300 Participants Needed

Food as Medicine for Cardiometabolic Health

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DS
Overseen ByDaniel Schultz, MS, RDN, LD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using incretin agonists (a type of diabetes medication).

What data supports the effectiveness of the treatment Food is Medicine for cardiometabolic health?

Research suggests that 'Food is Medicine' programs, like produce prescriptions, can improve cardiometabolic health by increasing fruit and vegetable intake and addressing food insecurity. However, more studies are needed to evaluate their impact on clinical outcomes and health status.12345

Is the 'Food as Medicine' approach generally safe for humans?

The 'Food as Medicine' approach, which includes programs like Produce Prescription Programs and culinary medicine, focuses on providing healthy foods to improve health. While there is limited research specifically on safety, these programs generally promote the consumption of fruits and vegetables, which are widely considered safe and beneficial for most people.15678

How is the Food is Medicine treatment different from other treatments for cardiometabolic health?

The Food is Medicine treatment is unique because it uses food-based interventions, like providing healthy food resources and nutrition education, to prevent and manage diet-related diseases, rather than relying on traditional medications. This approach integrates food into healthcare systems, aiming to improve diet and health outcomes through strategies like medically tailored meals and produce prescription programs.23569

What is the purpose of this trial?

Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. 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 Growing a Resilient, Enriching, Equitable, Nourishing food System (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.

Research Team

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Christina D Economos, PhD

Principal Investigator

Tufts University

Eligibility Criteria

The trial is for residents of Bolivar, Washington, and Sunflower counties in Mississippi who are experiencing food insecurity and have cardiometabolic risk factors like diabetes, high blood pressure, or obesity. Participants should be part of the health disparity population with a significant number living at or below poverty level.

Inclusion Criteria

BMI: ≥ 25
Patient at participating Delta Health Center (DHC) clinics
Hemoglobin A1C (HbA1c): >5.7 to 8.5%, inclusive

Exclusion Criteria

Drug or alcohol misuse that would impair the ability to complete study activities
I have had, or am considering, bariatric surgery within a year.
Type 1 diabetes
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive regularly distributed fruit and vegetable produce boxes and nutrition education materials

12 months
Monthly visits (in-person or virtual)

Control

Control group will receive produce boxes after completing study activities

12 months

Follow-up

Participants are monitored for changes in health outcomes such as HbA1c, cholesterol, and BMI

4 weeks

Treatment Details

Interventions

  • Food is Medicine
Trial Overview The Delta GREENS project tests a 'Food is Medicine' intervention to improve health outcomes. It provides fruit and vegetable produce boxes along with nutrition education materials to one group (intervention), while another group (control) will receive these after study activities.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group.
Group II: ControlActive Control1 Intervention
The control group will receive produce boxes later, after they complete study activities.

Food is Medicine is already approved in United States for the following indications:

🇺🇸
Approved in United States as Food is Medicine for:
  • Nutrition insecurity
  • Obesity
  • Diabetes
  • Chronic disease management

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials
271
Recruited
595,000+

Reuben V. Anderson Center for Justice at Tougaloo

Collaborator

Trials
1
Recruited
300+

Tougaloo College, Mississippi

Collaborator

Trials
1
Recruited
300+

Delta Health Center, Mississippi

Collaborator

Trials
1
Recruited
300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Findings from Research

A study involving 3881 individuals across 22 locations showed that produce prescriptions significantly increased fruit and vegetable intake by 0.85 cups per day for adults and 0.26 cups for children, improving overall dietary habits.
Participants also experienced notable health benefits, including a reduction in food insecurity by one-third, lower glycated hemoglobin levels, and decreased blood pressure among adults with hypertension, indicating that these programs can effectively enhance cardiometabolic health.
Impact of Produce Prescriptions on Diet, Food Security, and Cardiometabolic Health Outcomes: A Multisite Evaluation of 9 Produce Prescription Programs in the United States.Hager, K., Du, M., Li, Z., et al.[2023]
A 12-week 'produce prescription' program for 50 adults with type 2 diabetes and food insecurity significantly improved diet quality, with an increase in the Alternate Healthy Eating Index score by 12.9 points, indicating better consumption of fruits, vegetables, and whole grains.
Participants also experienced improvements in blood lipids and weight loss, with 92% completing the study, suggesting high feasibility and satisfaction with the program, warranting further research into its effectiveness.
Testing the Feasibility and Dietary Impact of a "Produce Prescription" Program for Adults with Undermanaged Type 2 Diabetes and Food Insecurity in Australia.Wu, JH., Trieu, K., Coyle, D., et al.[2023]
This study will evaluate the efficacy of a Medically Tailored Meals (MTM) program for individuals with type 2 diabetes and hyperglycemia, involving 212 participants over 26 weeks, to see if it can improve their blood sugar levels and overall health.
The trial aims to provide valuable data on the clinical outcomes of MTM, which could support its large-scale implementation in healthcare systems to help manage chronic conditions like diabetes.
Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia.Law, KK., Coyle, DH., Neal, B., et al.[2023]

References

Impact of Produce Prescriptions on Diet, Food Security, and Cardiometabolic Health Outcomes: A Multisite Evaluation of 9 Produce Prescription Programs in the United States. [2023]
Testing the Feasibility and Dietary Impact of a "Produce Prescription" Program for Adults with Undermanaged Type 2 Diabetes and Food Insecurity in Australia. [2023]
Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. [2023]
Food is medicine intervention shows promise for engaging patients attending a safety-net hospital in the Southeast United States. [2023]
Food Is Medicine: A Presidential Advisory From the American Heart Association. [2023]
Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. [2023]
Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. [2022]
Nutritional products as drugs or food implications for development. [2008]
Narrative review: food as medicine across the pediatric age continuum. [2023]
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