Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease

Participants in this arm will receive the culinary medicine intervention, led by a Chef-RD from UTHealth Nourish program.

The intervention includes 12 weekly, 2-3 hour sessions (in-person or virtual based on participant preference and logistics). While some sessions may take place in home to facilitate hands-on cooking instruction and skill-building, others may be conducted virtually. Virtual sessions will be designed to replicate hands-on instruction guiding participants in real-time using video conferencing tools, offering step-by-step guidance, observing technique, and providing feedback throughout the cooking process. Sessions will focus on patient-centered communication, culinary skills, meal preparation for children with ESKD, self-efficacy building, and feedback. Each family will receive a cooking kit and groceries tailored to dietary needs.

• CM intervention

Participants in this arm will receive weekly MTM renal-supportive meals from the Houston Food Bank. Renal-supportive meals suitable for pediatric patients with ESKD under medical supervision and designed with the guidelines of the National Kidney Foundation will be provided.

During the 12-week intervention, children in this arm will receive weekly delivery of 14 fully prepared, refrigerated and/or frozen meals (7 lunches, 7 dinners). They will also receive educational materials and resources to help align family meals with the child's dietary requirements, making it easier to manage meal preparation. HFB will also work with the participants to address any barriers related to delivery schedules.

Recruitment feasibility will be assessed by staff logs. Records will include number of families contacted, the number who qualified; the number who did not qualify and the reasons; and of those who qualified - number who agreed to participate; the number who did not participate and reasons; and the number who completed and return enrollment package and were enrolled.

CRITERION: recruitment goals are met (n=30 parent-child dyads). Investigators will determine if this criterion was met by comparing the number of families enrolled to the criterion.

Participation in intervention activities will be assessed through REDCap surveys. Culinary medicine (CM) participants will receive weekly text messages linking to surveys assessing session attendance, activity participation, and meal feedback. Participants receiving pre-prepared medically tailored meals (MTMs) will scan QR codes on meal boxes to complete meal-specific feedback surveys. Pre- and post-meal photographs will help estimate meal consumption and assess intervention adherence.

Criteria: CM participants will achieve ≥75% adherence to intervention activities, calculated as the average number of activities completed divided by the total activities offered, based on session logs and participant feedback. For the pre-prepared MTM group, the target is consumption of ≥70% of meals provided by the enrolled child, assessed through participant feedback and meal photographs.

Attrition rate is defined as the number of participants who did not complete the intervention (i.e. weekly CM sessions and MTMs) and all data collection activities (i.e. baseline, post intervention). It will be calculated by dividing the total number of participants who completed these activities by the total number providing informed consent.

CRITERION: overall attrition rate is <10%. Investigators will determine if this criterion was met by dividing the number of families who completed all intervention and data collection activities by the total number of families enrolled and comparing the result to the criterion.

Program satisfaction will be assessed at post intervention with a 10-item measure of satisfaction. Items will be rated using a 2-point Likert scale (no, yes). Scores can range from 10-20, with higher scores representing higher satisfaction.

CRITERION: >80% for both children and parents. Investigators will determine if this criterion was met by determining the average satisfaction score for parents and children separately and comparing the results to the criterion.

Data completeness is defined as the percentage of participants with complete self-report data at all assessment points (baseline, post intervention). These data will be obtained from the missing data in data files.

CRITERION: >80% of data are collected at baseline and post intervention. Investigators will determine if this criterion was met by calculating the number of families with complete data and comparing it to the criterion.

Post intervention interviews with parents and children will seek to obtain a better understanding of the acceptability of the intervention, participants' experiences, preferences, and challenges encountered during the program.

The EMR will be queried to obtain laboratory results including serum sodium, potassium, phosphorus, parathyroid hormone (PTH) and protein catabolic rate (nPCR) performed monthly as standard of care in the outpatient dialysis unit. Blood pressure information will be collected weekly on a day where the patient has not received hemodialysis in 48 hours (for the HD cohort). Pre and post dialysis weights would be collected weekly on day where the patient has not received hemodialysis in 48 hours (HD cohort). Dry weights would also be collected to assess fluid overload. Medication lists will be reviewed and information on number of antihypertensive medications and use of short acting anti-hypertensive medication collected. Information on phosphate binder use will also be collected.

To assess usual dietary intake, investigators will obtain two 24-hour dietary recalls (1 week day; 1 weekend day) over the telephone at each data collection (baseline, post-intervention). Investigators will obtain the dietary recalls (24hdr) by telephone on non- consecutive days at each observation. Children 8 years and older can give a reasonably accurate self-report of intake, For younger children, parent-reported dietary recalls will be conducted to ensure data validity. Dietary intake data gathered by interview is governed by a multiple-pass interview approach. Multiple 24-hour dietary recalls are considered the gold-standard for dietary assessment, and in addition to the calories and servings consumed, will allow us to compute a Healthy Eating Index (HEI-2015), a measure of diet quality. The recalls will be collected by trained staff using Nutrition Data System for Research (NDS-R, 2019 version).

Parents will complete a standard demographic survey assessing parent, child, and family characteristics at baseline. These will include: age of the child, date of birth, sex, school attendance, grade level, race, ethnicity, total number of people in the household - adults and children, language spoken at home, marital status, employment status, education, total annual household income, housing status, transportation, zip code of residence. Socio-demographic measures were obtained from the TCH EMR (age, gender, race/ethnicity). Any discrepancies in the responses will be clarified with the participant. For this study, the item assessing parent and child sex will be revised to be more gender inclusive: "What gender do you identify with (fill in response)" and "What sex was documented on your/your child's original birth certificate? (response options - male/female).

Parents will complete the 18-item USDA household food security questionnaire at baseline. It contains a series of questions about conditions and behaviors occurred at any time during the previous 12 months that characterize households when they are having difficulty meeting basic food needs. The series includes three questions about food conditions of the household, seven about food conditions of adults in the household, and an additional eight questions about children's food conditions. Participants will be categorized into food secure and food insecure depending on their responses. Food insecurity status was also obtained at baseline from the TCH EMR. TCH screens for food insecurity status system-wide using the two-item Hunger Vital Sign measures.

Parents will complete the food assistance program usage questionnaire at baseline. The questionnaire is designed to assess participation in food assistance program among individuals from low-income families using a checklist. It assesses household/adult participation in programs such as the Supplemental Nutrition Assistance Program (SNAP), Women, Infants and Children (WIC), Emergency Food Assistance Program (food bank/food panty/food kitchens), etc. For children, it assesses participation in child nutrition programs such as the National School Lunch Program (NSLP), School Breakfast Program (SBP), Summer Food Service Program (SFSP), etc.

Parents will complete the Fulkerson et al, home food inventory [DJM7.1]at baseline and post assessment. The 51-item measure extends previous work and includes healthful and less healthful food items grouped into 13 major food groups and 2 categories of ready-access foods. Parents complete the checklist as they view all food storage areas in their home (e.g., pantry, refrigerator, freezer, etc) using a yes (1 point) /no (0 points) format. They are also asked to identify form of the food (i.e., fresh, frozen, canned, dried) for fruits, vegetables, and breads. Scores are summed, with higher scores indicating greater availability. The inventory has demonstrated criterion (Cohen's Kappa statistics ranging from 0.61 - 0.83) and construct validity (Spearman's correlation between staff and participant report >0.70). For this study, the food groups of interest are fruits, vegetables, and whole grains.

A survey instrument will be used to assess the availability of some appliances and common kitchen tools in the household.

These will be measured using 10 items from a previously validated survey, e.g., "How often do you compare prices before you buy food?". Response options (1-5): never to always. All items will be assessed individually.

Chronic kidney disease knowledge test will be used to assess nutrition knowledge. The test includes seven questions to assess patient's understanding of their dietary restrictions respective to ESKD. Correct responses will summed into a continuous variable ranging from 0 to 7 with higher scores denoting better knowledge of disease-specific dietary restrictions.

This will be measured using previously validated scale of 5 items, e.g., "Before this program how sure were you that you could use basic cooking techniques (e.g., microwaving, sautéing, roasting)". Response options (0-4): not at all sure to extremely sure. Items will be assessed individually and as a summative scale.

The Perceived Support subscale of the Inventory of Social Reliance (ISR) will be used to measure perceived support. This subscale contains 5 items, with higher scores indicating a higher level of perceived support (Cronbach's α = 0.89).

This will be assessed using the subscales of control beliefs (six items) and perceived power (five items). A 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) will be used. The score of each subscale will be obtained by the average computed as the sum of items of it.