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NCT Number: NCT07383428

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.

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Key information

Conditions

Age range

0 day–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion para la Salud Integral de los Guatemaltecos

Coatepeque, Departamento de Quetzaltenango, Guatemala

Location status: Recruiting

Location contact

Neudy Rojop

CONTACT

Neudy Rojop <[email protected]>

+505-3794-4597

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutri-INICIO

Dietary Supplement

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.

Mediational Intervention for Sensitizing Caregivers (MISC

Behavioral

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 Control

Other

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.

Primary outcomes

  1. Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC)

    Time frame: 24 months of age

    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.

Secondary outcomes

  1. Mullen Scales of Early Learning Gross Motor Domain

    Time frame: 24 months

    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.

  2. Mullen Scales of Early Learning Fine Motor Domain

    Time frame: 24 months

    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.

  3. Mullen Scales of Early Learning Visual Reception Domain

    Time frame: 24 months

    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.

  4. Mullen Scales of Early Learning Receptive Language Domain

    Time frame: 24 months

    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.

  5. Mullen Scales of Early Learning Expressive Language Domain

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Neudy Rojop, MPH

CONTACT

[email protected]

+502-3794-4597

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Official study title

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

Acronym: INICIO

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 3, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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