F&V Vouchers for Type 2 Diabetes

Overseen By Kayla N Rutt, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Pregnancy, Uncontrolled mental illness, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether vouchers for fruits and vegetables can help people manage type 2 diabetes more effectively. Participants will receive either the vouchers alone (F&V Rx) or vouchers plus diabetes education (F&V Rx plus DSME/S). Researchers aim to determine if these methods improve diet, diabetes control, and program effectiveness. The trial seeks low-income individuals diagnosed with type 2 diabetes for more than six months who can provide a blood sample and communicate in English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies for diabetes management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on dietary changes rather than medication adjustments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that programs prescribing fruits and vegetables are generally safe and well-received. These programs link to positive health outcomes, such as increased fruit and vegetable consumption and better diabetes management. Studies have found that these programs can help control blood sugar and improve overall health without causing major side effects.

Research has also explored adding diabetes self-management education and support (DSME/S) to these fruit and vegetable programs. This combination helps people maintain healthy eating habits and manage their diabetes more effectively, with no serious negative effects reported.

In summary, both fruit and vegetable prescriptions alone and when combined with DSME/S are considered safe for people with type 2 diabetes. These programs aim to promote healthier eating habits, offering a low-risk way to help manage diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the F&V Rx treatments for type 2 diabetes because they offer a fresh approach by integrating food-based interventions. Unlike traditional medications like metformin or insulin, which directly target blood sugar levels, these treatments aim to improve overall health through nutrition by providing fruit and vegetable vouchers. The F&V Rx plus DSME/S arm is particularly intriguing because it combines these vouchers with diabetes self-management education and support, potentially enhancing adherence and lifestyle changes. This innovative strategy could empower patients to take control of their health in a more holistic way.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Studies have shown that programs prescribing fruits and vegetables can help people with type 2 diabetes by encouraging increased consumption of these foods. Eating more fruits and vegetables has been linked to better blood sugar control, as evidenced by lower hemoglobin A1c levels, which measure blood sugar over time. In this trial, one group of participants will receive F&V Rx vouchers alone, while another group will receive F&V Rx vouchers combined with diabetes self-management education and support (DSME/S). Research suggests that combining these programs with DSME/S may further improve diabetes care by promoting healthier eating habits and more regular participation in managing diabetes. Overall, these prescription programs are promising tools for improving diet and managing type 2 diabetes. ^{1 2 6 7 8}

Who Is on the Research Team?

Susan Veldheer, DEd, RD

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for low-income individuals with Type 2 Diabetes Mellitus who have had the condition for at least six months and an A1c level of 7% or higher. Participants must be able to give blood samples, respond to study contacts, consent to participate, and read/write in English or Spanish. Pregnant women, those with recent significant medical conditions, uncontrolled mental illness/substance abuse, or previous DSME/S sessions are excluded.

Inclusion Criteria

Can read and write in English or Spanish

Willing and able to give informed consent

I have been diagnosed with Type 2 Diabetes for at least 6 months.

Exclusion Criteria

I was diagnosed with Type 2 Diabetes within the last 6 months.

I have attended diabetes education sessions in the last year.

I haven't had any major health issues like a heart attack or stroke in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly F&V Rx vouchers, with some groups requiring DSME/S attendance for additional vouchers

16 weeks

Monthly visits for voucher distribution and DSME/S sessions

Follow-up

Participants are monitored for changes in A1c, dietary intake, and program implementation outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• F&V Rx alone
• F&V Rx plus DSME/S

Trial Overview The study tests if a Fruit & Vegetable Prescription (F&V Rx) program can improve diabetes self-management education/support (DSME/S) participation, fruit/vegetable intake and diet quality, glucose control via hemoglobin A1c levels. It compares usual care against F&V Rx alone and combined with DSME/S.

How Is the Trial Designed?

Group I: F&V Rx + DSME/S Group Active Control 1 Intervention

Will receive monthly F\&V Rx vouchers starting at the first group session and they will receive additional F\&V Rx vouchers only when they attend a monthly DSME/S group (up to 4 total)

Group II: F&V Rx Alone Group Active Control 1 Intervention

Will receive 4 monthly F\&V Rx vouchers regardless of their DSME/S attendance.

Group III: Usual Care Control Group Placebo Group 1 Intervention

Will receive usual care

F&V Rx alone is already approved in United States for the following indications:

Approved in United States as F&V Rx for:

• Type 2 Diabetes Management
• Diabetes Prevention

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

Community-based fruit and vegetable prescription programs, primarily targeting low-income, non-white females, have shown significant improvements in diet quality (94% of studies), health outcomes (83%), and food security (82%), indicating their effectiveness in promoting healthier eating habits.

Despite the positive outcomes, the considerable variation in study design and measurement techniques makes it difficult to compare the effectiveness of different program methodologies, highlighting the need for more standardized and well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. Greatorex Brooks, E., McInerney, M.[2023]

Over 47% of students reported increased fruit and vegetable intake due to the Fresh Fruit and Vegetable Program (FFVP), and more than 66% expressed a liking for the program, indicating its potential effectiveness in improving children's dietary habits.

Students suggested improvements for the program, such as offering more dipping sauces and cooking vegetables, which could enhance acceptance and further increase fruit and vegetable consumption among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Student feedback to improve the United States Department of Agriculture Fresh Fruit and Vegetable Program. Lin, YC., Fly, AD.[2020]

Participants in a produce prescription (PRx) program for hypertensive adults reported increased fruit and vegetable consumption and positive interactions with healthcare providers, indicating the program's effectiveness in promoting healthier eating habits.

Challenges included difficulties for providers in integrating the PRx program into their existing workflows, highlighting the need for improved efficiency in program implementation to better support economically disadvantaged patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"You Guys Really Care About Me…": a Qualitative Exploration of a Produce Prescription Program in Safety Net Clinics. Schlosser, AV., Smith, S., Joshi, K., et al.[2023]

The FLAM study, involving 92 parent-child pairs in a French urban district, demonstrated that providing vouchers for fruits and vegetables (FV) significantly reduced the number of children consuming less than 3.5 servings of FV per day, from 66.7% in the control group to 29.4% in the intervention group after one year.

The high utilization rate of the vouchers (82%) suggests that this intervention could effectively promote healthier eating habits among children from disadvantaged families, addressing social inequalities in health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fruits and vegetables at home (FLAM): a randomized controlled trial of the impact of fruits and vegetables vouchers in children from low-income families in an urban district of France. Buscail, C., Margat, A., Petit, S., et al.[2022]

Participation in a 13-week Fresh Prescription program significantly reduced hemoglobin A1C (HbA1C) levels in patients with uncontrolled type 2 diabetes, indicating improved blood sugar control (from 9.54% to 8.83%, p = 0.001).

Despite the positive impact on HbA1C, the program did not result in significant changes in weight or blood pressure among participants, suggesting that while fruit and vegetable prescriptions can improve glycemic control, they may not affect other health metrics in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in a farmers' market fruit and vegetable prescription program at a federally qualified health center improves hemoglobin A1C in low income uncontrolled diabetics. Bryce, R., Guajardo, C., Ilarraza, D., et al.[2020]

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]

A 6-month produce prescription program providing $60 monthly vouchers for fresh produce did not significantly improve glycemic control (HbA1c levels) in 252 patients with diabetes compared to 534 control participants receiving usual care.

No significant differences were found in secondary health outcomes such as blood pressure or BMI, indicating that the program did not have a measurable impact on overall health metrics during the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Produce Prescription Program for Patients With Diabetes: A Longitudinal Analysis of Glycemic Control. Hager, K., Shi, P., Li, Z., et al.[2023]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10529680/

The Impact of Produce Prescriptions on Diet, Food Security ... A recent review of produce prescription studies found that 21 of 22 published studies identified improvements in F&V intake compared with baseline. A pooled ...

2. diabetesjournals.org diabetesjournals.org/care/article/46/6/1169/148500/Evaluation-of-a-Produce-Prescription-Program-for

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. Our ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06107816/a-fruit-and-vegetable-prescription-program

A Fruit and Vegetable Prescription Program Preliminary F&V Rx studies in patients with T2DM have found F&V intake increases of 0.2-1.6 servings per day and hemoglobin A1c (A1c) reductions ...

4. withpower.com withpower.com/trial/phase-diabetes-mellitus-2-2024-9ca65

F&V Vouchers for Type 2 Diabetes Research shows that fruit and vegetable prescription programs can help improve blood sugar control in people with type 2 diabetes. Studies found that these ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06263751

Comparing the Effectiveness of Two Produce Prescription ... Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499404621007247

Impact of a Prescription Produce Program on Diabetes and ... Fruit and vegetable prescription programs may improve diabetes outcomes by incentivizing DSME uptake and retention.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10511821/

Community-based fruit and vegetable prescription programs Lowering HbA1c in food insecure type 2 diabetics through a fruit and vegetable prescription program. SSRN. 2019;1–12 10.2139/ssrn.3397202 ...

8. ahajournals.org ahajournals.org/doi/pdf/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security, ... The study found that produce prescription program participation was associated with improvements in fruit and vegetable intake, food insecurity, and self-.