PrediabetesNCT07472712
Integrating a Prescription Produce Program Within a Diabetes Prevention Program
A study testing Diabetes Prevention Program (DPP) and Produce Prescription Plan (PPP) in people with Prediabetes, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Type 2 Diabetes remains a major chronic disease among adults in the United States. A way to prevent Type 2 Diabetes is to engage in a diabetes prevention program. In the diabetes prevention program, individuals at risk of Type 2 Diabetes meet with a health coach to learn effective ways to build health behaviors around… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- Diabetes Prevention Program (DPP) and Produce Prescription Plan (PPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to 31 Aug 2028
- 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
- rationale: adolescents who are at-risk of T2DM may have unique needs that will not be addressed in this study
- Most recent BMI ≥ 25kg/m 2 and not pregnant
- rationale: elevated BMI is associated with higher risk of developing T2DM
- Elevated glucose as evidenced by one of the following criteria:
- Hemoglobin A1c 5.7-6.4% indicative of prediabetes within the last 36 months
Show all 15Show fewer
- Fasting blood glucose 100-125mg/dl or 2-hour glucose 140-199mg/dl within the last six months
- Physician diagnosis of prediabetes (impaired fasting glucose, impaired glucose intolerance)
- These criteria indicate the presence of prediabetes and places individuals are risk of T2DM
- Speak, read, and understand English
- rationale: current version of PPP intervention (cooking classes) is available in English
- Have a working U.S.- based phone number
- rationale: participants must have a working phone number because they will receive automated text messages as reminders to receive session reminders; participants must have a working phone number in case adverse event monitoring contacts are required
- Able to attend study-related sessions at the Health Hub @ 25th over the year long study (i.e., weekly for 4 months, then monthly for 7 months)
- rationale: participants must be able to attend study activities at the community site in order to engage in the intervention and study related sessions.
Who cannot join
- Individuals with HbA1c or glucose levels above the indicated glucose ranges will be advised to see their physician and excluded from participation unless they receive physician consent to participate.
- Pregnant adults (>18 years old) will not be included in this current study because prediabetes (HbA1c levels between 5.7% - 6.4% within the last 36 months) during pregnancy presents unique physiological challenges that the study intervention does not address.
- Pregnancy status will be based on participants self-report. We will not provide any pregnancy tests prior to enrollment.
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, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Ana Diallo, 804-828-3432, dialloa@vcu.edu
Ana Diallo, PhD, MPH, BA
About this study
Official title: Integrating a Prescription Produce Program Within a Diabetes Prevention Program to Address Health Inequities Among Adults
Type 2 Diabetes remains a major chronic disease among adults in the United States. A way to prevent Type 2 Diabetes is to engage in a diabetes prevention program. In the diabetes prevention program, individuals at risk of Type 2 Diabetes meet with a health coach to learn effective ways to build health behaviors around diet and physical activity. Individuals who participate in the diabetes prevention program are more likely to lose weight and eat a healthy diet.
Read the detailed description
The diabetes prevention program does not provide support for major factors influencing Type 2 diabetes, such as food insecurity or the challenge of accessing and eating healthy food to maintain optimal health. Millions of adults who are at risk of Type diabetes face challenges such as food insecurity and access to healthcare, transportation, and housing. A prescription produce program is a community-based initiative that supports an individual who may face food insecurity to access healthy fruits and vegetables and receive health advice and resources to manage their health, including referrals for health services, housing, and transportation. This research examines whether or not a diabetes prevention program integrating a prescription produce program provides more benefits in preventing Type 2 diabetes compared to a regular diabetes prevention program. Subjects in this study may lose weight, increase their knowledge of health, and provide additional services to manage their health.
- Conditions
- Prediabetes
- Being tested
- Diabetes Prevention Program (DPP), Produce Prescription Plan (PPP)
- Keywords
- Health Coach, Food Insecurity, Prevention Program, Diabetes Prevention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention Program (DPP)Behavioural
A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.
Produce Prescription Plan (PPP)Behavioural
The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources.
| Study group | Role | What they receive |
|---|---|---|
| Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP) | Experimental | The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources. Receives: Behavioral: Diabetes Prevention Program (DPP); Behavioral: Produce Prescription Plan (PPP) |
| Diabetes Prevention Program (DPP) only | Placebo comparator | All participants in this research study will participate in the Diabetes Prevention Program (DPP), which is a 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet. Additionally, all participants will be screened for social needs at regular timepoints and receive a list of available resources. Receives: Behavioral: Diabetes Prevention Program (DPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of recruitment rates
Assess feasibility and acceptability by recording and measuring the recruitment rates.
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of enrollment rates
Assess feasibility and acceptability by recording and measuring the enrollment rates.
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of attendance
Assess feasibility and acceptability by recording and measuring the attendance rates.
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of retention rates
Assess feasibility and acceptability by recording and measuring the retention rates.
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of blood glucose
Blood glucose (hemoglobin A1c) will be recorded and measured to asses the blood glucose levels.
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of weight
Weight will be will be recorded and measured for assessment
Measured: Baseline, weekly for the first 16 weeks, them monthly from 5 to 12 months
Minutes of physical activity
average amount (in minutes) of physical activity completed
Measured: weekly for the first 16 weeks, them monthly from month 5 to 12.
Secondary outcomes (7)
Assessment of food security needs
Using the Brief Social Needs evaluation to assess the participants food security needs using the Brief social needs including 2-item food security .
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of social needs
Using the American Academic of Family Physician Social Needs Screening form to assess the participants social needs. This assessment is a set of validated questions designed to help healthcare providers identify and address social determinants of health. Underlined answers generally indicate a positive response for a social need. For the Personal Safety section, a total numerical value greater than 10 indicates a positive screen.
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of diet quality
Using the Healthy Eating Index derived from DietID™,an assessment tool capturing dietary intake through innovative Diet Quality Photo Navigation (DQPN®) to assess the participants diet quality. The Diet ID scoring system provides a diet quality score on a 1-10 scale. A Diet ID score of 10 represents the highest quality (HEI 90-100), while a score of 1 represents the lowest.
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of medication adherence
Medication adherence will be recorded and measured for assessment
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of wellness goals set and met
Wellness goals set and met will be recorded and measured for assessment
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of physical activity
Physical activity will be recorded and measured for assessment using International Physical Activity Questionnaire (IPAQ) measures time spent sitting, light, moderate, and vigorous activity over a set period (e.g., past 7 days), increased activity time at a higher rate of activity will indicate increased physical activity.
Measured: Baseline, 16 weeks, 6 months, and 12 months
Assessment of Blood pressure
Both systolic and diastolic blood pressure will be recorded and measured for assessment.
Measured: Baseline, 16 weeks, 6 months, 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 posted16 Mar 2026
- Study start26 May 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- A feasibility and pilot study using a mixed method design with a two-arm parallel active control randomized trial and two focus groups. It is a pragmatic, real-world trial conducted in the community.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Diallo, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472712
- Sponsor's protocol ID
- HM300000239
- Other IDs
- R01DK142965
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2026
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating a Prescription Produce Program Within a Diabetes Prevention Program to Address Health Inequities Among Adults
- ClinicalTrials.gov ID
- NCT07472712
- Acronym / sponsor ID
- HM300000239
- Conditions
- Prediabetes
- Keywords
- Health Coach, Food Insecurity, Prevention Program, Diabetes Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 May 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 16 Mar 2026 (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.
Type 2 Diabetes remains a major chronic disease among adults in the United States. A way to prevent Type 2 Diabetes is to engage in a diabetes prevention program. In the diabetes prevention program, individuals at risk of Type 2 Diabetes meet with a health coach to learn effective ways to build health behaviors around diet and physical activity. Individuals who participate in the diabetes prevention program are more likely to lose weight and eat a healthy diet.
Detailed description
The diabetes prevention program does not provide support for major factors influencing Type 2 diabetes, such as food insecurity or the challenge of accessing and eating healthy food to maintain optimal health. Millions of adults who are at risk of Type diabetes face challenges such as food insecurity and access to healthcare, transportation, and housing. A prescription produce program is a community-based initiative that supports an individual who may face food insecurity to access healthy fruits and vegetables and receive health advice and resources to manage their health, including referrals for health services, housing, and transportation. This research examines whether or not a diabetes prevention program integrating a prescription produce program provides more benefits in preventing Type 2 diabetes compared to a regular diabetes prevention program. Subjects in this study may lose weight, increase their knowledge of health, and provide additional services to manage their health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A feasibility and pilot study using a mixed method design with a two-arm parallel active control randomized trial and two focus groups. It is a pragmatic, real-world trial conducted in the community.
| Arm | Type | Receives |
|---|---|---|
| Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP) | Experimental | Behavioral: Diabetes Prevention Program (DPP), Behavioral: Produce Prescription Plan (PPP)The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources. |
| Diabetes Prevention Program (DPP) only | Placebo comparator | Behavioral: Diabetes Prevention Program (DPP)All participants in this research study will participate in the Diabetes Prevention Program (DPP), which is a 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet. Additionally, all participants will be screened for social needs at regular timepoints and receive a list of available resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥age 18
- rationale: adolescents who are at-risk of T2DM may have unique needs that will not be addressed in this study
- Most recent BMI ≥ 25kg/m 2 and not pregnant
- rationale: elevated BMI is associated with higher risk of developing T2DM
- Elevated glucose as evidenced by one of the following criteria:
Key exclusion criteria (3 listed)
- Individuals with HbA1c or glucose levels above the indicated glucose ranges will be advised to see their physician and excluded from participation unless they receive physician consent to participate.
- Pregnant adults (>18 years old) will not be included in this current study because prediabetes (HbA1c levels between 5.7% - 6.4% within the last 36 months) during pregnancy presents unique physiological challenges that the study intervention does not address.
- Pregnancy status will be based on participants self-report. We will not provide any pregnancy tests prior to enrollment.
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 |
|---|---|---|
| Diabetes Prevention Program (DPP)A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet. | Behavioural | Diabetes Prevention Program (DPP) only, Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP) |
| Produce Prescription Plan (PPP)The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources. | Behavioural | Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP) |
Primary outcome
Assessment of recruitment rates
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the recruitment rates.
Assessment of enrollment rates
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the enrollment rates.
Assessment of attendance
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the attendance rates.
Assessment of retention rates
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the retention rates.
Assessment of blood glucose
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Blood glucose (hemoglobin A1c) will be recorded and measured to asses the blood glucose levels.
Assessment of weight
Time frame: Baseline, weekly for the first 16 weeks, them monthly from 5 to 12 months
Weight will be will be recorded and measured for assessment
Minutes of physical activity
Time frame: weekly for the first 16 weeks, them monthly from month 5 to 12.
average amount (in minutes) of physical activity completed
7 secondary outcomes
Assessment of food security needs
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assessment of social needs
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assessment of diet quality
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assessment of medication adherence
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assessment of wellness goals set and met
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assessment of physical activity
Time frame: Baseline, 16 weeks, 6 months, and 12 months
Assessment of Blood pressure
Time frame: Baseline, 16 weeks, 6 months, 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 9 Sep 2026.
- 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.
Ana Diallo principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Program (DPP) and Produce Prescription Plan (PPP) in people with Prediabetes, run by Virginia Commonwealth 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 15 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Sep 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. Some participants in this study may receive a placebo. 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 Ana Diallo ((804) 852-0538, dialloa@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of recruitment rates (time frame: Baseline, 16 weeks, 6 months, and 12 months). The study lists 7 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 9 Sep 2026.