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This study will recruit and consent approximately 120 subjects in the baseline study until the follow-up study recruitment goals of 20 subjects is met. This pilot proposal to: Aim 1) assess the feasibility of conducting a randomized controlled trial of iSIPsmarter among high-risk patients with newly detected large colorectal adenoma to reduce Sugar-Sweetened Beverages (SSB) consumption, and Aim 2) examine the investigators' central hypothesis that SSBs contribute to racial disparities in the development of side-specific colon neoplasia via differentially impacting epigenetic aging and methylation of right vs. left normal colon tissues of African-Americans (AA) vs European-Americans (EA). In order to do so, the investigators will first conduct a study to collect baseline information from eligible and interested participants. Behavioral, lifestyle, and genetic information will be collected from participants undergoing a colonoscopy with large polypectomy removal to set up a biobank. The participants enrolled in this study will then be screened for their interest and eligibility in participating in the follow-up study, a randomized iSIPsmarter intervention trial. The investigators will enroll 20 patients in the follow-up study (1:1 ratio intervention vs. control; equal number of AAs and EAs) with newly detected/resected large colorectal adenomas to collect normal colon tissue biopsies pre- and post-iSIPsmarter intervention and test the investigators' hypotheses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline | No Intervention | Baseline study collects baseline data and screens for potential participants for the follow-up study. | |
| Follow Up - Patient Education Group | Sham Comparator |
| |
| Follow Up - iSIPsmarter Program Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iSIPsmarter Program | Behavioral | web-based behavioral intervention to reduce sugary drink intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline sugar-sweetened beverages | Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz | Baseline, 9-weeks, 6-months, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 6 months. | Measured by comparing baseline physiological aging of right vs. left colon tissue biopsies with biopsies collected 6 months post-intervention. | Baseline, 6 months |
| Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 18 months. |
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Baseline Study:
Inclusion Criteria:
Exclusion Criteria:
Follow-up Study:
In order to be eligible to participate in the f/up study, an individual must meet all of the criteria for the Baseline study AND:
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samyukta Venkatesh, BA | Contact | 4342434983 | qgf7up@uvahealth.org | |
| Donna-Jean Brock, MA | Contact | 434-962-5870 | djbrock@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Li Li, MD, PhD | UVA, Dept of Family Medicine | Principal Investigator |
| Jamie Zoellner, PhD, RD | UVA, Dept of Public Health Sciences | Principal Investigator |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D000079402 | National Program of Cancer Registries |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Patient Education | Behavioral | website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer) |
|
|
Measured by comparing baseline physiological aging of right vs. left colon tissue biopsies with biopsies collected 18 months post-intervention. |
| Baseline, 18 months |
| Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) | 2 unannounced recalls (one weekend and one weekday) using state-of-the-art Nutrition Data System for Research (NDSR) software and multiple pass methods. HEI indicators will be extracted from the NDSR system and examined for changes in the total HEI score, on a 100-point continuous scale (higher scores reflective higher diet quality) | Baseline, 9-weeks, 6-months, 18 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002487 | Centers for Disease Control and Prevention, U.S. |
| D014492 | United States Public Health Service |
| D014483 | United States Dept. of Health and Human Services |
| D037041 | United States Government Agencies |
| D035082 | Federal Government |
| D006076 | Government |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |