Trial Summary
What is the purpose of this trial?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).
Eligibility Criteria
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.Inclusion Criteria
I am 18 years old or older.
Positive screening of food insecurity in the electronic health record (EHR) within the prior 2 months
Lives within 5 miles of Philadelphia
+2 more
Exclusion Criteria
Does not meet all of the inclusion criteria
I am unable to give my consent.
Non-English speaker
+2 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Produce PrescriptionExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor