Healthy Food First
HFF
1 other identifier
interventional
525
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Oct 2021
Typical duration for not_applicable hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedStudy Start
First participant enrolled
October 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2024
CompletedJuly 18, 2025
July 1, 2025
2.8 years
August 31, 2021
July 16, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Office-based Systolic Blood Pressure at Month 6
Systolic blood pressure recorded at office-based healthcare visits
6 months
Office-based Systolic Blood Pressure at Month 12
Systolic blood pressure recorded at office-based healthcare visits
12 months
Office-based Systolic Blood Pressure at Month 18
Systolic blood pressure recorded at office-based healthcare visits
18 months
Office-based Diastolic Blood Pressure at Month 6
Diastolic blood pressure recorded at office-based healthcare visits
6 months
Office-based Diastolic Blood Pressure at Month 12
Diastolic blood pressure recorded at office-based healthcare visits
12 months
Office-based Diastolic Blood Pressure at Month 18
Diastolic blood pressure recorded at office-based healthcare visits
18 months
Secondary Outcomes (28)
Ambulatory Systolic Blood Pressure at Month 6
6 months
Ambulatory Systolic Blood Pressure at Month 12
12 months
Ambulatory Systolic Blood Pressure at Month 18
18 months
Ambulatory Diastolic Blood Pressure at Month 6
6 months
Ambulatory Diastolic Blood Pressure at Month 12
12 months
- +23 more secondary outcomes
Study Arms (8)
Food subsidy, no lifestyle support, 6 months
EXPERIMENTALParticipant will receive $40 healthy food subsidy for 6 months.
Food delivery, no lifestyle support, 6 months
EXPERIMENTALParticipant will receive twice monthly healthy food delivery for 6 months.
Food subsidy, with lifestyle support, 6 months
EXPERIMENTALParticipants will receive food subsidy and healthy lifestyle support for 6 months.
Food delivery, with lifestyle support, 6 months
EXPERIMENTALParticipants will receive twice monthly food box deliveries and lifestyle support for 6 months.
Food subsidy, no lifestyle support, 12 months
EXPERIMENTALParticipants will receive food subsidy for 12 months.
Food delivery, no lifestyle support, 12 months
EXPERIMENTALParticipants will receive twice monthly food box deliveries for 12 months.
Food subsidy, with lifestyle support, 12 months
EXPERIMENTALParticipant will receive food subsidy and lifestyle support for 12 months.
Food delivery, with lifestyle support, 12 months
EXPERIMENTALParticipants will receive twice monthly food box deliveries and lifestyle support for 12 months.
Interventions
Food subsidy for 6 months
Food subsidy for 12 months
lifestyle support intervention delivered by community health workers for 6 months
lifestyle support intervention delivered by community health workers for 6 months
Twice monthly delivery of healthy food for 6 months
Twice monthly delivery of healthy food for 12 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnancy
- Malignancy
- Advanced kidney disease (estimated creatinine clearance \< 30 mL/min assessed by Chronic Kidney Disease Epidemiology Collaboration formula)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- Blue Cross Blue Shield of North Carolinacollaborator
- UNC Health Alliancecollaborator
- Duke Universitycollaborator
Study Sites (2)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-1651, United States
Duke University
Durham, North Carolina, 27708, United States
Related Publications (1)
Berkowitz SA, Ammerman AS, Knoepp P, Anderson RE 3rd, Taylor LH, Jedele JM, Archibald J, Xue K, Wertman E, Dellva B, Pignone K, Qaqish B, Dolor RJ, Turner S, Lumpkin JR, DeWalt DA. Food Insecurity Interventions to Improve Blood Pressure: The Healthy Food First Factorial Randomized Clinical Trial. JAMA Intern Med. 2025 Dec 1;185(12):1423-1433. doi: 10.1001/jamainternmed.2025.5287.
PMID: 41082188DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darren DeWalt, MD, MPH
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 17, 2021
Study Start
October 7, 2021
Primary Completion
August 12, 2024
Study Completion
August 12, 2024
Last Updated
July 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share