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Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• Resource information (behavioral)
• Community Health Worker (CHW) assistance (behavioral)
• Medically-tailored Meals (MTM) (behavioral)

Sponsor: Wake Forest University Health Sciences · Participants: 224 · Started: Aug 18, 2025

Contact the study team

• Rebecca Stone, MPH · Phone: 336-713-5544

Official record on ClinicalTrials.gov — NCT07031739

Locations in the U.S.

Conditions

• Cardiovascular Disease
• High Blood Pressure

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.