NCT04721197

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 23, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2026

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

5 years

First QC Date

January 18, 2021

Last Update Submit

September 24, 2024

Conditions

Malnutrition, Child

Keywords

StuntingEggsdiarrheacomplementary foods

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (13)

  • Changes in the prevalence of stunting from baseline at 6 months

    6 months

  • Changes in the prevalence of stunting from baseline at 12 months

    12 months

  • Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 6 months

    6 months

  • Changes in the prelavence of underweight (Weight-for-age z-score <-2) from baseline at 12 months

    12 months

  • Assessment of rapid weight gain after 6 months of intervention

    6 months

  • +8 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Egg vouchersOther: Standard of Care

Control group

ACTIVE COMPARATOR

Standard of care.

Other: Standard of Care

Interventions

Egg vouchersOTHER

30-day egg vouchers will be provided monthly, in addition to standard of care.

Intervention
Standard of CareOTHER

Participants will continue to receive the standard of care. No egg vouchers.

Control groupIntervention

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children from families that are considering leaving the region within the next 12 months
  • Known egg allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica medica Roy and Melaney Sanders

Concepción, Intibucá Department, Honduras

RECRUITING

MeSH Terms

Conditions

Child Nutrition DisordersGrowth DisordersDiarrhea

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ana Palacios, MD, PhD

    Indiana University, Bloomington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Palacios, MD, PhD

CONTACT

4193244643anapalac@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The principal investigator and statistician will be blinded to the treatment group.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 22, 2021

Study Start

January 23, 2021

Primary Completion

January 22, 2026

Study Completion

January 22, 2026

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations

HO(1)