Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer (METS)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity intervention
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Gut Microbiota, Butyrate, Physical activity
Eligibility Criteria
Inclusion Criteria:
- Fluent in English or Spanish;
- At high risk of developing colorectal cancer;
- No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
- No use of antibiotics in the previous 3 months; or current regular use of antibiotics
- Access to either smart phone or computer; and
- Currently physically inactive.
Exclusion Criteria:
Any criterion not met under inclusion.
Sites / Locations
- Columbia University Irving Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physical activity intervention
Arm Description
Subjects at higher risk of developing colorectal cancer will maintain the current level of activity during the first 4 weeks and exercise 150 minutes per week during the last 4 weeks. During the entire study, subjects will wear a Fitbit device on their wrist.
Outcomes
Primary Outcome Measures
Percentage of participants retained at the end of study
To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial
Secondary Outcome Measures
Percentage of participants with collected, processed, and analyzed stool samples
To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02780284
Brief Title
Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer
Acronym
METS
Official Title
Gut Microbiota, Butyrate, Inflammation and Physical Activity: A Pilot Study Among Individuals at High Risk for Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study has 2 aims:
Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial. Investigators hypothesize that it will be possible to recruit and retain this patient population to a physical activity intervention trial.
Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing the gut microbiome data. Investigators hypothesize that all of these steps are feasible.
Detailed Description
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. and is the third most common cancer in men and women. CRC risk factors include genetic predisposition, host factors and modifiable lifestyle behaviors (e.g., diet, physical activity, obesity). There are very limited data on the differences in the gut microbiota among populations at different levels of CRC risk, as well as the effects of behavioral interventions to alter the gut microbiome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Gut Microbiota, Butyrate, Physical activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical activity intervention
Arm Type
Experimental
Arm Description
Subjects at higher risk of developing colorectal cancer will maintain the current level of activity during the first 4 weeks and exercise 150 minutes per week during the last 4 weeks. During the entire study, subjects will wear a Fitbit device on their wrist.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention
Intervention Description
150 minutes per week of moderate intensity cardiovascular exercise. The exercise sessions will include a minimum of 30 minutes of exercise each day, 3 to 5 times per week for a total of 150 minutes of exercise per week.
Primary Outcome Measure Information:
Title
Percentage of participants retained at the end of study
Description
To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percentage of participants with collected, processed, and analyzed stool samples
Description
To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fluent in English or Spanish;
At high risk of developing colorectal cancer;
No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
No use of antibiotics in the previous 3 months; or current regular use of antibiotics
Access to either smart phone or computer; and
Currently physically inactive.
Exclusion Criteria:
Any criterion not met under inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Greenlee, ND, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer
We'll reach out to this number within 24 hrs