Clinical trial NCT06814795: Medically Tailored Meals for Kids
Official title: Feasibility of Medically Tailored Meals for Pediatric Populations at Risk for Disparities in Serious Illness Outcomes Due to Inequities in Social Drivers of Health (MTM-Kids)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: chemotherapy-induced alterations in taste
Food insecurity
Nutrition insecurity
Household material hardship
Resource hardship
Social drivers of health disparities
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility of study processes and the intervention
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this project is to learn whether an intervention that provides households with home-delivered healthy, frozen meals tailored to illness related conditions for 12 weeks during a child's treatment for serious illness is feasible and acceptable to the child and parent mainly responsible for the child's care.

Detailed description: Food insecurity (uncertainty about having enough food for the household) and nutrition insecurity (uncertainty about access and affordability of foods that promotes health and quality of life \[QOL\]) are clinically-relevant, actionable social drivers of health (SDOH) disparities for pediatric (age 0-17.9 years) populations. Food and nutrition insecurity are especially relevant in pediatric populations vulnerable to disparities in outcomes of serious illnesses (life-threatening illnesses with taxing symptoms, treatments, and caregiving requirements). Pediatric cancer is an example. Children living in poverty with associated adverse SDOH are less likely survive either highly treatable cancers, or high-risk cancers that require regimens with costly targeted immunotherapy to optimize prospects for survival.. Poor nutrition increases risk of infection and poorer treatment tolerance, QOL, daily functioning and treatment responsiveness. Food-related insecurities may partly account for links between household poverty and poorer outcomes, and for the accelerated biological aging observed in pediatric and young adult cancer survivors. Moreover, poor eating habits developed treatment can persist into survivorship to heighten risks for secondary cardio-vascular conditions and cancers. Research on serious illness-related cost-coping suggests that parents and other primary caregivers legally and financially responsible for meeting the child's medical and day-to-day needs (hereafter "parents") may stretch food dollars by purchasing low priced, processed food with poor nutritional value. These purchasing choices contribute to household nutrition insecurity. Processed foods are also easy to prepare and thus appeal to parents who juggle time demands of complex caregiving and usual social roles. Because of chemotherapy-induced alterations in taste, these foods also appeal to young patients who crave food high in sugar and/or sodium. Parents and siblings may go without food and other essentials (needed health or dental care, prescribed medications \[insulin\], health insurance) to conserve the household's monetary assets to meet the needs of the child who is ill; these decisions heighten parent and sibling vulnerabilities to poorer health and QOL. In pediatric cancer, one approach being studied to address outcome disparities driven by food-related insecurities is to provide the household with gift cards for an online grocery delivery platform. Card amount is determined by household size and minimal cost for the Thrifty Food Plan per United States Department of Agriculture (USDA). No nutritional guidance is provided and parental time demands may limit their capacity to prepare healthy meals. To address health disparities in households experiencing food-related insecurities in the context of serious pediatric illness, holistic models that embed equity in care delivery by integrating food and nutrition interventions with state-of-the-science clinical care to address adverse SDOH are needed. Medically tailor meals (MTM) offer a Food is Medicine approach to addressing health disparities in pediatric serious illness populations. MTM comprise home-delivered meals tailored to medical needs of individuals with at risk for health disparities and barriers to preparing healthy food. In studies of adults, MTM interventions were associated with better health outcomes and less health care spending. Here, the investigators propose Medically-Tailored Meals for Kids (MTM-Kids), an extension of the MTM concept to pediatric serious illness populations for whom SDOH inequities affect outcomes, using pediatric cancer as the proof of concept. MTM-Kids account for nutritional needs, chemotherapy-induced alterations in taste, and illness-related financial burden and time demands. The purpose of the investigation is to determine feasibility of the MTM-methods and intervention for a future efficacy trial to improve food and nutrition security for children at risk for poorer outcomes due to SDOH inequities. The investigators will work with Equiti Foods, a small social enterprise that makes tasty, healthy, and culturally conscious frozen meals with start-up funding from National Institutes of Minority Health and Health Disparities. The primary research question is, "For households experiencing related insecurities, is providing healthy, frozen meals tailored to chemotherapy-induced alterations in taste feasible, appropriate and acceptable to children in active treatment for cancer and their parents?". After tailoring flavorings of the existing healthy, frozen means, the investigators will: 1. determine the feasibility, appropriateness, acceptability and accessibility of MTM-Kids; and 2. identify signals of change in food-related insecurities, cost coping, parental role demands and financial well-being. The investigation will be guided by the CONSORT extension for feasibility studies. Quantitative and qualitative feedback at multiple time points will enable rapid refinements of the MTM-Kids program and protocol for the future efficacy trial. The results will inform the potential for a future 2-group randomized efficacy trial with gift cards for an online grocery home delivery website as the likely comparator, and later cost effectiveness studies that advance our goal to extend healthcare financing models to include MTM in pediatric healthcare settings where seriously ill children receive care.

Eligibility criteria: Inclusion Criteria:

Eligible children (n=15) will:

* be under the care of The University of North Carolina at Chapel Hill School of Medicine, Department of Pediatrics, Division of Pediatric Hematology/Oncology
* have completed at least one cycle of cancer chemotherapy that included an agent known to cause alterations in taste,
* expect to undergo at least two more cycles,
* be aged 12-17.9 years
* communicate in English or Spanish.

Eligible adults (n=15) will:

* be the primary parental caregiver of a study-eligible child,
* be aged 18 years or older
* communicate in English or Spanish.

Exclusion Criteria:

* none if inclusion criteria are met

Primary outcomes:
measure: Parent-reported feasibility, acceptability, appropriateness and accessibility of MTM-Kids
timeFrame: Baseline and 12 weeks
measure: Adolescent-reported acceptability and appropriateness of MTM-Kids
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
measure: Parent-reported household food insecurity
timeFrame: Baseline and 12 weeks
measure: Parent-reported household nutrition insecurity
timeFrame: Baseline and 12 weeks
measure: Parental role demands
timeFrame: Baseline and 12 weeks
measure: Parental financial coping behaviors
timeFrame: Baseline and 12 weeks
measure: Parental financial well-being
timeFrame: Baseline and 12 weeks
measure: Adolescent chemotherapy-induced alterations in taste
timeFrame: Baseline and up to 12 weeks
measure: Adolescent-reported other chemotherapy-related symptoms
timeFrame: Baseline and up to 12 weeks
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Basnight Cancer Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sheila J. Santacroce
role: PRINCIPAL_INVESTIGATOR
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