Food InsecurityVITAL-KTNCT06953336
Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant
A study testing Fruit and Vegetable Voucher Support Program in people with Food Insecurity and Kidney Transplant, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Food Insecurity, Kidney Transplant
- What is being tested?
- Fruit and Vegetable Voucher Support Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patient being on a diet consisting of only total parenteral nutrition or tube feeds.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital
San Francisco, California, 94107
About this study
Official title: Improving Dietary Quality and Health Outcomes: A Fruit and Vegetable Voucher Program for Kidney Transplant Patients With Food Insecurity.
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.
Read the 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.
- Conditions
- Food Insecurity, Kidney Transplant
- Being tested
- Fruit and Vegetable Voucher Support Program
- Keywords
- Food Vouchers, Food Insecurity, Kidney Transplant, Dietary Quality, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit and Vegetable Voucher Support ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fruit and Vegetable Voucher Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (5)
Number of participants who screen positively for food insecurity
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.
Measured: From enrollment to the end of treatment at 6 months
Dietary Quality Difference
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.
Measured: From enrollment to the end of treatment at 6 months
Number of participants who screen positively for nutrition insecurity
Nutrition security status will be assessed using validated nutrition security questions within the pre- and post-surveys.
Measured: From enrollment to the end of treatment at 6 months
Body mass index (BMI) Difference
Weight and height will be combined to report BMI in kg/m^2.
Measured: At baseline and 6 months.
Blood pressure difference
Difference of systolic and diastolic blood pressure as measured in mmHg.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start30 May 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Eva Glenn Lecea, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953336
- Sponsor's protocol ID
- 25-43473
- Other IDs
- P0580734
- Acronym
- VITAL-KT
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39631447Twichell 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.
PubMed 39729540Ridberg 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.
PubMed 35684128Basu 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.
PubMed 33749765
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dietary Quality and Health Outcomes: A Fruit and Vegetable Voucher Program for Kidney Transplant Patients With Food Insecurity.
- ClinicalTrials.gov ID
- NCT06953336
- Acronym / sponsor ID
- VITAL-KT / 25-43473
- Conditions
- Food Insecurity, Kidney Transplant
- Keywords
- Food Vouchers, Food Insecurity, Kidney Transplant, Dietary Quality, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute
- Study start
- 30 May 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food Voucher Intervention Arm | Experimental | Other: Fruit and Vegetable Voucher Support ProgramParticipants 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 may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient being on a diet consisting of only total parenteral nutrition or tube feeds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit and Vegetable Voucher Support ProgramParticipants 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. | Other | Food Voucher Intervention Arm |
Primary outcome
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.
5 secondary outcomes
Number of participants who screen positively for food insecurity
Time frame: From enrollment to the end of treatment at 6 months
Dietary Quality Difference
Time frame: From enrollment to the end of treatment at 6 months
Number of participants who screen positively for nutrition insecurity
Time frame: From enrollment to the end of treatment at 6 months
Body mass index (BMI) Difference
Time frame: At baseline and 6 months.
Blood pressure difference
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 39631447Stein 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.
- Background: PubMed 39729540Twichell 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.
- Background: PubMed 35684128Ridberg 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.
- Background: PubMed 33749765Basu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Glenn Lecea, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit and Vegetable Voucher Support Program in people with Food Insecurity and Kidney Transplant, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction Difference (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953336, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.