Healthful foods and caregiver training to support early learning in Guatemalan children
Official title: IGHID 12601 - Improving Neurodevelopment With an Intestinal Health and Caregivers' Intervention in the surOeste, Guatemala: The INICIO-Guatemala Study
Run by University of North Carolina, Chapel Hill · NCT07383428 · Data updated 2026-11-12
This trial tests whether a fortified porridge plus caregiver coaching help 2-year-old children in rural Guatemala develop better neurodevelopment skills, alone or together.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 50 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Coatepeque, Departamento de Quetzaltenango) |
| Status | Recruiting |
| Started | July 2, 2026 |
| Main results expected | June 15, 2030 |
| Study ends | June 15, 2030 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07383428 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children born to pregnant women in the Trifinio region who enroll in the second trimester and plan to reside in the area through 24 months, with caregiver willing to participate in sessions.
✕Probably not a fit
Children whose families relocate outside the study area or who cannot adhere to the intervention schedules may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, factorial study assesses the effects of an intestinal health-targeted nutritional intervention (Nutri-INICIO) and a caregiver training program (MISC) on early neurodevelopment in children from the Trifinio region of Guatemala. Pregnant women in their second trimester are enrolled, and their babies are followed from birth to 24 months, with randomization into four groups: nutrition only, caregiver training only, both interventions, or active control. The primary outcome is the Mullen Scales of Early Learning (ELC) score at 24 months, with secondary outcomes across motor and language domains. The study uses a 2×2 factorial design to evaluate both individual and combined effects of nutrition and caregiving on developmental outcomes.
Why it matters
Potential benefit: If successful, the interventions could improve early neurodevelopment and growth, potentially informing scalable strategies for child development in similar settings.
How similar studies have gone: Prior studies in nutrition and caregiver interventions have shown mixed but promising effects on developmental outcomes in low-resource settings; this trial tests a combined approach in a new regional context.
Who can join: the full rules
Show full inclusion / exclusion criteria
The investigators will offer enrollment to pregnant in the Trifinio region of southwest Guatemala and will enroll their newborns after birth. Inclusion Criteria: * Pregnant woman in the second trimester of pregnancy * Pregnant woman =\>15 years of age * Plan to live in the study area during pregnancy and up to 24 months after giving birth * Newborns born to enrolled women will join the study at birth Exclusion Criteria: * Pregnant woman less than 15 years of age * Planning to move during the study * Not willing or able to participate in the interventions, including following instructions for preparing the food, completing the adherence forms, participating in the caregiving sessions * Women who do not sign the consent form for their or their child's participation * Infants who require a hospital stay after birth of 21 days or longer
Where it's running
-
Fundacion para la Salud Integral de los Guatemaltecos
Coatepeque, Departamento de Quetzaltenango, Guatemala Recruiting
Study contacts
- Principal investigator: Sylvia Becker-Dreps, MD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Neudy Rojop, MPH
- Email: neudy.rojop.fsigcu@gmail.com
- Phone: +502-3794-4597
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.