Effects of Complementary Feeding of Eggs on Infant Development and Growth in Guatemala: The Saqmolo Study

NCT04316221 | Completed DMC

• 1 other identifier: AcademyND
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are: In a randomized controlled trial, the investigators will evaluate the impact of daily egg consumption during the complementary feeding period in addition to the local standard of nutrition care (i.e., intervention group), compared to the local standard of nutrition care alone (i.e., control group) on the following outcomes, in infants that are \~6-month old at baseline:

1. 1.Child development, as measured by global development scores (primary outcome)
2. 2.Growth, as measured by anthropometrics (secondary outcome)
3. 3.Diet quality, as measured by the World Health Organization infant and young child feeding indicators (secondary outcome)

Conditions

Growth; Development; Delayed

Keywords

Eggs; nutrition; growth stunting; infant development

Outcome Measures

Primary Outcomes (2)

• Caregiver Reported Child Development Instruments (CREDI)

  The long form CREDI uses caregiver report and captures five domains: motor, language, cognition, social-emotional, and mental health. The CREDI is designed specifically to measure normal development within populations and has been tested in high, middle and low income countries The CREDI included a Guatemalan sample in the validation

  6 months

• Guide for Monitoring Child Development (GMCD)

  The GMCD has been used in low- and middle-income countries in children ages 0-24 months and focuses on seven areas: expressive language, receptive language, fine motor, gross motor, relating, play, and self-help.

  6 months

Secondary Outcomes (5)

• changes in infant hemoglobin

  6 months

• weight-for-age

  6 months

• length-for-age

  6 months

• Head circumference

  6 months

• Infant diet quality

  6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

The standard of nutrition care in Guatemala includes the following clinical care, as determined to be necessary by the MHA medical and nutrition teams: frequent growth monitoring, general nutrition education, parasite treatment, and multiple micronutrient supplementation.

Other: Standar of care

Intervention

EXPERIMENTAL

The intervention group will receive an intervention to promote daily egg consumption for a six month period, in addition to the local standard of nutrition care. Specifically, intervention group participants will be provided with enough eggs for the infant to consume one egg, daily, for six months, and also with education on preparation and consumption of eggs.

Dietary Supplement: Eggs plus standard of care

Interventions

Eggs plus standard of care DIETARY_SUPPLEMENT

Eggs will be secured locally and delivered to families weekly.

Intervention

Standar of care OTHER

frequent growth monitoring, general nutrition education, parasite treatment, and multiple micronutrient supplementation.

Control

Eligibility Criteria

• Age: 6 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants who are 6.0-9.0 months of age at baseline
• At least one caregiver willing to provide oral informed consent
• Planned residence in the study area for approximately the next 18 months
• Singleton birth

You may not qualify if:

• Infants with moderate to severe acute malnutrition (weight-for-length z-score \< -2)
• Infants with severe anemia (Hgb \<7 g/dL per WHO guidelines, with adjustments for altitude as necessary)
• Infants with a chronic medical condition that affects growth (e.g., congenital heart disease, genetic condition) as determined by the MHA staff physician
• Infants whose caregivers have cognitive or other impairments that prevent them from being able to provide informed consent or to reliably provide information required for the developmental assessments
• Infants with a known egg allergy
• Infants with recalcitrant, moderate-to-severe atopic dermatitis
• Infants with a history of anaphylaxis or serious allergic reaction to any substance requiring emergency medical care
• Concurrent participation in any other clinical trial

Sponsors & Collaborators

• Academy of Nutrition and Dietetics: lead
• Wuqu' Kawoq, Maya Health Alliance: collaborator
• Think Healthy Group, Inc.: collaborator

Study Sites (1)

Wuqu' Kawoq/Maya Health Alliance

Tecpán Guatemala, Departamento de Chimaltenango, Guatemala

Location

MeSH Terms

Interventions

Eggs; Standard of Care

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial involving children ages \~6 to 12 months from communities in central Guatemala within Wuqu' Kawoq's catchment area individually randomized to either the intervention or control group.

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 20, 2020
• Study Start: April 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)