Clinical Trials Directory

Trials / Completed

CompletedNCT06953336

Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant

Improving Dietary Quality and Health Outcomes: A Fruit and Vegetable Voucher Program for Kidney Transplant Patients With Food Insecurity.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
2 Years – 25 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERFruit and Vegetable Voucher Support ProgramParticipants 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.

Timeline

Start date
2025-05-30
Primary completion
2026-01-20
Completion
2026-01-20
First posted
2025-05-01
Last updated
2026-03-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06953336. Inclusion in this directory is not an endorsement.