Hens Hatching Hope

Not Applicable

Active, not recruiting

• Conditions: Malnutrition, Child
• Interventions: Other: Egg vouchers; Other: Standard of Care

• Registration Number: NCT04721197
• Lead Sponsor: Georgia Southern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Study Start: 2021-01-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-31
• Primary Completion: 2024-02-22
• Study Completion: 2024-02-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Standard of Care	30-day egg vouchers, in addition to the standard of care.
Intervention	Egg vouchers	30-day egg vouchers, in addition to the standard of care.
Control group	Standard of Care	Standard of care.

Primary Outcome Measures

Name	Time	Method
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 12 months	Change from baseline zHAZ at 12 months	Calculated using the 2006 World Health Organization Child Growth Standards
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 6 months	6 months	Calculated using the 2006 World Health Organization Child Growth Standards

Secondary Outcome Measures

Name	Time	Method
Assessment of rapid weight gain after 12 months of intervention	12 months	Defined as a zBMI upward percentile crossing (\>+0.67 SD) Calculated using the 2006 World Health Organization Child Growth Standards
Changes in the prevalence of stunting from baseline at 6 months	6 months	Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ \<-2)
Changes in the prevalence of stunting from baseline at 12 months	12 months	Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ \<-2)
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 6 months	6 months	Calculated using the 2006 World Health Organization Child Growth Standards
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 12 months	12 months	Calculated using the 2006 World Health Organization Child Growth Standards
Assessment of rapid weight gain after 6 months of intervention	6 months	Defined as a zBMI upward percentile crossing (\>+0.67 SD) Calculated using the 2006 World Health Organization Child Growth Standards
Changes in the prevalence of diarrhea from baseline at 12 months	12 months	Defined as three or more liquid or semisolid stools in 24 hours
Changes in the prevalence of Respiratory symptoms from baseline at 12 months	12 months	Defined as reported presence of cough, or nasal congestion, or ear ache, or sore throat in the last 7 days.
Changes in the prevalence of Respiratory infections from baseline at 12 months	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
Changes in the food insecurity scores from baseline at 6 months	6 months	Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
Changes in the food insecurity scores from baseline at 12 months	12 months	Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
Changes in the dietary diversity scores from baseline at 6 months	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)
Changes in the dietary diversity scores from baseline at 12 months	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)

Trial Locations

Locations (1)

Clinica medica Roy and Melaney Sanders; 🇭🇳 Concepción, Intibucá, Honduras