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Behavioral Intervention
Produce Prescription for Chronic Kidney Disease
N/A
Waitlist Available
Led By Eliza Kinsey, PhD, MPH
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
Diagnosis of chronic kidney disease stages 3 -5
Must not have
Unable to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed via survey at baseline, 3 months, and 6 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the effects of providing produce prescriptions to adults with kidney disease who struggle with having enough food. Participants will be divided into two groups, one receiving the produce prescriptions and the other not
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 “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My kidney function is moderately to severely reduced.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to give my consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed via survey at baseline, 3 months, and 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed via survey at baseline, 3 months, and 6 months.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,078 Previous Clinical Trials
42,721,285 Total Patients Enrolled
Eliza Kinsey, PhD, MPHPrincipal InvestigatorUniversity of Pennsylvania
Sarah Schrauben, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
107 Total Patients Enrolled
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