RECRUITING Not applicable ClinicalTrials.gov

Integrating a Prescription Produce Program Within a Diabetes Prevention Program

Sponsor: Virginia Commonwealth University • ClinicalTrials.gov ID: NCT07472712

Registry updated: 2026-09-09

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Description

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.

Interventions

Diabetes Prevention Program (DPP) (Behavioral)
A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.
Produce Prescription Plan (PPP) (Behavioral)
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.

Eligibility criteria

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.

Conditions

Prediabetes

Locations

Virginia Commonwealth University — Richmond, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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