Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity

NCT07674979 | Not Yet Recruiting

• 1 other identifier: STUDY00000327
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing whether providing monthly vouchers to buy fruits and vegetables can help improve blood sugar control in adults with type 2 diabetes. People receiving care at WVU clinics who recently had an HbA1c level above 8% will be invited to participate in the study. Those who are interested will speak with a study coordinator, be screened for eligibility, and, if eligible, will provide written consent to join the study. Participants will be randomly assigned to one of two groups. One group will receive $100 per month in produce-only grocery vouchers and standardized dietary education for 5 months, followed by 5 months of usual diabetes care. The second group will receive usual diabetes care first for 5 months, followed by 5 months of produce-only grocery vouchers and standardized dietary education. This crossover design allows all participants to experience both approaches during the study. Researchers will measure changes in blood sugar (HbA1c) as the main outcome. Other outcomes include blood pressure, cholesterol levels, body weight, diet quality, food security, anxiety symptoms, depressive symptoms, and physical activity. These will be assessed through lab tests, clinic measurements, and surveys at certain time points during the 10 month study period. The study team will also track how often participants use the vouchers and any challenges they face. The risks of participating are expected to be minimal and similar to routine diabetes care. The total study duration, including enrollment, participation, and analysis, is expected to be about 18 months.

Conditions

Type 2 Diabetes

Keywords

Food Insecurity

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin A1c from Baseline to 5 Months

  Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 5-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.

  Baseline and 5 months

• Change in Hemoglobin A1c from Baseline to 10 Months

  Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 10-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period

  Baseline and 10 months

Secondary Outcomes (30)

• Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months

  Baseline and 5 months

• Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 10 Months

  Baseline and 10 months

• Change in Sitting Systolic Blood Pressure from Baseline to 5 Months

  Baseline and 5 months

• Change in Sitting Systolic Blood Pressure from Baseline to 10 Months

  Baseline and 10 months

• Change in Body Weight from Baseline to 5 Months

  Baseline and 5 months

Other Outcomes (4)

• Average Monthly Produce Voucher Spending per Participant

  10 months

• Protocol Retention at 5 Months (Proportion of Participants)

  5 months

• Protocol Retention at 10 Months (Proportion of Participants)

  10 months

Study Arms (2)

Produce Gift Card to Usual Care

EXPERIMENTAL

Participants are randomized to receive the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for 5 months, followed by crossover to usual care for an additional 5 months.

Behavioral: Produce Gift Card and Dietary Education; Other: Usual Care

Usual Care to Produce Gift Card

EXPERIMENTAL

Participants are randomized to receive usual care for 5 months, followed by crossover to the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for an additional 5 months.

Behavioral: Produce Gift Card and Dietary Education; Other: Usual Care

Interventions

Usual Care OTHER

Participants receive standard clinical care for management of type 2 diabetes. No study-provided produce vouchers or study-provided dietary education are provided during this period.

Produce Gift Card to Usual Care; Usual Care to Produce Gift Card

Produce Gift Card and Dietary Education BEHAVIORAL

Participants receive $100 per month in Walmart gift cards restricted to the purchase of fruits and vegetables. Gift cards are provided monthly during the intervention period and usage is tracked using participant-specific access codes. Participants also receive standardized dietary education consistent with current clinical guidelines, delivered by study personnel during the intervention period only.

Produce Gift Card to Usual Care; Usual Care to Produce Gift Card

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 2 diabetes mellitus
• Most recent HbA1c \>8% within the prior 6 months
• Must have had a clinic visit within the past 6 months
• Positive screening for food insecurity based on the USDA 6-item food security survey
• Receiving care through WVU cardiometabolic, endocrinology, or primary care clinics
• Able and willing to provide written informed consent

You may not qualify if:

• End-stage renal disease
• Advanced heart failure
• Severe cognitive impairment
• Chronic pancreatitis
• Pancreatic malignancy
• Pregnancy at time of enrollment
• Anticipated inability to utilize intervention vouchers (e.g., lack of access to Walmart)

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Heart and Vascular Institute

Morgantown, West Virginia, 26506, United States

Location

Related Publications (4)

• Panizza CE, Shvetsov YB, Harmon BE, Wilkens LR, Le Marchand L, Haiman C, Reedy J, Boushey CJ. Testing the Predictive Validity of the Healthy Eating Index-2015 in the Multiethnic Cohort: Is the Score Associated with a Reduced Risk of All-Cause and Cause-Specific Mortality? Nutrients. 2018 Apr 5;10(4):452. doi: 10.3390/nu10040452.

  PMID: 29621192 BACKGROUND

• Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

  PMID: 11832252 BACKGROUND

• Seligman HK, Angell SY, Berkowitz SA, Elkind MSV, Hager K, Moise N, Posner H, Muse J, Odoms-Young A, Ridberg R, Troxel AB, Yaroch AL, Volpp KG. A Systematic Review of "Food Is Medicine" Randomized Controlled Trials for Noncommunicable Disease in the United States: A Scientific Statement From the American Heart Association. Circulation. 2025 Jul 29;152(4):e32-e46. doi: 10.1161/CIR.0000000000001343. Epub 2025 Jun 18.

  PMID: 40528749 BACKGROUND

• Mozaffarian D, Aspry KE, Garfield K, Kris-Etherton P, Seligman H, Velarde GP, Williams K, Yang E; ACC Prevention of Cardiovascular Disease Section Nutrition and Lifestyle Working Group and Disparities of Care Working Group. "Food Is Medicine" Strategies for Nutrition Security and Cardiometabolic Health Equity: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024 Feb 27;83(8):843-864. doi: 10.1016/j.jacc.2023.12.023.

  PMID: 38383100 BACKGROUND

Related Links

• USDA 6-item food insecurity survey
• International Physical Activity Questionnaire scoring

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• George Sokos, DO, FACC

  West Virginia University Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Ahmad, MD

CONTACT

304-598-4850; syed.ahmad@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Medical Director, Non-Invasive Cardiology, Advanced Heart Failure, Pulmonary Hypertension, Cardiac Transplant

Model Details: This is a randomized crossover study in which participants are assigned to one of two sequences: a produce prescription intervention consisting of fruit and vegetable vouchers plus standardized dietary education for 5 months followed by usual care for 5 months, or usual care for 5 months followed by the produce prescription intervention for 5 months. Outcomes are assessed at baseline, 5 months, and 10 months. Analyses compare outcomes during intervention and usual care periods while accounting for treatment sequence and study period.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available, upon reasonable request, starting 6 months after the manuscript is published in a scientific peer-reviewed journal. This will be available for other researchers for up to one year.
• Access Criteria: Criteria include ethical use of data, appropriate citation of source of data (such as study team, grant, etc.), clear plan for use of data, and transparency in use of data. Those requesting access must provide proof of affiliation to United States-based academic institution or clinical facility.

Locations

US (1)