An interventional study of Nutri-INICIO and Mediational Intervention for Sensitizing Caregivers (MISC in Development, Child, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in Guatemala. Open to participants aged 0 Days to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
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.
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The investigators will offer enrollment to pregnant in the Trifinio region of southwest Guatemala and will enroll their newborns after birth.
Inclusion Criteria:
Exclusion Criteria:
Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age.
Dietary Supplement: Nutri-INICIO
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
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 · Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC
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
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.
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.
Time frame: 24 months of age
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Plan to share: Yes — 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/) .
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/).
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