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Hens Hatching Hope

Primary Purpose

Malnutrition, Child

Status
Active
Phase
Not Applicable
Locations
Honduras
Study Type
Interventional
Intervention
Egg vouchers
Standard of Care
Sponsored by
Georgia Southern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition, Child focused on measuring Stunting, Eggs, diarrhea, complementary foods

Eligibility Criteria

6 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinica medica Roy and Melaney Sanders

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control group

Arm Description

30-day egg vouchers, in addition to the standard of care.

Standard of care.

Outcomes

Primary Outcome Measures

Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 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
Calculated using the 2006 World Health Organization Child Growth Standards

Secondary Outcome Measures

Changes in the prevalence of stunting from baseline at 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
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
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
Calculated using the 2006 World Health Organization Child Growth Standards
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
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
Changes in the prevalence of diarrhea from baseline at 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
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
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
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
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
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
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)

Full Information

First Posted
January 18, 2021
Last Updated
January 27, 2023
Sponsor
Georgia Southern University
Collaborators
Shoulder to Shoulder
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1. Study Identification

Unique Protocol Identification Number
NCT04721197
Brief Title
Hens Hatching Hope
Official Title
Program Evaluation: Eggs Hatching Hope. Providing Egg Vouchers to Women With Young Children in Rural Honduras.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2021 (Actual)
Primary Completion Date
February 22, 2024 (Anticipated)
Study Completion Date
February 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia Southern University
Collaborators
Shoulder to Shoulder

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child
Keywords
Stunting, Eggs, diarrhea, complementary foods

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The principal investigator and statistician will be blinded to the treatment group.
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
30-day egg vouchers, in addition to the standard of care.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard of care.
Intervention Type
Other
Intervention Name(s)
Egg vouchers
Intervention Description
30-day egg vouchers will be provided monthly, in addition to standard of care.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Participants will continue to receive the standard of care. No egg vouchers.
Primary Outcome Measure Information:
Title
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 6 months
Description
Calculated using the 2006 World Health Organization Child Growth Standards
Time Frame
6 months
Title
Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 12 months
Description
Calculated using the 2006 World Health Organization Child Growth Standards
Time Frame
Change from baseline zHAZ at 12 months
Secondary Outcome Measure Information:
Title
Changes in the prevalence of stunting from baseline at 6 months
Description
Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ <-2)
Time Frame
6 months
Title
Changes in the prevalence of stunting from baseline at 12 months
Description
Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ <-2)
Time Frame
12 months
Title
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 6 months
Description
Calculated using the 2006 World Health Organization Child Growth Standards
Time Frame
6 months
Title
Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 12 months
Description
Calculated using the 2006 World Health Organization Child Growth Standards
Time Frame
12 months
Title
Assessment of rapid weight gain after 6 months of intervention
Description
Defined as a zBMI upward percentile crossing (>+0.67 SD) Calculated using the 2006 World Health Organization Child Growth Standards
Time Frame
6 months
Title
Assessment of rapid weight gain after 12 months of intervention
Description
Defined as a zBMI upward percentile crossing (>+0.67 SD) Calculated using the 2006 World Health Organization Child Growth Standards
Time Frame
12 months
Title
Changes in the prevalence of diarrhea from baseline at 12 months
Description
Defined as three or more liquid or semisolid stools in 24 hours
Time Frame
12 months
Title
Changes in the prevalence of Respiratory symptoms from baseline at 12 months
Description
Defined as reported presence of cough, or nasal congestion, or ear ache, or sore throat in the last 7 days.
Time Frame
12 months
Title
Changes in the prevalence of Respiratory infections from baseline at 12 months
Description
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
Time Frame
baseline and 12 months
Title
Changes in the food insecurity scores from baseline at 6 months
Description
Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
Time Frame
6 months
Title
Changes in the food insecurity scores from baseline at 12 months
Description
Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)
Time Frame
12 months
Title
Changes in the dietary diversity scores from baseline at 6 months
Description
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)
Time Frame
6 months
Title
Changes in the dietary diversity scores from baseline at 12 months
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Palacios, MD, PhD
Organizational Affiliation
Indiana University, Bloomington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica medica Roy and Melaney Sanders
City
Concepción
State/Province
Intibucá
Country
Honduras

12. IPD Sharing Statement

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Hens Hatching Hope

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