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.
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
End-stage renal disease
Advanced heart failure
Severe cognitive impairment
Chronic pancreatitis
Crossover
Produce Gift Card and Dietary Education
BehavioralParticipants 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.
Usual Care
Other interventionParticipants 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.
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.
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
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months
Change in food insecurity score measured using the USDA 6-item Food Security Survey at baseline and at the 5 month study visit. Scores range from 0 to 6, with higher scores indicating greater food insecurity. The outcome measure is the change in food insecurity score from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 10 Months
Change in food insecurity score measured using the USDA 6-item Food Security Survey at baseline and at the 10 month study visit. Scores range from 0 to 6, with higher scores indicating greater food insecurity. The outcome measure is the change in food insecurity score from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Change in Sitting Systolic Blood Pressure from Baseline to 5 Months
Change in sitting systolic blood pressure (mmHg), measured using an automated device at baseline and at the 5 month study visit. Three readings are obtained and averaged at each visit. The outcome measure is the change in systolic blood pressure from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Change in Sitting Systolic Blood Pressure from Baseline to 10 Months
Change in sitting systolic blood pressure (mmHg), measured using an automated device at baseline and at the 10 month study visit. Three readings are obtained and averaged at each visit. The outcome measure is the change in systolic blood pressure from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Average Monthly Produce Voucher Spending per Participant
Average monthly amount spent (USD) per participant during the produce prescription intervention period, calculated from gift card redemption records.
Protocol Retention at 5 Months (Proportion of Participants)
Proportion of enrolled participants who remain actively enrolled in the study and have not withdrawn consent or been lost to follow-up at the 5-month assessment. Retention is calculated as the number of active participants divided by the total number of enrolled participants.
Protocol Retention at 10 Months (Proportion of Participants)
Proportion of enrolled participants who remain actively enrolled in the study and have not withdrawn consent or been lost to follow-up at the 10-month assessment. Retention is calculated as the number of active participants divided by the total number of enrolled participants.
Protocol adherence (Proportion of Participants)
Proportion of enrolled participants who complete all required study procedures during the 10-month study period, including attendance at scheduled study visits, completion of required laboratory assessments, and completion of required study questionnaires. Adherence is calculated as the number of participants who complete all required study procedures divided by the total number of enrolled participants.
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