Pre-diabetesYPRxNCT06695104
YMCA Produce Prescription Project (YPRx)
A study testing YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP) in people with Pre-diabetes, run by Tessa Mork at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
YMCA of Metropolitan Washington
Washington D.C., District of Columbia, 20009
Kristy McCarron, MPH, 2158704053, kristy.mccarron@ymcadc.org
Tessa Mork
About this study
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.
Read the 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.
- Conditions
- Pre-diabetes
- Being tested
- YMCA Produce Rx (YPRx) Program Only (Control), YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP)
- Keywords
- diabetes prevention program, produce rx program, produce prescription
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMCA Produce Rx (YPRx) Program Only (Control)Behavioural
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.
YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Produce Rx Program Only (Control) | Active comparator | YMCA Produce Prescription Program deliveries of fresh produce bags once per week for 52 weeks. Receives: 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. Receives: Behavioral: YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months, 6, months, 9 months, and 12 months
Secondary outcomes (6)
Change in physical activity
Change in physical activity will be measured by the change in absolute minutes of physical activity and percent change in time spent being physically active. Minutes spent being physically active over the past 7 days, self-reported via quarterly online surveys at baseline, 3 months, 6 months, 9 months, and 12 months (endline).
Measured: Baseline, 3 months, 6, months, 9 months, and 12 months
Change in food security status
Change in food insecurity will be measured using the 6-question U.S. Household Food Security Screener Module which ask participants about food security within the household framed around personal and familial food consumption based on the ability to afford food in the past 30 days. Responses will be self-reported via online surveys at baseline and endline (12 months).
Measured: Baseline and 12 months
Change in participant dietary intake
Change in dietary intake will be measured using the National Cancer Institute's Dietary Screener Questionnaire. Frequency of food and beverage consumption over the previous month will be self-reported by participants via online surveys at baseline and endline (12 months). Foods and beverages include: "Pure Fruit Juices", "Fruit", "Green Leafy or Lettuce Salad", "Fried Potatoes", "Other Kinds of Potatoes", "Cooked Beans", "Vegetables", "Salsa", "Pizza", and "Tomato Sauce". Responses to all questions will be measured using 11-point scale ranging from "Never" to "6 or more times per day" for "Pure Fruit Juices", a 9-point scale ranging from "Never" to "2 or more times per day" for all other food categories, plus an additional response option "Don't know/Prefer not to answer" for each question.
Measured: Baseline and 12 months
Change in participant food behaviors
Change in food behavior will be measured as the change in number of days (0-7) the participant, or someone else in their family, cooked dinner at home during the preceding week. Frequencies will be self-reported by participants via online surveys at baseline and endline (12 months).
Measured: Baseline and 12 months
Change in personal health self-rated health assessment
Change in self-rated health assessment will be measured by the change in participant's self-rated health assessment collected via online survey at baseline and 12 months using a five-point Likert scale ("Poor" to "Excellent") .
Measured: Baseline and 12 months
Change in participant healthcare utilization- self-reported
Change in healthcare utilization will be measured by the change in frequency of accessing healthcare during the three months preceding baseline and endline. This outcome will be measured by whether or not the participant accessed various types of medical attention ("Yes", "No" "Don't know/Prefer not to answer"), and if so, how many times ("None" to "16 or more" plus "Don't know/Prefer not to answer") as self-reported via online surveys at baseline and endline (12 months).
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start6 Jan 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tessa Mork
- Sponsor type
- University, hospital or other
- Collaborators
- AmeriGroup, Hungry Harvest, Johns Hopkins Bloomberg School of Public Health, Elevance Health
- Responsible party
- Sponsor-investigator, Tessa Mork, YMCA of Metropolitan Washington
- Investigators
- Kristy McCarron, MPH, Principal investigator, YMCA of Metropolitan WashingtonJulia Wolfson, PhD MPP, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695104
- Sponsor's protocol ID
- 00022594
- Other IDs
- 2022-70424-38459
- Acronym
- YPRx
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YMCA Produce Prescription Project (YPRx)
- ClinicalTrials.gov ID
- NCT06695104
- Acronym / sponsor ID
- YPRx / 00022594
- Conditions
- Pre-diabetes
- Keywords
- diabetes prevention program, produce rx program, produce prescription
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tessa MorkUniversity, hospital or other
- Collaborators
- AmeriGroup, Hungry Harvest, Johns Hopkins Bloomberg School of Public Health, Elevance Health
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Produce Rx Program Only (Control) | Active comparator | Behavioral: YMCA Produce Rx (YPRx) Program Only (Control)YMCA Produce Prescription Program deliveries of fresh produce bags once per week for 52 weeks. |
| Produce Rx Program + Diabetes Prevention Program | Experimental | Behavioral: YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Produce Rx Program Only (Control) |
| 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. | Behavioural | Produce Rx Program + Diabetes Prevention Program |
Primary outcome
Change in body weight
Time frame: Baseline, 3 months, 6, months, 9 months, and 12 months
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).
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristy McCarron, MPH principal investigator
YMCA of Metropolitan Washington
Julia Wolfson, PhD MPP principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YMCA Produce Rx (YPRx) Program + the Diabetes Prevention Program (DPP) in people with Pre-diabetes, run by Tessa Mork at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristy McCarron, MPH (215-870-4053, kristy.mccarron@ymcadc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline, 3 months, 6, months, 9 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.