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

NCT05800145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-05

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Deepak Palakshappa, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2024-09-03
Completion
2024-09-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05800145 on ClinicalTrials.gov