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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how providing food, recipes, and educational resources can assist people with type 2 diabetes who face food insecurity. Participants will receive bimonthly food deliveries and meet with nutrition experts to better manage their diabetes. The goal is to understand how these interventions, collectively known as FRESH (Focus on Restaurant Engagement to Strengthen Health), can improve diet quality and diabetes management. This trial may suit adults diagnosed with type 2 diabetes who struggle with food access and are patients at El Rio Community Health Center. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for managing diabetes and improving access to nutritious food.

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.

What prior data suggests that the FRESH intervention is safe for individuals with type 2 diabetes?

Research shows that the FRESH program aims to help people with type 2 diabetes improve their diet and better manage their condition. It achieves this by providing food, recipes, and advice from registered dietitian nutritionists. Specific safety data from past studies on this exact program is unavailable because it focuses on dietary changes and education, not new drugs or medical procedures.

The trial is labeled as "Not Applicable" in terms of phase, suggesting it is likely low-risk since it involves non-invasive lifestyle changes. Early stages of clinical research usually address safety concerns, so any major issues would have been resolved before reaching this point.

Overall, the FRESH program appears safe and well-received, as it primarily involves dietary improvements and support for managing diabetes. Similar programs have not reported any major negative effects, indicating a high level of safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FRESH treatment for type 2 diabetes because it takes a holistic approach, combining bimonthly food deliveries, recipes, and self-management resources with personalized support from Registered Dietitian Nutritionists. Unlike standard treatments that primarily focus on medication and routine check-ups, FRESH emphasizes lifestyle changes and nutrition, which can empower patients to manage their condition more effectively. This personalized and proactive approach could lead to better long-term outcomes by directly addressing dietary habits and providing ongoing support.

What evidence suggests that the FRESH intervention could be effective for type 2 diabetes?

Research shows that the FRESH program, available to participants in this trial, might assist people with type 2 diabetes by facilitating access to healthier foods. Studies suggest that offering healthy food choices and resources for managing diabetes can enhance diet quality. In this trial, the FRESH program provides food supplies every two weeks, recipes, and regular meetings with dietitians. These efforts address food insecurity and poor nutrition, crucial factors in managing diabetes. Early findings indicate that focused food programs can significantly improve health for those at risk of diabetes-related issues. ^{1 2 4 6 7}

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39845656/

Design of the Focus on Restaurant Engagement to Strengthen ... The FRESH intervention will be implemented for 12 months in a total of 24 intervention and 24 comparison restaurants. The study is powered to detect a 5-point ...

2. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1427792/full

Design of the Focus on Restaurant Engagement to ... The FRESH study will test a novel, multilevel, multisite intervention that aims to improve access to healthier prepared food options among small, independently ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753239/

Design of the Focus on Restaurant Engagement to Strengthen ... The FRESH intervention will be implemented for 12 months in a total of 24 intervention and 24 comparison restaurants. The study is powered to ...

4. dietdisparities.com dietdisparities.com/2024/01/fresh-project/

fresh This study seeks to improve cancer-preventive diets of customers who frequent independently-owned restaurants in predominantly low-income urban neighborhoods.

5. hsrc.himmelfarb.gwu.edu hsrc.himmelfarb.gwu.edu/gwhpubs/6399/

Design of the Focus on Restaurant Engagement to Strengthen ... The intervention is theory-and practice-based, comprising three phases: restaurant engagement, low-sugar beverages and healthy meals. The FRESH ...

6. reporter.nih.gov reporter.nih.gov/search/kJPOT1QdmEmaz1JRo3BaKA/project-details/11030719

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. mdpi.com mdpi.com/2072-6643/16/10/1524

The Quality of Menu Offerings in Independently Owned ... ... Focus on Restaurant Engagement to Strengthen Health (FRESH). The RCT aims to promote healthy eating within low-income, racial and ethnic ...