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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Any criterion not met under inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Heather Greenlee, ND, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |