Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 5:18 AM
Study NCT ID:
NCT06695104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-19
First Post:
2024-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
YMCA Produce Prescription Project (YPRx)
Sponsor:
Tessa Mork
Organization:
Study Overview
Official Title:
YMCA Produce Prescription Project (YPRx)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YPRx
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-70424-38459 | OTHER_GRANT | USDA GusNIP award number | View |