The INICIO-Guatemala Study: Improving Neurodevelopment with an Intestinal Health and Caregivers’ Intervention in the Occidente, Guatemala

Child neurodevelopment (ND) is significantly impacted by nutrition in early life, a time of rapid growth and intricate development of the neurological system. In low resource settings, we now know that meeting nutrient recommendations alone is not enough to support optimal child growth and ND—a key driver of malnutrition and poor ND is environmental enteric dysfunction (EED), a subclinical intestinal condition of chronic inflammation and increased permeability. Therefore, to reduce the burden of poor ND, novel nutritional interventions are needed that incorporate this new understanding of intestinal health. Rice bran is a food with known prebiotic properties, important nutrients and phytochemicals, and has been shown to decrease biomarkers of intestinal damage and improve child growth. In addition, common beans provide essential amino acids and contain fiber, folate, iron and zinc that might further slow the progression of EED. In addition to appropriate nutrition, psychosocial stimulation in early childhood may have positive effects on ND, independent of nutrition. A caregiver training implemented by members of our research team resulted in higher quality caregiving and improved child ND in high-risk children in other low-resource settings. The potential benefits of combining this caregiver training with an “intestinal health-targeted” nutritional intervention on child ND are not known. Together with US academic partners, the Fundación para la Salud Integral de los Guatemaltecos (FSIG) has shown the feasibility of rice bran supplementation at the study site and has adapted the performance-based Mullen Scales of Early Learning (MSEL) to this context, revealing a high burden of poor child ND. In the proposed study, our multi-disciplinary team plans to conduct a randomized controlled trial with a 2X2 factorial design to understand the individual and combined effects of an intestinal health-targeted nutritional intervention and a caregiver training on child ND. We will integrate Guatemalan trainees in psychology, nursing, and nutrition into this research to build local capacity in child ND research. 400 Guatemalan mother-infant dyads will be randomized into 4 groups: 1) 100 children will receive 18 months of nutritional supplementation with “Frijolatole Plus,” a porridge (‘atole’) containing complete protein from common beans and maize, micronutrients, and rice bran as a prebiotic agent to support intestinal health and nutrition, 2) 100 will receive the Mediational Intervention for Sensitizing Caregivers between 12 and 24 months of age, 3) 100 will receive both interventions, and 4) 100 will form an active control group. Our primary outcome is ND at 24 months, as assessed by the MSEL. To accelerate future research on child ND in the region, we will contribute to international efforts to develop the WHO’s Global Scales of Early Development (GSED), as well as foster a cadre of Guatemalan students on their path to future research on child ND in the region. Project Number: 1R01HD116306-01A1 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Sylvia Becker-Dreps (+2 co-PIs) | Institution: UNIV OF NORTH CAROLINA CHAPEL HILL, CHAPEL HILL, NC | Award Amount: $504,248 | Activity Code: R01 | Study Section: Special Emphasis Panel[ZRG1 CN-H (55)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R01HD11630601A1