Clinical trial NCT06953336: Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant
Official title: Improving Dietary Quality and Health Outcomes: A Fruit and Vegetable Voucher Program for Kidney Transplant Patients With Food Insecurity.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Food Insecurity
Kidney Transplant
Keywords: Food Vouchers
Food Insecurity
Kidney Transplant
Dietary Quality
Patient Satisfaction
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Patient-Centered Outcomes Research Institute
First posted: 2025-05-01
Enrollment: 18
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant Satisfaction Difference
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Number of participants who screen positively for food insecurity
timeFrame: From enrollment to the end of treatment at 6 months
measure: Dietary Quality Difference
timeFrame: From enrollment to the end of treatment at 6 months
measure: Number of participants who screen positively for nutrition insecurity
timeFrame: From enrollment to the end of treatment at 6 months
measure: Body mass index (BMI) Difference
timeFrame: At baseline and 6 months.
measure: Blood pressure difference
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
measure: Serum Creatinine and GFR difference
timeFrame: From enrollment to the end of treatment at 6 months
measure: Tacrolimus Variability (Proxy for Medication Adherence)
timeFrame: From enrollment to the end of treatment at 6 months
measure: HbA1c difference
timeFrame: From enrollment to the end of treatment at 6 months
measure: Serum potassium difference
timeFrame: From enrollment to the end of treatment at 6 months
measure: Serum magnesium difference
timeFrame: From enrollment to the end of treatment at 6 months
measure: Serum bicarbonate difference
timeFrame: From enrollment to the end of treatment at 6 months
measure: Changes in medications
timeFrame: From enrollment to the end of treatment at 6 months
Locations:
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Eva Glenn Lecea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.