INICIO-Guatemala Study Evaluating Nutritional and Caregiver Interventions to Improve Child Neurodevelopment from Birth to 24 Months

What this Trial Is About

Researchers are evaluating how a nutritional intervention targeted at improving intestinal health and a caregiver training program affect childhood neurodevelopment in rural southwest Guatemala. This randomized controlled trial aims to understand the impact of these interventions alone and combined on child development, assessed primarily by the Mullen Scales of Early Learning MSEL Early Learning Composite Score at 24 months. Secondary measures include motor skills, language, and visual reception. The study enrolls pregnant women and follows mother-child pairs through early childhood. Participants will be divided into four groups using a factorial design one receiving the Nutri-INICIO nutritional porridge, another receiving caregiver training called the Mediational Intervention for Sensitizing Caregivers MISC, a third group receiving both interventions, and a control group receiving standard health care visits. Nutri-INICIO is a fortified maize-bean-rice bran porridge given daily in increasing amounts from 6 to 24 months of age. MISC involves twice-monthly video-feedback caregiver training sessions from 12 to 24 months. All groups receive essential childcare components including micronutrient supplementation, anti-parasite treatment, and anemia screening. Participants are enrolled as pregnant women in their second trimester and their newborns join the study at birth. Mother-child pairs are randomized when the child reaches 6 months and followed until 24 months. Researchers monitor development through scheduled assessments using the MSEL, track adherence to interventions, and provide anemia treatment when needed. The study collects developmental scores and health data to evaluate the interventions effects on child growth and neurodevelopment over an 18-month period after randomization.

The INICIO-Guatemala Study