Renal Insufficiency, ChronicNCT06561412
Penn Produce Prescription and Chronic Kidney Disease Study
A study testing Produce Prescription in people with Renal Insufficiency, Chronic and Food Insecurity, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Food Insecurity
- What is being tested?
- Produce Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 21 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not meet all of the inclusion criteria
- Unable to provide consent
- Non-English speaker
- Cognitive impairment, per principal investigators' discretion
- Marked as "do not contact" in EMR for research studies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Randomized Trial of a Produce Prescription Intervention to Improve Health Among Food Insecure Adults With Chronic Kidney Disease
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).
Read the detailed description
The study team will conduct a two-arm 1:1 randomized controlled trial 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 CKD stages 3-5. The study's specific aims are:
Aim 1: Establish a community advisory board (CAB) to inform and guide the produce prescription intervention. The CAB will include patients, community members, CKD providers and relevant community partners.
Aim 2: Evaluate the effectiveness of a produce prescription intervention on clinical and patient centered outcomes in a randomized trial among (n=100) people with CKD and food insecurity. People with CKD stages 3-5 and food insecurity will be randomized to either a control or intervention group, which will receive a twice monthly produce prescription voucher to purchase fruits and vegetables at local stores for 6 months. Participants will be followed for 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). The study's hypothesis is that participants receiving the intervention will have improvements in food and nutrition security, diet quality and other patient-centered outcomes compared to the control group. The CKD clinical outcomes are exploratory and will serve as a proof-of-concept for this type of intervention in a CKD population.
Aim 3: Determine intervention acceptability and uptake and explore patient experiences with managing food insecurity and CKD. Researchers will administer surveys to eligible individuals who decline study enrollment (n=20), monitor self-report of voucher delivery and usage, and track voucher redemption rates to assess acceptability and uptake. Researchers will also conduct in-depth semi-structured interviews with participants in the intervention (n=20) and control (n=10) group to elucidate the experience of food insecurity and CKD co-management, coping strategies, and perceptions of the intervention.
- Conditions
- Renal Insufficiency, Chronic, Food Insecurity
- Being tested
- Produce Prescription
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce PrescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Produce Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed via survey at baseline, 3 months, and 6 months.
Secondary outcomes (8)
Change in anxiety category
Change from baseline in anxiety category in the last two weeks as measured by the Primary Care Evaluation of Mental Health Disorders Patient Health Questionnaire's GAD-7 Anxiety survey. Outcome is ordered in 4 categories: minimal anxiety (score 0-4 on the scale), mild anxiety (score 5-9 on the scale), moderate anxiety (score 10-14 on the scale), severe anxiety (score 15-21 on the scale).
Measured: Assessed via survey at baseline, 3 months, and 6 months.
Change in depression category
Change from baseline in depression category in the last two weeks as measured by the Patient Health Questionnaire (PHQ-9). Outcome is ordered in 5 categories: none to minimal depression (score 0-4 on the scale), mild depression (score 5-9 on the scale), moderate depression (score 10-14 on the scale), moderately severe depression (score 15-18 on the scale), severe depression (score 20-27 on the scale).
Measured: Assessed via survey at baseline, 3 months, and 6 months.
Change in kidney disease quality of life
Change from baseline in kidney disease quality of life in the last four weeks as measured by the Kidney Disease and Quality of Life (KDQOL-36) survey. Outcome is ordered in 3 categories: above average, average, and below average, compared to others of the same age, gender, and diabetes status. The scale scores the patient from 0-100, with higher scores indicating higher health-related quality of life.
Measured: Assessed via survey at baseline, 3 months, and 6 months.
Serum albumin
Change from baseline in serum albumin
Measured: Assessed via blood draw at baseline and 6 months
Metabolic acidosis
Change from baseline in bicarbonate level
Measured: Assessed via blood draw at baseline and 6 months
Estimated Glomerular Filtration Rate (eGFR)
Change from baseline in eGFR
Measured: Assessed at baseline and 6 months
Blood Pressure
Change from baseline in blood pressure
Measured: Assessed at baseline and 6 months
Hemoglobin A1c
Change from baseline in HBA1c; only measured in participants diagnosed with diabetes mellitus
Measured: Assessed at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start18 Nov 2024
- Primary completion21 Feb 2026
- Study completion21 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliza Kinsey, PhD, MPH, Principal investigator, University of PennsylvaniaSarah Schrauben, MD, MSCE, Principal investigator, University of PennsylvaniaNandta Mitra, PhD, Principal investigator, University of PennsylvaniaStefanie Hinkle, PhD, Principal investigator, Assistant Professor of Epidemiology, Departments of Biostatistics, Epidemiology and Informatics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561412
- Sponsor's protocol ID
- 855783
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of a Produce Prescription Intervention to Improve Health Among Food Insecure Adults With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06561412
- Acronym / sponsor ID
- 855783
- Conditions
- Renal Insufficiency, Chronic, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 21 Feb 2026 (actual)
- Study completion
- 21 Feb 2026 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study team will conduct a two-arm 1:1 randomized controlled trial 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 CKD stages 3-5. The study's specific aims are:
Aim 1: Establish a community advisory board (CAB) to inform and guide the produce prescription intervention. The CAB will include patients, community members, CKD providers and relevant community partners.
Aim 2: Evaluate the effectiveness of a produce prescription intervention on clinical and patient centered outcomes in a randomized trial among (n=100) people with CKD and food insecurity. People with CKD stages 3-5 and food insecurity will be randomized to either a control or intervention group, which will receive a twice monthly produce prescription voucher to purchase fruits and vegetables at local stores for 6 months. Participants will be followed for 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). The study's hypothesis is that participants receiving the intervention will have improvements in food and nutrition security, diet quality and other patient-centered outcomes compared to the control group. The CKD clinical outcomes are exploratory and will serve as a proof-of-concept for this type of intervention in a CKD population.
Aim 3: Determine intervention acceptability and uptake and explore patient experiences with managing food insecurity and CKD. Researchers will administer surveys to eligible individuals who decline study enrollment (n=20), monitor self-report of voucher delivery and usage, and track voucher redemption rates to assess acceptability and uptake. Researchers will also conduct in-depth semi-structured interviews with participants in the intervention (n=20) and control (n=10) group to elucidate the experience of food insecurity and CKD co-management, coping strategies, and perceptions of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Produce PrescriptionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Does not meet all of the inclusion criteria
- Unable to provide consent
- Non-English speaker
- Cognitive impairment, per principal investigators' discretion
- Marked as "do not contact" in EMR for research studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce PrescriptionParticipants 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. | Behavioural | Produce Prescription |
Primary outcome
Change in food insecurity category
Time frame: Assessed via survey at baseline, 3 months, and 6 months.
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.
Change in nutritional security sore
Time frame: Assessed via survey at baseline, 3 months, and 6 months.
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.
Change in fruit and vegetable consumption
Time frame: Assessed via survey at baseline, 3 months, and 6 months.
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.
8 secondary outcomes
Change in anxiety category
Time frame: Assessed via survey at baseline, 3 months, and 6 months.
Change in depression category
Time frame: Assessed via survey at baseline, 3 months, and 6 months.
Change in kidney disease quality of life
Time frame: Assessed via survey at baseline, 3 months, and 6 months.
Serum albumin
Time frame: Assessed via blood draw at baseline and 6 months
Metabolic acidosis
Time frame: Assessed via blood draw at baseline and 6 months
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Assessed at baseline and 6 months
Blood Pressure
Time frame: Assessed at baseline and 6 months
Hemoglobin A1c
Time frame: Assessed at baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Renal Insufficiency, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliza Kinsey, PhD, MPH principal investigator
University of Pennsylvania
Sarah Schrauben, MD, MSCE principal investigator
University of Pennsylvania
Nandta Mitra, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Prescription in people with Renal Insufficiency, Chronic and Food Insecurity, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in food insecurity category (time frame: Assessed via survey at baseline, 3 months, and 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.