Penn Produce Prescription and Chronic Kidney Disease Study

A Pilot Randomized Trial of a Produce Prescription Intervention to Improve Health Among Food Insecure Adults With Chronic Kidney Disease

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).

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic; Food Insecurity
• Intervention / Treatment: Behavioral: Produce Prescription

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will not receive the produce prescription vouchers but will still receive compensation for completing different study related tasks and will receive their usual medical care.
Experimental: Produce Prescription; Participants will receive either $40 (families of 2 members or less) or $60 (families of more than 2 members) produce vouchers every 2 weeks for 6 months, for a total of $480 or $720. They will also receive compensation for completing different study related tasks and will receive their usual medical care.	Behavioral: Produce Prescription; Participants will receive either $40 (families of 2 members or less) or $60 (families of more than 2 members) produce vouchers every 2 weeks for 6 months, for a total of $480 or $720. These vouchers are sponsored by The Food Trust.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food insecurity category	Change from baseline in food insecurity in the last 30 days as measured by USDA Household Food Security six-item short form survey. Outcome is 3 ordered categories: high or marginal food insecurity (score 0-1 on the scale), low food security (score 2 -4 on the scale), very low food security (score 5 -6 on the scale). The minimum score is 0, and the maximum score is 6.	Assessed via survey at baseline, 3 months, and 6 months.
Change in nutritional security sore	Change from baseline in nutrition security score in the last 30 days as measured by the Center for Nutrition & Health Impact Nutrition Security Scale. Outcome is continuous (scores 0-4). Higher scores indicate a higher degree of household nutritional security.	Assessed via survey at baseline, 3 months, and 6 months.
Change in fruit and vegetable consumption	Change from baseline in fruit and vegetable consumption in the last month as measured by a food frequency questionnaire. Outcomes are ordered by frequency/quantity over the time period.	Assessed via survey at baseline, 3 months, and 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety category	Change from baseline in anxiety category in the last two weeks as measured by the Primary Care Evaluation of Mental Health Disorders Patient Health Questionnaire's GAD-7 Anxiety survey. Outcome is ordered in 4 categories: minimal anxiety (score 0-4 on the scale), mild anxiety (score 5-9 on the scale), moderate anxiety (score 10-14 on the scale), severe anxiety (score 15-21 on the scale).	Assessed via survey at baseline, 3 months, and 6 months.
Change in depression category	Change from baseline in depression category in the last two weeks as measured by the Patient Health Questionnaire (PHQ-9). Outcome is ordered in 5 categories: none to minimal depression (score 0-4 on the scale), mild depression (score 5-9 on the scale), moderate depression (score 10-14 on the scale), moderately severe depression (score 15-18 on the scale), severe depression (score 20-27 on the scale).	Assessed via survey at baseline, 3 months, and 6 months.
Change in kidney disease quality of life	Change from baseline in kidney disease quality of life in the last four weeks as measured by the Kidney Disease and Quality of Life (KDQOL-36) survey. Outcome is ordered in 3 categories: above average, average, and below average, compared to others of the same age, gender, and diabetes status. The scale scores the patient from 0-100, with higher scores indicating higher health-related quality of life.	Assessed via survey at baseline, 3 months, and 6 months.
Serum albumin	Change from baseline in serum albumin	Assessed via blood draw at baseline and 6 months
Metabolic acidosis	Change from baseline in bicarbonate level	Assessed via blood draw at baseline and 6 months
Estimated Glomerular Filtration Rate (eGFR)	Change from baseline in eGFR	Assessed at baseline and 6 months
Blood Pressure	Change from baseline in blood pressure	Assessed at baseline and 6 months
Hemoglobin A1c	Change from baseline in HBA1c; only measured in participants diagnosed with diabetes mellitus	Assessed at baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Sarah Schrauben, MD, MSCE, University of Pennsylvania; Principal Investigator: Eliza Kinsey, PhD, MPH, University of Pennsylvania; Principal Investigator: Nandta Mitra, PhD, University of Pennsylvania; Principal Investigator: Stefanie Hinkle, PhD, Assistant Professor of Epidemiology, Departments of Biostatistics, Epidemiology and Informatics

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): February 21, 2026
• Study Completion (Actual): February 21, 2026

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 855783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No