Produce Prescription for Chronic Kidney Disease

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if providing produce vouchers, known as "Produce Prescription," can enhance the health and well-being of individuals with chronic kidney disease. It targets those experiencing food insecurity, meaning they struggle to obtain enough nutritious food. Participants will be divided into two groups: one will receive regular produce vouchers, and the other will not. Researchers will compare these groups to assess the vouchers' impact on diet quality, mood, and overall health. Individuals with chronic kidney disease who reside near Philadelphia and face challenges in accessing sufficient food may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of produce vouchers on health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on providing produce prescriptions, so you may not need to change your medication routine.

What prior data suggests that this produce prescription intervention is safe?

Research shows that programs providing vouchers for fruits and vegetables can promote healthier eating and improve conditions like diabetes and heart health. However, specific safety information for individuals with chronic kidney disease (CKD) is lacking. Generally, these programs are considered safe, as they involve incorporating more healthy foods into the diet. No reports of side effects in other health conditions suggest they are well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about the Produce Prescription for chronic kidney disease because it's a fresh approach that emphasizes lifestyle change through diet. Unlike traditional treatments like medications to control blood pressure or blood sugar, this method involves providing participants with vouchers for fresh produce, aiming to improve diet quality and potentially slow disease progression naturally. The novelty lies in empowering patients to make healthier food choices, which could have a broader impact on their overall health beyond just managing kidney function. This approach also highlights the importance of diet in disease management, offering a complementary strategy to conventional medical care.

What evidence suggests that this produce prescription might be an effective treatment for chronic kidney disease?

Research shows that prescribing fruits and vegetables to people with chronic conditions can improve their health. One study found that providing fruits and vegetables to patients with kidney issues lowered a urine marker indicating kidney health. Other studies suggest these prescriptions can enhance diet quality and help control diabetes, benefiting kidney health. Additionally, these programs often lead to better overall health and can be cost-effective. In this trial, participants in the Produce Prescription arm will receive produce vouchers, which might help manage chronic kidney disease and improve quality of life.13678

Who Is on the Research Team?

SS

Sarah Schrauben, MD, MSCE

Principal Investigator

University of Pennsylvania

NM

Nandta Mitra, PhD

Principal Investigator

University of Pennsylvania

EK

Eliza Kinsey, PhD, MPH

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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

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
See 1 more

Exclusion Criteria

Does not meet all of the inclusion criteria
I am unable to give my consent.
Non-English speaker
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive produce prescription vouchers every two weeks for six months

6 months
12 visits (virtual or in-person for voucher distribution)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
3 visits (in-person or virtual for surveys and health measurements)

What Are the Treatments Tested in This Trial?

Interventions

  • Produce Prescription
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Produce PrescriptionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Published Research Related to This Trial

In a 6-month study involving 67 chronic kidney disease (CKD) patients, a clinical pharmacist's evaluation identified 142 drug-related problems (DRPs) in 93% of participants, highlighting issues like untreated indications and incorrect dosages.
The intervention not only detected these problems but also facilitated immediate therapeutic adjustments and improved patient education, revealing that many patients were unaware of their treatment benefits and engaged in self-medication.
Identification of drug-related problems in ambulatory chronic kidney disease patients: a 6-month prospective study.Belaiche, S., Romanet, T., Allenet, B., et al.[2019]
In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.
The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.
Patient-reported and actionable safety events in CKD.Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]
In a 6-month study involving 52 Stage III-V CKD patients, the interactive voice-inquiry dial-response system (IVRDS) detected significantly more adverse safety events (54% of participants) compared to a paper diary (15%), highlighting its effectiveness in monitoring patient-reported outcomes.
The IVRDS not only identified a higher rate of clinically significant events, such as hypoglycemia, but also received positive feedback from participants, suggesting it could enhance patient safety in chronic kidney disease management.
Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis.Fink, JC., Doerfler, RM., Yoffe, MR., et al.[2023]

Citations

Produce Prescription for Chronic Kidney DiseaseIn a 6-month study involving 67 chronic kidney disease (CKD) patients, a clinical pharmacist's evaluation identified 142 drug-related problems (DRPs) in 93% of ...
Health and Economic Impacts of Implementing Produce ...Our model suggests that implementing produce prescriptions among US adults with diabetes and food insecurity would generate substantial health gains and be ...
Prescribing patterns in older people with advanced chronic ...The aim of this study was to describe longitudinal prescribing patterns of oral medications in a cohort of older people with advanced CKD in their last years ...
The Fruit and Veggies for Kidney Health StudyProviding fruits and vegetables (F&Vs) to health care system patients with elevated urine albumin-creatinine ratio (ACR) reduced ACR, slowed chronic kidney ...
Health and Economic Impact and Cost-effectiveness of ...Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic outcomes.
Appropriateness of drug prescriptions in patients with ...Patients with CKD are at increased risk of medication-related problems. It is necessary to implement measures to improve the safety in the ...
Health and Economic Impacts of Implementing Produce ...Our model suggests that implementing produce prescriptions among US adults with diabetes and food insecurity would generate substantial health gains and be ...
A systematically collated library of prescribing safety indicators ...The aim of this study was to use a systematic search of the published literature to produce a library of PSIs specific to outpatient prescribing for people ...
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