Medically Tailored Meals for Kids (MTM-Kids)

January 12, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medically-tailored meals for children being treated for cancer with chemotherapy
The intervention will be 12-weeks induration, with weekly "doses" (meal deliveries) of up to 10 healthy, frozen meals per week for household use as needed, plus selected condiments for personalization.
Other: Medically tailored meals
The intervention will be 12-weeks in duration, with "doses" (meal deliveries) of up to 10 healthy, frozen meals per week for household use as needed, plus selected condiments for personalization
Other Names:
  • MTM-Kids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-reported feasibility, acceptability, appropriateness and accessibility of MTM-Kids
Time Frame: Baseline and 12 weeks
Each domain will be measured by 4-items developed by others and adapted for this study. Parents will be asked to read each item and indicate their response using 5-point scales anchored by 1=completely disagree and 5=completely aDomain scores will be calculated by summing item responses and dividing the sum by 4. Domain score range is 1-higher scores indicating better MTM program feasibility, acceptability, appropriateness and accessibility.
Baseline and 12 weeks
Adolescent-reported acceptability and appropriateness of MTM-Kids
Time Frame: Baseline and 12 weeks
Each of these two domains of feasibility will be measured using items developed and validated by others and adapted for this study. Each domain has 4-items. Adolescents will be asked to read each item and indicate their response using scales anchored by 1=completely disagree and 5=completely agree. Domain scores will be calculated by summing responses and dividing the sum by 4. Domain score range is 1-4, with higher scores indicating better acceptability appropriateness
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-reported household food insecurity
Time Frame: Baseline and 12 weeks
Measured by the 6-item Food Security Scale. Parents will be asked to indicate whether they experienced the condition during the past 3 month and, in some cases, how often. Scores will be estimated by counting the number of affirmative responses (yes, sometimes, or often); these scores can be categorized, such that 0-1=very low food insecurity, 2-4food insecurity, and 5-6=high food insecurity.
Baseline and 12 weeks
Parent-reported household nutrition insecurity
Time Frame: Baseline and 12 weeks
Measured by the 4-item Nutrition Security Scale plus 2 items from the Healthfulness Choice Scale. Parents will be use a 5-point scale, anchored by 1=never and 5=always, plus a don't know/prefer not to answer option. Scores will estimated by counting the number of affirmative responses (sometimes, often, or always); these scores can be categorized such that 0-1=very low nutrition insecurity, 2-4= low nutrition insecurity, and 5-6=high nutrition insecurity
Baseline and 12 weeks
Parental role demands
Time Frame: Baseline and 12 weeks
Measured with a set of Patient-Reported Outcome Measurement System v.2 (PROMIS v.2) items that ask about satisfaction with perceived social role performance. Parents will be asked to respond to the PROMIS items using a scale anchored by 1=not at all and 5=very much. Item responses will be summed and scored using the T-score metHigher scores indicate greater satisfaction with social role performance.
Baseline and 12 weeks
Parental financial coping behaviors
Time Frame: Baseline and 12 weeks
Measured by 7 questions from the Financial Coping Behaviors Scale currently being asked in a study of financial distress during treatment of pediatric acute lymphoblastic leukemia (ALL; ACCL20N1CD). Parents participating in MTM-Kidonly be asked about financial coping strategies with implications for the health of the adolescent or another family member. Parents will be asked to use a 3-point response scale anchored by 0=never and 2=several times) to indicate how often they used each coping behavior in the prior month. Item responses will be summed for a total score that can range from 0-14. (higher scores indicate use of more types of financial coping behaviors)
Baseline and 12 weeks
Parental financial well-being
Time Frame: Baseline and 12 weeks
Measured by the 8-item Personal Financial Well-being Scale (PFWS).The PFWS uses a 10-point response scale. Scores are calculated by summing item responses and dividing by 8. Scores can range from 1 to 10, with 1 indicating poorest wellbeing and 10 indicating highest financial wellbeing. The PFWS has undergone rigorous psychometric testing to establish validity of the latent construct, psychometric properties and norms.
Baseline and 12 weeks
Adolescent chemotherapy-induced alterations in taste
Time Frame: Baseline and up to 12 weeks
Measured by 13-items from the Chemotherapy-Induced Alterations in Taste Scale (CiTAS). Adolescents will be ask to use a 5-point scale to indicate how much the taste change bothered them this week. Scores will be calculated by summing item responses and dividing by 13 (lower scores indicate less alteration in taste).
Baseline and up to 12 weeks
Adolescent-reported other chemotherapy-related symptoms
Time Frame: Baseline and up to 12 weeks
Measured by the 15-item Symptom Screening in Pediatrics (SSPedi) tool. Adolescents will be asked to use a 5-point response scale anchored by 0 (not at all) and 4 (worst bother) to indicate how much each symptom bothered them today or yesterday Scores will be calculated by summing item responses. Scores can range from 0-60 (lower scores indicate less symptom severity)
Baseline and up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Sheila J. Santacroce, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC2427
  • R21NR021288 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request

IPD Sharing Time Frame

After publication of primary paper and for 5 years thereafter

IPD Sharing Access Criteria

Local Institutional Review Board (IRB)-approved application for proposed secondary analyses

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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