FRESH for Type 2 Diabetes

(FRESH Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Psychiatric disturbances, Dysphagia, 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: 7

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Food insecurity, poor nutrition, and economic disadvantage are critical social determinants of health that contribute to disparities in type 2 diabetes mellitus (T2DM), a serious diet-sensitive chronic disease affecting more than 20% of food insecure adults. There is a demonstrable need for food-focused interventions to address the diet quality of persons with, or at risk of, T2DM. Completion of the pilot study will produce recruitment, retention, adherence, and cost data for a future definitive randomized controlled clinical trial, bringing us closer to the long-term goal of a tested, efficacious model of diabetes care coordinated across Federally Qualified Health Centers and food bank networks.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

How does the FRESH treatment for Type 2 Diabetes differ from other treatments?

The FRESH treatment is unique because it involves a fruit and vegetable prescription program, which aims to improve access to healthy foods for low-income patients with diabetes. Unlike traditional treatments that may focus on medication, this program provides financial support to purchase produce, potentially reducing blood sugar levels by encouraging healthier eating habits. ^{1 2 3 4 5}

What data supports the effectiveness of the FRESH treatment for Type 2 Diabetes?

Research on similar programs, like culinary medicine and food prescription initiatives, shows they can help people with diabetes improve their blood sugar levels and eat healthier by increasing fruit and vegetable intake and making cooking easier. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who struggle to get enough food and have a poor diet, which can make their condition worse. It's especially aimed at those facing economic hardships that affect their ability to manage diabetes.

Inclusion Criteria

Willingness to participate in all study activities (Section C.6) for the duration of the study (12 months on study, including 6 months of intervention)

I have been diagnosed with type 2 diabetes by a doctor.

Patient at El Rio Community Health Center

Exclusion Criteria

Inability to read and write

No home phone or home address

I cannot speak or read English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FRESH intervention consisting of bimonthly food provision, recipes, and diabetes self-management education resources, along with four 30-minute visits with a Registered Dietitian Nutritionist over 6 months

6 months

4 visits (in-person)

Follow-up

Participants are monitored for changes in blood glucose control, diet quality, food security, diabetes self-care behaviors, and health-related quality of life

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• FRESH

Trial Overview The FRESH program is being tested in this study. It aims to improve the health of people with type 2 diabetes by providing better access to nutritious food and resources, potentially leading to a new model of care.

How Is the Trial Designed?

Group I: Wait-Listed Control Experimental Treatment 1 Intervention

Standard of Care for El Rio Community Health Center persons with type 2 diabetes.

Group II: Intervention Experimental Treatment 1 Intervention

FRESH-T2D Intervention consisting of bimonthly food, recipes, and diabetes self-management resources + 4 meetings with Registered Dietitian Nutritionists x 6 months duration

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

El Rio Community Health Center

Collaborator

Trials

4

Recruited

910+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Published Research Related to This Trial

The A Prescription for Healthy Living (APHL) culinary medicine curriculum led to a significant reduction in HbA1c levels among patients with diabetes, indicating improved blood sugar control, with a mean difference of -0.96% (p = 0.028).

Participants in the APHL program reported increased fruit and vegetable consumption, greater confidence in cooking healthy meals, and more frequent cooking from scratch, suggesting positive changes in dietary behaviors and self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. Sharma, SV., McWhorter, JW., Chow, J., et al.[2022]

The Food Rx program, a collaborative initiative involving a university, Walgreens, and local health centers, aims to improve healthy eating among diabetes patients in underserved communities by providing food prescriptions that promote behavior change and connect patients to local resources.

Preliminary implementation results suggest that Food Rx effectively integrates community resources into healthcare settings, showing potential as a model for supporting the health of underserved patients, although it is still in the early stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. Goddu, AP., Roberson, TS., Raffel, KE., et al.[2018]

The Fresh Prescription (Fresh Rx) program, which provided low-income patients with diabetes in Detroit up to $80 for purchasing fruits and vegetables, led to a significant decrease in hemoglobin A1C (HbA1c) levels from 9.64% to 9.14% over 15 weeks.

While the Fresh Rx group showed improvement in HbA1c, there were no significant changes in blood pressure or body mass index (BMI) for either the Fresh Rx or control groups, suggesting that while the program may help with blood sugar management, it may not impact weight or blood pressure in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. Bryce, R., WolfsonBryce, JA., CohenBryce, A., et al.[2023]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Linking the Flint Food Store Survey: Is Objective or Perceived Access to Healthy Foods Associated with Glycemic Control in Patients with Type 2 Diabetes? [2023]

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

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. [2018]

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

Patient-Centered Foodservice Model Improves Body Weight, Nutritional Intake and Patient Satisfaction in Patients Undergoing Cancer Treatment. [2020]

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

Partnering with REACH to create a "diabetes-friendly" restaurant: a restaurant owner's experience. [2021]

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

A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Evaluation of an Internet-Based Diabetes Nutrition Education Resource. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Societal Marketing in the Treatment of Type 2 Diabetes Mellitus: A Longitudinal Questionnaire Survey for Michelin-Starred Restaurants in Japan. [2020]