Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant

NCT06953336 | Completed

• 2 other identifiers: 25-43473P0580734
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant; Food Insecurity

Keywords

Food Vouchers; Food Insecurity; Kidney Transplant; Dietary Quality; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (5)

• Number of participants who screen positively for food insecurity

  From enrollment to the end of treatment at 6 months

• Dietary Quality Difference

  From enrollment to the end of treatment at 6 months

• Number of participants who screen positively for nutrition insecurity

  From enrollment to the end of treatment at 6 months

• Body mass index (BMI) Difference

  At baseline and 6 months.

• Blood pressure difference

  From enrollment to the end of treatment at 6 months

Other Outcomes (7)

• Serum Creatinine and GFR difference

  From enrollment to the end of treatment at 6 months

• Tacrolimus Variability (Proxy for Medication Adherence)

  From enrollment to the end of treatment at 6 months

• HbA1c difference

  From enrollment to the end of treatment at 6 months

Study Arms (1)

Food Voucher Intervention Arm

EXPERIMENTAL

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

Interventions

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.

Food Voucher Intervention Arm

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

UCSF Benioff Children's Hospital

San Francisco, California, 94107, United States

Location

Related Publications (4)

• Stein R, Finnie RKC, Harmon S, Peng Y, Pritchard C, Vecsey H, Emmons KM, Hargarten S, Simon MA, Blanck HM, Harris DM, Bellows L, Coleman-Jensen A, Fleischhacker S, Koenings MM, Odoms-Young A, Seligman HK, Grant C, Powell A; Community Preventive Services Task Force. Impact of Fruit and Vegetable Incentive Programs on Food Insecurity, Fruit and Vegetable Consumption, and Health Outcomes: A Community Guide Systematic Review. Am J Prev Med. 2025 Mar;68(3):627-637. doi: 10.1016/j.amepre.2024.11.016. Epub 2024 Dec 2.

  PMID: 39631447 BACKGROUND

• Twichell S, Hunt EAK, Ciurea R, Somers MJG; NAPRTCS investigators. Rapid Weight Gain After Pediatric Kidney Transplant and Development of Cardiometabolic Risk Factors Among Children Enrolled in the North American Pediatric Renal Trials and Collaborative Studies Cohort. Pediatr Transplant. 2025 Feb;29(1):e70005. doi: 10.1111/petr.70005.

  PMID: 39729540 BACKGROUND

• Ridberg RA, Levi R, Marpadga S, Akers M, Tancredi DJ, Seligman HK. Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality. Nutrients. 2022 Jun 1;14(11):2328. doi: 10.3390/nu14112328.

  PMID: 35684128 BACKGROUND

• Basu S, Akers M, Berkowitz SA, Josey K, Schillinger D, Seligman H. Comparison of Fruit and Vegetable Intake Among Urban Low-Income US Adults Receiving a Produce Voucher in 2 Cities. JAMA Netw Open. 2021 Mar 1;4(3):e211757. doi: 10.1001/jamanetworkopen.2021.1757.

  PMID: 33749765 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Fruit

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Eva Glenn Lecea, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 1, 2025
• Study Start: May 30, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)