Fruit and Vegetable Vouchers for Kidney Transplant

(VITAL-KT Trial)

Overseen By Eva M Glenn Lecea, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Parenteral nutrition, Tube feeds

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a six-month fruit and vegetable voucher program affects satisfaction, diet quality, and health in children and young adults who have had a kidney transplant and face food insecurity. Participants will receive monthly food vouchers to purchase more fruits and vegetables. The program targets children and young adults aged 2 to 25 who have had a kidney transplant and recently experienced food insecurity. Participants must receive care at the transplant center, and caregivers must join the intervention if the patient is under 18. The trial aims to support better nutrition and stability after a kidney transplant. As an unphased trial, this study offers a unique opportunity to improve diet and overall health post-transplant.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Fruit and Vegetable Voucher Support Program is safe for kidney transplant recipients?

Research has shown that fruit and vegetable vouchers are safe and easy to use. Users have reported feeling more satisfied, eating healthier, and experiencing better health. No safety issues have been identified with these vouchers. Instead, they encourage increased consumption of fruits and vegetables, which benefit health. For kidney transplant patients, a healthy diet can aid recovery and support long-term health. Thus, the voucher program is considered safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fruit and Vegetable Voucher Support Program because it addresses food insecurity among kidney transplant recipients in a unique way. Unlike standard post-transplant care, which typically focuses on medication and medical monitoring, this program provides monthly food vouchers to improve dietary quality and nutritional support. This approach targets the root of food insecurity, which can impact recovery and overall health, by supplementing household food purchases directly. By improving access to nutritious foods, the program aims to enhance patients' stability and health outcomes during the critical post-transplant period.

What evidence suggests that the Fruit and Vegetable Voucher Support Program is effective for kidney transplant recipients?

Research has shown that eating more fruits and vegetables can greatly improve health for people who have had a kidney transplant. One study found that eating more vegetables, but not necessarily more fruit, lowered the risk of developing diabetes after the transplant. This suggests that increasing vegetable intake can aid in managing health post-transplant. Good nutrition also supports recovery and helps the new kidney function well over time. In this trial, the Food Voucher Intervention Arm aims to help participants access fresh fruits and vegetables more easily, promoting better health for those who struggle to afford food after their transplant. ^{1 2 3 5 6}

Who Is on the Research Team?

Eva Glenn Lecea, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for pediatric and young adult kidney transplant recipients aged 2 to 25 who experience food insecurity. They must have screened positive for hunger recently, be receiving care at the transplant center, and if under 18, their caregivers must agree to participate.

Inclusion Criteria

Patients who have screened positive for food insecurity (FI) within the past six months, based on the Hunger Vital Sign

I am between 2 and 25 years old and have had a kidney transplant.

Caregivers of non-adult patients

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly fruit and vegetable vouchers for six months to improve dietary quality and health outcomes

6 months

No extra clinical visits beyond standard care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of dietary quality and health outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fruit and Vegetable Voucher Support Program

Trial Overview The study tests a six-month program providing vouchers for fruits and vegetables. It aims to see if this improves dietary satisfaction, quality of diet, and overall health outcomes in these patients.

How Is the Trial Designed?

Group I: Food Voucher Intervention Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

The Fruit and Vegetable Prescription Program (FVPP) in Michigan aims to improve children's diet, food security, and weight status by providing $15 prescriptions for fresh produce at pediatric clinic visits, with a total of 700 caregiver-child pairs enrolled for a two-year study.

The study will compare the effects of varying levels of exposure to the FVPP among children aged 8-16, assessing changes in their dietary habits and health outcomes, which will help determine the program's effectiveness and the necessary duration of exposure for significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. Saxe-Custack, A., Todem, D., Anthony, JC., et al.[2022]

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]

Community-based fruit and vegetable prescription programs, primarily targeting low-income, non-white females, have shown significant improvements in diet quality (94% of studies), health outcomes (83%), and food security (82%), indicating their effectiveness in promoting healthier eating habits.

Despite the positive outcomes, the considerable variation in study design and measurement techniques makes it difficult to compare the effectiveness of different program methodologies, highlighting the need for more standardized and well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. Greatorex Brooks, E., McInerney, M.[2023]

A study involving 671 low-income adults showed that providing $20 per month in fruit and vegetable vouchers for 6 months led to an overall increase in fruit and vegetable intake by 0.22 cup-equivalents per day, with a significant increase observed in Los Angeles (0.64 cup-equivalents) compared to San Francisco (0.10 cup-equivalents).

The findings suggest that fruit and vegetable vouchers are particularly beneficial for lower-income populations, indicating that flat-rate benefits may be more effective than income-scaled ones in improving nutritional intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Fruit and Vegetable Intake Among Urban Low-Income US Adults Receiving a Produce Voucher in 2 Cities. Basu, S., Akers, M., Berkowitz, SA., et al.[2022]

A low-protein, plant-based diet (0.6-0.8 g/kg/day) may help slow the decline of kidney function in transplant recipients, potentially due to reduced glomerular hyperfiltration.

High protein intake could negatively impact kidney allograft health, while diets like the Mediterranean and Dietary Approaches to Stop Hypertension show promising outcomes for kidney transplant longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional and dietary interventions to prolong renal allograft survival after kidney transplantation. Tantisattamo, E., Kalantar-Zadeh, K., Molnar, MZ.[2022]

Citations

1. withpower.com withpower.com/trial/phase-food-insecurity-4-2025-1da22

Fruit and Vegetable Vouchers for Kidney Transplant · Info ... This study evaluates the effect of a six-month fruit and vegetable voucher program on satisfaction, dietary quality, and health outcomes among pediatric and ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06953336

Vouchers for Improving Transplant Access to Lifestyle Nutrition This study evaluates the effect of a six-month fruit and vegetable voucher program on satisfaction, dietary quality, and health outcomes among ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31296643/

Fruit and Vegetable Intake and Risk of Posttransplantation ... In this study vegetable intake, but not fruit intake, was associated with lower risk of PTDM in RTRs, likely largely through beneficial ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05449496

Dietary Intervention to Improve Kidney Transplant Outcomes We have assembled an interdisciplinary team with expertise in transplant nephrology, lifestyle medicine, plant-based renal nutrition, health coaching and ...

5. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2025.14288/full

Dietary Guidelines Post Kidney Transplant: Is This the Missing ... This narrative review aims to summarise current knowledge of specific macro and micronutrients and their effect on allograft recovery and survival.

6. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/kidney-transplant

Kidney Transplant clinical trials at University of California Health This study evaluates the effect of a six-month fruit and vegetable voucher program on satisfaction, dietary quality, and health outcomes ...