Pathway for Produce Prescriptions in Diabetes Management

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Produce Prescription

• Registration Number: NCT06058338
• Lead Sponsor: Gretchen Swanson Center for Nutrition

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. diagnosed with Type 2 diabetes
2. have clinically screened positive for food insecurity and/or be income-eligible to receive Medicaid and/or SNAP-benefits
3. ≥ 18 years of age, and
4. be a patient at a participating healthcare site.

Exclusion Criteria

1. people who pregnant or nursing and
2. plans to move away during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Produce Prescription	Intervention arm participants will receive produce prescription services for a defined period of time (4-6months)

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	Months 0,6	Participant HbA1c will be collected by point-of-care venipuncture or from lab draws in electronic medical records.

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	Months 0,6	Participant BMI will be calculated from height/weight measurements from electronic medical records.
Food security	Months 0,6	Participant food security status as measured by the USDA 6-item food security survey.
Diabetes distress	Months 0,6	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
Self-efficacy	Months 0,6	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.
Blood pressure	Months 0,6	Participant systolic and diastolic blood pressure measurements will be collected from electronic medical records.
Health-related Quality of Life	Months 0,6	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
Self-reported health	Months 0,6	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
Fruit and vegetable intake	Months 0,6	Participant fruit and vegetable intake as measured by the NCI/NIH Dietary Screener Questionnaire (DSQ) 10-item fruit and vegetable module.
Program satisfaction	Month 6	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

Trial Locations

Locations (5)

Presbyterian Healthcare Services; 🇺🇸 Santa Fe, New Mexico, United States

Virtua Health; 🇺🇸 Marlton, New Jersey, United States

Parkview Hospital; 🇺🇸 Fort Wayne, Indiana, United States

Market Umbrella; 🇺🇸 New Orleans, Louisiana, United States

Chicago Botanic Gardens - Farm on Ogden; 🇺🇸 Chicago, Illinois, United States