Uncontrolled HypertensionSMARTNCT07031739
Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
A study testing Resource information, Community Health Worker (CHW) assistance and Medically-tailored Meals (MTM) in people with Uncontrolled Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Resource information, Community Health Worker (CHW) assistance and Medically-tailored Meals (MTM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Must Speak English or Spanish
- have a diagnosis of Hypertension (HTN)
- prescribed at least one blood pressure lowering medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
- past 2 blood pressures at their primary care doctor were greater than or equal to130/80mmHg (millimeters of Mercury)
- seen by their primary care doctor in the past 6 months
- experience Food Insecurities (FI) based on the 2-item Hunger Vital Sign
Who cannot join
- Systolic Blood Pressure > 210mmHg or a diastolic blood pressure > 120mmHg
- have a severe cognitive impairment or major psychiatric illness that prevents consent or serious medical condition which either limits life expectancy or requires active management (e.g. certain cancers)
- pregnant, breastfeeding, or planning to become pregnant in the next 6 months
- planning on moving out of the area within 6 months
- lack safe stable housing
- do not have the ability to store meals
- lack of a telephone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Rebecca Stone, MPH, 336-713-5544, Rebecca.J.Stone@Advocatehealth.org
Deepak Palakshappa, MD, MSHP
About this study
Official title: Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients With Hypertension
Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Interventions are being used to address food insecurity in clinical care settings, but people differ in the support they need to reduce food insecurity and little is known about which food insecurity interventions work best, or for whom. The goal of this study is to develop and test an adaptive food insecurity intervention using a Sequential Multiple Assignment Randomized Trial to determine which initial food insecurity intervention is more effective in improving adherence and blood pressure in patients with hypertension and for those who do not respond to the initial intervention, evaluate how to best provide additional support.
Read the detailed description
In the US, 47% of adults have hypertension (HTN), and HTN is the leading cause of cardiovascular disease morbidity and mortality. Uncontrolled HTN increases the risk of cardiovascular disease, chronic kidney disease, and cognitive impairment. Current guidelines recommend the adoption of a healthy diet as an integral part of ongoing treatment regardless of the underlying antihypertensive drug treatment. The Dietary Approaches to Stop Hypertension (DASH) eating pattern is a diet rich in fruits, vegetables, and whole grains with a reduced content of sodium and saturated fat. The DASH is the diet with the strongest evidence to be effective for lowering blood pressure. Despite the evidence base for the effectiveness of DASH as well as pharmacological treatments, economic factors are common barriers to individuals with HTN adhering to treatments. Adherence is multidimensional and involves initiation, implementation, and persistence. Food insecurity (FI), the lack of consistent access to the food needed for a healthy life, is an important factor that leads to HTN disparities. Individuals living in food insecure households are less likely to adhere to prescribed HTN treatments, such as DASH and medications, and more likely to have worse blood pressure control.
Because of the prevalence of FI and associated poor health outcomes, a growing number of health systems and health insurers are investing in integrating interventions to address FI as part of routine clinical care. These interventions include 1) providing information to patients about community resources), 2) utilizing community health workers (CHW), and 3) home delivery of medically tailored meals (MTM). Studies have shown these FI interventions have varying levels of success on improving food security and health. However, people often need varying levels of support to address needs, and, rather than using only one single intervention to address FI, there remains a gap in understanding whether adaptively allocating resources based on need has the potential to more effectively, equitably, and efficiently improve food security and health for a greater proportion of patients.
To advance the science in patient adherence and blood pressure management, this study will conduct a sequential multiple assignment randomized trial (SMART) among food-insecure patients with uncontrolled HTN. SMART uses experimental design principles to determine whether and how to alter treatments to build optimal adaptive interventions. This study will assess the change in adherence and blood pressure over time (0-9 months). This study will also evaluate if treatment options were more effective for particular patients. Several other measures are included in this study to learn more about how an adaptive intervention designed to address FI affects blood pressure, adherence, food security, health-related quality of life, and other key risk factors for blood pressure control in patients with HTN.
The proposed Sequential Multiple Assignment Randomized Trial to reduce Food Insecurity and Improve Adherence in Patients with Hypertension (SMART-FI) is a single-site, open-label, longitudinal two-stage SMART. Participants will be randomized to one of two first-stage treatments for 3 months: 1) information about community resources or 2) in-person CHW support. Participants who do not have a 10mmHg improvement in systolic blood pressure (SBP) at 3 months will be re-randomized to one of two second-stage treatments for an additional 3 months: 1) CHW support or 2) home delivery of MTM. The study will recruit 224 participants for this trial. Participants will engage in the interventions up to 6 months and will be followed for a total of 9 months. In Aim 1, the study will determine which first-stage FI intervention is more effective in improving adherence and blood pressure. In Aim 2, the study will evaluate which FI intervention is the best next step for those who do not respond to the initial intervention. In Aim 3, the study will explore how, why, and under what circumstances participants achieved improvements to the first- and second-stage interventions by conducting semi-structured interviews with participants and evaluating for potential predictors of heterogeneity in response to each intervention.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Resource information, Community Health Worker (CHW) assistance, Medically-tailored Meals (MTM)
- Keywords
- cardiovascular disease, hypertension, Food insecurity
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource informationBehavioural
Also called information about local food resources
Participants randomized to this arm will receive a tailored list of information about community resources.
Community Health Worker (CHW) assistanceBehavioural
Also called community advocates
The CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team.
Medically-tailored Meals (MTM)Behavioural
Also called meals are planned by a registered dietician
MTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly.
| Study group | Role | What they receive |
|---|---|---|
| Resource information | Experimental | Participants randomized to this arm will receive a tailored list of information about community resources. The list will include information about local food resources (e.g. local food pantries) and government programs (e.g. Supplemental Nutrition Assistance Program) to address Food Insecurities (FI). Receives: Behavioral: Resource information |
| Community Health Worker (CHW) assistance | Experimental | The CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team. As health advisors, CHW will help them overcome commonly experienced barriers in blood pressure management. Receives: Behavioral: Community Health Worker (CHW) assistance |
| Medically-tailored Meals (MTM) | Experimental | MTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly. All meals are planned by a registered dietician and based on the Dietary Approaches to Stop Hypertension (DASH) diet. Receives: Behavioral: Medically-tailored Meals (MTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure value
Systolic blood pressure measured as mmHg
Measured: Month 9
Diastolic blood pressure value
Diastolic blood pressure measured as mmHg
Measured: Month 9
Dietary Approaches to Stop Hypertension (DASH) diet adherence Score
Change in DASH diet adherence over time, based on the Mellen DASH diet adherence index - The Mellen DASH diet index is a nutrient-based method for assessing adherence to the Dietary Approaches to Stop Hypertension (DASH) diet. It uses nine key nutrients to determine a score ranging from 0 to 9, with 9 indicating the most adherence - Food items on the FFQ are assigned to 7 DASH food groups and 3 components using the Harvard nutrient database. Servings in each component are scored 0, 0.5, and 1. The DASH diet adherence score ranges from 0 to 10 and is the sum of the 10 component scores. Higher scores indicate greater diet concordance.
Measured: Month 9
Medication adherence Score
Change in medication adherence based on the 12-item Adherence to Refills and Medications Scale - The 12-item Adherence to Refills and Medications Scale (ARMS) is a self-report questionnaire designed to measure a patient's adherence to medication regimens - Each scale comprises five items that are scored on a Likert-type scale, where 1 = strongly disagree, 2 = disagree, 3 = uncertain, 4 = agree and 5 = strongly agree. Higher scores indicate stronger beliefs in the necessity of medication and greater concerns about taking it.
Measured: Month 9
Food Security Score
Change in food security over time based on the 10-item USDA Food Security Survey Module with a 30-day reference period - The USDA Food Security Survey Module (HFSSM) uses a 10-item adult-referenced module to assess food security status. A raw score is calculated based on affirmative responses to these 10 questions, and this score is then used to classify households into food security categories: high, marginal, low, or very low.
High Food Security (Raw Score 0): No affirmative responses. Marginal Food Security (Raw Score 1-2): One or two affirmative responses. Low Food Security (Raw Score 3-5): Three to five affirmative responses. Very Low Food Security (Raw Score 6-10): Six to ten affirmative responses.
Measured: Month 9
Secondary outcomes (2)
Health-related quality of life Score
Change in EQ-5D-5L scores - assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 (11,111, no problems on any dimension) to 25 (55,555, extreme problems on all dimensions)
Measured: Month 9
Number of Changes in Community resource Use
Changes in use of community resources (e.g. food pantries, supplemental nutrition assistance program)
Measured: Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start18 Aug 2025
- Primary completionSep 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Assignment Randomized Trial to reduce Food Insecurity and Improve Adherence in Patients with Hypertension (SMART-FI) is a single-site, open-label, longitudinal two-stage SMART. Participants will be randomized to one of two first-stage treatments for 3 months: 1) information about community resources or 2) in-person community health workers (CHW) support. Participants who do not have a 10mmHg improvement in systolic blood pressure (SBP) at 3 months will be re-randomized to one of two second-stage treatments for an additional 3 months: 1) CHW support or 2) home delivery of medically tailored meals (MTM).
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
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, MSHP, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031739
- Sponsor's protocol ID
- IRB00115742
- Other IDs
- 1R01HL173064-01A1
- Acronym
- SMART
- Status last verified
- May 2026
- First submitted
- 5 Jun 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palakshappa D, Stone RJ, Torres JB, Berkowitz SA, Rhodes SD, Kirkendall ES, Dressler EV, Paredes Acosta LM, Williamson JD, Ard J, Ramirez B, Bundy R, Caudill N, Martin H, Hodge LD, Damon A, Caicedo-Dussan L, Rigdon J. Protocol for the sequential multiple assignment randomized trial to reduce food insecurity and improve adherence in patients with hypertension (SMART-FI). Contemp Clin Trials. 2026 Jul;166:108331. doi: 10.1016/j.cct.2026.108331. Epub 2026 Apr 28.
PubMed 42061553
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT07031739
- Acronym / sponsor ID
- SMART / IRB00115742
- Conditions
- Uncontrolled Hypertension
- Keywords
- cardiovascular disease, hypertension, Food insecurity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Interventions are being used to address food insecurity in clinical care settings, but people differ in the support they need to reduce food insecurity and little is known about which food insecurity interventions work best, or for whom. The goal of this study is to develop and test an adaptive food insecurity intervention using a Sequential Multiple Assignment Randomized Trial to determine which initial food insecurity intervention is more effective in improving adherence and blood pressure in patients with hypertension and for those who do not respond to the initial intervention, evaluate how to best provide additional support.
Detailed description
In the US, 47% of adults have hypertension (HTN), and HTN is the leading cause of cardiovascular disease morbidity and mortality. Uncontrolled HTN increases the risk of cardiovascular disease, chronic kidney disease, and cognitive impairment. Current guidelines recommend the adoption of a healthy diet as an integral part of ongoing treatment regardless of the underlying antihypertensive drug treatment. The Dietary Approaches to Stop Hypertension (DASH) eating pattern is a diet rich in fruits, vegetables, and whole grains with a reduced content of sodium and saturated fat. The DASH is the diet with the strongest evidence to be effective for lowering blood pressure. Despite the evidence base for the effectiveness of DASH as well as pharmacological treatments, economic factors are common barriers to individuals with HTN adhering to treatments. Adherence is multidimensional and involves initiation, implementation, and persistence. Food insecurity (FI), the lack of consistent access to the food needed for a healthy life, is an important factor that leads to HTN disparities. Individuals living in food insecure households are less likely to adhere to prescribed HTN treatments, such as DASH and medications, and more likely to have worse blood pressure control.
Because of the prevalence of FI and associated poor health outcomes, a growing number of health systems and health insurers are investing in integrating interventions to address FI as part of routine clinical care. These interventions include 1) providing information to patients about community resources), 2) utilizing community health workers (CHW), and 3) home delivery of medically tailored meals (MTM). Studies have shown these FI interventions have varying levels of success on improving food security and health. However, people often need varying levels of support to address needs, and, rather than using only one single intervention to address FI, there remains a gap in understanding whether adaptively allocating resources based on need has the potential to more effectively, equitably, and efficiently improve food security and health for a greater proportion of patients.
To advance the science in patient adherence and blood pressure management, this study will conduct a sequential multiple assignment randomized trial (SMART) among food-insecure patients with uncontrolled HTN. SMART uses experimental design principles to determine whether and how to alter treatments to build optimal adaptive interventions. This study will assess the change in adherence and blood pressure over time (0-9 months). This study will also evaluate if treatment options were more effective for particular patients. Several other measures are included in this study to learn more about how an adaptive intervention designed to address FI affects blood pressure, adherence, food security, health-related quality of life, and other key risk factors for blood pressure control in patients with HTN.
The proposed Sequential Multiple Assignment Randomized Trial to reduce Food Insecurity and Improve Adherence in Patients with Hypertension (SMART-FI) is a single-site, open-label, longitudinal two-stage SMART. Participants will be randomized to one of two first-stage treatments for 3 months: 1) information about community resources or 2) in-person CHW support. Participants who do not have a 10mmHg improvement in systolic blood pressure (SBP) at 3 months will be re-randomized to one of two second-stage treatments for an additional 3 months: 1) CHW support or 2) home delivery of MTM. The study will recruit 224 participants for this trial. Participants will engage in the interventions up to 6 months and will be followed for a total of 9 months. In Aim 1, the study will determine which first-stage FI intervention is more effective in improving adherence and blood pressure. In Aim 2, the study will evaluate which FI intervention is the best next step for those who do not respond to the initial intervention. In Aim 3, the study will explore how, why, and under what circumstances participants achieved improvements to the first- and second-stage interventions by conducting semi-structured interviews with participants and evaluating for potential predictors of heterogeneity in response to each intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Assignment Randomized Trial to reduce Food Insecurity and Improve Adherence in Patients with Hypertension (SMART-FI) is a single-site, open-label, longitudinal two-stage SMART. Participants will be randomized to one of two first-stage treatments for 3 months: 1) information about community resources or 2) in-person community health workers (CHW) support. Participants who do not have a 10mmHg improvement in systolic blood pressure (SBP) at 3 months will be re-randomized to one of two second-stage treatments for an additional 3 months: 1) CHW support or 2) home delivery of medically tailored meals (MTM).
| Arm | Type | Receives |
|---|---|---|
| Resource information | Experimental | Behavioral: Resource informationParticipants randomized to this arm will receive a tailored list of information about community resources. The list will include information about local food resources (e.g. local food pantries) and government programs (e.g. Supplemental Nutrition Assistance Program) to address Food Insecurities (FI). |
| Community Health Worker (CHW) assistance | Experimental | Behavioral: Community Health Worker (CHW) assistanceThe CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team. As health advisors, CHW will help them overcome commonly experienced barriers in blood pressure management. |
| Medically-tailored Meals (MTM) | Experimental | Behavioral: Medically-tailored Meals (MTM)MTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly. All meals are planned by a registered dietician and based on the Dietary Approaches to Stop Hypertension (DASH) diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must Speak English or Spanish
- have a diagnosis of Hypertension (HTN)
- prescribed at least one blood pressure lowering medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
- past 2 blood pressures at their primary care doctor were greater than or equal to130/80mmHg (millimeters of Mercury)
- seen by their primary care doctor in the past 6 months
Key exclusion criteria (7 listed)
- Systolic Blood Pressure > 210mmHg or a diastolic blood pressure > 120mmHg
- have a severe cognitive impairment or major psychiatric illness that prevents consent or serious medical condition which either limits life expectancy or requires active management (e.g. certain cancers)
- pregnant, breastfeeding, or planning to become pregnant in the next 6 months
- planning on moving out of the area within 6 months
- lack safe stable housing
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 informationAlso: information about local food resourcesParticipants randomized to this arm will receive a tailored list of information about community resources. | Behavioural | Resource information |
| Community Health Worker (CHW) assistanceAlso: community advocatesThe CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team. | Behavioural | Community Health Worker (CHW) assistance |
| Medically-tailored Meals (MTM)Also: meals are planned by a registered dieticianMTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly. | Behavioural | Medically-tailored Meals (MTM) |
Primary outcome
Systolic blood pressure value
Time frame: Month 9
Systolic blood pressure measured as mmHg
Diastolic blood pressure value
Time frame: Month 9
Diastolic blood pressure measured as mmHg
Dietary Approaches to Stop Hypertension (DASH) diet adherence Score
Time frame: Month 9
Change in DASH diet adherence over time, based on the Mellen DASH diet adherence index - The Mellen DASH diet index is a nutrient-based method for assessing adherence to the Dietary Approaches to Stop Hypertension (DASH) diet. It uses nine key nutrients to determine a score ranging from 0 to 9, with 9 indicating the most adherence - Food items on the FFQ are assigned to 7 DASH food groups and 3 components using the Harvard nutrient database. Servings in each component are scored 0, 0.5, and 1. The DASH diet adherence score ranges from 0 to 10 and is the sum of the 10 component scores. Higher scores indicate greater diet concordance.
Medication adherence Score
Time frame: Month 9
Change in medication adherence based on the 12-item Adherence to Refills and Medications Scale - The 12-item Adherence to Refills and Medications Scale (ARMS) is a self-report questionnaire designed to measure a patient's adherence to medication regimens - Each scale comprises five items that are scored on a Likert-type scale, where 1 = strongly disagree, 2 = disagree, 3 = uncertain, 4 = agree and 5 = strongly agree. Higher scores indicate stronger beliefs in the necessity of medication and greater concerns about taking it.
Food Security Score
Time frame: Month 9
Change in food security over time based on the 10-item USDA Food Security Survey Module with a 30-day reference period - The USDA Food Security Survey Module (HFSSM) uses a 10-item adult-referenced module to assess food security status. A raw score is calculated based on affirmative responses to these 10 questions, and this score is then used to classify households into food security categories: high, marginal, low, or very low. High Food Security (Raw Score 0): No affirmative responses. Marginal Food Security (Raw Score 1-2): One or two affirmative responses. Low Food Security (Raw Score 3-5): Three to five affirmative responses. Very Low Food Security (Raw Score 6-10): Six to ten affirmative responses.
2 secondary outcomes
Health-related quality of life Score
Time frame: Month 9
Number of Changes in Community resource Use
Time frame: Month 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 42061553Palakshappa D, Stone RJ, Torres JB, Berkowitz SA, Rhodes SD, Kirkendall ES, Dressler EV, Paredes Acosta LM, Williamson JD, Ard J, Ramirez B, Bundy R, Caudill N, Martin H, Hodge LD, Damon A, Caicedo-Dussan L, Rigdon J. Protocol for the sequential multiple assignment randomized trial to reduce food insecurity and improve adherence in patients with hypertension (SMART-FI). Contemp Clin Trials. 2026 Jul;166:108331. doi: 10.1016/j.cct.2026.108331. Epub 2026 Apr 28.
- Individual participant dataSharing planned: No
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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.
Deepak Palakshappa, MD, MSHP 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, Community Health Worker (CHW) assistance and Medically-tailored Meals (MTM) in people with Uncontrolled 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Stone, MPH (336-713-5544, Rebecca.J.Stone@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure value (time frame: Month 9). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07031739, which also lists 1 linked publication.
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 6 May 2026.