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

Wake Forest University (WFU)

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: community health worker (CHW); Behavioral: Resource information Supplemental Nutrition Assistance Program (SNAP); Behavioral: medically tailored meals

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05800145

IRB00094934

5K23HL146902-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

resource referral

Experimental group

Description:

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).

Treatment:

Behavioral: Resource information Supplemental Nutrition Assistance Program (SNAP)

community health worker (CHW) intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: community health worker (CHW)

medically tailored meals (MTM)

Active Comparator group

Description:

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

Treatment:

Behavioral: medically tailored meals