The INICIO-Guatemala Study

University of North Carolina (UNC)

Status: Begins enrollment in 4 months

Conditions: Development, Child

Treatments: Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC; Dietary Supplement: Nutri-INICIO; Other: Active Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07383428

26-0089

R01HD116306 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: Under 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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400 participants in 4 patient groups

Nutritional Intervention

Experimental group

Description:

Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age.

Treatment:

Dietary Supplement: Nutri-INICIO

Caregiver Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC

Nutritional Intervention and Caregiver Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nutri-INICIO

Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC

Active Control

Active Comparator group

Description:

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.

Treatment:

Other: Active Control