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

BACKGROUND

Food insecurity is a barrier to patients adhering to prescribed hypertension treatments and is strongly associated with worse blood pressure. Health systems are implementing interventions to assist patients with food insecurity, but rather than providing a single intervention, a stepped-care approach to providing interventions could be a more effective strategy. Our objective is to determine the effectiveness of a stepped-care food insecurity intervention on blood pressure and adherence among patients with uncontrolled hypertension.

METHODS/

DESIGN

We will conduct a sequential multiple assignment randomized trial. Adults (≥18 years) with uncontrolled hypertension (>130/80) who report food insecurity will be randomized to one of two first-stage interventions: 1) information about community resources or 2) community health worker (CHW) support. Participants who do not have ≥10 mmHg improvement in systolic blood pressure after 3 months will be re-randomized to one of two second-stage interventions for an additional 3 months: 1) CHW support or 2) delivery of medically tailored meals. In Aim 1, we will determine which first-stage intervention is more effective in improving blood pressure and adherence. In Aim 2, we will evaluate which intervention is the best next step for those who do not respond to the initial intervention. In Aim 3, we will advance our understanding of how and why participants achieved improvements through qualitative and quantitative data analysis.

CONCLUSIONS

This will be the first study to test the effectiveness of a stepped-care food insecurity intervention. Given the growing interest among health systems, an efficacious, stepped-care food insecurity intervention could be broadly disseminated.

TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov (NCT07031739) on June 22, 2025.