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Completed

NCT Number: NCT06953336

Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant

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.

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Key information

Conditions

Food Insecurity Behavior Health Behavior Kidney Transplant Patient Satisfaction Treatment Adherence and Compliance

Age range

2 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital

San Francisco, California, 94107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Fruit and Vegetable Voucher Support Program

Other

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.

Primary outcomes

  1. Participant Satisfaction Difference

    Time frame: From enrollment to the end of treatment at 6 months

    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.

Secondary outcomes

  1. Number of participants who screen positively for food insecurity

    Time frame: From enrollment to the end of treatment at 6 months

    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.

  2. Dietary Quality Difference

    Time frame: From enrollment to the end of treatment at 6 months

    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.

  3. Number of participants who screen positively for nutrition insecurity

    Time frame: From enrollment to the end of treatment at 6 months

    Nutrition security status will be assessed using validated nutrition security questions within the pre- and post-surveys.

  4. Body mass index (BMI) Difference

    Time frame: At baseline and 6 months.

    Weight and height will be combined to report BMI in kg/m^2.

  5. Blood pressure difference

    Time frame: From enrollment to the end of treatment at 6 months

    Difference of systolic and diastolic blood pressure as measured in mmHg.

Other outcomes

  1. Serum Creatinine and GFR difference

    Time frame: From enrollment to the end of treatment at 6 months

    Kidney function assessed through serum creatinine and estimated GFR.

  2. Tacrolimus Variability (Proxy for Medication Adherence)

    Time frame: From enrollment to the end of treatment at 6 months

    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.

  3. HbA1c difference

    Time frame: From enrollment to the end of treatment at 6 months

    Glycemic control assessed by difference of HbA1c percent (%) values

  4. Serum potassium difference

    Time frame: From enrollment to the end of treatment at 6 months

    Difference on serum potassium as measured in mEq/L

  5. Serum magnesium difference

    Time frame: From enrollment to the end of treatment at 6 months

    Serum magnesium difference as measured in mg/dL.

  6. Serum bicarbonate difference

    Time frame: From enrollment to the end of treatment at 6 months

    Serum bicarbonate difference measured in CO2 content in blood in mEq/L

  7. Changes in medications

    Time frame: From enrollment to the end of treatment at 6 months

    Changes in medications such as blood rpessure mendications and supplementation

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: VITAL-KT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
Mar 11, 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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