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

NCT06669923 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms

Interventions

BEHAVIORAL

iSIPsmarter Program

web-based behavioral intervention to reduce sugary drink intake

BEHAVIORAL

Patient Education

website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer)

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Li Li, MD, PhD · UVA, Dept of Family Medicine

  • Jamie Zoellner, PhD, RD · UVA, Dept of Public Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2029-11-15
Completion
2030-11-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06669923 on ClinicalTrials.gov