An interventional study of Fruit and Vegetable Voucher Support Program in Food Insecurity and Kidney Transplant, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 2 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
This study evaluates the effect of a six-month fruit and vegetable voucher program on satisfaction, dietary quality, and health outcomes among pediatric and young adult kidney transplant recipients experiencing food insecurity.
This is a single-arm, prospective interventional study enrolling 18 participants aged 6 to 25 years who have undergone kidney transplantation and screened positive for food insecurity within the past six months.
Participants will receive monthly fruit and vegetable vouchers for six months, distributed via Electronic Benefit Transfer (EBT) cards. The EBT cards, managed by an external partner, will be automatically reloaded monthly and be redeemable at participating retailers.
Data collection will include participant-reported satisfaction surveys post-intervention, food security and dietary quality assessments at baseline and study end, biophysical outcomes (BMI, blood pressure) from routine clinical care, laboratory markers related to kidney and nutritional health (serum potassium, phosphorus, magnesium, albumin, bicarbonate, fasting glucose or HbA1c, and creatinine/GFR), tacrolimus variability to serve as a proxy for medication adherence.
No extra clinical visits or lab draws beyond standard care are required. The findings aim to inform future strategies to address food insecurity in transplant populations.
256 studies on the registry are indexed under Patient Satisfaction; 127 are open to participants now.
This study's enrollment of 19 is below the median of 90 across 196 interventional studies indexed under Patient Satisfaction.
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Exclusion Criteria:
Participants in this arm will receive monthly food vouchers in the form of an Electronic Benefit Transfer (EBT) card, which will be mailed to their home and refilled each month for a total of 6 months. The EBT cards are provided and managed by an external community-based organization in partnership with the research team. The voucher amount is intended to supplement household food purchases and reduce food insecurity. The intervention targets pediatric and young adult kidney transplant recipients who have screened positive for food insecurity within the past 6 months. The participants will use the vouchers, and both pre- and post-intervention surveys will be administered to assess food security status and dietary quality. This supportive care intervention is designed to enhance nutritional support and promote stability during the post-transplant period.
Other: Fruit and Vegetable Voucher Support Program
Participants will receive a monthly food voucher in the form of an Electronic Benefit Transfer (EBT) card, mailed to their home and refilled each month for 6 months. The EBT cards are provided and managed by an external community-based organization in partnership with the research team. The intervention is designed to supplement household food purchases, reduce food insecurity, and support nutritional well-being among pediatric and young adult kidney transplant recipients who have recently screened positive for food insecurity. Pre- and post-intervention surveys will be used to assess food security status and dietary quality.
Participant Satisfaction Difference
Participant satisfaction with the food voucher program assessed through a survey administered by the end of the 6-month intervention period. This survey will evaluate participants' overall satisfaction with the EBT card, including the perceived impact on food security, ease of use, and the perceived value of the program.
Time frame: From enrollment to the end of treatment at 6 months
Number of participants who screen positively for food insecurity
Food security status will be assessed using a validated food security questionnaire at baseline and post-intervention. This measure will capture changes in household food access and adequacy as a result of the intervention.
Time frame: From enrollment to the end of treatment at 6 months
Dietary Quality Difference
Dietary quality will be assessed using self-reported dietary intake questions included in the pre- and post-intervention surveys. This measure will provide insight into any changes in the participants' food choices and nutritional habits due to the intervention, focusing on the amount of monthly fruit and vegetable intake.
Time frame: From enrollment to the end of treatment at 6 months
Number of participants who screen positively for nutrition insecurity
Nutrition security status will be assessed using validated nutrition security questions within the pre- and post-surveys.
Time frame: From enrollment to the end of treatment at 6 months
Body mass index (BMI) Difference
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: At baseline and 6 months.
Blood pressure difference
Difference of systolic and diastolic blood pressure as measured in mmHg.
Time frame: From enrollment to the end of treatment at 6 months
Serum Creatinine and GFR difference
Kidney function assessed through serum creatinine and estimated GFR.
Time frame: From enrollment to the end of treatment at 6 months
Tacrolimus Variability (Proxy for Medication Adherence)
Tacrolimus variability will be assessed by measuring fluctuations in tacrolimus blood levels during the study period. Variability in tacrolimus levels can serve as a proxy for medication adherence in pediatric kidney transplant recipients. Stable tacrolimus levels typically reflect better adherence to prescribed medication regimens, and variability can indicate missed doses or inconsistent adherence.
Time frame: From enrollment to the end of treatment at 6 months
HbA1c difference
Glycemic control assessed by difference of HbA1c percent (%) values
Time frame: From enrollment to the end of treatment at 6 months
Serum potassium difference
Difference on serum potassium as measured in mEq/L
Time frame: From enrollment to the end of treatment at 6 months
Serum magnesium difference
Serum magnesium difference as measured in mg/dL.
Time frame: From enrollment to the end of treatment at 6 months
Serum bicarbonate difference
Serum bicarbonate difference measured in CO2 content in blood in mEq/L
Time frame: From enrollment to the end of treatment at 6 months
Changes in medications
Changes in medications such as blood rpessure mendications and supplementation
Time frame: From enrollment to the end of treatment at 6 months
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco