Fruit and vegetable (FV) intake decrease the risk of type 2 diabetes (T2D) and is important for T2D management but is difficult to achieve in adequate amounts for those with a low- income. Produce Prescription (PPR) projects are an intervention aligned with the social determinants of health that help individuals with a low-income purchase FV by providing an incentive. The impacts of PPR projects on populations with T2D and a low-income is less understood. The Multi-level evaluation of Produce Prescription Projects on type 2 diabetes- related outcomes: A pathway to policy change by addressing social determinants of health study will determine the impact of PPR projects on hemo-globin A1c (HbA1c; primary outcome), fruit and vegetable intake (FVI), food security, and related behaviors among a diverse sample of PPR participants diagnosed with T2D and low-income (Aim 1), and will conduct a cost and cost-effective analysis of PPR projects (Aim 2), and a mixed methods process evaluation to understand feasibility and best practices for PPR projects for people with/at risk for T2D (Aim 3). We hypothesize that PPR participants will see greater declines in HbA1c and improvements in other health and food-related behaviors, compared to the Standard of Care. We will recruit five GusNIP PPR projects, whose healthcare partners serve patients with T2D, and who have participating and matched non-participating control populations. We will collect data at baseline and post-intervention using validated, survey modules, clinical measures, and cost data. Five types of data will be used for this project: 1.Health and healthcare utilization data from the EHR or point-of-care, 2.Participant survey data, 3.Qualitative data, 4.Program cost data (NOT human subjects), and 5.Process data (NOT human subjects). Information extracted from medical records includes HbA1c, weight, and blood pressure and will be collected at 2 time points (months 0,6), following their standard of care protocols. Staff will also extract healthcare utilization data (e.g., #primary care and #ER visits) from the EHR at each of site. Primary analyses will use an intention to treat strategy. Analysis will include a linear mixed-effect model to the HbA1c with an interaction between group and time to examine whether there is a difference in HbA1c trajectories between intervention and control groups. Similar models will be used to determine impact on each of the secondary outcomes (e.g., healthcare utilization, BMI).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
600
Produce prescriptions mitigate health and food access inequities by partnering with healthcare providers to prescribe fruits and vegetables via financial incentives to patients experiencing food insecurity, low income, and/or chronic disease(s) risk.
Chicago Botanic Gardens - Farm on Ogden
Chicago, Illinois, United States
Parkview Hospital
Fort Wayne, Indiana, United States
Market Umbrella
New Orleans, Louisiana, United States
Virtua Health
Marlton, New Jersey, United States
Presbyterian Healthcare Services
Santa Fe, New Mexico, United States
Hemoglobin A1c
Participant HbA1c will be collected by point-of-care venipuncture or from lab draws in electronic medical records.
Time frame: Months 0,6
Body Mass Index
Participant BMI will be calculated from height/weight measurements from electronic medical records.
Time frame: Months 0,6
Blood pressure
Participant systolic and diastolic blood pressure measurements will be collected from electronic medical records.
Time frame: Months 0,6
Fruit and vegetable intake
Participant fruit and vegetable intake as measured by the NCI/NIH Dietary Screener Questionnaire (DSQ) 10-item fruit and vegetable module.
Time frame: Months 0,6
Food security
Participant food security status as measured by the USDA 6-item food security survey.
Time frame: Months 0,6
Diabetes distress
Participant diabetes distress as measured by the Problem Areas in Diabetes Scale (PAID-5) using the scale of 0, not a problem, to 4, serious problem with higher scores indicating more emotional stress from living with diabetes
Time frame: Months 0,6
Health-related Quality of Life
Participant health-related quality of life as measured by the Short Form (SF)-12 module that addresses 8 domains of physical and mental health along a scale ranging from 0 to 100, with higher scores indicating better physical and mental health functioning
Time frame: Months 0,6
Self-efficacy
Participant self-efficacy for eating fruits and vegetables as measured by a single survey question using a 5 point scale from 0 to 5 with 0 indicating not at all confident and 5 indicating very confident.
Time frame: Months 0,6
Self-reported health
Participant self-reported health status as measured by a single survey question using a 5 point scale from 0 to 5 with 0 indicating poor health and 5 indicating excellent health
Time frame: Months 0,6
Program satisfaction
Participant produce prescription program satisfaction as measured by a single survey question using a 5 point scale from 0 to 5 with 0 indicating very negative satisfaction and 5 indicating very positive satisfaction
Time frame: Month 6
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