Recruiting

Diabetes Prevention Program

Sponsor:

Virginia Commonwealth University

Code:

NCT07472712

Conditions

Prediabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diabetes Prevention Program (DPP)

Produce Prescription Plan (PPP)

Study Details

Brief 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.

Conditions

Prediabetes

Study ID

NCT07472712

Start date

May 26, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Diabetes Prevention Program (DPP)

A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.

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.

Primary outcome measure

  • Assessment of recruitment rates [ Time Frame: Baseline, 16 weeks, 6 months, and 12 months ]
  • Assessment of enrollment rates [ Time Frame: Baseline, 16 weeks, 6 months, and 12 months ]
  • Assessment of attendance [ Time Frame: Baseline, 16 weeks, 6 months, and 12 months ]
  • Assessment of retention rates [ Time Frame: Baseline, 16 weeks, 6 months, and 12 months ]
  • Assessment of blood glucose [ Time Frame: Baseline, 16 weeks, 6 months, and 12 months ]
  • Assessment of weight [ Time Frame: Baseline, weekly for the first 16 weeks, them monthly from 5 to 12 months ]
  • Minutes of physical activity [ Time Frame: weekly for the first 16 weeks, them monthly from month 5 to 12. ]

Central Contacts and Locations

Central contacts

Ana Diallo

(804) 852-0538dialloa@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Ana Diallo

804-828-3432dialloa@vcu.edu

Principal Investigator:

Ana Diallo, PhD, MPH, BA

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Sep 9, 2026

Last verified

Aug, 2026

Keywords

  • Health Coach
  • Food Insecurity
  • Prevention Program
  • Diabetes Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-09-09.