The INICIO-Guatemala Study

Official title

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

Overview

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.

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.

Interventions

• 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
• 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.
• 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.

Primary outcome measures

• Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC) [Time frame: 24 months of age]

Secondary outcome measures (5)

• Mullen Scales of Early Learning Gross Motor Domain [Time frame: 24 months]
• Mullen Scales of Early Learning Fine Motor Domain [Time frame: 24 months]
• Mullen Scales of Early Learning Visual Reception Domain [Time frame: 24 months]
• Mullen Scales of Early Learning Receptive Language Domain [Time frame: 24 months]
• Mullen Scales of Early Learning Expressive Language Domain [Time frame: 24 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Prevention

Study locations

Guatemala · 1 center

• Fundacion para la Salud Integral de los Guatemaltecos — Coatepeque

Identifiers

NCT: NCT07383428 · 26-0089 · R01HD116306

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗