Pathway for Produce Prescriptions in Diabetes Management

Type 2 Diabetes Clinical Trial

— PPT2D  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06058338
• Other study ID #: 7-22-ICTSN-40
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2023
• Source: Gretchen Swanson Center for Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Chicago Botanic Gardens - Farm on Ogden	Chicago	Illinois
United States	Parkview Hospital	Fort Wayne	Indiana
United States	Virtua Health	Marlton	New Jersey
United States	Market Umbrella	New Orleans	Louisiana
United States	Presbyterian Healthcare Services	Santa Fe	New Mexico

Sponsors (10)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program cost	The estimated cost to operate a produce prescription program for four-to-six months as measured by clinic administrative records and staff interviews.	Months 1-6
Other	Cost-effectiveness (HbA1c -1%)	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).	Months 0-6
Other	Cost-effectiveness (HbA1c <7%)	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).	Months 0-6
Other	Program reach	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.	Months 1-6
Other	Dose delivered	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.	Months 1-6
Other	Dose received	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.	Months 1-6
Other	Fidelity	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.	Months 1-6
Other	Participant experiences	A process evaluation measure for participant experience with the produce prescription as measured by participant focus groups.	Months 7-8
Other	Program feasibility	A process evaluation measure for the feasibility of produce prescription programs as measured by interviews with key partners.	Months 1-2, 7-8
Primary	Hemoglobin A1c	Participant HbA1c will be collected by point-of-care venipuncture or from lab draws in electronic medical records.	Months 0,6
Secondary	Body Mass Index	Participant BMI will be calculated from height/weight measurements from electronic medical records.	Months 0,6
Secondary	Blood pressure	Participant systolic and diastolic blood pressure measurements will be collected from electronic medical records.	Months 0,6
Secondary	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.	Months 0,6
Secondary	Food security	Participant food security status as measured by the USDA 6-item food security survey.	Months 0,6
Secondary	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	Months 0,6
Secondary	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	Months 0,6
Secondary	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.	Months 0,6
Secondary	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	Months 0,6
Secondary	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	Month 6