YMCA Produce Prescription Project (YPRx)

Tessa Mork

Status: Not yet enrolling

Conditions: Pre-diabetes

Treatments: Behavioral: YMCA Produce Rx (YPRx) Program Only (Control); Behavioral: YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06695104

2022-70424-38459 (Other Grant/Funding Number)

00022594

Details and patient eligibility

About

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.

Full description

This study is a randomized control trial testing the impact of adding disease-specific, evidence-based health education (DPP) to produce prescriptions (YPRx) on participants' health. DPP is a 12-month diabetes prevention behavioral weight loss program developed by the Centers for Disease Control and Prevention and implemented nationwide. In this study, investigators will test whether the addition of health education, coaching, and peer support through DPP improves the effectiveness of YPRx. This trial will take place in the Washington D.C. Metropolitan Area in collaboration with the YMCA of Metropolitan Washington, a provider of DPP and YPRx, Hungry Harvest, a purveyor of produce deliveries, and Amerigroup/Elevance Health, a Medicaid managed care organization. Participants will be randomized 1:1 to either participate in YPRx only or to participate in YPRx plus the DPP. The length of the trial will be 12 months for each participant, and outcomes will be measured at baseline, 4 weeks, 3 months, 6 months, 9 months, and 12 months.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over the age of 18
• Recipient of Medicaid through Amerigroup
• Has never been diagnosed with type I or type II diabetes
• Access to laptop, computer, or phone with internet, or willing to use a provided device
• District of Columbia resident
• Available to attend DPP classes at the scheduled recurring day and time
• Not pregnant

Exclusion criteria

• Under the age of 18
• Not a recipient of Medicaid through Amerigroup
• Has been diagnosed with type I or type II diabetes
• No access to laptop, computer, or phone with internet
• Not a resident of the District of Columbia
• Cannot attend DPP classes at the scheduled recurring day and time
• Pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Produce Rx Program Only (Control)

Active Comparator group

Description:

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

Treatment:

Behavioral: YMCA Produce Rx (YPRx) Program Only (Control)

Produce Rx Program + Diabetes Prevention Program

Experimental group

Description:

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.

Treatment:

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