Type 2 Diabetes
Conditions
Keywords
Food Insecurity
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.
Interventions
BEHAVIORALProduce Gift Card and Dietary Education
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.
OTHERUsual Care
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.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c from Baseline to 10 Months | Baseline and 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 Hemoglobin A1c from Baseline to 5 Months | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PREVENT Cardiovascular Risk Score from Baseline to 5 Months | Baseline and 5 months | Change in estimated 10-year cardiovascular risk (%) calculated using the American Heart Association PREVENT cardiovascular risk equation at baseline and at the 5-month study visit. Higher values indicate greater cardiovascular risk. The outcome measure is the change in estimated cardiovascular risk from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in PREVENT Cardiovascular Risk Score from Baseline to 10 Months | Baseline and 10 months | hange in estimated 10-year cardiovascular risk (%) calculated using the American Heart Association PREVENT cardiovascular risk equation at baseline and at the 5-month study visit. Higher values indicate greater cardiovascular risk. The outcome measure is the change in estimated cardiovascular risk from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in High-Density Lipoprotein (HDL) Cholesterol Baseline to 10 months | Baseline and 10 months | Change in high-density lipoprotein (HDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. HDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in HDL from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Triglycerides from Baseline to 5 Months | Baseline and 5 months | Change in triglycerides (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. Triglycerides are quantified using standard clinical laboratory methods. The outcome measure is the change in triglycerides 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 | Baseline and 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. |
| Change in Body Weight from Baseline to 5 Months | Baseline and 5 months | Change in body weight (kg), measured at baseline and at the 5 month study visit. Weight is measured using a calibrated scale. The outcome is the mean change in body weight between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Body Weight from Baseline to 10 Months | Baseline and 10 months | Change in body weight (kg), measured at baseline and at the 10 month study visit. Weight is measured using a calibrated scale. The outcome is the mean change in body weight between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Body Mass Index (BMI) from Baseline to 5 Months | Baseline and 5 months | Change in body mass index (kg/m²), measured at baseline and at the 5 month study visit. BMI is calculated as weight in kilograms divided by height in meters squared using measurements obtained at each visit. The outcome is the mean change in BMI between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Body Mass Index (BMI) from Baseline to 10 Months | Baseline and 10 months | Change in body mass index (kg/m²), measured at baseline and at the 10 month study visit. BMI is calculated as weight in kilograms divided by height in meters squared using measurements obtained at each visit. The outcome is the mean change in BMI between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Waist Circumference from Baseline to 5 Months | Baseline and 5 months | Change in waist circumference (cm), measured at baseline and at the 5 month study visit using a standardized measuring tape. The outcome is the mean change in waist circumference between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Sitting Systolic Blood Pressure from Baseline to 5 Months | Baseline and 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 Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months | Baseline and 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 | Baseline and 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 Healthy Eating Index (HEI) Score from Baseline to 5 Months | Baseline and 5 months | The Healthy Eating Index (HEI) score will be measured at baseline and at 5 months using a 24-hour recall of everything the participant ate and drank the previous day, collected by trained study staff. The HEI-2015 scoring method will be used, which compares the participant's diet to national dietary guidelines. The total score ranges from 0 to 100, where higher scores indicate a healthier overall diet. The outcome measure is the change in Healthy Eating Index score from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Healthy Eating Index (HEI) Score from Baseline to 10 Months | Baseline and 10 months | The Healthy Eating Index (HEI) score will be measured at baseline and at 10 months using a 24-hour recall of everything the participant ate and drank the previous day, collected by trained study staff. The HEI-2015 scoring method will be used, which compares the participant's diet to national dietary guidelines. The total score ranges from 0 to 100, where higher scores indicate a healthier overall diet. The outcome measure is the change in Healthy Eating Index score from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Daily Fruit and Vegetable Intake from Baseline to 5 Months | Baseline and 5 months | Change in mean daily fruit and vegetable intake (cups/day) from baseline and 5 months. Intake is assessed using a 24-hour dietary recall administered by a trained study team member or clinical research coordinator. The outcome measure is the change in average daily fruit and vegetable intake from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Daily Fruit and Vegetable Intake from Baseline to 10 Months | Baseline and 10 months | Change in mean daily fruit and vegetable intake (cups/day) from baseline and 10 months. Intake is assessed using a 24-hour dietary recall administered by a trained study team member or clinical research coordinator. The outcome measure is the change in average daily fruit and vegetable intake from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Anxiety Score (HADS-A) from Baseline to 5 Months | Baseline and 5 months | Change in anxiety score, measured using the HADS Anxiety subscale (0 to 21) at baseline and at the 5 month study visit. Higher scores indicate greater anxiety symptoms. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Anxiety Score (HADS-A) from Baseline to 10 Months | Baseline and 10 months | Change in anxiety score, measured using the HADS Anxiety subscale (0 to 21) at baseline and at the 10 month study visit. Higher scores indicate greater anxiety symptoms. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Depression Score (HADS-D) from Baseline to 5 Months | Baseline and 5 months | Change in depression score, measured using the HADS Depression subscale (0 to 21) at baseline and at the 5 month study visit. Higher scores indicate greater depressive symptoms. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Depression Score (HADS-D) from Baseline to 10 Months | Baseline and 10 months | Change in depression score, measured using the HADS Depression subscale (0 to 21) at baseline and at the 10 month study visit. Higher scores indicate greater depressive symptoms. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Physical Activity (IPAQ) from Baseline to 5 Months | Baseline and 5 months | Change in physical activity measured using the International Physical Activity Questionnaire (IPAQ), reported as total metabolic equivalent (MET) minutes per week. The IPAQ assesses physical activity over the past 7 days. Measurements are obtained at baseline and at the 5 month study visit. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Physical Activity (IPAQ) from Baseline to 10 Months | Baseline and 10 months | Change in physical activity measured using the International Physical Activity Questionnaire (IPAQ), reported as total metabolic equivalent (MET) minutes per week. The IPAQ assesses physical activity over the past 7 days. Measurements are obtained at baseline and at the 10 month study visit. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Total Cholesterol from Baseline to 5 Months | Baseline and 5 months | Change in total cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. Total cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in total cholesterol from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Total Cholesterol from Baseline to 10 Months | Baseline and 10 months | Change in total cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. Total cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in total cholesterol from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 5 Months | Baseline and 5 months | Change in low-density lipoprotein (LDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. LDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in LDL from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Low-Density Lipoprotein (LDL) Cholesterol Baseline to 10 months | Baseline and 10 months | Change in low-density lipoprotein (LDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. LDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in LDL from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Triglycerides Baseline to 10 months | Baseline and 10 months | Change in triglycerides (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. Triglycerides are quantified using standard clinical laboratory methods. The outcome measure is the change in triglycerides from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 5 Months | Baseline and 5 months | Change in high-density lipoprotein (HDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. HDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in HDL from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period. |
| Change in Waist Circumference from Baseline to 10 Months | Baseline and 10 months | Change in waist circumference (cm), measured at baseline and at the 10 month study visit using a standardized measuring tape. The outcome is the mean change in waist circumference between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGeorge Sokos, DO, FACC
West Virginia University Heart and Vascular Institute
Outcome results
None listed