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

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 (%) 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 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 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 (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 (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 (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 (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 (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 (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 (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 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.

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.

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.

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.

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.

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.

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, 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, 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, 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, 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 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 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 (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 (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 (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 (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 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 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 (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 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.

Average monthly amount spent (USD) per participant during the produce prescription intervention period, calculated from gift card redemption records.

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.

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.

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.