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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gut Microbiota, Butyrate, Inflammation and Physical Activity: A Pilot Study Among Individuals at High Risk for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Physical activity intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Microbiota, Butyrate, Physical activity