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

NCT ID: NCT05800145

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2024-09-03

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

resource referral

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 Food Insecurities (FI) Supplemental Nutrition Assistance Program (SNAP).

Group Type: EXPERIMENTAL

Resource information Supplemental Nutrition Assistance Program (SNAP)

Intervention Type: BEHAVIORAL

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).

community health worker (CHW) intervention

assist participants in addressing FI and supporting them in their blood pressure management

Group Type: ACTIVE_COMPARATOR

community health worker (CHW)

Intervention Type: BEHAVIORAL

Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.

medically tailored meals (MTM)

Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months

Group Type: ACTIVE_COMPARATOR

medically tailored meals

Intervention Type: BEHAVIORAL

Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months

Interventions

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).

Intervention Type: BEHAVIORAL

community health worker (CHW)

Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.

Intervention Type: BEHAVIORAL

medically tailored meals

Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months

Intervention Type: BEHAVIORAL

Other Intervention Names

SNAP; CHW; MTM

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥18 years of age)
• diagnosis of Hypertension (HTN) (defined by ICD-10 code) or have been prescribed at least one blood pressure medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
• blood pressures at their primary care office was >130/80
• experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
• live in Winston-Salem or Forsyth County

Exclusion Criteria

• unable to speak English or Spanish
• have severe cognitive impairment or major psychiatric illness that prevents consent and participation
• lack of safe, stable residence and ability to store meals
• pregnant, breastfeeding, or planning to become pregnant in the next year
• advance kidney disease (estimated creatine clearance < 30 mL/min)
• serious medical condition which either limits life expectancy or requires active management
• those planning on moving out of the geographic area within 12 months
• lack of a telephone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deepak Palakshappa, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5K23HL146902-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00094934

Identifier Type: -

Identifier Source: org_study_id