Clinical trial NCT06561412: Penn Produce Prescription and Chronic Kidney Disease Study
Official title: A Pilot Randomized Trial of a Produce Prescription Intervention to Improve Health Among Food Insecure Adults With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Renal Insufficiency, Chronic
Food Insecurity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the end of the baseline assessment, participants will be randomized using a permuted block technique with block size of 4 to either usual care (Arm 1) or to the produce prescription intervention (Arm 2).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this pilot clinical trial is to examine the feasibility, acceptability, and likely effect of a produce prescription intervention on patient-centered outcomes, health behaviors and health outcomes, among food insecure adults with chronic kidney disease stages 3 - 5.

Participants will complete surveys at three timepoints, each three months apart, and complete health measurements at two timepoints 6 months apart. Half of the participants will be randomly assigned to the treatment where they will receive produce prescriptions with amount of the vouchers depending on their reported family size, every two weeks over six months. Researchers will compare the treatment group and the control group to see if there are any improvements in patient-centered outcomes (food and nutrition insecurity, health-related quality of life, depression and anxiety) and clinical outcomes (diet quality, metabolic acidosis, serum albumin, estimated GFR, blood pressure, and HbA1C).

Detailed description: The study team will conduct a two-arm 1:1 randomized controlled trial to examine the feasibility, acceptability, and likely effect of a produce prescription intervention on patient-centered outcomes, health behaviors and health outcomes, among food insecure adults with CKD stages 3-5. The study's specific aims are:

Aim 1: Establish a community advisory board (CAB) to inform and guide the produce prescription intervention. The CAB will include patients, community members, CKD providers and relevant community partners.

Aim 2: Evaluate the effectiveness of a produce prescription intervention on clinical and patient centered outcomes in a randomized trial among (n=100) people with CKD and food insecurity. People with CKD stages 3-5 and food insecurity will be randomized to either a control or intervention group, which will receive a twice monthly produce prescription voucher to purchase fruits and vegetables at local stores for 6 months. Participants will be followed for patient-centered outcomes (food and nutrition insecurity, health-related quality of life, depression, and anxiety) and clinical outcomes (diet quality, metabolic acidosis, serum albumin, estimated GFR, blood pressure, and HbA1c). The study's hypothesis is that participants receiving the intervention will have improvements in food and nutrition security, diet quality and other patient-centered outcomes compared to the control group. The CKD clinical outcomes are exploratory and will serve as a proof-of-concept for this type of intervention in a CKD population.

Aim 3: Determine intervention acceptability and uptake and explore patient experiences with managing food insecurity and CKD. Researchers will administer surveys to eligible individuals who decline study enrollment (n=20), monitor self-report of voucher delivery and usage, and track voucher redemption rates to assess acceptability and uptake. Researchers will also conduct in-depth semi-structured interviews with participants in the intervention (n=20) and control (n=10) group to elucidate the experience of food insecurity and CKD co-management, coping strategies, and perceptions of the intervention.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or greater
* Lives within 5 miles of Philadelphia
* At least one recent clinic visit at Penn Renal Care, or one clinic visit at Penn Primary Care (earliest six months before start of recruitment)
* Positive screening of food insecurity in the electronic health record (EHR) within the prior 2 months
* Diagnosis of chronic kidney disease stages 3 -5

Exclusion Criteria:

* Does not meet all of the inclusion criteria
* Unable to provide consent
* Non-English speaker
* Cognitive impairment, per principal investigators' discretion
* Marked as "do not contact" in EMR for research studies

Primary outcomes:
measure: Change in food insecurity category
timeFrame: Assessed via survey at baseline, 3 months, and 6 months.
measure: Change in nutritional security sore
timeFrame: Assessed via survey at baseline, 3 months, and 6 months.
measure: Change in fruit and vegetable consumption
timeFrame: Assessed via survey at baseline, 3 months, and 6 months.
Secondary outcomes:
measure: Change in anxiety category
timeFrame: Assessed via survey at baseline, 3 months, and 6 months.
measure: Change in depression category
timeFrame: Assessed via survey at baseline, 3 months, and 6 months.
measure: Change in kidney disease quality of life
timeFrame: Assessed via survey at baseline, 3 months, and 6 months.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Eliza Kinsey, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Sarah Schrauben, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Nandta Mitra, PhD
role: PRINCIPAL_INVESTIGATOR
References: