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

18 Participants Needed

Trial Summary

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 data supports the effectiveness of the Fruit and Vegetable Voucher Support Program treatment for kidney transplant patients?

Research shows that fruit and vegetable voucher programs can improve diet quality and health outcomes by increasing the consumption of fruits and vegetables, especially among low-income populations. These programs have been effective in other contexts, suggesting they might also help kidney transplant patients improve their dietary habits and overall health. ^{1 2 3 4 5}

Is the Fruit and Vegetable Voucher Program safe for humans?

The studies on fruit and vegetable voucher programs, which provide produce prescriptions and nutrition education, do not report any safety concerns for participants. These programs aim to improve access to healthy foods and have been implemented in various populations without noted adverse effects. ^{1 2 6 7 8}

How does the Fruit and Vegetable Voucher Support Program treatment differ from other treatments for kidney transplant recipients?

The Fruit and Vegetable Voucher Support Program is unique because it provides financial support to kidney transplant recipients to increase their consumption of fruits and vegetables, addressing dietary barriers that can affect transplant outcomes. Unlike traditional medical treatments, this program focuses on improving diet quality to support kidney health and overall well-being. ^{3 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

Eva Glenn Lecea, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects Of Alternative Food Voucher Delivery Strategies On Nutrition Among Low-Income Adults. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators of Fruit and Vegetable Consumption in Renal Transplant Recipients, Family Members and Healthcare Professionals-A Focus Group Study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Fruit and Vegetable Intake Among Urban Low-Income US Adults Receiving a Produce Voucher in 2 Cities. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Veggie Van Pilot Study: Impact of a Mobile Produce Market for Underserved Communities on Fruit and Vegetable Access and Intake. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A VA Health Care Innovation: Healthier Kidneys Through Your Kitchen-Earlier Nutrition Intervention for Chronic Kidney Disease. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The Fruit and Veggies for Kidney Health Study: A Prospective Randomized Trial. [2023]

11. China pubmed.ncbi.nlm.nih.gov

Unfavorable dietary quality and overweight or obesity in kidney transplant recipients as judged by the Chinese diet balance index 2016 (DBI-16). [2023]

12. England pubmed.ncbi.nlm.nih.gov

Nutritional and dietary interventions to prolong renal allograft survival after kidney transplantation. [2022]