Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Physical activity intervention

• Registration Number: NCT02780284
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-23
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Fluent in English or Spanish;
2. At high risk of developing colorectal cancer;
3. No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
4. No use of antibiotics in the previous 3 months; or current regular use of antibiotics
5. Access to either smart phone or computer; and
6. Currently physically inactive.

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Exclusion Criteria

Any criterion not met under inclusion.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical activity intervention	Physical activity intervention	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States