NCT05800145

Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)

Pilot Study to Evaluate the Feasibility of Using a Sequential Multiple Assignment Randomized Trial to Address Food Insecurity in Patients With Hypertension (Pilot SMART-FI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the US, 47% of adults have hypertension (HTN), and HTN accounts for more cardiovascular disease (CVD) deaths than any other CVD risk factor. Thus, the lack of an adaptive, stepped-care intervention to address FI in patients with HTN is a critical problem affecting a large, vulnerable population.

Detailed description

Despite advances in prevention and treatment, barriers to adherence are common and HTN disparities remain pervasive. Populations that have been socially and economically disadvantaged have a greater prevalence of HTN, worse blood pressure control, and are at higher risk of developing CVD from HTN. Food insecurity (FI), the lack of consistent access to nutritionally adequate foods, is an important social need that affects 30 million people in the US, impacts adherence to treatment, and contributes to HTN disparities. Increasingly, health systems are investing in interventions to address FI as part of routine care, including lower-cost, low intensity (e.g. providing information about community resources) and higher-cost, high intensity (e.g. using community health workers (CHWs), delivery of medical tailored meals (MTM)) interventions

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Resource information Supplemental Nutrition Assistance Program (SNAP)	Participants randomized to the resource referral arm will receive a tailored list of information about community resources. The list will include information about local emergency food resources (e.g. local food pantries) and government programs to address FI (e.g. SNAP).
BEHAVIORAL	community health worker (CHW)	Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.
BEHAVIORAL	medically tailored meals	Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months

Timeline

• Start date: 2023-05-16
• Primary completion: 2024-09-03
• Completion: 2024-09-03
• First posted: 2023-04-05
• Last updated: 2025-08-05
• Results posted: 2025-08-05

Locations

1 site across 1 country: United States