Hens Hatching Hope

Malnutrition, Child Clinical Trial

Official title:

Program Evaluation: Eggs Hatching Hope. Providing Egg Vouchers to Women With Young Children in Rural Honduras.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04721197
• Other study ID #: 2012965659
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2021
• Est. completion date: February 22, 2024

Study information

• Verified date: January 2023
• Source: Georgia Southern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

Other:
• Egg vouchers
30-day egg vouchers will be provided monthly, in addition to standard of care.
• Standard of Care
Participants will continue to receive the standard of care. No egg vouchers.

Locations

Country	Name	City	State
Honduras	Clinica medica Roy and Melaney Sanders	Concepción	Intibucá

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Southern University	Shoulder to Shoulder

Country where clinical trial is conducted

Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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