Penn Produce Prescription and Chronic Kidney Disease Study

University of Pennsylvania

Status: Active, not recruiting

Conditions: Food Insecurity; Renal Insufficiency, Chronic

Treatments: Behavioral: Produce Prescription

Study type: Interventional

Funder types: Other

Identifiers

NCT06561412

855783

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Produce Prescription