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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Mengxi Du, RD, PhD, MPH
- 電話番号:617-726-5405
- メール:mdu1@mgh.harvard.edu
研究場所
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-
Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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コンタクト:
- Mengxi Du, RD, PhD, MPH
- 電話番号:617-726-5405
- メール:mdu1@mgh.harvard.edu
-
主任研究者:
- Mengxi Du, RD, PhD, MPH
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Medically Tailored Meals (MTM)
3 prepared meals per day (i.e., breakfast, lunch, and dinner) for a total of 126 meals.
|
3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
|
|
実験的:Medically Tailored Melas (MTM) plus Fresh Produce
2 prepared meals per day (84 meals total), plus weekly fresh produce and recipes to help prepare a third meal each day.
|
2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
|
|
アクティブコンパレータ:Control group
weekly meal planning materials and recipes only; no food will be provided.
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weekly recipes and meal-planning materials only; no food will be provided.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluation of feasibility of consuming medically tailored meals through study participation
時間枠:From enrollment to the end of study, assessed at year 3 follow-up
|
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
|
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Evaluation of feasibility of consuming medically tailored meals through retention
時間枠:From enrollment to the end of study, assessed at year 3 follow-up
|
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
時間枠:From enrollment to the final visit at 8 weeks
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
MTM Impact on Diet
時間枠:From enrollment to the end of study, assessed at year 3 follow-up
|
The extent to which the MTM-based intervention improves dietary intake and food insecurity across study arms
|
From enrollment to the end of study, assessed at year 3 follow-up
|
|
MTM Impact on Patient Outcomes
時間枠:From enrollment to the end of study, assessed at year 3 follow-up
|
The extent to which the MTM-based intervention improves quality of life and patient-reported outcomes across study arms
|
From enrollment to the end of study, assessed at year 3 follow-up
|
|
Relative Composition of Gut Microbiome Features
時間枠:From enrollment to the final visit at 8 weeks
|
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.
|
From enrollment to the final visit at 8 weeks
|
|
Relative Composition of Gut Metabolites
時間枠:From enrollment to the final visit at 8 weeks
|
Comparing change in gut metabolites using deep meta'omic profiling in pre- and post- treatment samples.
|
From enrollment to the final visit at 8 weeks
|
|
Change in Stool Metabolomics
時間枠:From enrollment to the final visit at 8 weeks
|
Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.
|
From enrollment to the final visit at 8 weeks
|
|
Change in Plasma Metabolomics
時間枠:From enrollment to the final visit at 8 weeks
|
Comparing change in plasma metabolomics, using non-targeted global metabolomics analysis on blood samples to examine intensity changes in the blood metabolite profile.
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From enrollment to the final visit at 8 weeks
|
|
Longitudinal Biomarker Changes
時間枠:From enrollment to the end of study, assessed at year 3 follow-up
|
Changes in clinical biomarkers using EHR data.
|
From enrollment to the end of study, assessed at year 3 follow-up
|
|
Longitudinal Disease Progression Changes
時間枠:From enrollment to the end of study, assessed at year 3 follow-up
|
Changes in disease progression outcomes using EHR data.
|
From enrollment to the end of study, assessed at year 3 follow-up
|
協力者と研究者
捜査官
- 主任研究者:Mengxi Du, RD, PhD, MPH、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 26-210
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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