Design of a clinical trial to isolate the experience of food insecurity and elucidate the biological mechanisms of risk for childhood health outcomes

Abstract

BackgroundFood insecurity affects one in seven households with children in the United States, disproportionately impacts households headed by women and minorities, and is associated with childhood comorbidities, including obesity. While food insecurity likely contributes to poor health through its effect on diet, such a simplistic understanding likely obscures the effects of poverty-related stress and other Adverse Childhood Experiences, on metabolic health. MethodsOver two summers, 100 children, ages 8–12 years, will be recruited from low-income households in an urban, Rhode Island community, to participate in an 8-week trial designed to isolate the experience of food insecurity. Summer represents a natural risk period of food insecurity in children, such that children will be randomized to receive weekly shipments of five breakfast and lunch meals that mimic school meals or to experience the likely onset of summertime food insecurity and receive a weekly newsletter on community resources that is not expected to affect food insecurity. Through assessment visits at baseline, mid-summer and end of summer, we will examine group differences in change in diet quality, biomarkers of Metabolic Syndrome, inflammation, and stress, BMI z-scores, and child measures of behavior and anxiety and depression symptoms. We will also explore the impact of caregiver mood and stress on the health effects of food insecurity. ConclusionsFindings stand to clarify the mechanisms by which food insecurity affects child health outcomes and to inform how to best address food insecurity in the context of poverty-related stress. Trial registrationThis trial has been registered at ClinicalTrials.gov (NCT04968496).