Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant (VITAL-KT)

University of California San Francisco (UCSF)

Status: Invitation-only

Conditions: Kidney Transplant; Food Insecurity

Treatments: Other: Fruit and Vegetable Voucher Support Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06953336

P0580734 (Other Grant/Funding Number)

25-43473

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 2 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: Children and young adults aged 2 to 25 years who have received a kidney transplant.
• Food Insecurity: Patients who have screened positive for food insecurity (FI) within the past six months, based on the Hunger Vital Sign
• Patients who are currently receiving care at the transplant center and whose caregivers (if the patient is less than 18 years of age) are willing to participate in the intervention.
• Caregivers of non-adult patients

Exclusion criteria

• Patient being on a diet consisting of only total parenteral nutrition or tube feeds.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Food Voucher Intervention Arm

Experimental group

Description:

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.

Treatment:

Other: Fruit and Vegetable Voucher Support Program