Evidence map›Paper›PMID 42061553›Full record

ArticleContemporary clinical trials2026

Protocol for the sequential multiple assignment randomized trial to reduce food insecurity and improve adherence in patients with hypertension (SMART-FI).

Deepak Palakshappa, Rebecca J Stone, Jesus Betancourt Torres, Seth A Berkowitz, Scott D Rhodes, Eric S Kirkendall, Emily V Dressler, Luisa M Paredes Acosta, Jeff D Williamson, Jamy Ard and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07031739 (Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients With Hypertension), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07031739 narecruitingnot on this map

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients With Hypertension

TypeinterventionalSponsorWake Forest University Health SciencesRan2025 to 2030Enrolled224ConditionsUncontrolled HypertensionArmsResource information, Community Health Worker (CHW) assistance, Medically-tailored Meals (MTM)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Deepak PalakshappaDepartment of Internal Medicine, Wake Forest University School of Medicine, Winston, Salem, NC, USA; Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, NC, USA; Department of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA. Electronic address: Deepak.palakshappa@wfusm.edu.
Rebecca J StoneDepartment of Internal Medicine, Wake Forest University School of Medicine, Winston, Salem, NC, USA.
Jesus Betancourt TorresDepartment of Internal Medicine, Wake Forest University School of Medicine, Winston, Salem, NC, USA.
Seth A BerkowitzDivision of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Scott D RhodesDepartment of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Eric S KirkendallDepartment of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, NC, USA; Center for Healthcare Innovation, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Emily V DresslerDepartment of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Luisa M Paredes AcostaDepartment of Internal Medicine, Wake Forest University School of Medicine, Winston, Salem, NC, USA.
Jeff D WilliamsonDepartment of Internal Medicine, Wake Forest University School of Medicine, Winston, Salem, NC, USA; Center for Healthcare Innovation, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Jamy ArdDepartment of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Brenda RamirezDepartment of Internal Medicine, Wake Forest University School of Medicine, Winston, Salem, NC, USA; Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Richa BundyDepartment of Internal Medicine, Wake Forest University School of Medicine, Winston, Salem, NC, USA.
Nicole CaudillSecond Harvest Food Bank of Northwest NC, Winston-Salem, NC, USA.
Heather MartinSecond Harvest Food Bank of Northwest NC, Winston-Salem, NC, USA.
Lakesha D HodgePopulation Health, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Antoinette DamonPopulation Health, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Luciana Caicedo-DussanWake Forest University, Winston-Salem, NC, USA.
Joseph RigdonDepartment of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.

Funding

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients with HypertensionR01HL173064 · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2025 to 2025
$709k
NHLBI NIH HHS R01 HL173064
6 · The paper itself

Abstract

backgroundFood insecurity is a barrier to patients adhering to prescribed hypertension treatments and is strongly associated with worse blood pressure. Health systems are implementing interventions to assist patients with food insecurity, but rather than providing a single intervention, a stepped-care approach to providing interventions could be a more effective strategy. Our objective is to determine the effectiveness of a stepped-care food insecurity intervention on blood pressure and adherence among patients with uncontrolled hypertension. METHODS/

designWe will conduct a sequential multiple assignment randomized trial. Adults (≥18 years) with uncontrolled hypertension (>130/80) who report food insecurity will be randomized to one of two first-stage interventions: 1) information about community resources or 2) community health worker (CHW) support. Participants who do not have ≥10 mmHg improvement in systolic blood pressure after 3 months will be re-randomized to one of two second-stage interventions for an additional 3 months: 1) CHW support or 2) delivery of medically tailored meals. In Aim 1, we will determine which first-stage intervention is more effective in improving blood pressure and adherence. In Aim 2, we will evaluate which intervention is the best next step for those who do not respond to the initial intervention. In Aim 3, we will advance our understanding of how and why participants achieved improvements through qualitative and quantitative data analysis.

conclusionsThis will be the first study to test the effectiveness of a stepped-care food insecurity intervention. Given the growing interest among health systems, an efficacious, stepped-care food insecurity intervention could be broadly disseminated.

trial registrationThe study was registered with ClinicalTrials.gov (NCT07031739) on June 22, 2025.

Indexed as

Adherence InterventionsAntihypertensive AgentsFood InsecurityHypertensionAdultBlood PressureCommunity Health WorkersFemaleHumansMaleRandomized Controlled Trials as TopicAntihypertensive AgentsAdherenceBlood pressureFood insecurityFood is medicineHypertensionMedically tailored meals

Identifiers

PMID42061553
PMCPMC13459900

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.