Integrating a Prescription Produce Program Within a Diabetes Prevention Program (NCT07472712) | Clinical Trial Compass
RecruitingNot Applicable
Integrating a Prescription Produce Program Within a Diabetes Prevention Program
United States100 participantsStarted 2026-05-26
Plain-language 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 diet and physical activity. Individuals who participate in the diabetes prevention program are more likely to lose weight and eat a healthy diet.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥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
* 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.
Exclusion Criteria:
* Individuals with HbA1c or glucose levels above the indicated…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of recruitment rates
Timeframe: Baseline, 16 weeks, 6 months, and 12 months
2
Assessment of enrollment rates
Timeframe: Baseline, 16 weeks, 6 months, and 12 months
3
Assessment of attendance
Timeframe: Baseline, 16 weeks, 6 months, and 12 months
4
Assessment of retention rates
Timeframe: Baseline, 16 weeks, 6 months, and 12 months
5
Assessment of blood glucose
Timeframe: Baseline, 16 weeks, 6 months, and 12 months
6
Assessment of weight
Timeframe: Baseline, 16 weeks, 6 months, and 12 months