Type 2 Diabetes (T2D) Clinical Trials

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Integrating a Prescription Produce Program Within a Diabetes Prevention Program to Address Health Inequities Among Adults

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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.

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Ana Diallo
dialloa@vcu.edu
(804) 852-0538
Time Frame
Start Date: 2026-05-26
Estimated Completion Date: 2028-05
Participants
Target number of participants: 100
Treatments
Experimental: Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP)
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.
Placebo_comparator: Diabetes Prevention Program (DPP) only
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Virginia Commonwealth University

This content was sourced from clinicaltrials.gov