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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04721197
Other study ID # 2012965659
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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