Medically Tailored Meals to Reduce Ultra-processed Food Intake in Colorectal Cancer Survivors
MTM
A Pilot Medically Tailored Meal-Based Intervention to Reduce Ultra-processed Food Intake Among Patients With Stages I-III Colorectal Cancer
1 other identifier
interventional
60
1 country
1
Brief Summary
This research study is a three-arm, parallel-group randomized clinical trial that examines the feasibility and initial impact of consuming medically tailored meals to reduce intake of ultra-processed food and improve health and survival outcomes among 60 patients with stage I-III colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedStudy Start
First participant enrolled
August 10, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2028
Study Completion
Last participant's last visit for all outcomes
October 10, 2028
July 14, 2026
July 1, 2026
2 years
June 22, 2026
July 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Evaluation of feasibility of consuming medically tailored meals through study participation
Feasibility will be assessed by the following metrics: • percentage of eligible patients who enroll
From enrollment to the end of study, assessed at year 3 follow-up
Evaluation of feasibility of consuming medically tailored meals through retention
Feasibility will be assessed by the following metrics: • percentage of enrolled participants who complete study visits and outcome assessments
From enrollment to the end of study, assessed at year 3 follow-up
Evaluation of feasibility of consuming medically tailored meals through compliance
Feasibility will be assessed by the following metrics: • proportion of participants who adhere to assigned interventions, defined as consumption of provided meals and/or produce (for intervention arms), completion of at least two dietary assessments, and provision of blood, tumor tissue, and fecal samples at baseline and end of intervention
From enrollment to the final visit at 8 weeks
Secondary Outcomes (8)
MTM Impact on Diet
From enrollment to the end of study, assessed at year 3 follow-up
MTM Impact on Patient Outcomes
From enrollment to the end of study, assessed at year 3 follow-up
Relative Composition of Gut Microbiome Features
From enrollment to the final visit at 8 weeks
Relative Composition of Gut Metabolites
From enrollment to the final visit at 8 weeks
Change in Stool Metabolomics
From enrollment to the final visit at 8 weeks
- +3 more secondary outcomes
Study Arms (3)
Medically Tailored Meals (MTM)
EXPERIMENTAL3 prepared meals per day (i.e., breakfast, lunch, and dinner) for a total of 126 meals.
Medically Tailored Melas (MTM) plus Fresh Produce
EXPERIMENTAL2 prepared meals per day (84 meals total), plus weekly fresh produce and recipes to help prepare a third meal each day.
Control group
ACTIVE COMPARATORweekly meal planning materials and recipes only; no food will be provided.
Interventions
3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
weekly recipes and meal-planning materials only; no food will be provided.
Eligibility Criteria
You may qualify if:
- Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy, and radiotherapy) at least 2 months ago.
- Age ≥18 years.
- ECOG = 0 or 1
- Participants must have a high intake of UPFs, defined as meeting at least three of the following criteria, each consumed on more than or equal to 3 days per week:
- Ready-to-eat or ready-to-heat dishes, such as packaged frozen meals, prepared entrées, quick dishes, or microwaveable packaged foods;
- Sugar- or artificially sweetened beverages (e.g., soda, diet coke, sweetened teas, bubble tea, flavored instant coffee mixes), alcoholic beverages, or other commercially prepared sweetened drinks;
- Packaged snack foods, such as chips, cookies, ice cream, desserts, or other commercially prepared snack items;
- Frequent fast-food consumption, including meals or beverages purchased from fast-food or quick-service restaurants, such as McDonald's, Wendy's, KFC, Burger King, Five Guys, Chick-fil-A, Dairy Queen, etc.
- Home-cooked meals that rely primarily on pre-prepared ingredients, such as deli meats, canned fish, canned fruits and vegetables, frozen foods or ingredients, or similar products used more often than fresh produce, raw meat/seafood, or raw fruits and vegetables.
- Subjects must be able and willing to follow study procedures and instructions.
- Ability to understand and the willingness to sign a written informed consent document.
You may not qualify if:
- Participants who are receiving any other investigational agents or lifestyle/dietary interventions.
- Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
- Any prior diagnosis of invasive (i.e., excluding intramucosal cancer) gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (except non-melanoma skin) in which there has been any active treatment within the last three years.
- Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.
- Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
- Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.
- Participants who are pregnant Participants who may become pregnant or partners of those who may become pregnant while on study will receive contraception counseling. Participants or partners of those who become pregnant while participating in the study should immediately inform their doctor.
- Participants who are unwilling to make dietary changes.
- Individuals who do not have access to or are not able to participate in remote nutrition counseling and assessment sessions via Zoom or phone calls.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mengxi Du, RD, PhD, MPH
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 22, 2026
First Posted
July 14, 2026
Study Start (Estimated)
August 10, 2026
Primary Completion (Estimated)
August 10, 2028
Study Completion (Estimated)
October 10, 2028
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the MGB Innovation at PHSINNOVATIONSUPPORT@partners.org
The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Mengxi Du, RD, PhD, MPH. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.