Penn Produce Prescription and Chronic Kidney Disease Study
NCT Number: NCT06561412
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Renal Insufficiency, Chronic|Food Insecurity
Interventions: BEHAVIORAL: Produce Prescription
Sponsor: University of Pennsylvania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-09
Locations: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

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.

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).

Primary Outcome Measures: 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., 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., 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., Assessed via survey at baseline, 3 months, and 6 months.
Secondary Outcome Measures: 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)., 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)., 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., Assessed via survey at baseline, 3 months, and 6 months.