Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P0580734 | Other Grant/Funding Number | Agency of Healthcare Research and Quality |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine and GFR difference | Kidney function assessed through serum creatinine and estimated GFR. | From enrollment to the end of treatment at 6 months |
| Tacrolimus Variability (Proxy for Medication Adherence) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Glenn Lecea, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39631447 | Background | 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. | |
| 39729540 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D005638 | Fruit |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| 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. | 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. | At baseline and 6 months. |
| Blood pressure difference | Difference of systolic and diastolic blood pressure as measured in mmHg. | From enrollment to the end of treatment at 6 months |
Tacrolimus variability will be assessed by measuring fluctuations in tacrolimus blood levels during the study period. Variability in tacrolimus levels can serve as a proxy for medication adherence in pediatric kidney transplant recipients. Stable tacrolimus levels typically reflect better adherence to prescribed medication regimens, and variability can indicate missed doses or inconsistent adherence.
| From enrollment to the end of treatment at 6 months |
| HbA1c difference | Glycemic control assessed by difference of HbA1c percent (%) values | From enrollment to the end of treatment at 6 months |
| Serum potassium difference | Difference on serum potassium as measured in mEq/L | From enrollment to the end of treatment at 6 months |
| Serum magnesium difference | Serum magnesium difference as measured in mg/dL. | From enrollment to the end of treatment at 6 months |
| Serum bicarbonate difference | Serum bicarbonate difference measured in CO2 content in blood in mEq/L | From enrollment to the end of treatment at 6 months |
| Changes in medications | Changes in medications such as blood rpessure mendications and supplementation | From enrollment to the end of treatment at 6 months |
| 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. |
| 35684128 | 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. |
| 33749765 | 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. |