Vouchers for Improving Transplant Access to Lifestyle Nutrition - Kidney Transplant
- Conditions
- Food InsecurityKidney Transplant
- Registration Number
- NCT06953336
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 18
- 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
- Patient being on a diet consisting of only total parenteral nutrition or tube feeds.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
UCSF Benioff Children's Hospital
🇺🇸San Francisco, California, United States