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NCT Number: NCT07472712

Integrating a Prescription Produce Program Within a Diabetes Prevention Program

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location status: Recruiting

Location contact

Ana Diallo

CONTACT

[email protected]

804-828-3432

Ana Diallo, PhD, MPH, BA

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Assessment of recruitment rates

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

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

  2. Assessment of enrollment rates

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

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

  3. Assessment of attendance

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

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

  4. Assessment of retention rates

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

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

  5. Assessment of blood glucose

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

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

  6. Assessment of weight

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

    Weight will be will be recorded and measured for assessment

Secondary outcomes

  1. Assessment of food security needs

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

    Using the Brief Social Needs evaluation to assess the participants food security needs using the Brief social needs including 2-item food security .

  2. Assessment of social needs

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

    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.

  3. Assessment of diet quality

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

    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.

  4. Assessment of medication adherence

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

    Medication adherence will be recorded and measured for assessment

  5. Assessment of wellness goals set and met

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

    Wellness goals set and met will be recorded and measured for assessment

  6. Assessment of physical activity

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

    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.

  7. Assessment of Blood pressure

    Time frame: Baseline, 16 weeks, 6 months, and 12 months

    Both systolic and diastolic blood pressure will be recorded and measured for assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Diallo

CONTACT

[email protected]

(804) 852-0538

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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