Produce Prescription for Prediabetes

(YPRx Trial)

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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

In this randomized control study, participants will be randomized 1:1 to either participate in the YMCA's Produce Prescription Program (YPRx) and receive weekly deliveries of fresh produce bags for their household or to receive YPRx plus participate in the Diabetes Prevention Program (DPP). The investigators hypothesize that participants randomized to receive YPRx plus DPP will have greater weight loss, increased physical activity, improved diet quality and behaviors, increased food security, improved self-rated health assessment, decreased healthcare utilization from baseline to endline (12 months) compared to those randomized to receive YPRx produce deliveries only. We will also collect data on process measures for implementation purposes.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment YMCA Produce Rx (YPRx) Program and YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP) for prediabetes?

Research shows that lifestyle programs like the Diabetes Prevention Program (DPP) can help people lose weight and reduce the risk of developing diabetes by encouraging healthy eating and regular physical activity. A YMCA-based program for children at risk of diabetes also showed positive changes in weight and family health habits, suggesting that similar programs could be effective for adults with prediabetes. ^{1 2 3 4 5}

Is the Produce Prescription for Prediabetes safe for humans?

The Produce Prescription program, which involves prescribing fresh fruits and vegetables, has been associated with improvements in health factors like weight, blood pressure, and mood in adults at risk of type 2 diabetes, suggesting it is generally safe for humans. ^{2 4 6 7 8}

How is the YMCA Produce Rx Program treatment different from other treatments for prediabetes?

The YMCA Produce Rx Program is unique because it focuses on providing subsidized access to fruits and vegetables to improve diet quality, which is not a standard approach for prediabetes. This program emphasizes dietary changes through produce prescriptions, which is different from typical medical treatments that might focus on medication or lifestyle advice without direct food support. ^{9 10 11 12 13}

Research Team

Julia Wolfson, PhD MPP

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Kristy McCarron, MPH

Principal Investigator

YMCA of Metropolitan Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of prediabetes nutrition shared medical appointments: prevention of diabetes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Weight loss in the prevention and treatment of diabetes. [2022]

4. United States 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Prevention of diabetes self-management program (PREDIAS): effects on weight, metabolic risk factors, and behavioral outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Evaluating the implementation and customer acceptability of a sugar-sweetened beverage reduction initiative in thirty Australian aquatic and recreation centres. [2021]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of a Prescription Produce Program on Diabetes and Cardiovascular Risk Outcomes. [2022]

9. United States 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. [2023]

10. United States 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Implementation of the YMCA Diabetes Prevention Program throughout an Integrated Health System: A Translational Study. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Clinical Identification and Referral of Adults With Prediabetes to a Diabetes Prevention Program. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

How Much Does Attendance Impact Weight Loss and Health Care Spending in a Diabetes Prevention Program Serving Older Adults? [2022]