YMCA Produce Prescription Project (YPRx)

NCT06695104 | Not Yet Recruiting

• 2 other identifiers: 000225942022-70424-38459
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

diabetes prevention program; produce rx program; produce prescription

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Change in body weight will be measured by change in absolute pounds and percent of body weight. Participants will provide self-reported weight in pounds via quarterly online surveys at baseline, 3 months, 6 months, 9 months, and 12 months (endline).

  Baseline, 3 months, 6, months, 9 months, and 12 months

Secondary Outcomes (6)

• Change in physical activity

  Baseline, 3 months, 6, months, 9 months, and 12 months

• Change in food security status

  Baseline and 12 months

• Change in participant dietary intake

  Baseline and 12 months

• Change in participant food behaviors

  Baseline and 12 months

• Change in personal health self-rated health assessment

  Baseline and 12 months

Other Outcomes (5)

• Change in participant healthcare utilization- healthcare records

  Baseline and 12 months

• Change in participant HbA1c

  Baseline and 12 months

• YMCA Produce Rx (YPRx) program satisfaction- quantitative process measure

  4 weeks, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

Produce Rx Program Only (Control)

ACTIVE COMPARATOR

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

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

Produce Rx Program + Diabetes Prevention Program

EXPERIMENTAL

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.

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

Interventions

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

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

Produce Rx Program + Diabetes Prevention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tessa Mork: lead
• AmeriGroup: collaborator
• Hungry Harvest: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Elevance Health: collaborator

Study Sites (1)

YMCA of Metropolitan Washington

Washington D.C., District of Columbia, 20009, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kristy McCarron, MPH

  YMCA of Metropolitan Washington

  PRINCIPAL INVESTIGATOR

• Julia Wolfson, PhD MPP

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristy McCarron, MPH

CONTACT

215-870-4053; kristy.mccarron@ymcadc.org

Tessa Mork

CONTACT

2403837408; tessa.mork@ymcadc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Association Director of Community Health

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: January 6, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

US (1)