Cardiometabolic Risk FactorsNCT06358859
Delta GREENS Food is Medicine Intervention
A study testing Food is Medicine in people with Cardiometabolic Risk Factors and Diabetes, run by Tufts University at 1 site in United States.
Trial summary
Mississippi is a place deeply rooted in cultural values, yet also a place where generations of communities have experienced persistent health challenges intertwined with poverty. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors, Diabetes, High Blood Pressure
- What is being tested?
- Food is Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to May 2027
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient at participating Delta Health Center (DHC) clinics
- BMI: ≥ 25
- Hemoglobin A1C (HbA1c): >5.7 to 8.5%, inclusive
Who cannot join
- Type 1 diabetes
- Current use of incretin agonists (e.g., semaglutide, dulaglutide, liraglutide)
- Uncontrolled hypertension:
- Systolic blood pressure > 160 mmHg
- Diastolic blood pressure > 100 mmHg
- Severe symptomatic cardiovascular disease
Show all 20Show fewer
- Recent (6 months) history of:
- Myocardial infarction
- Percutaneous coronary intervention
- Coronary artery bypass graft
- Cerebrovascular disease
- Participant in diabetes, nutrition, or weight intervention research in the last 12 months
- Another family member or household member is a study participant
- History of bariatric surgery or considering bariatric surgery in the next year or prior bariatric surgery
- Lack of safe, stable residence and ability to store produce
- Lack of telephone
- Pregnancy/breastfeeding or intended pregnancy in the next year
- Drug or alcohol misuse that would impair the ability to complete study activities
- Known psychosis or major psychiatric illness that prevents participation in study activities
- Any other reason that in the investigators' best judgment places the participants at risk or increases likelihood of poor adherence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delta GREENS Mississippi Food is Medicine Intervention
Mississippi is a place deeply rooted in cultural values, yet also a place where generations of communities have experienced persistent health challenges intertwined with poverty. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and ~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta GREENS Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide.
Read the detailed description
Mississippi is a place deeply rooted in cultural values, yet also a place where generations of communities have experienced persistent health challenges intertwined with poverty. In fact, about 77% of Mississippi counties meet the U.S. Department of Agriculture's definition of food deserts. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and ~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Food is medicine programs -- health clinic mobile markets, produce prescription programs, and produce delivery - hold significant promise for addressing the alarming crisis of nutrition-related diseases. Across the U.S., Food is Medicine programs are in their infancy and accelerating at a rapid pace; since 2019, USDA has funded 116 produce prescription grants. However, no studies have evaluated the impact of food is medicine programs in a rigorous, randomized controlled trial measuring objective cardiometabolic risk factors among minority populations in communities with persistent disadvantage. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. This study is focused on Delta GREENS Food is Medicine (FIM) Project. Delta GREENS Food is Medicine is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. Participants will be patients at Delta Health Center (DHC) clinics in Mississippi. The project capitalizes on the past success of community-based efforts and decades of community-engaged research at Tufts University, including prior nutrition work in the Delta region. Despite its unique cultural and agricultural background, the Mississippi Delta has experienced persistent health challenges intertwined with poverty. By collaborating and building upon previous successes, the Delta GREENS FIM Project aims to address these challenges, and become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide.
- Being tested
- Food is Medicine
- Keywords
- Food is Medicine, Diabetes, High blood pressure, Cardiometabolic risk factors, Nutrition-related diseases
- Medical subject headings
- Diabetes Mellitus, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food is MedicineOther
Regularly distributed fruit and vegetable produce boxes and nutrition education materials.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. Receives: Other: Food is Medicine |
| Control | No intervention | The control group will receive produce boxes later, after they complete study activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin A1c (HbA1c)
Change in HbA1c in the intervention group compared to the control group
Measured: 12 month study period for each participant
Secondary outcomes (9)
Change in cardiometabolic risk factor composite score
Change in cardiometabolic risk factor composite score which is computed using LDL and non-HDL cholesterol, blood pressure and HbA1c measures), in the intervention group compared to the control group.
Measured: 12 month study period for each participant
Change in BMI
Change in body mass index (BMI) in intervention group compared to control group
Measured: 12 month study period for each participant
Change in LDL cholesterol
Change in LDL cholesterol levels in intervention group compared to the control group
Measured: 12 month study period for each participant
Change in non-HDL cholesterol
Change in non-HDL cholesterol levels in intervention group compared to the control group
Measured: 12 month study period for each participant
Change in blood pressure
Change in blood pressure in intervention group compared to the control group
Measured: 12 month study period for each participant
Change in nutrition security, assessed via a survey
Change in nutrition security in intervention group compared to the control group. This outcome measure will be assessed via a survey.
Measured: 12 month study period for each participant
Change in dietary intake of fruits and vegetables, assessed via a survey
Change in dietary intake of fruits and vegetables in intervention group compared to the control group. This outcome measure will be assessed via a survey.
Measured: 12 month study period for each participant
Change in health care utilization, assessed via review of Electronic Health Records (EHR)
Change in health care utilization, including instances of hospitalization and emergency room visit, in intervention group compared to the control group. This outcome measure will be assessed via review of Electronic Health Records (EHR).
Measured: 12 month study period for each participant
Change in food insecurity, assessed via a survey
Change in food insecurity in the intervention group compared to the control group. This outcome measure will be assessed via a survey.
Measured: 12 month study period for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start5 Jun 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary objective is to test whether a multi-level, community-engaged intervention with a food-is-medicine program in the Mississippi Delta can improve metabolic disease in specific minority groups. The basic study design is a cluster randomized controlled trial (RCT), with equal numbers of participants randomized to intervention and control groups. Each participant will be enrolled in the study for 12 months. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group during their 12-month study period. The control group will receive produce boxes later, after their 12-month study participation has ended. Participants will be patients at participating Delta Health Center (DHC) clinics in Mississippi.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Tougaloo College, Mississippi, Delta Health Center, Mississippi, Reuben V. Anderson Center
- Responsible party
- Principal investigator, Christina Economos, Tufts University
- Investigators
- Christina D Economos, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358859
- Sponsor's protocol ID
- STUDY00004203
- Other IDs
- 1R01MD018208-01
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delta GREENS Mississippi Food is Medicine Intervention
- ClinicalTrials.gov ID
- NCT06358859
- Acronym / sponsor ID
- STUDY00004203
- Keywords
- Food is Medicine, Diabetes, High blood pressure, Cardiometabolic risk factors, Nutrition-related diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Tougaloo College, Mississippi, Delta Health Center, Mississippi, Reuben V. Anderson Center
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 11 Apr 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.
Mississippi is a place deeply rooted in cultural values, yet also a place where generations of communities have experienced persistent health challenges intertwined with poverty. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and ~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta GREENS Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide.
Detailed description
Mississippi is a place deeply rooted in cultural values, yet also a place where generations of communities have experienced persistent health challenges intertwined with poverty. In fact, about 77% of Mississippi counties meet the U.S. Department of Agriculture's definition of food deserts. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and ~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Food is medicine programs -- health clinic mobile markets, produce prescription programs, and produce delivery - hold significant promise for addressing the alarming crisis of nutrition-related diseases. Across the U.S., Food is Medicine programs are in their infancy and accelerating at a rapid pace; since 2019, USDA has funded 116 produce prescription grants. However, no studies have evaluated the impact of food is medicine programs in a rigorous, randomized controlled trial measuring objective cardiometabolic risk factors among minority populations in communities with persistent disadvantage. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. This study is focused on Delta GREENS Food is Medicine (FIM) Project. Delta GREENS Food is Medicine is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. Participants will be patients at Delta Health Center (DHC) clinics in Mississippi. The project capitalizes on the past success of community-based efforts and decades of community-engaged research at Tufts University, including prior nutrition work in the Delta region. Despite its unique cultural and agricultural background, the Mississippi Delta has experienced persistent health challenges intertwined with poverty. By collaborating and building upon previous successes, the Delta GREENS FIM Project aims to address these challenges, and become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary objective is to test whether a multi-level, community-engaged intervention with a food-is-medicine program in the Mississippi Delta can improve metabolic disease in specific minority groups. The basic study design is a cluster randomized controlled trial (RCT), with equal numbers of participants randomized to intervention and control groups. Each participant will be enrolled in the study for 12 months. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group during their 12-month study period. The control group will receive produce boxes later, after their 12-month study participation has ended. Participants will be patients at participating Delta Health Center (DHC) clinics in Mississippi.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Food is MedicineThe intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. |
| Control | No intervention | –The control group will receive produce boxes later, after they complete study activities. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient at participating Delta Health Center (DHC) clinics
- BMI: ≥ 25
- Hemoglobin A1C (HbA1c): >5.7 to 8.5%, inclusive
Key exclusion criteria (20 listed)
- Type 1 diabetes
- Current use of incretin agonists (e.g., semaglutide, dulaglutide, liraglutide)
- Uncontrolled hypertension:
- Severe symptomatic cardiovascular disease
- Recent (6 months) history of:
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 is MedicineRegularly distributed fruit and vegetable produce boxes and nutrition education materials. | Other | Intervention |
Primary outcome
Change in hemoglobin A1c (HbA1c)
Time frame: 12 month study period for each participant
Change in HbA1c in the intervention group compared to the control group
9 secondary outcomes
Change in cardiometabolic risk factor composite score
Time frame: 12 month study period for each participant
Change in BMI
Time frame: 12 month study period for each participant
Change in LDL cholesterol
Time frame: 12 month study period for each participant
Change in non-HDL cholesterol
Time frame: 12 month study period for each participant
Change in blood pressure
Time frame: 12 month study period for each participant
Change in nutrition security, assessed via a survey
Time frame: 12 month study period for each participant
Change in dietary intake of fruits and vegetables, assessed via a survey
Time frame: 12 month study period for each participant
Change in health care utilization, assessed via review of Electronic Health Records (EHR)
Time frame: 12 month study period for each participant
Change in food insecurity, assessed via a survey
Time frame: 12 month study period for each participant
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 18 Aug 2026.
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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.
Christina D Economos, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food is Medicine in people with Cardiometabolic Risk Factors and Diabetes, run by Tufts University 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 20 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 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?
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?
Change in hemoglobin A1c (HbA1c) (time frame: 12 month study period for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.