Does a food insecurity intervention improve perinatal outcomes for mother and child? A randomized control study protocol of the Fresh Rx: Nourishing Healthy Starts program

Background: Pregnancy and postpartum periods represent critical times to support nutrition and household food security, especially for families with limited or strained economic resources. The Fresh Rx: Nourishing Healthy Starts study uses a randomized design to examine a comprehensive, holistic "food is medicine" program targeting food insecure expectant mothers in an area with high rates of inequitable adverse maternal and birth outcomes. Participants receive weekly fresh food deliveries from a Combined Community Supported Agriculture partner, cooking and nutrition supports, access to culinary skills education from a trained chef, and counseling and care management. In addition to providing basic cooking tools and pantry staples, the program links participants with locally available community resources and federal food assistance programs such as the Supplemental Nutrition Assistance Program and Special Supplemental Nutrition Program for Women, Infants, and Children. Design and methods: This study protocol establishes a randomized control design with a control and two treatment groups to isolate distinct program components and examine variation across outcomes including household food security, maternal depressive symptoms, gestational age, and birthweight. The study design and protocol follow Consolidated Standards of Reporting Trials (CONSORT) principles to emphasize transparency and replicability. Expected impact of the study for Public Health: Guided by the Cycle of Food Insecurity and Chronic Disease, study implications for public health are significant given the program's potential for improving birth outcomes, reducing per capita healthcare costs, and filling a notable policy and program gap during the critical perinatal period for mother and child alike.