Microbiome, Exercise Tracking Study (METS)

Sponsor

Columbia University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02780284

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Physical activity intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Physical Activity and the Microbiome Among Individuals at High Risk of Colorectal Cancer

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical activity intervention Observation phase of usual activity and an intervention phase of regular physical activity	Behavioral: Physical activity intervention 150 minutes per week of moderate intensity cardiovascular exercise

Arm

Intervention/Treatment

Experimental: Physical activity intervention

Observation phase of usual activity and an intervention phase of regular physical activity

Behavioral: Physical activity intervention

150 minutes per week of moderate intensity cardiovascular exercise

Outcome Measures

Primary Outcome Measures

Percentage of participants retained at the end of study [8 weeks]
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 [8 weeks]
To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator: Heather Greenlee, ND, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heather Greenlee, Assistant Professor of Epidemiology, Columbia University

ClinicalTrials.gov Identifier:

NCT02780284

Other Study ID Numbers:

AAAP1611

First Posted:

May 23, 2016

Last Update Posted:

May 23, 2016

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Heather Greenlee, Assistant Professor of Epidemiology, Columbia University

Gut Microbiota

Butyrate

Physical activity

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of May 23, 2016