43 Participants NeededMy employer runs this trial

Produce Prescription Program for Type 2 Diabetes

(F4H Trial)

MP
Overseen ByMaja Pedersen, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Montana
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a Produce Prescription Program designed to help older Native American adults on the Flathead Reservation improve nutrition and reduce the risk of Type 2 Diabetes. Participants will receive vouchers for fruits and vegetables, redeemable at local food centers, along with nutrition education rooted in Native culture. Initially, the trial will test the program's acceptability with a small group, then assess its impact on a larger group by examining food insecurity and diabetes risk factors. This trial suits Native American adults aged 55 or older who live on the Flathead Reservation, experience food insecurity, and have diabetes or are at risk for it. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and cultural nutrition education.

What prior data suggests that this Produce Prescription Program is safe for older adults with Type 2 Diabetes?

Research shows that Produce Prescription Programs (PPPs) are generally safe and can improve health for people with Type 2 Diabetes. These programs encourage better eating habits and help manage diabetes-related health issues. For instance, one study with 303 adults showed that a three-month program led to noticeable weight loss, indicating that PPPs can manage diabetes without harmful side effects.

No specific reports of negative effects have emerged from participating in PPPs, suggesting they are safe for people with diabetes. However, results can vary, and some studies have shown limited effects on certain aspects like blood sugar levels. Overall, evidence supports that PPPs are a safe way to improve diet and health for people with diabetes, especially those who struggle to afford enough food.12345

Why are researchers excited about this trial?

Unlike traditional treatments for Type 2 Diabetes that often focus on medications like metformin or insulin to manage blood sugar levels, the Produce Prescription Program takes a different approach by emphasizing dietary changes as a form of treatment. Researchers are excited about this program because it shifts the focus from medication to nutrition, using prescribed access to fresh produce to potentially improve blood glucose control naturally. This innovative approach not only targets the root cause of blood sugar issues but also promotes overall health by encouraging a balanced diet rich in fruits and vegetables.

What evidence suggests that the Produce Prescription Program might be an effective treatment for Type 2 Diabetes?

Research has shown that Produce Prescription Programs (PPPs), like the one tested in this trial, can help people with Type 2 Diabetes (T2D) improve their health by eating healthier foods. Studies have found that these programs lead to better eating habits and improved diabetes management. They help control blood sugar levels, lower body weight, and reduce blood pressure. Some research even suggests these programs can enhance heart health for people with diabetes. Although one study found no change in HbA1c (a measure of long-term blood sugar) for some participants, the overall evidence indicates significant health benefits, especially when addressing food insecurity.12367

Are You a Good Fit for This Trial?

Inclusion Criteria

I live on the Flathead Reservation.
I identify as Native American.
I have been identified as experiencing food insecurity.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Pilot Testing

Pilot test the acceptability of the Food for Health program with a small group of older adults to refine and improve the program.

8 weeks
Pre (week 0), mid (week 8), post intervention (week 17)

Phase 2: Feasibility and Impact Testing

Test the feasibility and impact of the refined Food for Health program with a larger group of older adults, measuring food insecurity and T2D risk factors.

17 weeks
Pre (week 0), mid (week 8), post intervention (week 17)

Follow-up

Participants are monitored for long-term effectiveness and sustainability of the program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Produce Prescription Program

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Food for Health Healthy Food Prescription Intervention ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials
29
Recruited
4,700+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Citations

Health and Economic Impacts of Implementing Produce ... - PMC

Figure 2. The number of CVD cases averted per 100 000 patients by produce prescriptions nationally for adults with diabetes and food security, ...

Health and Economic Impact and Cost-effectiveness of ...

Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic outcomes.

Factors Associated with Produce Prescription Program ...

Abstract. Background. Food insecurity exacerbates Type 2 Diabetes (T2D) by limiting access to nutritious foods and worsening glycemic control.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40767914/

Health and Economic Impact and Cost-effectiveness of ...

Objective: Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic ...

NCT06837805 | Iowa Produce Prescription Program

The goal of this study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition and overall ...

Produce Prescription Program Shows Limited Impact on ...

Patients with diabetes who face food insecurity are at heightened risk for poor cardiometabolic outcomes, including elevated blood glucose, ...

Evaluation of a Produce Prescription Program for Patients ...

Produce prescriptions have shown promise in improving diabetes care, although most studies have used small samples or lacked controls.