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

NCT05800145 | Completed Results

• 2 other identifiers: IRB000949345K23HL146902-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Food Insecurities; Systolic Blood Pressure; cardiovascular disease

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

resource referral

EXPERIMENTAL

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)

community health worker (CHW) intervention

ACTIVE COMPARATOR

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

Behavioral: community health worker (CHW)

medically tailored meals (MTM)

ACTIVE COMPARATOR

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

Behavioral: medically tailored meals

Interventions

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).

Also known as: SNAP

resource referral

community health worker (CHW) BEHAVIORAL

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

Also known as: CHW

community health worker (CHW) intervention

medically tailored meals BEHAVIORAL

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

Also known as: MTM

medically tailored meals (MTM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Deepak Palakshappa, MD
• Organization: Wake Forest University Health Sciences

dpalaksh@wakehealth.edu

3367161795

Study Officials

• Deepak Palakshappa, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The objective of this study is to conduct a pilot sequential multiple assignment randomized trial (SMART) addressing food insecurity in patients with uncontrolled Hypertension (HTN) to determine the feasibility of recruitment/retention and the potential impact on blood pressure in anticipation of a larger more definitive trial.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 5, 2023
• Study Start: May 16, 2023
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose

Locations

US (1)