120 Participants Needed

F&V Vouchers for Type 2 Diabetes

SV
KN
Overseen ByKayla N Rutt, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Milton S. Hershey Medical Center

Trial Summary

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.

What data supports the effectiveness of the treatment F&V Rx 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 programs led to a significant decrease in hemoglobin A1C levels, which is a measure of long-term blood sugar control.12345

Is the Fruit and Vegetable Prescription Program safe for humans?

The Fruit and Vegetable Prescription Program, which provides vouchers for fresh produce, has been studied in various settings and has not shown any safety concerns. It aims to improve access to fruits and vegetables, and while it focuses on health benefits, no adverse effects have been reported in the studies available.14678

How is the F&V Rx treatment for Type 2 Diabetes different from other treatments?

The F&V Rx treatment is unique because it involves providing vouchers for fruits and vegetables to improve diet quality and health outcomes, particularly for food-insecure populations. Unlike traditional medications, this approach focuses on dietary changes and may include educational and social support components to encourage long-term health improvements.126910

What is the purpose of this trial?

Dietary intake of fruits and vegetables (F\&V) is a cornerstone for the treatment of type 2 diabetes, however less than 16% of Hispanic adults consume the recommended number of servings each day. F\&V prescription (F\&V Rx) programs are embedded into clinical settings and provide patients with vouchers to purchase F\&V at local retailers. The proposed study aims to test the effects of a F\&V Rx on diabetes self-management education and support (DSME/S) uptake and retention, dietary intake of F\&V and diet quality, glucose control (hemoglobin A1c), and program implementation outcomes.

Research Team

SV

Susan Veldheer, DEd, RD

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

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.
See 5 more

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.
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: F&V Rx + DSME/S GroupActive Control1 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 GroupActive Control1 Intervention
Will receive 4 monthly F\&V Rx vouchers regardless of their DSME/S attendance.
Group III: Usual Care Control GroupPlacebo Group1 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

Find a Clinic Near You

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+

Findings from Research

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

References

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]
Community-based fruit and vegetable prescription programs: a scoping review. [2023]
Evaluation of a Produce Prescription Program for Patients With Diabetes: A Longitudinal Analysis of Glycemic Control. [2023]
A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. [2023]
Participation in a farmers' market fruit and vegetable prescription program at a federally qualified health center improves hemoglobin A1C in low income uncontrolled diabetics. [2020]
Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. [2022]
"You Guys Really Care About Me…": a Qualitative Exploration of a Produce Prescription Program in Safety Net Clinics. [2023]
Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]
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. [2022]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Student feedback to improve the United States Department of Agriculture Fresh Fruit and Vegetable Program. [2020]
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