Medically Tailored Meals for Kids

NCT06814795 | Recruiting

• 2 other identifiers: LCCC2427R21NR021288
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

chemotherapy-induced alterations in taste; Food insecurity; Nutrition insecurity; Household material hardship; Resource hardship; Social drivers of health disparities

Outcome Measures

Primary Outcomes (2)

• Parent-reported feasibility, acceptability, appropriateness and accessibility of MTM-Kids

  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

  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 Outcomes (7)

• Parent-reported household food insecurity

  Baseline and 12 weeks

• Parent-reported household nutrition insecurity

  Baseline and 12 weeks

• Parental role demands

  Baseline and 12 weeks

Study Arms (1)

Medically-tailored meals for children being treated for cancer with chemotherapy

EXPERIMENTAL

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

Interventions

Medically tailored meals OTHER

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

Also known as: MTM-Kids

Medically-tailored meals for children being treated for cancer with chemotherapy

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

North Carolina Basnight Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (35)

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  PMID: 40743050 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sheila J. Santacroce

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila J. Santacroce, PhD

CONTACT

(984) 974-0000; sheila.santacroce@unc.edu

Andrew Smitherman, MD

CONTACT

(984) 974-0000; andrew_smitherman@med.und.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility of study processes and the intervention

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 7, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of primary paper and for 5 years thereafter
• Access Criteria: Local Institutional Review Board (IRB)-approved application for proposed secondary analyses

Locations

US (1)