Food as Medicine for Cardiometabolic Health

Overseen By Daniel Schultz, MS, RDN, LD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Must not be taking: Incretin agonists

Disqualifiers: Type 1 diabetes, Uncontrolled hypertension, Severe cardiovascular disease, Recent myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

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.

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).

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 4 7 8 9}

Who Is on the Research Team?

Christina D Economos, PhD

Principal Investigator

Tufts University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group.

Group II: Control Active Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Food as Medicine (FAM) program at Grady Health System is a collaborative intervention aimed at reducing food insecurity and improving health outcomes, highlighting the importance of community resources and partnerships in healthcare.

This case study emphasizes the need for standardized approaches and metrics in food and nutrition programs to ensure their effectiveness, replicability, and sustainability in promoting health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food is medicine intervention shows promise for engaging patients attending a safety-net hospital in the Southeast United States. Owens, C., Cook, M., Goetz, J., et al.[2023]

Unhealthy diets significantly hinder the health of the U.S. population, with many Americans not following recommended dietary guidelines due to barriers like food insecurity and marketing practices.

The 'Food Is Medicine' approach, which provides healthy food resources to manage health conditions, shows promise but lacks strong evidence linking these interventions to improved health outcomes and cost savings, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Is Medicine: A Presidential Advisory From the American Heart Association. Volpp, KG., Berkowitz, SA., Sharma, SV., et al.[2023]

Culinary medicine programs, which include teaching kitchens and gardens, have shown promising preliminary outcomes in improving health metrics like weight and cardiometabolic risk factors in pediatric patients dealing with obesity.

Participation in culinary medicine workshops has increased healthcare employees' confidence and knowledge in preparing whole plant-based meals, suggesting that such programs can enhance healthy lifestyle behaviors both in patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. Fals, AM., Brennan, AM.[2023]

The Fruit and Vegetable Prescription Program (FVPP) in Michigan aims to improve children's diet, food security, and weight status by providing $15 prescriptions for fresh produce at pediatric clinic visits, with a total of 700 caregiver-child pairs enrolled for a two-year study.

The study will compare the effects of varying levels of exposure to the FVPP among children aged 8-16, assessing changes in their dietary habits and health outcomes, which will help determine the program's effectiveness and the necessary duration of exposure for significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. Saxe-Custack, A., Todem, D., Anthony, JC., et al.[2022]

There is a growing recognition that food impacts bodily functions beyond just providing calories, yet much of the information available to consumers about food and diets is unverified for safety and efficacy.

The paper suggests a framework for improving research and development in food safety and health benefits, emphasizing the need for regulatory oversight and addressing patent issues to support long-term investment in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional products as drugs or food implications for development. Richards, DJ.[2008]

Food as Medicine (FAM) interventions have shown positive effects on diet quality and food security in both adults and children, suggesting they can help manage diet-related diseases and reduce healthcare costs.

Recent evidence indicates that implementing FAM interventions in pediatric populations can improve children's diet quality and food security, potentially leading to better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrative review: food as medicine across the pediatric age continuum. Fischer, L., Muleta, H., Essel, K.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Testing the Feasibility and Dietary Impact of a "Produce Prescription" Program for Adults with Undermanaged Type 2 Diabetes and Food Insecurity in Australia. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Food is medicine intervention shows promise for engaging patients attending a safety-net hospital in the Southeast United States. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Food Is Medicine: A Presidential Advisory From the American Heart Association. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Nutritional products as drugs or food implications for development. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Narrative review: food as medicine across the pediatric age continuum. [2023]