Diabetes Mellitus Type 2I-PPPNCT06837805
Iowa Produce Prescription Program
A study testing Iowa Produce Prescription Program (I-PPP) and Produce Your Path Behavioral Nutrition Intervention (PYP) in people with Diabetes Mellitus Type 2 and Pre-diabetes, run by Iowa State University at 1 site in United States.
Trial summary
The goal of this study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition and overall health in low-income Iowans with type 2 diabetes or pre-diabetes. Research questions include: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Pre-diabetes
- What is being tested?
- Iowa Produce Prescription Program (I-PPP) and Produce Your Path Behavioral Nutrition Intervention (PYP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to May 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
- Age 18 and older
- Pre-diabetic or diabetic diagnosis by medical provider;
- Receiving medical assistance under a state plan (Medicaid) or eligible for Supplemental Nutrition Assistance Program (SNAP) benefits;
- Owns a smart phone;
- Able to read and understand English; speaks English;
- Patient at a partnering health care clinic;
- No one else in the household is enrolled in I-PPP
Who cannot join
- Under 18 years old;
- Not pre-diabetic or diabetic (as diagnosed by medical provider);
- Does not receive medical assistance under a state plan (Medicaid) or is not eligible for SNAP benefits;
- Does not own a smart phone;
- Cannot read or understand English;
- Does not speak English;
- Is not a patient at a partnering health care clinic;
- Others in household participating in I-PPP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Iowa Produce Prescription Program: Improving the Health Status of Iowans Facing Nutrition Insecurity
The goal of this study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition and overall health in low-income Iowans with type 2 diabetes or pre-diabetes. Research questions include:
- What impact does a produce prescription program paired with a behavioral nutrition intervention on nutrition security compared to the behavioral nutrition intervention alone and usual care groups?
- What impact does a produce prescription program paired with a behavioral nutrition intervention on hemoglobin A1c, fruit and vegetables intake, food security, and related behaviors compared to the behavioral nutrition intervention alone and usual care groups?
Read more
Participants of the behavioral nutrition intervention (Produce Your Path) alone will:
- Watch monthly nutrition education videos about topics like planning and budgeting for groceries, reading nutrition labels, eating more fruits and vegetables, and new recipes to try
- Complete a short quiz about their own goals and habits related to the topic
- (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions
Participants of both the Produce Prescription and Produce Your Path Interventions will:
- Complete each monthly nutrition education module and monthly quiz
- (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions
- Receive $30.00 per each person in their household monthly to buy fresh fruits and vegetables
Participants of the control group will:
- Follow their usual care for health conditions
- Complete the required data collection for the study
- Conditions
- Diabetes Mellitus Type 2, Pre-diabetes
- Being tested
- Iowa Produce Prescription Program (I-PPP), Produce Your Path Behavioral Nutrition Intervention (PYP)
- Keywords
- produce prescription, behavioral nutrition intervention, online nutrition education, self determination theory
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iowa Produce Prescription Program (I-PPP)Other
The I-PPP intervention offers a produce prescription in the form of $30.00 per family member in a household every month to spend on fruit and vegetables. The dollars can be used at local retail partners, which are specific to each community. A mobile app has been developed for the I-PPP intervention participants. At the beginning of each month for six months, the app asks participants to complete a nutrition education module and a corresponding short quiz. After the participant completes the module, $30.00 per family member in the house will be loaded into the app for participants to use over the next month at local retail partners to buy fresh fruits and vegetables. Participants will have 30 days from the date of distribution to spend the funds before they expire.
Produce Your Path Behavioral Nutrition Intervention (PYP)Behavioural
The PYP Intervention is a six-month virtual behavioral intervention grounded in Self Determination Theory. The intervention aims to improve participants' competence, autonomy, and sense of relatedness through educational videos, recipes, and supplemental resources. Each monthly module contains several short videos, totaling around 15 minutes in length. The module topics include goal-setting, planning meals, preparing fruits and vegetables, reading nutrition labels, budgeting for healthier eating, and making healthier food swaps. The videos are tailored to represent a variety of cultures, ethnicities, and backgrounds, with diverse actors and recipes. Upon completion of each monthly module, a short quiz is administered to participants to measure self-efficacy related to the topic and prompt goal-setting. To further increase social support, an optional Facebook Group component allows participants to post questions, share goals and recipes, and answer prompts from the research team.
| Study group | Role | What they receive |
|---|---|---|
| I-PPP+PYP Group | Experimental | The I-PPP+PYP participants will participate in both the Iowa Produce Prescription Program and the Produce Your Path Behavioral Nutrition Intervention. This group will complete the monthly PYP intervention modules to receive the produce prescription dollar amount, which can be redeemed at partnering retail locations on fresh fruits and vegetables. An optional Facebook group for the I-PPP+PYP participants with offer additional social support and resources for participants, who can use the Facebook page to post questions, share goals and recipes, and answer prompts posted by the research team. Receives: Other: Iowa Produce Prescription Program (I-PPP); Behavioral: Produce Your Path Behavioral Nutrition Intervention (PYP) |
| PYP Alone Group | Experimental | The PYP Alone Group will complete the six-month behavioral nutrition intervention, but will not receive monthly incentives to redeem for fresh fruits and vegetables. PYP Alone participants will still complete the corresponding quizzes to monthly education modules. The PYP Alone participants will also have access to separate optional Facebook group to post questions, share goals and recipes, and answer prompts posted by the research team. Receives: Behavioral: Produce Your Path Behavioral Nutrition Intervention (PYP) |
| Control Group | No intervention | This group will not receive the produce prescription incentive or behavioral intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition Security
The USDA's definition of Nutrition Security is 'all Americans have consistent and equitable access to healthy, safe, affordable foods essential to optimal health and well-being'. To measure participant's nutrition security, the investigators will administer the four-item Household Nutrition Security tool developed by the Center for Nutrition \& Health Impact. Participants of every arm of the study will complete the nutrition security items as part of the Baseline Survey (Month 1) and Post-Survey (Month 6). Participants will answer the four questions using a 5-point Likert frequency scale (never to always). The answers correspond to a number, and the overall score is the mean of the four answers, with lower scores indicating less nutrition security.
Measured: From Month 1 of the intervention to the end of the intervention (Month 6)
Secondary outcomes (3)
Hemoglobin A1c (HA1c)
Participant's hemoglobin A1c levels (HA1c) will be measured to help identify how well blood sugar levels are being managed. The Hemoglobin A1c test measures what percentage of blood hemoglobin proteins are glycated, with higher percentages indicating poorer glucose control and prediabetes or diabetes. This test is conducted by participant's primary care providers and data is released to the research team. HA1c will be collected from lab draws in electronic medical records.
Measured: From Month 1 of the intervention to the end of the intervention (Month 6)
Dietary Intake
Investigators will measure participant's fruit and vegetable consumption using the 10-item dietary assessment tool from the Center for Nutrition, which was previously adapted from the Dietary Screener Questionnaire from developed by NIH and the National Cancer Insititute. The assessment tool asks participants how often they consumed certain fruits, vegetables, and food products over the last 30 days. This dietary assessment tool is part of the Baseline Survey (Month 1) and Post-Survey (Month 6).
Measured: From Month 1 of the intervention to the end of the intervention (Month 6)
Psychosocial Mediators
Psychosocial constructs including self-efficacy, social support, and motivation level are measured in the Baseline Survey (Month 1) and Post-Survey (Month 6). Self-efficacy and social support are measured using a two- and three-item tool recommended by the Center for Nutrition, respectively. Motivational level is measured using the 15-item Treatment Self-Regulation Questionnaire, which was specifically developed to measure how intrinsically motivated a person is, as proposed by Self Determination Theory. These psychosocial constructs were chosen because the intervention is designed to increase self-efficacy and social support, and is also grounded in Self Determination Theory, aiming to increase intrinsic motivation.
Measured: From Month 1 of the intervention to the end of the intervention (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Feb 2025
- Primary completionJan 2026 (estimated)
- Study completionMay 2026 (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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyndi Buckingham-Schutt, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837805
- Sponsor's protocol ID
- 22-314
- Acronym
- I-PPP
- Status last verified
- Apr 2025
- First submitted
- 11 Feb 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iowa Produce Prescription Program: Improving the Health Status of Iowans Facing Nutrition Insecurity
- ClinicalTrials.gov ID
- NCT06837805
- Acronym / sponsor ID
- I-PPP / 22-314
- Conditions
- Diabetes Mellitus Type 2, Pre-diabetes
- Keywords
- produce prescription, behavioral nutrition intervention, online nutrition education, self determination theory
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 20 Feb 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 study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition and overall health in low-income Iowans with type 2 diabetes or pre-diabetes. Research questions include:
- What impact does a produce prescription program paired with a behavioral nutrition intervention on nutrition security compared to the behavioral nutrition intervention alone and usual care groups?
- What impact does a produce prescription program paired with a behavioral nutrition intervention on hemoglobin A1c, fruit and vegetables intake, food security, and related behaviors compared to the behavioral nutrition intervention alone and usual care groups?
Participants of the behavioral nutrition intervention (Produce Your Path) alone will:
- Watch monthly nutrition education videos about topics like planning and budgeting for groceries, reading nutrition labels, eating more fruits and vegetables, and new recipes to try
- Complete a short quiz about their own goals and habits related to the topic
- (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions
Participants of both the Produce Prescription and Produce Your Path Interventions will:
- Complete each monthly nutrition education module and monthly quiz
- (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions
- Receive $30.00 per each person in their household monthly to buy fresh fruits and vegetables
Participants of the control group will:
- Follow their usual care for health conditions
- Complete the required data collection for the study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I-PPP+PYP Group | Experimental | Other: Iowa Produce Prescription Program (I-PPP), Behavioral: Produce Your Path Behavioral Nutrition Intervention (PYP)The I-PPP+PYP participants will participate in both the Iowa Produce Prescription Program and the Produce Your Path Behavioral Nutrition Intervention. This group will complete the monthly PYP intervention modules to receive the produce prescription dollar amount, which can be redeemed at partnering retail locations on fresh fruits and vegetables. An optional Facebook group for the I-PPP+PYP participants with offer additional social support and resources for participants, who can use the Facebook page to post questions, share goals and recipes, and answer prompts posted by the research team. |
| PYP Alone Group | Experimental | Behavioral: Produce Your Path Behavioral Nutrition Intervention (PYP)The PYP Alone Group will complete the six-month behavioral nutrition intervention, but will not receive monthly incentives to redeem for fresh fruits and vegetables. PYP Alone participants will still complete the corresponding quizzes to monthly education modules. The PYP Alone participants will also have access to separate optional Facebook group to post questions, share goals and recipes, and answer prompts posted by the research team. |
| Control Group | No intervention | –This group will not receive the produce prescription incentive or behavioral intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 and older
- Pre-diabetic or diabetic diagnosis by medical provider;
- Receiving medical assistance under a state plan (Medicaid) or eligible for Supplemental Nutrition Assistance Program (SNAP) benefits;
- Owns a smart phone;
- Able to read and understand English; speaks English;
Key exclusion criteria (8 listed)
- Under 18 years old;
- Not pre-diabetic or diabetic (as diagnosed by medical provider);
- Does not receive medical assistance under a state plan (Medicaid) or is not eligible for SNAP benefits;
- Does not own a smart phone;
- Cannot read or understand English;
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 |
|---|---|---|
| Iowa Produce Prescription Program (I-PPP)The I-PPP intervention offers a produce prescription in the form of $30.00 per family member in a household every month to spend on fruit and vegetables. The dollars can be used at local retail partners, which are specific to each community. A mobile app has been developed for the I-PPP intervention participants. At the beginning of each month for six months, the app asks participants to complete a nutrition education module and a corresponding short quiz. After the participant completes the module, $30.00 per family member in the house will be loaded into the app for participants to use over the next month at local retail partners to buy fresh fruits and vegetables. Participants will have 30 days from the date of distribution to spend the funds before they expire. | Other | I-PPP+PYP Group |
| Produce Your Path Behavioral Nutrition Intervention (PYP)The PYP Intervention is a six-month virtual behavioral intervention grounded in Self Determination Theory. The intervention aims to improve participants' competence, autonomy, and sense of relatedness through educational videos, recipes, and supplemental resources. Each monthly module contains several short videos, totaling around 15 minutes in length. The module topics include goal-setting, planning meals, preparing fruits and vegetables, reading nutrition labels, budgeting for healthier eating, and making healthier food swaps. The videos are tailored to represent a variety of cultures, ethnicities, and backgrounds, with diverse actors and recipes. Upon completion of each monthly module, a short quiz is administered to participants to measure self-efficacy related to the topic and prompt goal-setting. To further increase social support, an optional Facebook Group component allows participants to post questions, share goals and recipes, and answer prompts from the research team. | Behavioural | I-PPP+PYP Group, PYP Alone Group |
Primary outcome
Nutrition Security
Time frame: From Month 1 of the intervention to the end of the intervention (Month 6)
The USDA's definition of Nutrition Security is 'all Americans have consistent and equitable access to healthy, safe, affordable foods essential to optimal health and well-being'. To measure participant's nutrition security, the investigators will administer the four-item Household Nutrition Security tool developed by the Center for Nutrition \& Health Impact. Participants of every arm of the study will complete the nutrition security items as part of the Baseline Survey (Month 1) and Post-Survey (Month 6). Participants will answer the four questions using a 5-point Likert frequency scale (never to always). The answers correspond to a number, and the overall score is the mean of the four answers, with lower scores indicating less nutrition security.
3 secondary outcomes
Hemoglobin A1c (HA1c)
Time frame: From Month 1 of the intervention to the end of the intervention (Month 6)
Dietary Intake
Time frame: From Month 1 of the intervention to the end of the intervention (Month 6)
Psychosocial Mediators
Time frame: From Month 1 of the intervention to the end of the intervention (Month 6)
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 1 May 2025.
- Iowa Healthiest State Initiative's Iowa Produce Rx webpage.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iowa Produce Prescription Program (I-PPP) and Produce Your Path Behavioral Nutrition Intervention (PYP) in people with Diabetes Mellitus Type 2 and Pre-diabetes, run by Iowa State 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 7 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 1 May 2025. 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?
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?
Nutrition Security (time frame: From Month 1 of the intervention to the end of the intervention (Month 6)). 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 1 May 2025.