Penn Produce Prescription and Chronic Kidney Disease Study

NCT06561412 | Completed

• 1 other identifier: 855783
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Insufficiency, Chronic; Food Insecurity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Change in anxiety category

  Assessed via survey at baseline, 3 months, and 6 months.

• Change in depression category

  Assessed via survey at baseline, 3 months, and 6 months.

• Change in kidney disease quality of life

  Assessed via survey at baseline, 3 months, and 6 months.

• Serum albumin

  Assessed via blood draw at baseline and 6 months

• Metabolic acidosis

  Assessed via blood draw at baseline and 6 months

Study Arms (2)

Control

NO INTERVENTION

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.

Produce Prescription

EXPERIMENTAL

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

Interventions

Produce Prescription BEHAVIORAL

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.

Produce Prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide consent
• Non-English speaker
• Cognitive impairment, per principal investigators' discretion
• Marked as "do not contact" in EMR for research studies

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eliza Kinsey, PhD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Sarah Schrauben, MD, MSCE

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 20, 2024
• Study Start: November 18, 2024
• Primary Completion: February 21, 2026
• Study Completion: February 21, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)