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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Resource information Supplemental Nutrition Assistance Program (SNAP); Behavioral: community health worker (CHW); Behavioral: medically tailored meals

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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).; Other Names: SNAP
Active Comparator: community health worker (CHW) intervention; assist participants in addressing FI and supporting them in their blood pressure management	Behavioral: community health worker (CHW); Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.; Other Names: CHW
Active Comparator: medically tailored meals (MTM); Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months	Behavioral: medically tailored meals; Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months; Other Names: MTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Baseline
Feasibility of Recruitment Percentage	Feasibility will be measured based on the proportion of patients screened who consented to be part of the study	Baseline
Feasibility of Retention	Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups	Month 6
Diastolic Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Baseline
Systolic Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Month 3
Diastolic Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Month 3
Systolic Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Month 6
Diastolic Blood Pressure Readings	assess blood pressure (using ambulatory blood pressure cuffs)	Month 6

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Deepak Palakshappa, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: cardiovascular disease; Systolic Blood Pressure; Food Insecurities
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: IRB00094934; 5K23HL146902-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual Participant data that underlie the Results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No