Integrating a Prescription Produce Program Within a Diabetes Prevention Program

NCT07472712 | Recruiting

• 2 other identifiers: HM300000239R01DK142965
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Type2diabetes

Keywords

Health Coach; Food Insecurity; Prevention Program

Outcome Measures

Primary Outcomes (6)

• Assessment of recruitment rates

  Assess feasibility and acceptability by recording and measuring the recruitment rates.

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of enrollment rates

  Assess feasibility and acceptability by recording and measuring the enrollment rates.

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of attendance

  Assess feasibility and acceptability by recording and measuring the attendance rates.

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of retention rates

  Assess feasibility and acceptability by recording and measuring the retention rates.

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of blood glucose

  Blood glucose (hemoglobin A1c) will be recorded and measured to asses the blood glucose levels.

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of weight

  Weight will be will be recorded and measured for assessment

  Baseline, 16 weeks, 6 months, and 12 months

Secondary Outcomes (7)

• Assessment of food security needs

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of social needs

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of diet quality

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of medication adherence

  Baseline, 16 weeks, 6 months, and 12 months

• Assessment of wellness goals set and met

  Baseline, 16 weeks, 6 months, and 12 months

Study Arms (2)

Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP)

EXPERIMENTAL

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.

Behavioral: Diabetes Prevention Program (DPP); Behavioral: Produce Prescription Plan (PPP)

Diabetes Prevention Program (DPP) only

PLACEBO COMPARATOR

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.

Behavioral: Diabetes Prevention Program (DPP)

Interventions

Diabetes Prevention Program (DPP) BEHAVIORAL

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

Diabetes Prevention Program (DPP) only; Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP)

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.

Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

• Ana Diallo

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Diallo

CONTACT

(804) 852-0538; dialloa@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A feasibility and pilot study using a mixed method design with a two-arm parallel active control randomized trial and two focus groups. It is a pragmatic, real-world trial conducted in the community.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)