The INICIO-Guatemala Study
INICIO
IGHID 12601 - Improving Neurodevelopment With an Intestinal Health and Caregivers' Intervention in the surOeste, Guatemala: The INICIO-Guatemala Study
2 other identifiers
interventional
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2026
CompletedFirst Posted
Study publicly available on registry
February 3, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2030
Study Completion
Last participant's last visit for all outcomes
June 15, 2030
February 3, 2026
January 1, 2026
4 years
January 26, 2026
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Mullen Scales of Early Learning Gross Motor Domain
24 months
Mullen Scales of Early Learning Fine Motor Domain
24 months
Mullen Scales of Early Learning Visual Reception Domain
24 months
Mullen Scales of Early Learning Receptive Language Domain
24 months
Mullen Scales of Early Learning Expressive Language Domain
24 months
Study Arms (4)
Nutritional Intervention
EXPERIMENTALChildren in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age.
Caregiver Intervention
EXPERIMENTALCaregivers 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.
Nutritional Intervention and Caregiver Intervention
EXPERIMENTALChildren 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.
Active Control
ACTIVE COMPARATORChildren 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.
Interventions
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.
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundacion para la Salud Integral de los Guatemaltecos
Coatepeque, Departamento de Quetzaltenango, Guatemala
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2026
First Posted
February 3, 2026
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
June 15, 2030
Study Completion (Estimated)
June 15, 2030
Last Updated
February 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- At the time of publication and will continue to be available for a period of at least 7 years.
- 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/).
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/) .