Diabetes Type 2NCT06401668
Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes
A study testing Community health worker (CHW) strategy and PRx Program in people with Diabetes Type 2, run by Yale University at 1 site in United States.
Trial summary
Produce prescription programs (PRx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (T2D) and food insecurity, but uptake has been suboptimal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Community health worker (CHW) strategy and PRx Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Be a current primary or specialty care patient at Hartford Hospital
- Live in Hartford County
- Identify as Hispanic
- Have a current diagnosis of Type II Diabetes
- Be eligible for Medicaid based on household income and size.
Who cannot join
- Does not speak English or Spanish
- Has a diagnosis of gestational diabetes
- Individuals who are members of vulnerable populations, such as individuals who are incarcerated and individuals who are not able to consent.
- Participants who are pregnant will be eligible for the study if they meet all of the inclusion criteria and do not have any of the exclusion criteria, as the study activities (additional funds to purchase fruits and vegetables, nutrition education, and support from a Community Health Worker) does not pose any additional risk to this group.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hartford HealthCare/ St. Vincent Medical Center
Hartford, Connecticut, 06102
About this study
Produce prescription programs (PRx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (T2D) and food insecurity, but uptake has been suboptimal. There is a critical need for scalable, evidence-based implementation strategies for improving PRx uptake and optimizing the effectiveness and cost-effectiveness of these interventions. This study will co-design and pilot a community health worker (CHW) strategy and test the effectiveness of the strategy compared to PRx participants without a CHW. The overall objective of this study is to test and evaluate a theory-informed, user-centered community health worker (CHW) implementation strategy to improve uptake of a PRx, among Hispanic Medicaid-eligible patients with T2D in Connecticut (CT). CHWs will offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.
Read the detailed description
This study will have a small pilot followed by a randomized controlled trial. The focus of this registration is the randomized controlled trial.
First, following community co-design of the CHW strategy, investigators will conduct a two-month pilot study with an anticipated 10 participants to test the CHW strategy, the produce prescription program Rx, and overall study procedures. All participants will receive the PRx program with CHW strategy for two months.
Second, a randomized controlled trial to evaluate the effectiveness of the CHW strategy on barriers to PRx uptake, level of PRx engagement, and short-term program, behavioral, and health outcomes will be conducted.
Investigators hypothesize that participants who receive added CHW support during their enrollment in the PRx program will have reduced barriers to PRx uptake, higher PRx uptake, and greater improvements in the defined short-term program outcomes compared with participants who do not receive the CHW support during their enrollment in the PRx.
- Conditions
- Diabetes Type 2
- Being tested
- Community health worker (CHW) strategy, PRx Program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health worker (CHW) strategyBehavioural
CHWs will offer participants personalized support to assist in overcoming barriers and leveraging facilitators to PRx uptake. CHWs are trained lay members of the communities they serve. The CHW strategy is an evidence-based.
PRx ProgramBehavioural
The PRx Program provides free fruit and vegetables and nutrition education to patients with T2D and food insecurity.
| Study group | Role | What they receive |
|---|---|---|
| PRx with the CHW strategy | Experimental | Participants in this group will have CHWs to offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake. Receives: Behavioral: Community health worker (CHW) strategy; Behavioral: PRx Program |
| PRx without the CHW strategy | Active comparator | Participants in this group will participate in the PRx without the use of CHWs Receives: Behavioral: PRx Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRx redemption
PRx redemption is defined as produce debit card dollars used/total dollars available will be collected from the produce debit card platform.
Measured: Monthly, beginning 1 month after the study start though the end of the six month study period.
Secondary outcomes (9)
Barriers to PRx uptake
Barriers to PRx uptake will be captured through post-program survey questions on participant barriers to buying and consuming produce as well as from listening sessions and CHW process tracking data on participant encounters.
Measured: 3 months, 6 months
PRx uptake: Initiation
PRx initiation defined as the number of participants initiating use of the debit card/number enrolled
Measured: 6 months
PRx uptake: Usage
- Months used (defined as #/% participants using any incentives each month for 6mo and % using incentives every month)
Measured: 6 months
PRx uptake: Attendance
Nutrition class attendance defined as a yes/no variable for each of the three classes.
Measured: 6 months
Program Satisfaction
Assessed through listening sessions and a short satisfaction module, coded on a five-point Likert scale in the post survey. Total score range from 0-4 with higher scores indicating greater satisfaction.
Measured: 6 months
Change in Fruit and Vegetable Intake
Assessed with the 29-item Diet Quality Questionnaire. The 5-minute module asks yes/no questions about consumption of a series of sentinel foods that correspond to pre-defined food groups. It has a total score of 0-10. The higher the score, the higher the likelihood of nutrient adequacy.
Measured: baseline, 3 months, and 6 months
Change in Household Food Insecurity
Assessed using the 6-item US Department of Agriculture Household Food Security Survey Module. The total score range from 0 to 27, with higher scores indicating more food security.
Measured: baseline, 3 months, and 6 months
Change in Glycemic control
Assessed with HbA1c concentration (%) data from patient electronic medical records. A decrease in HbA1c concentration indicates better glycemic control.
Measured: baseline and 6 months
Change in Self-rated Health
Assessed with a single question with a five-item response scale from poor to excellent.
Measured: baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start8 Apr 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will include primary and specialty care patients who identify as Hispanic with T2D and low incomes.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Rafael Perez-Escamilla, MD, Principal investigator, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401668
- Sponsor's protocol ID
- 2000037606
- Other IDs
- 24FIM1264456
- Status last verified
- Jun 2026
- First submitted
- 1 May 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated within this study will be provided to the American Heart Association in a de-identified form, to be deposited within the Health Care x Food data repository on the Precision Medicine Platform, and subject to the Precision Medicine Platform Terms and Conditions. Data on the Precision Medicine Platform will be collated with data from other studies that are funded by the American Heart Association Health Care x Food initiative, and used by future investigators for analysis. In addition, data will be made available on Clinicaltrials.gov in alignment with agreed-upon Open Science Policies at the American Heart Association, whereby any factual data that is needed for independent verification of research results must be made freely and publicly available in an AHA-approved repository as soon as possible, and no later than the time of an associated publication or the end of the award period (and any no-cost extension), whichever come first.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes
- ClinicalTrials.gov ID
- NCT06401668
- Acronym / sponsor ID
- 2000037606
- Conditions
- Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 7 May 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.
Produce prescription programs (PRx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (T2D) and food insecurity, but uptake has been suboptimal. There is a critical need for scalable, evidence-based implementation strategies for improving PRx uptake and optimizing the effectiveness and cost-effectiveness of these interventions. This study will co-design and pilot a community health worker (CHW) strategy and test the effectiveness of the strategy compared to PRx participants without a CHW. The overall objective of this study is to test and evaluate a theory-informed, user-centered community health worker (CHW) implementation strategy to improve uptake of a PRx, among Hispanic Medicaid-eligible patients with T2D in Connecticut (CT). CHWs will offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.
Detailed description
This study will have a small pilot followed by a randomized controlled trial. The focus of this registration is the randomized controlled trial.
First, following community co-design of the CHW strategy, investigators will conduct a two-month pilot study with an anticipated 10 participants to test the CHW strategy, the produce prescription program Rx, and overall study procedures. All participants will receive the PRx program with CHW strategy for two months.
Second, a randomized controlled trial to evaluate the effectiveness of the CHW strategy on barriers to PRx uptake, level of PRx engagement, and short-term program, behavioral, and health outcomes will be conducted.
Investigators hypothesize that participants who receive added CHW support during their enrollment in the PRx program will have reduced barriers to PRx uptake, higher PRx uptake, and greater improvements in the defined short-term program outcomes compared with participants who do not receive the CHW support during their enrollment in the PRx.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will include primary and specialty care patients who identify as Hispanic with T2D and low incomes.
| Arm | Type | Receives |
|---|---|---|
| PRx with the CHW strategy | Experimental | Behavioral: Community health worker (CHW) strategy, Behavioral: PRx ProgramParticipants in this group will have CHWs to offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake. |
| PRx without the CHW strategy | Active comparator | Behavioral: PRx ProgramParticipants in this group will participate in the PRx without the use of CHWs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be a current primary or specialty care patient at Hartford Hospital
- Live in Hartford County
- Identify as Hispanic
- Have a current diagnosis of Type II Diabetes
- Be eligible for Medicaid based on household income and size.
Key exclusion criteria (4 listed)
- Does not speak English or Spanish
- Has a diagnosis of gestational diabetes
- Individuals who are members of vulnerable populations, such as individuals who are incarcerated and individuals who are not able to consent.
- Participants who are pregnant will be eligible for the study if they meet all of the inclusion criteria and do not have any of the exclusion criteria, as the study activities (additional funds to purchase fruits and vegetables, nutrition education, and support from a Community Health Worker) does not pose any additional risk to this group.
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 |
|---|---|---|
| Community health worker (CHW) strategyCHWs will offer participants personalized support to assist in overcoming barriers and leveraging facilitators to PRx uptake. CHWs are trained lay members of the communities they serve. The CHW strategy is an evidence-based. | Behavioural | PRx with the CHW strategy |
| PRx ProgramThe PRx Program provides free fruit and vegetables and nutrition education to patients with T2D and food insecurity. | Behavioural | PRx with the CHW strategy, PRx without the CHW strategy |
Primary outcome
PRx redemption
Time frame: Monthly, beginning 1 month after the study start though the end of the six month study period.
PRx redemption is defined as produce debit card dollars used/total dollars available will be collected from the produce debit card platform.
9 secondary outcomes
Barriers to PRx uptake
Time frame: 3 months, 6 months
PRx uptake: Initiation
Time frame: 6 months
PRx uptake: Usage
Time frame: 6 months
PRx uptake: Attendance
Time frame: 6 months
Program Satisfaction
Time frame: 6 months
Change in Fruit and Vegetable Intake
Time frame: baseline, 3 months, and 6 months
Change in Household Food Insecurity
Time frame: baseline, 3 months, and 6 months
Change in Glycemic control
Time frame: baseline and 6 months
Change in Self-rated Health
Time frame: baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. Data generated within this study will be provided to the American Heart Association in a de-identified form, to be deposited within the Health Care x Food data repository on the Precision Medicine Platform, and subject to the Precision Medicine Platform Terms and Conditions. Data on the Precision Medicine Platform will be collated with data from other studies that are funded by the American Heart Association Health Care x Food initiative, and used by future investigators for analysis. In addition, data will be made available on Clinicaltrials.gov in alignment with agreed-upon Open Science Policies at the American Heart Association, whereby any factual data that is needed for independent verification of research results must be made freely and publicly available in an AHA-approved repository as soon as possible, and no later than the time of an associated publication or the end of the award period (and any no-cost extension), whichever come first.
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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.
Rafael Perez-Escamilla, MD principal investigator
Yale 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 Community health worker (CHW) strategy and PRx Program in people with Diabetes Type 2, run by Yale University 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PRx redemption (time frame: Monthly, beginning 1 month after the study start though the end of the six month study period.). 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 3 Jun 2026.