Pathway for Produce Prescriptions in Diabetes Management

NCT06058338 | Unknown

• 1 other identifier: 7-22-ICTSN-40
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

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).

Conditions

Type 2 Diabetes

Keywords

Produce Prescriptions; Social Determinants of Health; Food Security

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Participant HbA1c will be collected by point-of-care venipuncture or from lab draws in electronic medical records.

  Months 0,6

Secondary Outcomes (9)

• Body Mass Index

  Months 0,6

• Blood pressure

  Months 0,6

• Fruit and vegetable intake

  Months 0,6

• Food security

  Months 0,6

• Diabetes distress

  Months 0,6

Other Outcomes (9)

• Program cost

  Months 1-6

• Cost-effectiveness (HbA1c -1%)

  Months 0-6

• Cost-effectiveness (HbA1c <7%)

  Months 0-6

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Behavioral: Produce Prescription

Control Arm

NO INTERVENTION

Control arm participants will not receive produce prescriptions but will receive standard of care services for diabetes management

Interventions

Produce Prescription BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gretchen Swanson Center for Nutrition: lead
• American Diabetes Association: collaborator
• University of Colorado, Denver: collaborator
• University of California, San Francisco: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Lawndale Christian Health Center: collaborator
• Virtua Health: collaborator
• Parkview Hospital, Indiana: collaborator
• Presbyterian Healthcare Services: collaborator
• Market Umbrella: collaborator

Study Sites (5)

Chicago Botanic Gardens - Farm on Ogden

Chicago, Illinois, 60623, United States

Location

Parkview Hospital

Fort Wayne, Indiana, 46808, United States

Location

Market Umbrella

New Orleans, Louisiana, 70118, United States

Location

Virtua Health

Marlton, New Jersey, 08053, United States

Location

Presbyterian Healthcare Services

Santa Fe, New Mexico, 87507, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Carmen Byker Shanks, PhD

  Gretchen Swanson Center for Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: May 31, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

US (5)