The INICIO-Guatemala Study

Summary

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.

Conditions

• Development, Child

Interventions

DIETARY_SUPPLEMENT

Nutri-INICIO

Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. Caregivers will be instructed on Nutri-INICIO preparation methods. Children 6-11 months old will receive a 20 gram daily serving, children 12-17 months old will receive a 30 gram daily serving, children 18-24 months old will receive a 40 gram daily serving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.

BEHAVIORAL

Mediational Intervention for Sensitizing Caregivers (MISC

The Mediational Intervention for Sensitizing Caregivers (MISC) consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.

OTHER

Active Control

The control group will receive the same number of visits as the experimental groups and the investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Sylvia Becker-Dreps, MD, MPH · University of North Carolina, Chapel Hill

• Amy K Connery, PsyD · University of Colorado School of Medicine

• Diva Mirella Barrientos Giron, MD · Fundacion para la Salud Integral de los Guatemaltecos

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

0 Days

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-02

Primary Completion

2030-06-15

Completion

2030-06-15

Countries

• Guatemala

Study Locations