NCT07031739Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 18 Aug 2025
- Primary completion date
- Sept 2029
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- High blood pressure
- NCT number
- NCT07031739
What you commit to
- Study type: Interventional
- Planned participants: 224
- From 18 Aug 2025 to the primary completion date, Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
Related publications
- Protocol for the sequential multiple assignment randomized trial to reduce food insecurity and improve adherence in patients with hypertension (SMART-FI).Contemp Clin Trials · 2026 · PMID 42061553
This page is information, not medical advice. Discuss any trial with your doctor.