Produce Prescription for Prediabetes

(YPRx Trial)

Not yet recruiting at 1 trial location

Overseen By Kristy McCarron, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tessa Mork

Disqualifiers: Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how fresh produce deliveries and a diabetes prevention program can help individuals with prediabetes improve their health. Participants will either receive weekly fresh produce bags or receive produce plus join online coaching sessions focused on healthy habits. The trial aims to determine if the combination of produce and coaching leads to better weight management, activity levels, diet, and overall health. It is suitable for adults on Medicaid in the District of Columbia who have not been diagnosed with diabetes and can attend virtual classes. As an unphased trial, this study provides a unique opportunity to explore innovative health strategies without the constraints of traditional clinical trial phases.

Will I have to stop taking my current medications?

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

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

Research shows that the YMCA Produce Prescription Program (YPRx) is safe. In a recent study, participants in a 3-month program lost weight without any safety issues. The program provides fresh produce, a healthy addition to any diet.

When combined with the Diabetes Prevention Program (DPP), research from the National Institutes of Health indicates that programs like the DPP can lower the risk of developing type 2 diabetes by 58%. This demonstrates the program's effectiveness and good tolerance.

Both programs aim to improve diet and lifestyle, which are generally safe and beneficial. Studies have not reported any negative effects for either approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the YMCA Produce Rx (YPRx) Program because it offers a fresh approach to managing prediabetes by providing participants with weekly deliveries of fresh produce for an entire year. Unlike traditional methods that often rely on medication or lifestyle advice alone, this program integrates regular access to healthy food, which may directly influence dietary habits and health outcomes. Additionally, the experimental arm combines this produce delivery with the Diabetes Prevention Program, which includes 26 virtual coaching sessions, potentially enhancing support and motivation for lifestyle changes. This dual approach targets both nutritional intake and behavioral support, setting it apart from standard care options.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research has shown that the YMCA Produce Prescription Program, one of the treatment arms in this trial, can improve health for people with prediabetes. This trial will also test the combination of the Produce Prescription Program with the Diabetes Prevention Program (DPP) in another treatment arm. Studies have found that this combined approach led to an average weight loss of 2.3 kg (about 5 pounds) over a year, outperforming standard care for low-income individuals. The DPP has also been shown to reduce the risk of developing type 2 diabetes by 58% over about three years. Adding the DPP to the produce program could aid in weight management and lower the risk of diabetes. Participants might also experience benefits such as increased physical activity and healthier eating habits. ^{1 2 6 7 8}

Who Is on the Research Team?

Kristy McCarron, MPH

Principal Investigator

YMCA of Metropolitan Washington

Julia Wolfson, PhD MPP

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for individuals with Polycystic Ovary Syndrome (PCOS) and prediabetes. Participants will be involved in a study for 12 months, receiving weekly fresh produce deliveries. The exact eligibility criteria are not provided.

Inclusion Criteria

Access to laptop, computer, or phone with internet, or willing to use a provided device

District of Columbia resident

I can attend all scheduled classes.

Exclusion Criteria

Pregnant

No access to laptop, computer, or phone with internet

Not a resident of the District of Columbia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly deliveries of fresh produce bags for 52 weeks, with some also participating in the Diabetes Prevention Program (DPP) via 26 virtual coaching and support sessions over 12 months

52 weeks

Weekly produce deliveries, 26 virtual sessions

Follow-up

Participants are monitored for changes in weight, physical activity, dietary intake, and other health metrics at multiple intervals

12 months

Online surveys at baseline, 4 weeks, 3 months, 6 months, 9 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• YMCA Produce Rx (YPRx) Program
• YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP)

Trial Overview The study tests the effectiveness of the YMCA Produce Prescription Program alone versus combined with the Diabetes Prevention Program on weight loss, physical activity, diet quality, food security, health assessment, and healthcare use.

How Is the Trial Designed?

Group I: Produce Rx Program + Diabetes Prevention Program Experimental Treatment 1 Intervention

YMCA Produce Prescription Program deliveries of fresh produce bags once per week for 52 weeks plus the Diabetes Prevention Program via 26 virtual coaching and support sessions over 12 months.

Group II: Produce Rx Program Only (Control) Active Control 1 Intervention

YMCA Produce Prescription Program deliveries of fresh produce bags once per week for 52 weeks.

Who Is Running the Clinical Trial?

Tessa Mork

Lead Sponsor

Trials

1

Recruited

150+

Johns Hopkins Bloomberg School of Public Health

Collaborator

Trials

441

Recruited

2,157,000+

Hungry Harvest

Collaborator

Trials

1

Recruited

150+

AmeriGroup

Collaborator

Trials

1

Recruited

150+

Elevance Health

Industry Sponsor

Trials

3

Recruited

15,500+

Published Research Related to This Trial

The YMCA adaptation of the Diabetes Prevention Program (YDPP) led to a mean weight loss of 2.3 kg over 12 months compared to standard care for low-income, overweight or obese adults, indicating its effectiveness.

Participants who attended 9 or more YDPP lessons experienced an even greater weight loss of 5.3 kg, highlighting the importance of engagement in the program for achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes. Ackermann, RT., Liss, DT., Finch, EA., et al.[2022]

A 3-month produce prescription program for 303 predominantly Hispanic/Latino adults with or at risk of type 2 diabetes led to significant reductions in weight, waist circumference, and systolic blood pressure, indicating improved cardio-metabolic health.

Participants with higher baseline HbA1c levels experienced a notable decrease in HbA1c, alongside improvements in food security and mental health measures, suggesting that access to fresh produce can positively impact both physical and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal changes in bio-behavioral and glycemic outcomes following a produce prescription program among predominantly Hispanic/Latino adults with or at risk of type 2 diabetes. Sato Imuro, SE., Sabharwal, A., Conneely, C., et al.[2023]

A 12-week family-focused lifestyle intervention at YMCA showed feasibility for children at risk of type 2 diabetes, with 75% of the 48 enrolled children completing the program.

The intervention led to significant improvements in child BMI-z scores and enhanced family nutrition and physical activity environments, indicating potential effectiveness in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a family-focused YMCA-based diabetes prevention program in youth: The E.P.I.C. Kids (Encourage, Practice, and Inspire Change) Study. Hingle, MD., Turner, T., Going, S., et al.[2020]

A prescription (PRx) program in rural Eastern North Carolina provided patients with type 2 diabetes weekly home deliveries of fruits and vegetables, leading to high patient satisfaction and increased consumption of produce.

The program not only improved dietary habits but also significantly enhanced glycemic control, demonstrating the effectiveness of combining food access with nutrition education and culinary resources for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. Sastre, LR., Stroud, B., Smith, E., 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. portal.nifa.usda.gov portal.nifa.usda.gov/web/crisprojectpages/1029383-ymca-produce-prescription-project-yprx.html

YMCA Produce Prescription Project (YPRx) YPRx will 1) address diet quality and food insecurity among Medicaid-enrolled adults with prediabetes and 2) evaluate potential systems-level enhancements to ...

2. withpower.com withpower.com/trial/produce-prescription-for-prediabetes-f1cd7

Produce Prescription for Prediabetes (YPRx Trial) The YMCA adaptation of the Diabetes Prevention Program (YDPP) led to a mean weight loss of 2.3 kg over 12 months compared to standard care for low-income, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06841796

The YMCA Healthy Lifestyle Program for Prediabetes An estimated 97.6 million adults had prediabetes in 2021. The Diabetes Prevention Program (DPP) study published in 2002 clearly showed the benefit of lifestyle ...

4. trial.medpath.com trial.medpath.com/clinical-trial/a945cf01f5191092/nct06695104-ymca-produce-prescription

YMCA Produce Prescription Project (YPRx) - MedPath The investigators hypothesize that participants randomized to receive YPRx plus DPP will have greater weight loss, increased physical activity, improved diet ...

5. niddk.nih.gov niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp

Diabetes Prevention Program (DPP) - NIDDK After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...

6. link.springer.com link.springer.com/article/10.1007/s11606-025-09687-0

Fresh Food Rx: Evaluating the Impact of a Produce ... The Fresh Food Rx (FFRx) program was a 12-month produce prescription (PRx) intervention that enrolled 112 participants and compared outcomes to ...

7. ctv.veeva.com ctv.veeva.com/study/ymca-produce-prescription-project-yprx

YMCA Produce Prescription Project (YPRx) YMCA Produce Prescription Program deliveries of fresh produce bags once per week for 52 weeks plus the Diabetes Prevention Program via 26 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40659972/

Fresh Food Rx: Evaluating the Impact of a Produce ... Our study generated novel evidence regarding PRx implementation. We found that PRx implementation was limited by logistical and financial ...