Clinical trial NCT06058338: Pathway for Produce Prescriptions in Diabetes Management
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Produce Prescriptions
Social Determinants of Health
Food Security
Lead sponsor: Gretchen Swanson Center for Nutrition
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
name: University of Colorado, Denver
name: University of California, San Francisco
name: Children's Hospital Medical Center, Cincinnati
name: Lawndale Christian Health Center
name: Virtua Health
name: Parkview Hospital, Indiana
name: Presbyterian Healthcare Services
name: Market Umbrella
First posted: 2023-09-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility 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.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Months 0,6
Secondary outcomes:
measure: Body Mass Index
timeFrame: Months 0,6
measure: Blood pressure
timeFrame: Months 0,6
measure: Fruit and vegetable intake
timeFrame: Months 0,6
measure: Food security
timeFrame: Months 0,6
measure: Diabetes distress
timeFrame: Months 0,6
measure: Health-related Quality of Life
timeFrame: Months 0,6
measure: Self-efficacy
timeFrame: Months 0,6
measure: Self-reported health
timeFrame: Months 0,6
measure: Program satisfaction
timeFrame: Month 6
Other outcomes:
measure: Program cost
timeFrame: Months 1-6
measure: Cost-effectiveness (HbA1c -1%)
timeFrame: Months 0-6
measure: Cost-effectiveness (HbA1c <7%)
timeFrame: Months 0-6
measure: Program reach
timeFrame: Months 1-6
measure: Dose delivered
timeFrame: Months 1-6
measure: Dose received
timeFrame: Months 1-6
measure: Fidelity
timeFrame: Months 1-6
measure: Participant experiences
timeFrame: Months 7-8
measure: Program feasibility
timeFrame: Months 1-2, 7-8
Locations:
city: Chicago
country: United States
facility: Chicago Botanic Gardens - Farm on Ogden
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: New Orleans
country: United States
facility: Market Umbrella
state: Louisiana
city: Marlton
country: United States
facility: Virtua Health
state: New Jersey
city: Santa Fe
country: United States
facility: Presbyterian Healthcare Services
state: New Mexico
Study officials:
affiliation: Gretchen Swanson Center for Nutrition
name: Carmen Byker Shanks, PhD
role: PRINCIPAL_INVESTIGATOR
References: