YMCA Produce Prescription Project (YPRx)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into one of two study arms: intervention or control. All participants, regardless of study arm, will be enrolled in a year-long Produce Rx Program through which they will receive weekly deliveries of grocery bags containing fresh produce. Additionally, participants assigned to the intervention arm will be enrolled in a Diabetes Prevention Program, coordinated by the Y, through which they will receive health education, coaching, and peer support for a year via 26 virtual group sessions.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Produce Rx Program Only (Control)

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

Group Type ACTIVE_COMPARATOR

YMCA Produce Rx (YPRx) Program Only (Control)

Intervention Type BEHAVIORAL

Participants in the control group will receive weekly, home-delivered produce bags of fresh vegetables and fruits and sized for each participants' household. Produce deliveries will be administered for 52 weeks.

Produce Rx Program + Diabetes Prevention Program

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 Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Participants will receive weekly, home-delivered produce bags of fresh vegetables and fruits and sized for each participants' household. Produce deliveries will be administered for 52 weeks. Additionally, participants will be registered for a free, year-long YMCA membership and enrolled in the DPP. Through the DPP, participants will receive health education, coaching, and peer support via 26 virtual group sessions over a year.

Interventions

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YMCA Produce Rx (YPRx) Program Only (Control)

Participants in the control group will receive weekly, home-delivered produce bags of fresh vegetables and fruits and sized for each participants' household. Produce deliveries will be administered for 52 weeks.

Intervention Type BEHAVIORAL

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

Participants will receive weekly, home-delivered produce bags of fresh vegetables and fruits and sized for each participants' household. Produce deliveries will be administered for 52 weeks. Additionally, participants will be registered for a free, year-long YMCA membership and enrolled in the DPP. Through the DPP, participants will receive health education, coaching, and peer support via 26 virtual group sessions over a year.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No