NCT05800145Completed
Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
Pilot Study to Evaluate the Feasibility of Using a Sequential Multiple Assignment Randomized Trial to Address Food Insecurity in Patients With Hypertension (Pilot SMART-FI)
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
In the US, 47% of adults have hypertension (HTN), and HTN accounts for more cardiovascular disease (CVD) deaths than any other CVD risk factor. Thus, the lack of an adaptive, stepped-care intervention to address FI in patients with HTN is a critical problem affecting a large, vulnerable population.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 22 Mar 2023
- Start date
- May 2023
- Primary completion date
- Sept 2024
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- High blood pressure
- NCT number
- NCT05800145
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From May 2023 to the primary completion date, Sept 2024
- 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 severe cognitive impairment or major psychiatric illness that prevents consent and participation
- serious medical condition which either limits life expectancy or requires active management
Lab values
- advance kidney disease (estimated creatine clearance \< 30 mL/min)
Other
- unable to speak English or Spanish
- lack of safe, stable residence and ability to store meals
- pregnant, breastfeeding, or planning to become pregnant in the next year
- those planning on moving out of the geographic area within 12 months
- lack of a telephone
Who the study is looking for
- Adult patients (≥18 years of age)
- diagnosis of Hypertension (HTN) (defined by ICD-10 code) or have been prescribed at least one blood pressure medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
- blood pressures at their primary care office was \>130/80
- experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
- live in Winston-Salem or Forsyth County
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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.