Health LiteracyNCT06614920
Addressing Food Insecurity: Plant-Based Food Prescription Program
A study testing Plant-Based Food Provision (with or without food prescription) and Plant-Based Nutrition Education in people with Health Literacy and Nutrition, Healthy, run by University of Miami at 1 site in United States.
Trial summary
Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve. Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Nutrition, Healthy, Nutrition Poor
- What is being tested?
- Plant-Based Food Provision (with or without food prescription) and Plant-Based Nutrition Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants will be all ages 0-99 (all arms)
- Families living under the federal poverty line AND who have food insecurity (all arms except Arm 2 which can include families with income above the federal poverty line who do not have food insecurity).
- Families cared for in either the Pediatric Mobile Clinic, Pediatric, Family Medicine, Internal Medicine or Med-Peds primary care clinics in the UHealth/Jackson Health System/Dade County Street Response.
Who cannot join
- Families who are not under the federal poverty line AND are not food insecure (all arms except Arm 2, which will include participants of all socioeconomic statuses and regardless of food security status, with no exclusion criteria in this category).
- Families who are not actively receiving outpatient primary care (all arms).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Freedom Lab 4300 NW 12th Ave
Miami, Florida, 33127
Brayland M Brown, MBA, 954-600-3326, brayland@thesmiletrust.org
Azaria V Lewis, DO, MS
About this study
Official title: Addressing Food-Insecurity: Plant-Based Food Prescription Program to Improve Health Food Access
Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.
- Conditions
- Health Literacy, Nutrition, Healthy, Nutrition Poor, Food Insecurity, Food Insecurity Among Children, Low Income Population
- Being tested
- Plant-Based Food Provision (with or without food prescription), Plant-Based Nutrition Education
- Keywords
- Plant-based food prescription program, Plant-based, Food prescription, Food insecurity, Poverty, Nutrition education, Plant-based nutrition literacy, Plant-based nutrition education
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-Based Food Provision (with or without food prescription)Other
Food Prescription: Participants will bring the food prescription obtained from the nutrition class to Village FREEdge, food pantry at the Freedom Lab, where it will function as a voucher. Each voucher will allow for participants to pick up enough plant-based food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day). We expect that participants will pick up food twice per week from Village FREEdge to obtain enough meals to feed each participant's household for 6 days out of the week for up to 1 year.
Without food prescription: Participants will be given plant-based meals from Village FREEdge (up to two meals per day with a maximum of two meals per pick-up) without the use of a food prescription.
Plant-Based Nutrition EducationOther
A once weekly classes for a 5-week nutrition course. The parents/guardians would bring their children and any additional household member(s) to the nutrition class, which will organize participants in different classrooms by age (children 4 years, 4-12 years old, 12-14 years old, 14+ years old). Each classrooms will engage in age-appropriate interactive nutrition-based activities. All children below 18 will engage in interactive activities for the full 1.5 hours. Adolescents aged 14 up will join the classroom with adults and listen to a 45 minute lecture and engage in a subsequent 45 minute interactive activity that incorporates content from the lecture. The interactive activities for the children range from creating a fruit and veggie "Tik Tok" song and performing it, drawing foods on a "balanced plate", etc. The interactive activities for participants 14 year old and older range from discussions about fiber in diet, guided plant-based meal preparation, reading nutrition label etc.
| Study group | Role | What they receive |
|---|---|---|
| Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention) | Experimental | Participants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education), we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age (detailed in Arm 2 description).
Participants in Arm 1 only (dual intervention) will be provided with a food prescription at the end of each class. Participants will bring this food prescription to Village FREEdge, where it will function as a voucher. Each voucher will allow for participants to pick up enough food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day). Receives: Other: Plant-Based Food Provision (with or without food prescription); Other: Plant-Based Nutrition Education |
| Plant-Based Nutrition Education Only (single intervention 1) | Experimental | Participants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education) and Arm 2 (single intervention 1- nutrition education only) we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age. If participants are 14 years old or older, they will listen to a 45-minute plant-based nutrition lecture and engage in a 45-minute interactive activity, including but not limited to plant-based meal preparation. Participants younger than 14 years old will be guided through age-appropriate interactive activities for the full 1.5-2 hours in a nearby classroom. Receives: Other: Plant-Based Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables
The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed fruits and vegetables.
Measured: Up to 1 year
Number of Servings of Unprocessed and Minimally Processed Whole Grains
The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed whole grains.
Measured: Up to 1 year
Number of Servings of Unprocessed and Minimally Processed Legumes
The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed legumes.
Measured: Up to 1 year
Number Servings of Unprocessed and Minimally Processed Nuts/Seeds
The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed nuts/seeds.
Measured: Up to 1 year
Secondary outcomes (2)
Presence of Food Insecurity
Affirmative response to either of the two, validated screening questions for food insecurity. Investigators measured food insecurity using the validated two-question "Hunger Vital Sign" screening tool, with yes/no responses. These two questions are: "we worried whether our food would run out before we got money to buy more" and "the food we bought just didn't last and we didn't have money to get more."
Measured: Up to 1 year
Change in Plant-Based Nutrition Knowledge of Participants
The nutrition knowledge of participants will be measured by a change in nutrition literacy pre-post test (less than 30 multiple choice questions) scores. (The pre-test will be given prior to the plant-based nutrition education course and the post-test after completion of the course).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start9 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, Committee of Interns and Residents SEIU Healthcare
- Responsible party
- Principal investigator, Azaria Lewis, University of Miami
- Investigators
- Azaria V Lewis, DO, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614920
- Sponsor's protocol ID
- 20240753
- Status last verified
- Feb 2026
- First submitted
- 24 Sep 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning on sharing IPD with other researchers as that is not the arrangement of this study. We are not working with other researchers at this time.
Publications
Bryce R, WolfsonBryce JA, CohenBryce A, Milgrom N, Garcia D, Steele A, Yaphe S, Pike D, Valbuena F, Miller-Matero LR. A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. Prev Med Rep. 2021 May 31;23:101410. doi: 10.1016/j.pmedr.2021.101410. eCollection 2021 Sep.
PubMed 34150472Ridberg RA, Bell JF, Merritt KE, Harris DM, Young HM, Tancredi DJ. Effect of a Fruit and Vegetable Prescription Program on Children's Fruit and Vegetable Consumption. Prev Chronic Dis. 2019 Jun 13;16:E73. doi: 10.5888/pcd16.180555.
PubMed 31198165Oronce CIA, Miake-Lye IM, Begashaw MM, Booth M, Shrank WH, Shekelle PG. Interventions to Address Food Insecurity Among Adults in Canada and the US: A Systematic Review and Meta-analysis. JAMA Health Forum. 2021 Aug 6;2(8):e212001. doi: 10.1001/jamahealthforum.2021.2001. eCollection 2021 Aug.
PubMed 35977189Bhat S, Coyle DH, Trieu K, Neal B, Mozaffarian D, Marklund M, Wu JHY. Healthy Food Prescription Programs and their Impact on Dietary Behavior and Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Oct 1;12(5):1944-1956. doi: 10.1093/advances/nmab039.
PubMed 33999108Xie J, Price A, Curran N, Ostbye T. The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. Public Health Nutr. 2021 Aug;24(12):3945-3955. doi: 10.1017/S1368980021001828. Epub 2021 Apr 27.
PubMed 33902771Fuchs D. An overview of nutrition in medical education. JAMA. 2018;319(15):1551. doi:10.1001/jama.2018.1919.
Centers for Disease Control and Prevention. Chronic disease prevention. Accessed January 23, 2024. Available from: https://www.cdc.gov/chronic-disease/prevention/
Stanford Medicine. Why medical schools need to focus on nutrition. Accessed January 23, 2024. Available from: https://med.stanford.edu/school/leadership/dean/precision-health-in-the-news/why-medica-schools-need-focus-nutrition.html
Centers for Disease Control and Prevention. Hypertension cascade: hypertension prevalence, treatment, and control estimates among US adults aged 18 years and older applying the criteria from the American College of Cardiology and American Heart Association's 2017 Hypertension Guideline-NHANES 2015-2018. US Department of Health and Human Services; 2019. Accessed January 23, 2024. Available from: https://millionhearts.hhs.gov/data-reports/hypertension-prevalence.html
Centers for Disease Control and Prevention. Non-Hispanic Black participants had higher rates of hypertension compared to White and Hispanic participants. Accessed January 23, 2024. Available from: https://www.cdc.gov/pcd/issues/2023/23_0065.htm
U.S. Food and Drug Administration. Improving nutrition to turn the tide on diet-related chronic disease. Accessed January 23, 2024. Available from: https://www.fda.gov/news-events/fda-voices/improving-nutrition-turn-tide-diet-related-chronic-disease
US Burden of Disease Collaborators; Mokdad AH, Ballestros K, Echko M, Glenn S, Olsen HE, Mullany E, Lee A, Khan AR, Ahmadi A, Ferrari AJ, Kasaeian A, Werdecker A, Carter A, Zipkin B, Sartorius B, Serdar B, Sykes BL, Troeger C, Fitzmaurice C, Rehm CD, Santomauro D, Kim D, Colombara D, Schwebel DC, Tsoi D, Kolte D, Nsoesie E, Nichols E, Oren E, Charlson FJ, Patton GC, Roth GA, Hosgood HD, Whiteford HA, Kyu H, Erskine HE, Huang H, Martopullo I, Singh JA, Nachega JB, Sanabria JR, Abbas K, Ong K, Tabb K, Krohn KJ, Cornaby L, Degenhardt L, Moses M, Farvid M, Griswold M, Criqui M, Bell M, Nguyen M, Wallin M, Mirarefin M, Qorbani M, Younis M, Fullman N, Liu P, Briant P, Gona P, Havmoller R, Leung R, Kimokoti R, Bazargan-Hejazi S, Hay SI, Yadgir S, Biryukov S, Vollset SE, Alam T, Frank T, Farid T, Miller T, Vos T, Barnighausen T, Gebrehiwot TT, Yano Y, Al-Aly Z, Mehari A, Handal A, Kandel A, Anderson B, Biroscak B, Mozaffarian D, Dorsey ER, Ding EL, Park EK, Wagner G, Hu G, Chen H, Sunshine JE, Khubchandani J, Leasher J, Leung J, Salomon J, Unutzer J, Cahill L, Cooper L, Horino M, Brauer M, Breitborde N, Hotez P, Topor-Madry R, Soneji S, Stranges S, James S, Amrock S, Jayaraman S, Patel T, Akinyemiju T, Skirbekk V, Kinfu Y, Bhutta Z, Jonas JB, Murray CJL. The State of US Health, 1990-2016: Burden of Diseases, Injuries, and Risk Factors Among US States. JAMA. 2018 Apr 10;319(14):1444-1472. doi: 10.1001/jama.2018.0158.
PubMed 29634829
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Food-Insecurity: Plant-Based Food Prescription Program to Improve Health Food Access
- ClinicalTrials.gov ID
- NCT06614920
- Acronym / sponsor ID
- 20240753
- Conditions
- Health Literacy, Nutrition, Healthy, Nutrition Poor, Food Insecurity, Food Insecurity Among Children, Low Income Population
- Keywords
- Plant-based food prescription program, Plant-based, Food prescription, Food insecurity, Poverty, Nutrition education, Plant-based nutrition literacy, Plant-based nutrition education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, Committee of Interns and Residents SEIU Healthcare
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Sep 2024 (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.
Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention) | Experimental | Other: Plant-Based Food Provision (with or without food prescription), Other: Plant-Based Nutrition EducationParticipants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education), we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age (detailed in Arm 2 description). Participants in Arm 1 only (dual intervention) will be provided with a food prescription at the end of each class. Participants will bring this food prescription to Village FREEdge, where it will function as a voucher. Each voucher will allow for participants to pick up enough food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day). |
| Plant-Based Nutrition Education Only (single intervention 1) | Experimental | Other: Plant-Based Nutrition EducationParticipants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education) and Arm 2 (single intervention 1- nutrition education only) we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age. If participants are 14 years old or older, they will listen to a 45-minute plant-based nutrition lecture and engage in a 45-minute interactive activity, including but not limited to plant-based meal preparation. Participants younger than 14 years old will be guided through age-appropriate interactive activities for the full 1.5-2 hours in a nearby classroom. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be all ages 0-99 (all arms)
- Families living under the federal poverty line AND who have food insecurity (all arms except Arm 2 which can include families with income above the federal poverty line who do not have food insecurity).
- Families cared for in either the Pediatric Mobile Clinic, Pediatric, Family Medicine, Internal Medicine or Med-Peds primary care clinics in the UHealth/Jackson Health System/Dade County Street Response.
Key exclusion criteria (2 listed)
- Families who are not under the federal poverty line AND are not food insecure (all arms except Arm 2, which will include participants of all socioeconomic statuses and regardless of food security status, with no exclusion criteria in this category).
- Families who are not actively receiving outpatient primary care (all arms).
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 |
|---|---|---|
| Plant-Based Food Provision (with or without food prescription)Food Prescription: Participants will bring the food prescription obtained from the nutrition class to Village FREEdge, food pantry at the Freedom Lab, where it will function as a voucher. Each voucher will allow for participants to pick up enough plant-based food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day). We expect that participants will pick up food twice per week from Village FREEdge to obtain enough meals to feed each participant's household for 6 days out of the week for up to 1 year. Without food prescription: Participants will be given plant-based meals from Village FREEdge (up to two meals per day with a maximum of two meals per pick-up) without the use of a food prescription. | Other | Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention) |
| Plant-Based Nutrition EducationA once weekly classes for a 5-week nutrition course. The parents/guardians would bring their children and any additional household member(s) to the nutrition class, which will organize participants in different classrooms by age (children 4 years, 4-12 years old, 12-14 years old, 14+ years old). Each classrooms will engage in age-appropriate interactive nutrition-based activities. All children below 18 will engage in interactive activities for the full 1.5 hours. Adolescents aged 14 up will join the classroom with adults and listen to a 45 minute lecture and engage in a subsequent 45 minute interactive activity that incorporates content from the lecture. The interactive activities for the children range from creating a fruit and veggie "Tik Tok" song and performing it, drawing foods on a "balanced plate", etc. The interactive activities for participants 14 year old and older range from discussions about fiber in diet, guided plant-based meal preparation, reading nutrition label etc. | Other | Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention), Plant-Based Nutrition Education Only (single intervention 1) |
Primary outcome
Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables
Time frame: Up to 1 year
The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed fruits and vegetables.
Number of Servings of Unprocessed and Minimally Processed Whole Grains
Time frame: Up to 1 year
The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed whole grains.
Number of Servings of Unprocessed and Minimally Processed Legumes
Time frame: Up to 1 year
The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed legumes.
Number Servings of Unprocessed and Minimally Processed Nuts/Seeds
Time frame: Up to 1 year
The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed nuts/seeds.
2 secondary outcomes
Presence of Food Insecurity
Time frame: Up to 1 year
Change in Plant-Based Nutrition Knowledge of Participants
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 34150472Bryce R, WolfsonBryce JA, CohenBryce A, Milgrom N, Garcia D, Steele A, Yaphe S, Pike D, Valbuena F, Miller-Matero LR. A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. Prev Med Rep. 2021 May 31;23:101410. doi: 10.1016/j.pmedr.2021.101410. eCollection 2021 Sep.
- Background: PubMed 31198165Ridberg RA, Bell JF, Merritt KE, Harris DM, Young HM, Tancredi DJ. Effect of a Fruit and Vegetable Prescription Program on Children's Fruit and Vegetable Consumption. Prev Chronic Dis. 2019 Jun 13;16:E73. doi: 10.5888/pcd16.180555.
- Background: PubMed 35977189Oronce CIA, Miake-Lye IM, Begashaw MM, Booth M, Shrank WH, Shekelle PG. Interventions to Address Food Insecurity Among Adults in Canada and the US: A Systematic Review and Meta-analysis. JAMA Health Forum. 2021 Aug 6;2(8):e212001. doi: 10.1001/jamahealthforum.2021.2001. eCollection 2021 Aug.
- Background: PubMed 33999108Bhat S, Coyle DH, Trieu K, Neal B, Mozaffarian D, Marklund M, Wu JHY. Healthy Food Prescription Programs and their Impact on Dietary Behavior and Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Oct 1;12(5):1944-1956. doi: 10.1093/advances/nmab039.
- Background: PubMed 33902771Xie J, Price A, Curran N, Ostbye T. The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. Public Health Nutr. 2021 Aug;24(12):3945-3955. doi: 10.1017/S1368980021001828. Epub 2021 Apr 27.
- BackgroundFuchs D. An overview of nutrition in medical education. JAMA. 2018;319(15):1551. doi:10.1001/jama.2018.1919.
- BackgroundCenters for Disease Control and Prevention. Chronic disease prevention. Accessed January 23, 2024. Available from: https://www.cdc.gov/chronic-disease/prevention/
- BackgroundStanford Medicine. Why medical schools need to focus on nutrition. Accessed January 23, 2024. Available from: https://med.stanford.edu/school/leadership/dean/precision-health-in-the-news/why-medica-schools-need-focus-nutrition.html
- BackgroundCenters for Disease Control and Prevention. Hypertension cascade: hypertension prevalence, treatment, and control estimates among US adults aged 18 years and older applying the criteria from the American College of Cardiology and American Heart Association's 2017 Hypertension Guideline-NHANES 2015-2018. US Department of Health and Human Services; 2019. Accessed January 23, 2024. Available from: https://millionhearts.hhs.gov/data-reports/hypertension-prevalence.html
- BackgroundCenters for Disease Control and Prevention. Non-Hispanic Black participants had higher rates of hypertension compared to White and Hispanic participants. Accessed January 23, 2024. Available from: https://www.cdc.gov/pcd/issues/2023/23_0065.htm
- BackgroundU.S. Food and Drug Administration. Improving nutrition to turn the tide on diet-related chronic disease. Accessed January 23, 2024. Available from: https://www.fda.gov/news-events/fda-voices/improving-nutrition-turn-tide-diet-related-chronic-disease
- Background: PubMed 29634829US Burden of Disease Collaborators; Mokdad AH, Ballestros K, Echko M, Glenn S, Olsen HE, Mullany E, Lee A, Khan AR, Ahmadi A, Ferrari AJ, Kasaeian A, Werdecker A, Carter A, Zipkin B, Sartorius B, Serdar B, Sykes BL, Troeger C, Fitzmaurice C, Rehm CD, Santomauro D, Kim D, Colombara D, Schwebel DC, Tsoi D, Kolte D, Nsoesie E, Nichols E, Oren E, Charlson FJ, Patton GC, Roth GA, Hosgood HD, Whiteford HA, Kyu H, Erskine HE, Huang H, Martopullo I, Singh JA, Nachega JB, Sanabria JR, Abbas K, Ong K, Tabb K, Krohn KJ, Cornaby L, Degenhardt L, Moses M, Farvid M, Griswold M, Criqui M, Bell M, Nguyen M, Wallin M, Mirarefin M, Qorbani M, Younis M, Fullman N, Liu P, Briant P, Gona P, Havmoller R, Leung R, Kimokoti R, Bazargan-Hejazi S, Hay SI, Yadgir S, Biryukov S, Vollset SE, Alam T, Frank T, Farid T, Miller T, Vos T, Barnighausen T, Gebrehiwot TT, Yano Y, Al-Aly Z, Mehari A, Handal A, Kandel A, Anderson B, Biroscak B, Mozaffarian D, Dorsey ER, Ding EL, Park EK, Wagner G, Hu G, Chen H, Sunshine JE, Khubchandani J, Leasher J, Leung J, Salomon J, Unutzer J, Cahill L, Cooper L, Horino M, Brauer M, Breitborde N, Hotez P, Topor-Madry R, Soneji S, Stranges S, James S, Amrock S, Jayaraman S, Patel T, Akinyemiju T, Skirbekk V, Kinfu Y, Bhutta Z, Jonas JB, Murray CJL. The State of US Health, 1990-2016: Burden of Diseases, Injuries, and Risk Factors Among US States. JAMA. 2018 Apr 10;319(14):1444-1472. doi: 10.1001/jama.2018.0158.
- Individual participant dataSharing planned: No. We are not planning on sharing IPD with other researchers as that is not the arrangement of this study. We are not working with other researchers at this time.
Related trials for Health Literacy
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
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.
Azaria V Lewis, DO principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-Based Food Provision (with or without food prescription) and Plant-Based Nutrition Education in people with Health Literacy and Nutrition, Healthy, run by University of Miami at 1 site 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azaria V Lewis, DO, MS (707-741-1396, Axl4415@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables (time frame: Up to 1 year). The study lists 4 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 NCT06614920, which also lists 12 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 4 Feb 2026.