The INICIO-Guatemala Study

Recruiting now · Not applicable

Conditions studied: Development, Child

In brief

The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala. The main questions it aims to answer are: what is the impact of an intestinal-targeted nutritional intervention on child ND and what is the added benefit of a caregiver intervention on child ND. The primary endpoint is the Mullen Scales of Early Learning (MSEL) Early Learning Composite (ELC) Score at 24 months. Secondary endpoints include MSEL subdomain scores (gross motor, fine motor, expressive language, receptive language, visual reception). Researchers will compare child ND between the four study arms using a factorial design: (1) intestinal health-targeted nutritional intervention, (2) caregiving training program, (3) combined intestinal health-targeted nutritional intervention and caregiving training program, and (4) active control. Participants will be randomized as mother-child dyads at 6 months of age and followed until 24 months of age.

Key facts

Study ID

NCT07383428

Run by

University of North Carolina, Chapel Hill

People needed

400

Starts

2026-07-02

Expected to finish

2030-06-15

Last updated by the study team

2026-07-24

Who can join

Age: any, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Fundacion para la Salud Integral de los Guatemaltecos — Coatepeque, Departamento de Quetzaltenango, Guatemala (enrolling)

Full record on ClinicalTrials.gov

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