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Recruiting

NCT Number: NCT04721197

Hens Hatching Hope

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.

Recruiting

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Key information

Conditions

Malnutrition, Child Child Nutrition Disorders Diarrhea Growth Disorders Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica medica Roy and Melaney Sanders

Concepción, Intibucá Department, Honduras

Location status: Recruiting

Location contact

Laura Manship

CONTACT

[email protected]

+5049829-0262

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Egg vouchers

Other

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

Standard of care

Other

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

Primary outcomes

  1. Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 6 months

    Time frame: 6 months

    Calculated using the 2006 World Health Organization Child Growth Standards

  2. Changes in Length/Height-for-age z-scores (zHAZ) from baseline at 12 months

    Time frame: Change from baseline zHAZ at 12 months

    Calculated using the 2006 World Health Organization Child Growth Standards

Secondary outcomes

  1. Changes in the prevalence of stunting from baseline at 6 months

    Time frame: 6 months

    Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ <-2)

  2. Changes in the prevalence of stunting from baseline at 12 months

    Time frame: 12 months

    Calculated using the 2006 World Health Organization Child Growth Standards (zHAZ <-2)

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

    Time frame: 6 months

    Calculated using the 2006 World Health Organization Child Growth Standards

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

    Time frame: 12 months

    Calculated using the 2006 World Health Organization Child Growth Standards

  5. Assessment of rapid weight gain after 6 months of intervention

    Time frame: 6 months

    Defined as a zBMI upward percentile crossing (>+0.67 SD) Calculated using the 2006 World Health Organization Child Growth Standards

  6. Assessment of rapid weight gain after 12 months of intervention

    Time frame: 12 months

    Defined as a zBMI upward percentile crossing (>+0.67 SD) Calculated using the 2006 World Health Organization Child Growth Standards

  7. Changes in the prevalence of diarrhea from baseline at 12 months

    Time frame: 12 months

    Defined as three or more liquid or semisolid stools in 24 hours

  8. Changes in the prevalence of Respiratory symptoms from baseline at 12 months

    Time frame: 12 months

    Defined as reported presence of cough, or nasal congestion, or ear ache, or sore throat in the last 7 days.

  9. Changes in the prevalence of Respiratory infections from baseline at 12 months

    Time frame: 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

  10. Changes in the food insecurity scores from baseline at 6 months

    Time frame: 6 months

    Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)

  11. Changes in the food insecurity scores from baseline at 12 months

    Time frame: 12 months

    Measured using the 2012 Latin American and Caribbean scale of Food insecurity (Escala Latinoamercana y Caribeña de Seguridad Alimentaria)

  12. Changes in the dietary diversity scores from baseline at 6 months

    Time frame: 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)

  13. Changes in the dietary diversity scores from baseline at 12 months

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Palacios, MD, PhD

CONTACT

[email protected]

4193244643

Sponsors and collaborators

Lead sponsor

Georgia Southern University

Other

Collaborators

  • Shoulder to Shoulder

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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