Tests food support options for adults with uncontrolled high blood pressure and food insecurity
Tests food support options in adults with high blood pressure and food insecurity.
Plain-language title generated from the registry record
Registry title: Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
Key facts
- Where
- Winston-Salem, United StatesSee the site
Where in United States
- Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT07031739
- Record updated
- 6 May 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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); Systolic Blood Pressure > 210mmHg or a diastolic blood pressure > 120mmHg; 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.