Feasibility of an ADAPTive intervention to improve food security and Maternal-Child Health (ADAPT-MCH): Protocol for a pilot sequential multiple assignment randomized trial

Top Things to Know

This study demonstrates that food interventions can be escalated based on individual need.

The design and results of this study reinforce that FIM programs must go beyond access to include relational and logistical support to be effective.

Weekly deliveries of fresh produce or dietitian-designed meals offer targeted nutritional interventions during a critical window for maternal and fetal health

Summary of Conclusion/Findings

The ADAPT-MCH pilot study tests the feasibility of a stepped-care, adaptive Food Is Medicine intervention to improve food security and maternal-child health among pregnant individuals. Conducted at obstetrics clinics in North Carolina, the study enrolls 60 food-insecure pregnant patients and randomizes them to either an electronic health record (EHR) referral to WIC or WIC referral plus care navigation. Those who do not show improvement in food insecurity after three months are re-randomized to receive either weekly produce prescriptions or medically tailored meals (MTM). The study aims to assess feasibility across recruitment, retention, and re-randomization, while also collecting data on maternal and infant health outcomes, dietary intake, and psychological well-being. It is the first trial to test a sequential multiple assignment randomized trial (SMART) design for food insecurity in pregnancy. Findings will inform a future fully powered trial and help determine which combinations of interventions are most effective and scalable.