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

Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Behavioral: Patient Education; Behavioral: iSIPsmarter Program

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samyukta Venkatesh, BA; Phone Number: 4342434983; Email: qgf7up@uvahealth.org
• Study Contact Backup: Name: Donna-Jean Brock, MA; Phone Number: 434-962-5870; Email: djbrock@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline; Baseline study collects baseline data and screens for potential participants for the follow-up study.
Sham Comparator: Follow Up - Patient Education Group	Behavioral: Patient Education; website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer); Other Names: Cancer Prevention Program
Experimental: Follow Up - iSIPsmarter Program Group	Behavioral: iSIPsmarter Program; web-based behavioral intervention to reduce sugary drink intake; Other Names: Sugary Drink Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Li Li, MD, PhD, UVA, Dept of Family Medicine; Principal Investigator: Jamie Zoellner, PhD, RD, UVA, Dept of Public Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): November 15, 2029
• Study Completion (Estimated): November 15, 2030

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HSR230101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No