Understanding Sugar-Sweetened Beverages (SSB) and Colorectal Cancer (CRC) (SSB and CRC)

University of Virginia

Status: Not yet enrolling

Conditions: Colorectal Neoplasms

Treatments: Behavioral: iSIPsmarter Program; Behavioral: Patient Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06669923

HSR230101

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 3 patient groups

Baseline

No Intervention group

Description:

Baseline study collects baseline data and screens for potential participants for the follow-up study.

Follow Up - Patient Education Group

Sham Comparator group

Treatment:

Behavioral: Patient Education

Follow Up - iSIPsmarter Program Group

Experimental group

Treatment:

Behavioral: iSIPsmarter Program