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Behavioral Intervention

Produce Prescription for Chronic Kidney Disease

N/A
Waitlist Available
Led By Sarah Schrauben, MD, MSCE
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age 18 years or greater
* Lives within 5 miles of Philadelphia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed via survey at baseline, 3 months, and 6 months.
Awards & highlights

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).

Who is the study for?
This trial is for adults with moderate to severe chronic kidney disease (stages 3-5) who don't have enough access to food. They should be willing to complete surveys and health measurements during the study. People with other significant health issues that could interfere with the study or those unable to follow its procedures may not qualify.
What is being tested?
The trial is testing a 'produce prescription' where participants get vouchers for free produce based on family size, every two weeks for six months. The aim is to see if this improves their diet, quality of life, and specific health markers like blood pressure and kidney function compared to a control group not receiving these vouchers.
What are the potential side effects?
Since this intervention involves providing fresh produce, there are no direct medical side effects expected from participating in this trial. However, changes in diet can sometimes cause digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed via survey at baseline, 3 months, and 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed via survey at baseline, 3 months, and 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in food insecurity category
Change in fruit and vegetable consumption
Change in nutritional security sore
Secondary study objectives
Change in anxiety category
Change in depression category
Change in kidney disease quality of life

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Produce PrescriptionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,043 Previous Clinical Trials
42,889,527 Total Patients Enrolled
Sarah Schrauben, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
107 Total Patients Enrolled
Eliza Kinsey, PhD, MPHPrincipal InvestigatorUniversity of Pennsylvania
~67 spots leftby Sep 2025