Integrating a Prescription Produce Program Within a Diabetes Prevention Program

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type2diabetes
• Intervention / Treatment: Behavioral: Diabetes Prevention Program (DPP); Behavioral: Produce Prescription Plan (PPP)

Detailed Description

The diabetes prevention program does not provide support for major factors influencing Type 2 diabetes, such as food insecurity or the challenge of accessing and eating healthy food to maintain optimal health. Millions of adults who are at risk of Type diabetes face challenges such as food insecurity and access to healthcare, transportation, and housing. A prescription produce program is a community-based initiative that supports an individual who may face food insecurity to access healthy fruits and vegetables and receive health advice and resources to manage their health, including referrals for health services, housing, and transportation. This research examines whether or not a diabetes prevention program integrating a prescription produce program provides more benefits in preventing Type 2 diabetes compared to a regular diabetes prevention program. Subjects in this study may lose weight, increase their knowledge of health, and provide additional services to manage their health.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Diallo; Phone Number: (804) 852-0538; Email: dialloa@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Ana Diallo; Phone Number: 804-828-3432; Email: dialloa@vcu.edu
      • Principal Investigator: Ana Diallo, PhD, MPH, BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Diabetes Prevention Program (DPP); A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.; Behavioral: 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.
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.	Behavioral: Diabetes Prevention Program (DPP); A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of food security needs	Using the Brief Social Needs evaluation to assess the participants food security needs using the Brief social needs including 2-item food security .	Baseline, 16 weeks, 6 months, and 12 months
Assessment of social needs	Using the American Academic of Family Physician Social Needs Screening form to assess the participants social needs. This assessment is a set of validated questions designed to help healthcare providers identify and address social determinants of health. Underlined answers generally indicate a positive response for a social need. For the Personal Safety section, a total numerical value greater than 10 indicates a positive screen.	Baseline, 16 weeks, 6 months, and 12 months
Assessment of diet quality	Using the Healthy Eating Index derived from DietID™,an assessment tool capturing dietary intake through innovative Diet Quality Photo Navigation (DQPN®) to assess the participants diet quality. The Diet ID scoring system provides a diet quality score on a 1-10 scale. A Diet ID score of 10 represents the highest quality (HEI 90-100), while a score of 1 represents the lowest.	Baseline, 16 weeks, 6 months, and 12 months
Assessment of medication adherence	Medication adherence will be recorded and measured for assessment	Baseline, 16 weeks, 6 months, and 12 months
Assessment of wellness goals set and met	Wellness goals set and met will be recorded and measured for assessment	Baseline, 16 weeks, 6 months, and 12 months
Assessment of physical activity	Physical activity will be recorded and measured for assessment using International Physical Activity Questionnaire (IPAQ) measures time spent sitting, light, moderate, and vigorous activity over a set period (e.g., past 7 days), increased activity time at a higher rate of activity will indicate increased physical activity.	Baseline, 16 weeks, 6 months, and 12 months
Assessment of Blood pressure	Both systolic and diastolic blood pressure will be recorded and measured for assessment.	Baseline, 16 weeks, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ana Diallo, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Food Insecurity; Health Coach; Prevention Program
• Other Study ID Numbers: HM300000239; R01DK142965 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No