The INICIO-Guatemala Study (INICIO)

IGHID 12601 - Improving Neurodevelopment With an Intestinal Health and Caregivers' Intervention in the surOeste, Guatemala: The INICIO-Guatemala Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Development, Child
• Intervention / Treatment: Dietary supplement: Nutri-INICIO; Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC; Other: Active Control

Detailed Description

The investigators plan to enroll 400 pregnant women during the second trimester of pregnancy; randomization of mother-child dyads into the four study groups will occur at 6 months of infant age; infants will be followed through 24 months of age. Randomization will occur using a 2×2 factorial design into the four groups. The nutritional intervention, Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. The caregiver intervention, the Mediational Intervention for Sensitizing Caregivers (MISC), consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neudy Rojop, MPH; Phone Number: +502-3794-4597; Email: neudy.rojop.fsigcu@gmail.com

Study Locations

• Guatemala
  • Departamento de Quetzaltenango
    • Coatepeque, Departamento de Quetzaltenango, Guatemala
      • Fundacion para la Salud Integral de los Guatemaltecos
      • Contact: Neudy Rojop; Phone Number: +505-3794-4597; Email: Neudy Rojop <neudy.rojop.fsigcu@gmail.com>

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Intervention; Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age.	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.
Experimental: Caregiver Intervention; Caregivers of child participants in this arm will be trained in the Mediational Intervention for Sensitizing Caregivers (MISC) between 12 and 24 months of child age.	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.
Experimental: Nutritional Intervention and Caregiver Intervention; Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age and their caregivers will be trained in the MISC between 12 and 24 months of child age.	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.
Active Comparator: Active Control; Children in this arm will receive the same number of study visits as the experimental groups and will receive essential components of the Minister of Health's childcare package, including micronutrient supplementation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC)	Comprehensive neurodevelopment score, combining scores from the four "cognitive" domains of fine motor, visual reception, receptive language, and expressive language. Z-scores for each of the 4 domains will be calculated by regressing raw score for age. The mean of those four Z-scores will make up the Early Learning Composite Z-score. The score will range from -3 to +3, with the higher score indicating more advanced neurodevelopment.	24 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mullen Scales of Early Learning Gross Motor Domain	The MSEL gross motor domain measures the child's gross motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced gross motor development.	24 months
Mullen Scales of Early Learning Fine Motor Domain	The MSEL fine motor domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced fine motor development.	24 months
Mullen Scales of Early Learning Visual Reception Domain	The MSEL visual reception domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced fine motor development.	24 months
Mullen Scales of Early Learning Receptive Language Domain	The MSEL receptive language domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced receptive language development.	24 months
Mullen Scales of Early Learning Expressive Language Domain	The MSEL expressive language domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced expressive language development.	24 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Sylvia Becker-Dreps, MD, MPH, University of North Carolina, Chapel Hill; Principal Investigator: Amy K Connery, PsyD, University of Colorado School of Medicine; Principal Investigator: Diva Mirella Barrientos Giron, MD, Fundacion para la Salud Integral de los Guatemaltecos

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2030
• Study Completion (Estimated): June 15, 2030

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Microbiome; Caregiving; Nutritional intervention; Rice bran; Bean flour
• Other Study ID Numbers: 26-0089; R01HD116306 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared at the time of publication. The data from this study will be made publicly available on the NICHD Data and Specimen Hub (DASH) (https://dash.nichd.nih.gov/) .
• IPD Sharing Time Frame: At the time of publication and will continue to be available for a period of at least 7 years.
• IPD Sharing Access Criteria: The data from this study will be made publicly available on the NICHD Data and Specimen Hub (DASH) (https://dash.nichd.nih.gov/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No