Skip to main content
OpenTrials
Completed

NCT Number: NCT05800145

Trial to Address Food Insecurity in Patients With Hypertension (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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resource information Supplemental Nutrition Assistance Program (SNAP)

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).

Other names: SNAP

Community Health Worker (CHW)

Behavioral

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

Other names: CHW

Medically tailored meals

Behavioral

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

Other names: MTM

Primary outcomes

  1. Systolic Blood Pressure Readings

    Time frame: Baseline

    assess blood pressure (using ambulatory blood pressure cuffs)

  2. Feasibility of Recruitment Percentage

    Time frame: Baseline

    Feasibility will be measured based on the proportion of patients screened who consented to be part of the study

  3. Feasibility of Retention

    Time frame: Month 6

    Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups

  4. Diastolic Blood Pressure Readings

    Time frame: Baseline

    assess blood pressure (using ambulatory blood pressure cuffs)

  5. Systolic Blood Pressure Readings

    Time frame: Month 3

    assess blood pressure (using ambulatory blood pressure cuffs)

  6. Diastolic Blood Pressure Readings

    Time frame: Month 3

    assess blood pressure (using ambulatory blood pressure cuffs)

  7. Systolic Blood Pressure Readings

    Time frame: Month 6

    assess blood pressure (using ambulatory blood pressure cuffs)

  8. Diastolic Blood Pressure Readings

    Time frame: Month 6

    assess blood pressure (using ambulatory blood pressure cuffs)

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

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

Registry information

Official study title

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)

Acronym: SMART-FI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.