Protocol for the sequential multiple assignment randomized trial to reduce food insecurity and improve adherence in patients with hypertension (SMART-FI)

Top Things to Know

The study addresses a major gap in understanding how to match patients to the “right” level and type of nutrition support over time.

The trial evaluates whether escalating intensity based on response improves outcomes and efficiency in FIM programs.

The inclusion of qualitative and quantitative analyses aims to clarify how and for whom FIM interventions work.

Summary of Conclusion/Findings

This paper describes the SMART-FI study, a sequential multiple assignment randomized trial designed to evaluate a stepped-care approach to addressing food insecurity among adults with uncontrolled hypertension. Participants will first be randomized to either low-intensity support (resource information) or moderate-intensity support (community health worker [CHW] engagement), and those who do not achieve meaningful blood pressure improvement after 3 months will be re-randomized to more intensive interventions, including continued CHW support or medically tailored meals. The study aims to determine which initial and follow-up interventions are most effective for improving blood pressure, dietary adherence (e.g., DASH diet), medication adherence, and food security over a 6–9 month period. It also incorporates mixed methods, including qualitative interviews, to understand mechanisms, participant experiences, and contextual factors influencing outcomes. The trial addresses variability seen in prior food insecurity interventions by testing an adaptive, tiered model that escalates intensity based on patient response rather than applying a single uniform intervention. If effective, this approach could provide a scalable framework for integrating Food is Medicine strategies into clinical care while optimizing resource use.