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

NCT02780284 | Completed DMC

• 1 other identifier: AAAP1611
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Gut Microbiota; Butyrate; Physical activity

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (1)

• Percentage of participants with collected, processed, and analyzed stool samples

  8 weeks

Study Arms (1)

Physical activity intervention

EXPERIMENTAL

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.

Behavioral: Physical activity intervention

Interventions

Physical activity intervention BEHAVIORAL

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.

Physical activity intervention

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Study Officials

• Heather Greenlee, ND, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 23, 2016
• Study Start: March 1, 2015
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

US (1)