Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Interventions are being used to address food insecurity in clinical care settings, but people differ in the support they need to reduce food insecurity and little is known about which food insecurity interventions work best, or for whom. The goal of this study is to develop and test an adaptive food insecurity intervention using a Sequential Multiple Assignment Randomized Trial to determine which initial food insecurity intervention is more effective in improving adherence and blood pressure in patients with hypertension and for those who do not respond to the initial intervention, evaluate how to best provide additional support.

NCT Number	NCT07031739
Lead Sponsor	Wake Forest University Health Sciences Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Uncontrolled Hypertension
Enrollment	224 participants
Start Date	2025-08-18
Primary Completion	2029-09 (estimated)
Study Completion	2030-02 (estimated)
Updated on ClinicalTrials.gov	2026-05-06