Diabetes Mellitus Type 2CP3NCT06920355
Community Pharmacy Produce Prescriptions
A study testing Produce Prescription and Nutrition Education in people with Diabetes Mellitus Type 2 and Hypertension, run by Tufts University at 3 sites in United States.
Trial summary
The goal of this clinical trial is to generate evidence on the feasibility and effectiveness of community pharmacies as the implementers of a produce prescription program for adults with diabetes and/or hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Hypertension
- What is being tested?
- Produce Prescription and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 May 2025to Jun 2027
- 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
- Provision of signed and dated informed consent form
- Age 18 years or older
- Presence of one or more of the following conditions: type 2 diabetes or hypertension. (Type 2 diabetes and hypertension will be defined by the combination of a self-reported physician diagnosis of one of the conditions and at least one pharmacy prescription for one of the conditions.)
- Able to converse, and complete the research surveys in English or Spanish, based on self-report.
- Positive screening for food or nutrition insecurity by:
- Hunger Vital Sign™ screening and,
- Nutrition Security Screener
Who cannot join
- Unable to provide informed consent.
- Unable to read and write.
- Self-reported serious medical conditions that may be expected to shorten life expectancy to less than one year
- A condition that limits participant's ability to grocery shop or choose food for themselves
- Plans to move to a new home in the next 6 months that would require use of a different pharmacy
- Currently pregnant or pregnancy planned within the next 6 months
Show all 9Show fewer
- Currently using or planning to start an insulin pump or other automated insulin delivery device within the next 6 months
- Currently on a GLP-1 agonist or planning to start a GLP-1 agonist within the next 6 months
- Currently receiving or planning to receive within the next 6 months another Food is Medicine program, like PRx, Grocery Rx, or Medically Tailored Meals
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walmart
Bentonville, Arkansas, 72716
Kroger Co.
Cincinnati, Ohio, 45202
Hy-Vee
Des Moines, Iowa, 50266
About this study
Official title: Community Pharmacy Produce Prescriptions (CP3): Design, Implementation, and Evaluation of a Produce Prescription Program in Community Pharmacies
The goal of this clinical trial is to generate evidence on the feasibility and effectiveness of community pharmacies as the implementers of a produce prescription program for adults with diabetes and/or hypertension. The main question this study plans to answer is if using community pharmacies as a point-of-service for improving nutrition and health is feasible and effective. The trial also explores the impact of the program on food security, nutrition security, diet quality and health and patient centered outcomes.
Participants will be enrolled in a produce prescription program to purchase healthy foods at the grocery store where they are currently receiving their pharmacy services. Participants will be asked to attend pharmacy visits to collect biometrics at two different time points and complete electronic surveys at three different time points.
Read the detailed description
Produce prescription programs are an increasingly common Food is Medicine (FIM) intervention, with over 100 programs launched in US healthcare systems over the past decade. Mounting evidence from these programs suggests health-related benefits, including reductions in household food insecurity, increased consumption of fruits and vegetables, and improvements in clinical outcomes such as diastolic blood pressure, hemoglobin A1c, and body mass index.
Pharmacies routinely engage in vital screening and referral services, including monitoring blood glucose, blood pressure, cholesterol levels, and administering vaccinations, among other patient care services. However, the community pharmacy setting has remained a largely underutilized and understudied platform for advancing FIM. Historically, FIM interventions have been designed and delivered through hospitals, medical clinics, or community non-profit organizations. The next phase of FIM efforts involves expanding screening and referral for such programs to community pharmacies, including those affiliated or co-located with grocery stores. Community Pharmacy Produce Prescriptions study intervention will be delivered via a Produce Prescription (PRx) electronic benefit card. Each month, participants will receive a fixed amount of funds on the PRx card to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.
- Conditions
- Diabetes Mellitus Type 2, Hypertension
- Being tested
- Produce Prescription, Nutrition Education
- Keywords
- Food is Medicine, Produce Prescriptions, Produce Rx, Community Pharmacy, Nutrition Security, Food Security, Nutrition Intervention, Food as Medicine
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce PrescriptionOther
Also called Produce Rx
Each month, participants will receive a fixed amount of funds on the PRx card. Participants will be able to use these funds to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided through an electronic PRx benefit card that is activated after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.
Nutrition EducationBehavioural
Participating pharmacies/grocery chains will have Registered Dietitians (RD/RDN) on staff who can provide participants with nutrition education programs, coaching, and/or nudges.
| Study group | Role | What they receive |
|---|---|---|
| Produce Prescription Group | Experimental | Not described Receives: Other: Produce Prescription; Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PRx Program Utilization
The utilization rate will be calculated by dividing the number of PRx cards redeemed by the total number of PRx cards distributed at each pharmacy.
Measured: Up to 6-months
Rate of PRx Program Redemption
The redemption rates will be calculated based on the average proportion of dollar amounts redeemed over the total dollar amounts of benefits distributed.
Measured: Up to 6-months
Change in Food Security
Assessed by the USDA's Household Food Security Survey Module: Six-Item Short Form. The sum of affirmative responses to the six questions is the household's raw score. A raw score of 0-1 indicates food security, while a score of 2-6 indicates food insecurity.
Measured: baseline, 3-months, 6-months
Change in Nutrition Security
Assessed by the Nutrition Security Screener. Respondents will be classified as nutrition secure if they answer, "Not hard at all" or "Not very hard" to item 1 or nutrition insecure if they answer, "Somewhat hard", "Hard", or "Very Hard."
Measured: baseline, 3-months, 6-months
Change in Diet Quality
Assessed by a modified Mini-Eating Assessment Tool (EAT). A calculated score will be created such that a higher score is indicative of healthier dietary patterns.
Measured: baseline, 3-months, 6-months
Secondary outcomes (6)
Change in Hemoglobin A1c
For participants with diabetes, pharmacy staff will conduct a point-of-care hemoglobin A1c measurement of blood obtained by fingerstick.
Measured: baseline and 6-months
Change in Continuous Glucose Monitor (CGM) Time-in-range
Time-in-range is the percentage of time spent with glucose levels in the target range. For participants with diabetes, pharmacy staff place a CGM, per product instructions, on the participant with a goal to wear for 10 days (each time).
Measured: baseline and 6-months
Change in Blood Pressure
Pharmacy staff will measure participants' systolic and diastolic blood pressure.
Measured: baseline and 6-months
Change in Body Mass Index
Pharmacy staff will collect height and weight.
Measured: baseline and 6-months
Change in Patient Reported Health Related Quality of Life
Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health, the scoring system converts responses from a 10-item questionnaire into T-scores for Global Physical Health (GPH) and Global Mental Health (GMH), where higher scores indicate better health.
Measured: baseline, 3-months, 6-months
Change in Disease Self-management
Assessed by the 6-item Self Efficacy for Managing Chronic Disease (SEMCD) scale. Scores will be calculated as the mean response to the six questions. A higher score is indicative of higher self-efficacy.
Measured: baseline, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start22 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Association of Chain Drug Stores, The Kroger Company, Walmart, Hy-Vee
- Responsible party
- Principal investigator, Dariush Mozaffarian, Tufts University
- Investigators
- Dariush Mozaffarian, MD, DrPH, Principal investigator, The Food is Medicine Institute at the Friedman School of Nutrition Science and Policy at Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920355
- Sponsor's protocol ID
- STUDY00005176
- Acronym
- CP3
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Pharmacy Produce Prescriptions (CP3): Design, Implementation, and Evaluation of a Produce Prescription Program in Community Pharmacies
- ClinicalTrials.gov ID
- NCT06920355
- Acronym / sponsor ID
- CP3 / STUDY00005176
- Conditions
- Diabetes Mellitus Type 2, Hypertension
- Keywords
- Food is Medicine, Produce Prescriptions, Produce Rx, Community Pharmacy, Nutrition Security, Food Security, Nutrition Intervention, Food as Medicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Association of Chain Drug Stores, The Kroger Company, Walmart, Hy-Vee
- Study start
- 22 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Apr 2025 (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.
The goal of this clinical trial is to generate evidence on the feasibility and effectiveness of community pharmacies as the implementers of a produce prescription program for adults with diabetes and/or hypertension. The main question this study plans to answer is if using community pharmacies as a point-of-service for improving nutrition and health is feasible and effective. The trial also explores the impact of the program on food security, nutrition security, diet quality and health and patient centered outcomes.
Participants will be enrolled in a produce prescription program to purchase healthy foods at the grocery store where they are currently receiving their pharmacy services. Participants will be asked to attend pharmacy visits to collect biometrics at two different time points and complete electronic surveys at three different time points.
Detailed description
Produce prescription programs are an increasingly common Food is Medicine (FIM) intervention, with over 100 programs launched in US healthcare systems over the past decade. Mounting evidence from these programs suggests health-related benefits, including reductions in household food insecurity, increased consumption of fruits and vegetables, and improvements in clinical outcomes such as diastolic blood pressure, hemoglobin A1c, and body mass index.
Pharmacies routinely engage in vital screening and referral services, including monitoring blood glucose, blood pressure, cholesterol levels, and administering vaccinations, among other patient care services. However, the community pharmacy setting has remained a largely underutilized and understudied platform for advancing FIM. Historically, FIM interventions have been designed and delivered through hospitals, medical clinics, or community non-profit organizations. The next phase of FIM efforts involves expanding screening and referral for such programs to community pharmacies, including those affiliated or co-located with grocery stores. Community Pharmacy Produce Prescriptions study intervention will be delivered via a Produce Prescription (PRx) electronic benefit card. Each month, participants will receive a fixed amount of funds on the PRx card to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Produce Prescription Group | Experimental | Other: Produce Prescription, Behavioral: Nutrition Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Age 18 years or older
- Presence of one or more of the following conditions: type 2 diabetes or hypertension. (Type 2 diabetes and hypertension will be defined by the combination of a self-reported physician diagnosis of one of the conditions and at least one pharmacy prescription for one of the conditions.)
- Able to converse, and complete the research surveys in English or Spanish, based on self-report.
- Positive screening for food or nutrition insecurity by:
Key exclusion criteria (9 listed)
- Unable to provide informed consent.
- Unable to read and write.
- Self-reported serious medical conditions that may be expected to shorten life expectancy to less than one year
- A condition that limits participant's ability to grocery shop or choose food for themselves
- Plans to move to a new home in the next 6 months that would require use of a different pharmacy
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 |
|---|---|---|
| Produce PrescriptionAlso: Produce RxEach month, participants will receive a fixed amount of funds on the PRx card. Participants will be able to use these funds to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided through an electronic PRx benefit card that is activated after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months. | Other | Produce Prescription Group |
| Nutrition EducationParticipating pharmacies/grocery chains will have Registered Dietitians (RD/RDN) on staff who can provide participants with nutrition education programs, coaching, and/or nudges. | Behavioural | Produce Prescription Group |
Primary outcome
Rate of PRx Program Utilization
Time frame: Up to 6-months
The utilization rate will be calculated by dividing the number of PRx cards redeemed by the total number of PRx cards distributed at each pharmacy.
Rate of PRx Program Redemption
Time frame: Up to 6-months
The redemption rates will be calculated based on the average proportion of dollar amounts redeemed over the total dollar amounts of benefits distributed.
Change in Food Security
Time frame: baseline, 3-months, 6-months
Assessed by the USDA's Household Food Security Survey Module: Six-Item Short Form. The sum of affirmative responses to the six questions is the household's raw score. A raw score of 0-1 indicates food security, while a score of 2-6 indicates food insecurity.
Change in Nutrition Security
Time frame: baseline, 3-months, 6-months
Assessed by the Nutrition Security Screener. Respondents will be classified as nutrition secure if they answer, "Not hard at all" or "Not very hard" to item 1 or nutrition insecure if they answer, "Somewhat hard", "Hard", or "Very Hard."
Change in Diet Quality
Time frame: baseline, 3-months, 6-months
Assessed by a modified Mini-Eating Assessment Tool (EAT). A calculated score will be created such that a higher score is indicative of healthier dietary patterns.
6 secondary outcomes
Change in Hemoglobin A1c
Time frame: baseline and 6-months
Change in Continuous Glucose Monitor (CGM) Time-in-range
Time frame: baseline and 6-months
Change in Blood Pressure
Time frame: baseline and 6-months
Change in Body Mass Index
Time frame: baseline and 6-months
Change in Patient Reported Health Related Quality of Life
Time frame: baseline, 3-months, 6-months
Change in Disease Self-management
Time frame: baseline, 3-months, 6-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 31 Aug 2026.
- Study Information WebsiteLink provided by the sponsor.
- Eligibility WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dariush Mozaffarian, MD, DrPH principal investigator
The Food is Medicine Institute at the Friedman School of Nutrition Science and Policy at Tufts University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Prescription and Nutrition Education in people with Diabetes Mellitus Type 2 and Hypertension, run by Tufts University at 3 sites 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 9 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PRx Program Utilization (time frame: Up to 6-months). The study lists 5 primary outcomes in all. 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 31 Aug 2026.