Actively Recruiting
Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
Led by Wake Forest University Health Sciences · Updated on 2026-05-06
224
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must speak English or Spanish
- Have a diagnosis of hypertension
- Prescribed at least one blood pressure lowering medication
- Last two blood pressure readings of 130/80 mmHg or higher
- Seen by primary care doctor in the past 6 months
- Experience food insecurity based on the 2-item Hunger Vital Sign
You will not qualify if you...
- Systolic blood pressure over 210 mmHg or diastolic blood pressure over 120 mmHg
- Severe cognitive impairment or major psychiatric illness preventing consent
- Serious medical condition limiting life expectancy or requiring active management
- Pregnant, breastfeeding, or planning pregnancy in the next 6 months
- Planning to move out of the area within 6 months
- Lack of safe, stable housing
- Unable to store meals
- Lack of a telephone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
R
Rebecca Stone, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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