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

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ClinicalTrials.gov Identifier: NCT04316221
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : July 8, 2021
Sponsor:
Collaborators:
Wuqu' Kawoq, Maya Health Alliance
Think Healthy Group, Inc.
Information provided by (Responsible Party):
Academy of Nutrition and Dietetics

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

Hypothesis: The investigators hypothesize that daily consumption of eggs during the complementary feeding period, in addition to the local standard of nutrition care, will improve child development, growth, and diet quality compared to the local standard of care alone.


Condition or disease Intervention/treatment Phase
Growth Development; Delayed Dietary Supplement: Eggs plus standard of care Other: Standar of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects ofComplementary Feeding of Eggs on Infant Developmentand Growth in Guatemala: The Saqmolo Study
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2023

Arm Intervention/treatment
Active Comparator: Control
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
frequent growth monitoring, general nutrition education, parasite treatment, and multiple micronutrient supplementation.

Experimental: Intervention
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
Eggs will be secured locally and delivered to families weekly.




Primary Outcome Measures :
  1. Caregiver Reported Child Development Instruments (CREDI) [ Time Frame: 6 months ]
    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

  2. Guide for Monitoring Child Development (GMCD) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. changes in infant hemoglobin [ Time Frame: 6 months ]
    Point-of-care hemoglobin will be assessed using a capillary blood sample obtained from the infant's heel or finger and a HemoCue® Hb201+ promo (HemoCue AB, Angelholm, Sweden).

  2. weight-for-age [ Time Frame: 6 months ]
    weight as appropriate for chronological age. Weight will be monitored using a hanging Salter scale to the nearest 0.1 kg.

  3. length-for-age [ Time Frame: 6 months ]
    Infant length will be measured using a portable stadiometer to the nearest 1 mm.

  4. Head circumference [ Time Frame: 6 months ]
    Head circumference will be measured using non-stretchy measuring tape to the nearest 1 mm.

  5. Infant diet quality [ Time Frame: 6 months ]
    Infant diet quality will be measured using the World Health Organization Infant and Young Child Feeding indicators questionnaire



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Ages Eligible for Study:   6 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316221


Contacts
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Contact: Alison L Steiber 2162124060 asteiber@eatright.org
Contact: Gabriela Proano 312-899-4742 gproano@eatright.org

Locations
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Guatemala
Wuqu' Kawoq/Maya Health Alliance Recruiting
Tecpán Guatemala, Chimaltenango, Guatemala
Contact: Peter Rohloff, MD, PhD    617-447-3034    peter@wuqukawoq.org   
Contact: Gabriela Proano, MS, RDN    312-899-4842    gproano@eatright.org   
Principal Investigator: Taylor C Wallace, PhD         
Principal Investigator: Alison L Steiber, PhD, RDN         
Principal Investigator: Elizabeth Yake Jimenez, PhD, RDN         
Sponsors and Collaborators
Academy of Nutrition and Dietetics
Wuqu' Kawoq, Maya Health Alliance
Think Healthy Group, Inc.
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Responsible Party: Academy of Nutrition and Dietetics
ClinicalTrials.gov Identifier: NCT04316221    
Other Study ID Numbers: AcademyND
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Academy of Nutrition and Dietetics:
Eggs
nutrition
growth stunting
infant development