Colorectal Neoplasms
Conditions
Brief summary
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.
Interventions
BEHAVIORALiSIPsmarter Program
web-based behavioral intervention to reduce sugary drink intake
BEHAVIORALPatient Education
website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer)
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Baseline Study: Inclusion Criteria: * Patients scheduled for a colonoscopy (large polyp removal) * Patients 18+
Exclusion criteria
* Subjects who do not speak English * Subjects diagnosed with inflammatory bowel disorder * Subjects diagnosed with cancer (except non-melanoma skin cancer) * Subjects taking blood thinners at time of colonoscopy (except 325 mg daily aspirin) 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: * Regular access (\<1/week) to the internet. * Drink more than recommended amount of sugar-sweetened beverages per day (assessed from participant's responses to the Beverage Questionnaire section (BEVQ-15) of the Computer Administered Phone Interview (CAPI), from the Baseline study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline sugar-sweetened beverages | Baseline, 9-weeks, 6-months, 18 months | Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 6 months. | Baseline, 6 months | Measured by comparing baseline physiological aging of right vs. left colon tissue biopsies with biopsies collected 6 months post-intervention. |
| Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 18 months. | Baseline, 18 months | Measured by comparing baseline physiological aging of right vs. left colon tissue biopsies with biopsies collected 18 months post-intervention. |
| Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) | Baseline, 9-weeks, 6-months, 18 months | 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) |
Contacts
Primary ContactSamyukta Venkatesh, BA
Backup ContactDonna-Jean Brock, MA
Outcome results
None listed