Fresh RX: Nourishing Healthy Starts Clinical Study

What this Trial Is About

This research evaluates the Fresh Rx: Nourishing Healthy Starts program run by Operation Food Search, a nonprofit in St. Louis. It aims to support food insecure pregnant women with food and nutrition assistance alongside integrative care services. The study tests how effective this approach is in improving health and birth outcomes for mothers and babies, and whether it can reduce healthcare costs. Participants are women receiving care through a Medicaid Managed Care Organization who screen positive for food insecurity. The study randomly assigns participants to one of three groups. The control group receives enhanced usual care including access to a hotline, help enrolling in nutrition assistance programs like SNAP and WIC, and guidance to food pantries. Treatment 1 adds weekly deliveries of fresh food meal kits with recipes, access to kitchen tools, online cooking resources, and nutrition counseling by a registered dietitian. Treatment 2 includes all Treatment 1 services plus integrative care from a licensed social worker to assist with housing, social services, and community connections. Participants provide data through surveys at multiple points: baseline, about 3 months later, 60 days postpartum, and one year postpartum. Health claims data from Medicaid will also be analyzed, without personally identifying information. Researchers will measure food insecurity changes, birth outcomes like gestational age and weight, health visits, maternal mental and physical health, and infant outcomes including hospitalization and growth. The study runs from enrollment through one year postpartum, with detailed monitoring of both mother and child health.

Fresh RX: NHS 2020