Hens Hatching Hope

Sponsor

Georgia Southern University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04721197

Collaborator

Shoulder to Shoulder (Other)

400

Enrollment

Location

Arms

22.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 23, 2021

Anticipated Primary Completion Date :

Feb 22, 2022

Anticipated Study Completion Date :

Dec 1, 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.

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

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
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

Secondary Outcome Measures

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
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 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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