NCT05048836Completed
Healthy Food First
Source: ClinicalTrials.gov · Last updated 18 Jul 2025
Brief summary (registry, in English)
Socioeconomic barriers to healthy eating, particularly food insecurity, are a major reason for poor blood pressure control and hypertension complications. Healthy diet patterns have been shown to improve health. Unfortunately, food insecurity makes it difficult for individuals to maintain healthy diet patterns. This pragmatic randomized trial will compare two food insecurity interventions (a healthy food subsidy versus a delivered food box), with or without lifestyle support delivered by community health workers, for 6 versus 12 months duration. Key outcomes include blood pressure, food insecurity, and other patient reported outcomes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 525 (actual)
- First submitted
- 31 Aug 2021
- Start date
- 7 Oct 2021
- Primary completion date
- 12 Aug 2024
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- High blood pressure
- NCT number
- NCT05048836
What you commit to
- Study type: Interventional
- Participants enrolled: 525
- From 7 Oct 2021 to the primary completion date, 12 Aug 2024
- 2 sites 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
- Malignancy
Lab values
- Advanced kidney disease (estimated creatinine clearance \< 30 mL/min assessed by Chronic Kidney Disease Epidemiology Collaboration formula)
Other
- Pregnancy
Who the study is looking for
- Diagnosis of hypertension with systolic blood pressure \> 130 mm Hg
- Report of food insecurity by 2-item 'Hunger Vital Sign'
- English or Spanish speaking
- Age ≥ 18 years
- Lives within delivery area of intervention services.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.