HypertensionHFFNCT05048836
Healthy Food First
A study testing Food Subsidy, 6 months, Food Subsidy, 12 months and Lifestyle Support, 6 months in people with Hypertension and Food Insecurity, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertension, Food Insecurity, Diet, Mediterranean
- What is being tested?
- Food Subsidy, 6 months, Food Subsidy, 12 months and Lifestyle Support, 6 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2021to 12 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Malignancy
- Advanced kidney disease (estimated creatinine clearance < 30 mL/min assessed by Chronic Kidney Disease Epidemiology Collaboration formula)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-1651
Duke University
Durham, North Carolina, 27708
About this study
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.
Read the detailed description
Socioeconomic barriers to healthy eating, particularly food insecurity ("insufficient or uncertain access to enough food for an active, healthy life") are a major reason for poor blood pressure control, and hypertension complications. Healthful dietary patterns, such as a Mediterranean (Med)-style diet, improve blood pressure control and reduce cardiovascular risk, risk for other chronic diseases, and premature mortality. However, food insecurity incentivizes individuals away from healthful diet patterns, resulting in wide disparities in diet-related diseases such as hypertension. Though two major ways to address food insecurity are commonly proposed-- providing subsidies for healthy food and home delivery of healthy food boxes--investigators do not know which will have the greater effect. Further, as these interventions cannot be provided indefinitely, investigators need to determine whether adding an intervention to support healthy lifestyle change, such as a culturally-tailored Med-style diet intervention, can lead to improved health even after provision of the food insecurity intervention ends.
Thus, the study team proposes to conduct 2x2x2 factorial design randomized trial to compare two food insecurity interventions, with or without a lifestyle support intervention that provides culturally tailored Med-style dietary pattern education, disease self-management support, and navigation to community resources for health related social needs, over 2 different time periods. To realize the vision of "food as medicine" to promote equity in clinical care, the study team has drawn on an extensive background of previously tested programs to create the novel multi-component interventions that will be tested in this trial. This novel intervention focuses on lowering blood pressure and addressing food insecurity. Specifically, participants will be separately randomized to receive 1) a food subsidy versus home delivery of a healthy food box, and 2) a structured lifestyle support intervention, delivered by community health workers and supervised by a registered dietitian versus usual care for 3) either 6 or 12 months. The proposed study will be conducted in central NC, enrolling 1400 participants with a history of hypertension and food insecurity. Six months after the end of each participant's intervention, investigators will re-assess study outcomes to evaluate for sustained effects.
- Conditions
- Hypertension, Food Insecurity, Diet, Mediterranean
- Being tested
- Food Subsidy, 6 months, Food Subsidy, 12 months, Lifestyle Support, 6 months, Lifestyle Support, 12 months, Food Delivery, 6 months
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Subsidy, 6 monthsOther
Food subsidy for 6 months
Food Subsidy, 12 monthsOther
Food subsidy for 12 months
Lifestyle Support, 6 monthsBehavioural
lifestyle support intervention delivered by community health workers for 6 months
Lifestyle Support, 12 monthsBehavioural
lifestyle support intervention delivered by community health workers for 6 months
Food Delivery, 6 monthsOther
Twice monthly delivery of healthy food for 6 months
Food Delivery, 12 monthsOther
Twice monthly delivery of healthy food for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Food subsidy, no lifestyle support, 6 months | Experimental | Participant will receive $40 healthy food subsidy for 6 months. Receives: Other: Food Subsidy, 6 months |
| Food delivery, no lifestyle support, 6 months | Experimental | Participant will receive twice monthly healthy food delivery for 6 months. Receives: Other: Food Delivery, 6 months |
| Food subsidy, with lifestyle support, 6 months | Experimental | Participants will receive food subsidy and healthy lifestyle support for 6 months. Receives: Other: Food Subsidy, 6 months; Behavioral: Lifestyle Support, 6 months |
| Food delivery, with lifestyle support, 6 months | Experimental | Participants will receive twice monthly food box deliveries and lifestyle support for 6 months. Receives: Behavioral: Lifestyle Support, 6 months; Other: Food Delivery, 6 months |
| Food subsidy, no lifestyle support, 12 months | Experimental | Participants will receive food subsidy for 12 months. Receives: Other: Food Subsidy, 12 months |
| Food delivery, no lifestyle support, 12 months | Experimental | Participants will receive twice monthly food box deliveries for 12 months. Receives: Other: Food Delivery, 12 months |
| Food subsidy, with lifestyle support, 12 months | Experimental | Participant will receive food subsidy and lifestyle support for 12 months. Receives: Other: Food Subsidy, 12 months; Behavioral: Lifestyle Support, 12 months |
| Food delivery, with lifestyle support, 12 months | Experimental | Participants will receive twice monthly food box deliveries and lifestyle support for 12 months. Receives: Behavioral: Lifestyle Support, 12 months; Other: Food Delivery, 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office-based Systolic Blood Pressure at Month 6
Systolic blood pressure recorded at office-based healthcare visits
Measured: 6 months
Office-based Systolic Blood Pressure at Month 12
Systolic blood pressure recorded at office-based healthcare visits
Measured: 12 months
Office-based Systolic Blood Pressure at Month 18
Systolic blood pressure recorded at office-based healthcare visits
Measured: 18 months
Office-based Diastolic Blood Pressure at Month 6
Diastolic blood pressure recorded at office-based healthcare visits
Measured: 6 months
Office-based Diastolic Blood Pressure at Month 12
Diastolic blood pressure recorded at office-based healthcare visits
Measured: 12 months
Office-based Diastolic Blood Pressure at Month 18
Diastolic blood pressure recorded at office-based healthcare visits
Measured: 18 months
Secondary outcomes (28)
Ambulatory Systolic Blood Pressure at Month 6
Systolic blood pressure recorded outside the healthcare system.
Measured: 6 months
Ambulatory Systolic Blood Pressure at Month 12
Systolic blood pressure recorded outside the healthcare system.
Measured: 12 months
Ambulatory Systolic Blood Pressure at Month 18
Systolic blood pressure recorded outside the healthcare system.
Measured: 18 months
Ambulatory Diastolic Blood Pressure at Month 6
Diastolic blood pressure recorded outside the healthcare system.
Measured: 6 months
Ambulatory Diastolic Blood Pressure at Month 12
Diastolic blood pressure recorded outside the healthcare system.
Measured: 12 months
Ambulatory Diastolic Blood Pressure at Month 18
Diastolic blood pressure recorded outside the healthcare system.
Measured: 18 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 6
Systolic blood pressure recorded either inside or outside the healthcare system.
Measured: 6 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 12
Systolic blood pressure recorded either inside or outside the healthcare system.
Measured: 12 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 18
Systolic blood pressure recorded either inside or outside the healthcare system.
Measured: 18 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 6
Diastolic blood pressure recorded either inside or outside the healthcare system.
Measured: 6 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 12
Diastolic blood pressure recorded either inside or outside the healthcare system.
Measured: 12 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 18
Diastolic blood pressure recorded either inside or outside the healthcare system.
Measured: 18 months
Food Insecurity Score at Month 6
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Measured: 6 months
Food Insecurity Score at Month 12
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Measured: 12 months
Food Insecurity Score at Month 18
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Measured: 18 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 6
The Patient-Reported Outcomes Measurement Information System(PROMIS)-14 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data investigators will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Measured: 6 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 12
The Patient-Reported Outcomes Measurement Information System (PROMIS) -14 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data investigators will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Measured: 12 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 18
The Patient-Reported Outcomes Measurement Information System (PROMIS)-14 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data investigators will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Measured: 18 months
Diet Quality at Month 6
Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.
Measured: 6 months
Diet Quality at Month 12
Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.
Measured: 12 months
Diet Quality at Month 18
Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.
Measured: 18 months
Food/ medication trade-offs at Month 6
Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
Measured: 6 months
Food/ medication trade-offs at Month 12
Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
Measured: 12 months
Food/ medication trade-offs Month 18
Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
Measured: 18 months
Diet self-efficacy at Month 6
Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
Measured: 6 months
Diet self-efficacy at Month 12
Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
Measured: 12 months
Diet self-efficacy at Month 18
Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
Measured: 18 months
Physical Activity Levels at Month 12
Assessed by the International Physical Activity Questionnaire(Short Form). Higher scores indicate higher levels of physical activity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start7 Oct 2021
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Thus, the investigators propose conducting a 2x2x2 factorial design randomized trial to compare two food insecurity interventions, with or without a lifestyle support intervention that provides culturally tailored Med-style dietary pattern education, disease self-management support, and navigation to community resources for health related social needs, over 2 different time periods.
- Masking
- None (open label)
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield, UNC Health Alliance, Duke University
- Responsible party
- Sponsor
- Investigators
- Darren DeWalt, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048836
- Sponsor's protocol ID
- 21-0992
- Acronym
- HFF
- Status last verified
- Jul 2025
- First submitted
- 31 Aug 2021
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson RE 3rd, Berkowitz SA, Burger KS, Valle CG, Taillie LS, Ammerman AS. Community Health Worker Coaching, Food Insecurity, and Physical Activity in the Healthy Food First Trial: A Causal Mediation and Longitudinal Analysis. Am J Lifestyle Med. 2026 Oct 23:15598276261498203. doi: 10.1177/15598276261498203. Online ahead of print.
PubMed 42927090Anderson RE 3rd, Berkowitz SA, Knoepp P, Pignone K, Burger KS, Valle CG, Taillie LS, Ammerman AS. Exploring the Facilitators and Barriers to Physical Activity among Adults Experiencing Food Insecurity During the Healthy Food First Trial: A Qualitative Study. Curr Dev Nutr. 2026 Jul 21;10(8):109443. doi: 10.1016/j.cdnut.2026.109443. eCollection 2026 Aug.
PubMed 42602884Berkowitz 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.
PubMed 41082188
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Food First
- ClinicalTrials.gov ID
- NCT05048836
- Acronym / sponsor ID
- HFF / 21-0992
- Conditions
- Hypertension, Food Insecurity, Diet, Mediterranean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield, UNC Health Alliance, Duke University
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Socioeconomic barriers to healthy eating, particularly food insecurity ("insufficient or uncertain access to enough food for an active, healthy life") are a major reason for poor blood pressure control, and hypertension complications. Healthful dietary patterns, such as a Mediterranean (Med)-style diet, improve blood pressure control and reduce cardiovascular risk, risk for other chronic diseases, and premature mortality. However, food insecurity incentivizes individuals away from healthful diet patterns, resulting in wide disparities in diet-related diseases such as hypertension. Though two major ways to address food insecurity are commonly proposed-- providing subsidies for healthy food and home delivery of healthy food boxes--investigators do not know which will have the greater effect. Further, as these interventions cannot be provided indefinitely, investigators need to determine whether adding an intervention to support healthy lifestyle change, such as a culturally-tailored Med-style diet intervention, can lead to improved health even after provision of the food insecurity intervention ends.
Thus, the study team proposes to conduct 2x2x2 factorial design randomized trial to compare two food insecurity interventions, with or without a lifestyle support intervention that provides culturally tailored Med-style dietary pattern education, disease self-management support, and navigation to community resources for health related social needs, over 2 different time periods. To realize the vision of "food as medicine" to promote equity in clinical care, the study team has drawn on an extensive background of previously tested programs to create the novel multi-component interventions that will be tested in this trial. This novel intervention focuses on lowering blood pressure and addressing food insecurity. Specifically, participants will be separately randomized to receive 1) a food subsidy versus home delivery of a healthy food box, and 2) a structured lifestyle support intervention, delivered by community health workers and supervised by a registered dietitian versus usual care for 3) either 6 or 12 months. The proposed study will be conducted in central NC, enrolling 1400 participants with a history of hypertension and food insecurity. Six months after the end of each participant's intervention, investigators will re-assess study outcomes to evaluate for sustained effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Thus, the investigators propose conducting a 2x2x2 factorial design randomized trial to compare two food insecurity interventions, with or without a lifestyle support intervention that provides culturally tailored Med-style dietary pattern education, disease self-management support, and navigation to community resources for health related social needs, over 2 different time periods.
| Arm | Type | Receives |
|---|---|---|
| Food subsidy, no lifestyle support, 6 months | Experimental | Other: Food Subsidy, 6 monthsParticipant will receive $40 healthy food subsidy for 6 months. |
| Food delivery, no lifestyle support, 6 months | Experimental | Other: Food Delivery, 6 monthsParticipant will receive twice monthly healthy food delivery for 6 months. |
| Food subsidy, with lifestyle support, 6 months | Experimental | Other: Food Subsidy, 6 months, Behavioral: Lifestyle Support, 6 monthsParticipants will receive food subsidy and healthy lifestyle support for 6 months. |
| Food delivery, with lifestyle support, 6 months | Experimental | Behavioral: Lifestyle Support, 6 months, Other: Food Delivery, 6 monthsParticipants will receive twice monthly food box deliveries and lifestyle support for 6 months. |
| Food subsidy, no lifestyle support, 12 months | Experimental | Other: Food Subsidy, 12 monthsParticipants will receive food subsidy for 12 months. |
| Food delivery, no lifestyle support, 12 months | Experimental | Other: Food Delivery, 12 monthsParticipants will receive twice monthly food box deliveries for 12 months. |
| Food subsidy, with lifestyle support, 12 months | Experimental | Other: Food Subsidy, 12 months, Behavioral: Lifestyle Support, 12 monthsParticipant will receive food subsidy and lifestyle support for 12 months. |
| Food delivery, with lifestyle support, 12 months | Experimental | Behavioral: Lifestyle Support, 12 months, Other: Food Delivery, 12 monthsParticipants will receive twice monthly food box deliveries and lifestyle support for 12 months. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy
- Malignancy
- Advanced kidney disease (estimated creatinine clearance < 30 mL/min assessed by Chronic Kidney Disease Epidemiology Collaboration formula)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Subsidy, 6 monthsFood subsidy for 6 months | Other | Food subsidy, no lifestyle support, 6 months, Food subsidy, with lifestyle support, 6 months |
| Food Subsidy, 12 monthsFood subsidy for 12 months | Other | Food subsidy, no lifestyle support, 12 months, Food subsidy, with lifestyle support, 12 months |
| Lifestyle Support, 6 monthslifestyle support intervention delivered by community health workers for 6 months | Behavioural | Food delivery, with lifestyle support, 6 months, Food subsidy, with lifestyle support, 6 months |
| Lifestyle Support, 12 monthslifestyle support intervention delivered by community health workers for 6 months | Behavioural | Food delivery, with lifestyle support, 12 months, Food subsidy, with lifestyle support, 12 months |
| Food Delivery, 6 monthsTwice monthly delivery of healthy food for 6 months | Other | Food delivery, no lifestyle support, 6 months, Food delivery, with lifestyle support, 6 months |
| Food Delivery, 12 monthsTwice monthly delivery of healthy food for 12 months | Other | Food delivery, no lifestyle support, 12 months, Food delivery, with lifestyle support, 12 months |
Primary outcome
Office-based Systolic Blood Pressure at Month 6
Time frame: 6 months
Systolic blood pressure recorded at office-based healthcare visits
Office-based Systolic Blood Pressure at Month 12
Time frame: 12 months
Systolic blood pressure recorded at office-based healthcare visits
Office-based Systolic Blood Pressure at Month 18
Time frame: 18 months
Systolic blood pressure recorded at office-based healthcare visits
Office-based Diastolic Blood Pressure at Month 6
Time frame: 6 months
Diastolic blood pressure recorded at office-based healthcare visits
Office-based Diastolic Blood Pressure at Month 12
Time frame: 12 months
Diastolic blood pressure recorded at office-based healthcare visits
Office-based Diastolic Blood Pressure at Month 18
Time frame: 18 months
Diastolic blood pressure recorded at office-based healthcare visits
28 secondary outcomes
Ambulatory Systolic Blood Pressure at Month 6
Time frame: 6 months
Ambulatory Systolic Blood Pressure at Month 12
Time frame: 12 months
Ambulatory Systolic Blood Pressure at Month 18
Time frame: 18 months
Ambulatory Diastolic Blood Pressure at Month 6
Time frame: 6 months
Ambulatory Diastolic Blood Pressure at Month 12
Time frame: 12 months
Ambulatory Diastolic Blood Pressure at Month 18
Time frame: 18 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 6
Time frame: 6 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 12
Time frame: 12 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 18
Time frame: 18 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 6
Time frame: 6 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 12
Time frame: 12 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 18
Time frame: 18 months
Food Insecurity Score at Month 6
Time frame: 6 months
Food Insecurity Score at Month 12
Time frame: 12 months
Food Insecurity Score at Month 18
Time frame: 18 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 6
Time frame: 6 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 12
Time frame: 12 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 18
Time frame: 18 months
Diet Quality at Month 6
Time frame: 6 months
Diet Quality at Month 12
Time frame: 12 months
Diet Quality at Month 18
Time frame: 18 months
Food/ medication trade-offs at Month 6
Time frame: 6 months
Food/ medication trade-offs at Month 12
Time frame: 12 months
Food/ medication trade-offs Month 18
Time frame: 18 months
Diet self-efficacy at Month 6
Time frame: 6 months
Diet self-efficacy at Month 12
Time frame: 12 months
Diet self-efficacy at Month 18
Time frame: 18 months
Physical Activity Levels at Month 12
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 42927090Anderson RE 3rd, Berkowitz SA, Burger KS, Valle CG, Taillie LS, Ammerman AS. Community Health Worker Coaching, Food Insecurity, and Physical Activity in the Healthy Food First Trial: A Causal Mediation and Longitudinal Analysis. Am J Lifestyle Med. 2026 Oct 23:15598276261498203. doi: 10.1177/15598276261498203. Online ahead of print.
- Derived from this study: PubMed 42602884Anderson RE 3rd, Berkowitz SA, Knoepp P, Pignone K, Burger KS, Valle CG, Taillie LS, Ammerman AS. Exploring the Facilitators and Barriers to Physical Activity among Adults Experiencing Food Insecurity During the Healthy Food First Trial: A Qualitative Study. Curr Dev Nutr. 2026 Jul 21;10(8):109443. doi: 10.1016/j.cdnut.2026.109443. eCollection 2026 Aug.
- Derived from this study: PubMed 41082188Berkowitz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren DeWalt, MD, MPH principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Subsidy, 6 months, Food Subsidy, 12 months and Lifestyle Support, 6 months in people with Hypertension and Food Insecurity, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office-based Systolic Blood Pressure at Month 6 (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05048836, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.