Clinical trial NCT06695104: YMCA Produce Prescription Project (YPRx)
Official title: YMCA Produce Prescription Project (YPRx)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-diabetes
Keywords: diabetes prevention program
produce rx program
produce prescription
Lead sponsor: YMCA of Metropolitan Washington
Sponsor class: OTHER
Collaborators: name: AmeriGroup
name: Hungry Harvest
name: Johns Hopkins Bloomberg School of Public Health
name: Elevance Health
First posted: 2024-11-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline, 3 months, 6, months, 9 months, and 12 months
Secondary outcomes:
measure: Change in physical activity
timeFrame: Baseline, 3 months, 6, months, 9 months, and 12 months
measure: Change in food security status
timeFrame: Baseline and 12 months
measure: Change in participant dietary intake
timeFrame: Baseline and 12 months
measure: Change in participant food behaviors
timeFrame: Baseline and 12 months
measure: Change in personal health self-rated health assessment
timeFrame: Baseline and 12 months
measure: Change in participant healthcare utilization- self-reported
timeFrame: Baseline and 12 months
Other outcomes:
measure: Change in participant healthcare utilization- healthcare records
timeFrame: Baseline and 12 months
measure: Change in participant HbA1c
timeFrame: Baseline and 12 months
measure: YMCA Produce Rx (YPRx) program satisfaction- quantitative process measure
timeFrame: 4 weeks, 3 months, 6 months, 9 months, 12 months
measure: YMCA Produce Rx (YPRx) program satisfaction- qualitative process measure
timeFrame: 4 weeks, 3 months, 6 months, 9 months, 12 months
measure: Self-perceived YMCA Produce Rx (YPRx) program impact- quantitative measure
timeFrame: 12 months
Locations:
city: Washington
country: United States
facility: YMCA of Metropolitan Washington
state: District of Columbia
Study officials:
affiliation: YMCA of Metropolitan Washington
name: Kristy McCarron, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Julia Wolfson, PhD MPP
role: PRINCIPAL_INVESTIGATOR
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