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Completed

NCT Number: NCT06561412

Penn Produce Prescription and Chronic Kidney Disease Study

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).

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Food Insecurity Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Produce prescription

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in anxiety category

    Time frame: Assessed via survey at baseline, 3 months, and 6 months.

    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).

  2. Change in depression category

    Time frame: Assessed via survey at baseline, 3 months, and 6 months.

    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).

  3. Change in kidney disease quality of life

    Time frame: Assessed via survey at baseline, 3 months, and 6 months.

    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.

  4. Serum albumin

    Time frame: Assessed via blood draw at baseline and 6 months

    Change from baseline in serum albumin

  5. Metabolic acidosis

    Time frame: Assessed via blood draw at baseline and 6 months

    Change from baseline in bicarbonate level

  6. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Assessed at baseline and 6 months

    Change from baseline in eGFR

  7. Blood Pressure

    Time frame: Assessed at baseline and 6 months

    Change from baseline in blood pressure

  8. Hemoglobin A1c

    Time frame: Assessed at baseline and 6 months

    Change from baseline in HBA1c; only measured in participants diagnosed with diabetes mellitus

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

A Pilot Randomized Trial of a Produce Prescription Intervention to Improve Health Among Food Insecure Adults With Chronic Kidney Disease

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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