N/A
N=60
Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT05800145 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Systolic Blood Pressure Readings — 144.3; 138.1; 136.8; 151.7 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resource information Supplemental Nutrition Assistance Program (SNAP) (Behavioral); community health worker (CHW) (Behavioral); medically tailored meals (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure Readings |
134.3; 158.2; 143.7; 138.3; 146.6; 158.7 | — |
| PRIMARY Feasibility of Recruitment Percentage |
0.98 | — |
| PRIMARY Feasibility of Retention |
0.5; 0.625 | — |
| PRIMARY Diastolic Blood Pressure Readings |
84.8; 116.3; 88; 86; 87.8; 98.0 | — |
| PRIMARY Systolic Blood Pressure Readings |
134.3; 158.2; 143.7; 138.3; 146.6; 158.7 | — |
| PRIMARY Diastolic Blood Pressure Readings |
84.8; 116.3; 88; 86; 87.8; 98.0 | — |
| PRIMARY Systolic Blood Pressure Readings |
134.3; 158.2; 143.7; 138.3; 146.6; 158.7 | — |
| PRIMARY Diastolic Blood Pressure Readings |
84.8; 116.3; 88; 86; 87.8; 98.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- unable to speak English or Spanish
- have severe cognitive impairment or major psychiatric illness that prevents consent and participation
- lack of safe, stable residence and ability to store meals
- pregnant, breastfeeding, or planning to become pregnant in the next year
- advance kidney disease (estimated creatine clearance < 30 mL/min)
- serious medical condition which either limits life expectancy or requires active management
- those planning on moving out of the geographic area within 12 months
- lack of a telephone
Data sourced from ClinicalTrials.gov (NCT05800145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.