HypertensionSMART-FINCT05800145
Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
A study testing Resource information Supplemental Nutrition Assistance Program (SNAP), community health worker (CHW) and medically tailored meals in people with Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Resource information Supplemental Nutrition Assistance Program (SNAP), community health worker (CHW) and medically tailored meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official 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)
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.
Read the 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
- Being tested
- Resource information Supplemental Nutrition Assistance Program (SNAP), community health worker (CHW), medically tailored meals
- Keywords
- Food Insecurities, Systolic Blood Pressure, cardiovascular disease
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource information Supplemental Nutrition Assistance Program (SNAP)Behavioural
Also called 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).
community health worker (CHW)Behavioural
Also called CHW
Participants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location.
medically tailored mealsBehavioural
Also called MTM
Participants will receive 10 medically tailored meals delivery to their home weekly for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: 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 Receives: Behavioral: medically tailored meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Measured: Baseline
Feasibility of Recruitment Percentage
Feasibility will be measured based on the proportion of patients screened who consented to be part of the study
Measured: Baseline
Feasibility of Retention
Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
Measured: Month 6
Diastolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Measured: Baseline
Systolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Measured: Month 3
Diastolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Measured: Month 3
Systolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Measured: Month 6
Diastolic Blood Pressure Readings
assess blood pressure (using ambulatory blood pressure cuffs)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start16 May 2023
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Deepak Palakshappa, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800145
- Sponsor's protocol ID
- IRB00094934
- Other IDs
- 5K23HL146902-04
- Acronym
- SMART-FI
- Status last verified
- Sep 2024
- First submitted
- 22 Mar 2023
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant data that underlie the Results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05800145
- Acronym / sponsor ID
- SMART-FI / IRB00094934
- Conditions
- Hypertension
- Keywords
- Food Insecurities, Systolic Blood Pressure, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 May 2023 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| resource referral | Experimental | Behavioral: Resource information Supplemental Nutrition Assistance Program (SNAP)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). |
| community health worker (CHW) intervention | Active comparator | Behavioral: community health worker (CHW)assist participants in addressing FI and supporting them in their blood pressure management |
| medically tailored meals (MTM) | Active comparator | Behavioral: medically tailored mealsParticipants will receive 10 medically tailored meals delivery to their home weekly for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resource information Supplemental Nutrition Assistance Program (SNAP)Also: SNAPParticipants 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). | Behavioural | resource referral |
| community health worker (CHW)Also: CHWParticipants randomized to the CHW intervention will have an initial baseline visit scheduled at a mutually convenient location. | Behavioural | community health worker (CHW) intervention |
| medically tailored mealsAlso: MTMParticipants will receive 10 medically tailored meals delivery to their home weekly for 3 months | Behavioural | medically tailored meals (MTM) |
Primary outcome
Systolic Blood Pressure Readings
Time frame: Baseline
assess blood pressure (using ambulatory blood pressure cuffs)
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
Feasibility of Retention
Time frame: Month 6
Feasibility will be measured at the proportion of participants who completed 3 and 6 month follow ups
Diastolic Blood Pressure Readings
Time frame: Baseline
assess blood pressure (using ambulatory blood pressure cuffs)
Systolic Blood Pressure Readings
Time frame: Month 3
assess blood pressure (using ambulatory blood pressure cuffs)
Diastolic Blood Pressure Readings
Time frame: Month 3
assess blood pressure (using ambulatory blood pressure cuffs)
Systolic Blood Pressure Readings
Time frame: Month 6
assess blood pressure (using ambulatory blood pressure cuffs)
Diastolic Blood Pressure Readings
Time frame: Month 6
assess blood pressure (using ambulatory blood pressure cuffs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual Participant data that underlie the Results reported in this article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Palakshappa, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resource information Supplemental Nutrition Assistance Program (SNAP), community health worker (CHW) and medically tailored meals in people with Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure Readings (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.