Food Insecurity, Kidney Transplant
Conditions
Keywords
Food Vouchers, Food Insecurity, Kidney Transplant, Dietary Quality, Patient Satisfaction
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.
Interventions
OTHERFruit and Vegetable Voucher Support Program
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.
Sponsors
University of California, San Francisco
Agency for Healthcare Research and Quality (AHRQ)
Patient-Centered Outcomes Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction Difference | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who screen positively for food insecurity | From enrollment to the end of treatment at 6 months | 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. |
| Dietary Quality Difference | From enrollment to the end of treatment at 6 months | 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. |
| Number of participants who screen positively for nutrition insecurity | From enrollment to the end of treatment at 6 months | Nutrition security status will be assessed using validated nutrition security questions within the pre- and post-surveys. |
| Body mass index (BMI) Difference | At baseline and 6 months. | Weight and height will be combined to report BMI in kg/m\^2. |
| Blood pressure difference | From enrollment to the end of treatment at 6 months | Difference of systolic and diastolic blood pressure as measured in mmHg. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREva Glenn Lecea, MD
University of California, San Francisco
Outcome results
None listed