The INICIO-Guatemala Study
ConditionDevelopment, Child
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-50
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nutri-INICIO
- Mediational Intervention for Sensitizing Caregivers (MISC
- Active Control
Treatment groups
400 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov