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Not yet recruiting NCT06695104

YMCA Produce Prescription Project (YPRx)

No phase Interventional Pre-diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: YMCA Produce Rx (YPRx) Program Only (Control), YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP).
Who it may be relevant to
Registry conditions: Pre-diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed 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.

Interventions

  • Behavioral 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.
  • 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.

Primary outcome measures

  • Change in body weight [Time frame: Baseline, 3 months, 6, months, 9 months, and 12 months]
Secondary outcome measures (6)
  • Change in physical activity [Time frame: Baseline, 3 months, 6, months, 9 months, and 12 months]
  • Change in food security status [Time frame: Baseline and 12 months]
  • Change in participant dietary intake [Time frame: Baseline and 12 months]
  • Change in participant food behaviors [Time frame: Baseline and 12 months]
  • Change in personal health self-rated health assessment [Time frame: Baseline and 12 months]
  • Change in participant healthcare utilization- self-reported [Time frame: Baseline and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • YMCA of Metropolitan Washington — Washington D.C.

Identifiers

NCT: NCT06695104 · 00022594 · 2022-70424-38459

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗