Integrating a Produce Prescription into a Diabetes Prevention Program

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study combines a diabetes prevention program with a produce prescription plan to address food insecurity and healthy eating. Participants receive coaching, access to prescribed fruits and vegetables, and referrals to health and social services. The study aims to see if the enhanced program improves weight management, knowledge of healthy habits, and overall health outcomes compared with a standard diabetes prevention program. Eligibility focuses on adults with prediabetes, sufficient BMI, and English proficiency with a working phone for reminders. Conducted at Virginia Commonwealth University with collaboration from NIDDK, the trial assesses benefits beyond a usual DPP model by integrating food access components.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Ana Diallo — Virginia Commonwealth University
• Study coordinator: Ana Diallo
• Email: dialloa@vcu.edu
• Phone: (804) 852-0538

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.