Recruiting

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

ClinicalTrials.gov IDNCT07031739

PhaseNA

Enrollment224

SponsorWake Forest University Health Sciences

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Uncontrolled Hypertension

About this 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.

Interventions

Behavioral: Resource information — Participants randomized to this arm will receive a tailored list of information about community resources.
Behavioral: Community Health Worker (CHW) assistance — 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.
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.

Primary outcomes

Systolic blood pressure value (Month 9)
Diastolic blood pressure value (Month 9)
Dietary Approaches to Stop Hypertension (DASH) diet adherence Score (Month 9)
Medication adherence Score (Month 9)
Food Security Score (Month 9)

Eligibility information

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

Study locations

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.