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
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:
- Child development, as measured by global development scores (primary outcome)
- Growth, as measured by anthropometrics (secondary outcome)
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|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)|
|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|
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.
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.
- 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
- 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.
- 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).
- 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.
- length-for-age [ Time Frame: 6 months ]Infant length will be measured using a portable stadiometer to the nearest 1 mm.
- Head circumference [ Time Frame: 6 months ]Head circumference will be measured using non-stretchy measuring tape to the nearest 1 mm.
- 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
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
|Contact: Alison L Steiberemail@example.com|
|Contact: Gabriela Proanofirstname.lastname@example.org|
|Wuqu' Kawoq/Maya Health Alliance||Recruiting|
|Tecpán Guatemala, Chimaltenango, Guatemala|
|Contact: Peter Rohloff, MD, PhD 617-447-3034 email@example.com|
|Contact: Gabriela Proano, MS, RDN 312-899-4842 firstname.lastname@example.org|
|Principal Investigator: Taylor C Wallace, PhD|
|Principal Investigator: Alison L Steiber, PhD, RDN|
|Principal Investigator: Elizabeth Yake Jimenez, PhD, RDN|