg vouchers; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Palacios, MD, PhD; Phone Number: 4193244643; Email: anapalac@iu.edu

Study Locations

• Honduras
  • Intibucá
    • Concepción, Intibucá, Honduras
      • Recruiting
      • Clinica medica Roy and Melaney Sanders
      • Contact: Laura Manship; Phone Number: +5049829-0262; Email: paulandlaura@shouldertoshoulder.org

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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	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	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	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	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	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	Calculated using the 2006 World Health Organization Child Growth Standards	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	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	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	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.	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	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)	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)	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)	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)	12 months

Collaborators and Investigators

• Sponsor: Georgia Southern University
• Collaborators: Shoulder to Shoulder
• Investigators: Principal Investigator: Ana Palacios, MD, PhD, Indiana University, Bloomington

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2021
• Primary Completion (Estimated): January 22, 2026
• Study Completion (Estimated): January 22, 2026

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 25, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: diarrhea; Stunting; Eggs; complementary foods
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• 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