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.
This research study is exploring whether medically tailored meals can help survivors with stage I-III colorectal cancer reduce their intake of ultra-processed foods and improve their health. Ultra-processed foods, such as packaged snacks, fast food, and sugary drinks, make up a large portion of many Americans' diets and have been linked to a higher risk of colorectal cancer and poorer survival. While experts recommend limiting these foods, many patients face challenges like limited time, cooking skills, or access to healthy options, making dietary changes difficult. Medically tailored meals, designed by dietitians to meet specific health needs, may offer a practical solution by making healthy eating easier and more accessible. This study will evaluate whether these meals, with or without fresh produce, can improve diet quality, support healthier gut bacteria, and reduce inflammation. Researchers will measure changes in gut health and blood markers before and after the program to better understand how diet can influence recovery and long-term outcomes for colorectal cancer survivors. This research study will last about 3 years. It includes a 2-week preparation period, a 6-week intervention with a medically tailored meals (MTM) program, 2 clinic visits (one prior to starting and one following the 6-week intervention period), 2 nutrition counseling visits with a registered dietitian (also conducted before and after the intervention), and follow-up contacts (4 weeks after the final visit and then every year for 3 years). Because it is unknown which meal plan is best, participants will be randomized to one of these 3 meal plan groups: * MTM: participants will receive 3 fully prepared, home-delivered, medically tailored meals per day for 6 weeks. * MTM plus Fresh Produce: participants will receive 2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks. * Control group: participants will receive weekly recipes and meal-planning materials only; no food will be provided.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the final visit at 8 weeks
MTM Impact on Diet
The extent to which the MTM-based intervention improves dietary intake and food insecurity across study arms
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
MTM Impact on Patient Outcomes
The extent to which the MTM-based intervention improves quality of life and patient-reported outcomes across study arms
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
Relative Composition of Gut Microbiome Features
Comparing change in gut microbiome features (species - to strain level specificity; metabolic pathways; enzymes) using deep meta'omic profiling in pre- and post- treatment samples.
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Time frame: From enrollment to the final visit at 8 weeks
Relative Composition of Gut Metabolites
Comparing change in gut metabolites using deep meta'omic profiling in pre- and post- treatment samples.
Time frame: From enrollment to the final visit at 8 weeks
Change in Stool Metabolomics
Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.
Time frame: From enrollment to the final visit at 8 weeks
Change in Plasma Metabolomics
Comparing change in plasma metabolomics, using non-targeted global metabolomics analysis on blood samples to examine intensity changes in the blood metabolite profile.
Time frame: From enrollment to the final visit at 8 weeks
Longitudinal Biomarker Changes
Changes in clinical biomarkers using EHR data.
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
Longitudinal Disease Progression Changes
Changes in disease progression outcomes using EHR data.
Time frame: From enrollment to the end of study, assessed at year 3 follow-up