Pathway for Produce Prescriptions in Diabetes Management (PPT2D)

• ClinicalTrials.gov Identifier: NCT06058338
• Recruitment Status: Enrolling by invitation
• First Posted: September 28, 2023
• Last Update Posted: October 5, 2023
• Sponsor: Gretchen Swanson Center for Nutrition
• Collaborators: American Diabetes Association; University of Colorado, Denver; University of California, San Francisco; Children's Hospital Medical Center, Cincinnati; Lawndale Christian Health Center; Virtua Health; Parkview Hospital, Indiana; Presbyterian Healthcare Services; Market Umbrella
• Information provided by (Responsible Party): Carmen Byker Shanks, Gretchen Swanson Center for Nutrition

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Behavioral: Produce Prescription	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Multi-level Evaluation of Produce Prescription Projects on Type 2 Diabetes-related Outcomes: A Pathway to Policy Change by Addressing Social Determinants of Health
• Actual Study Start Date: May 31, 2023
• Estimated Primary Completion Date: August 30, 2024
• Estimated Study Completion Date: August 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Arm; Intervention arm participants will receive produce prescription services for a defined period of time (4-6months)	Behavioral: Produce Prescription; 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.
No Intervention: Control Arm; Control arm participants will not receive produce prescriptions but will receive standard of care services for diabetes management

Outcome Measures

Primary Outcome Measures :

1. Hemoglobin A1c [ Time Frame: Months 0,6 ]
   Participant HbA1c will be collected by point-of-care venipuncture or from lab draws in electronic medical records.

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Program cost [ Time Frame: Months 1-6 ]
   The estimated cost to operate a produce prescription program for four-to-six months as measured by clinic administrative records and staff interviews.
2. Cost-effectiveness (HbA1c -1%) [ Time Frame: Months 0-6 ]
   The cost-effectiveness of produce prescription program on a 1% decrease in HbA1c over four-to-six months as measured by clinic administrative records and staff interviews (combines outcome 1 and outcome 11).
3. Cost-effectiveness (HbA1c <7%) [ Time Frame: Months 0-6 ]
   The cost-effectiveness of produce prescription program on reducing HbA1c to <7% among participants with HbA1c >=7% as measured by clinic administrative records and staff interviews (combines outcome 1 and outcome 11).
4. Program reach [ Time Frame: Months 1-6 ]
   A process evaluation measure for the proportion of intervention group participants that received at least one produce prescription incentive as measured by clinic administrative records.
5. Dose delivered [ Time Frame: Months 1-6 ]
   A process evaluation measure for the percentage of intended intervention components delivered to participants (e.g., dollar amount and frequency of prescriptions issued) as measured by clinic administrative records.
6. Dose received [ Time Frame: Months 1-6 ]
   A process evaluation measure for the percentage of intended intervention components received by participants (e.g., number of nutrition education activities attended) as measured by clinic administrative records.
7. Fidelity [ Time Frame: Months 1-6 ]
   A process evaluation measure for how well intervention components were delivered according to plan (e.g., number of nutrition educational activities delivered compared to the number scheduled) as measured by clinic administrative records and semi-structured interviews.
8. Participant experiences [ Time Frame: Months 7-8 ]
   A process evaluation measure for participant experience with the produce prescription as measured by participant focus groups.
9. Program feasibility [ Time Frame: Months 1-2, 7-8 ]
   A process evaluation measure for the feasibility of produce prescription programs as measured by interviews with key partners.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

Chicago Botanic Gardens - Farm on Ogden

Chicago, Illinois, United States, 60623

United States, Indiana

Parkview Hospital

Fort Wayne, Indiana, United States, 46808

United States, Louisiana

Market Umbrella

New Orleans, Louisiana, United States, 70118

United States, New Jersey

Virtua Health

Marlton, New Jersey, United States, 08053

United States, New Mexico

Presbyterian Healthcare Services

Santa Fe, New Mexico, United States, 87507

Sponsors and Collaborators

Gretchen Swanson Center for Nutrition

American Diabetes Association

University of Colorado, Denver

University of California, San Francisco

Children's Hospital Medical Center, Cincinnati

Lawndale Christian Health Center

Virtua Health

Parkview Hospital, Indiana

Presbyterian Healthcare Services

Market Umbrella

Investigators

• Principal Investigator: Carmen Byker Shanks, PhD; Gretchen Swanson Center for Nutrition

More Information

• Responsible Party: Carmen Byker Shanks, Principal Research Scientist, Gretchen Swanson Center for Nutrition
• ClinicalTrials.gov Identifier: NCT06058338
• Other Study ID Numbers: 7-22-ICTSN-40
• First Posted: September 28, 2023
• Last Update Posted: October 5, 2023
• Last Verified: October 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carmen Byker Shanks, Gretchen Swanson Center for Nutrition:

Produce Prescriptions; Social Determinants of Health; Food Security

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases