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Study plans to test a sugar drink program in people with large bowel growths

Opening soon · University of Virginia

What this means

This is a plan for a small trial that has not started recruiting yet. It will check if a program can help people drink fewer sugary drinks, and whether it is practical to test.

Plain-English summary written by an AI model from the registry listing.

Status
Opening soon
Who can join
Ages 18 and over · About 120 adults in the baseline study, and 20 patients in the follow-up trial
Where
Not listed

Contacts and how to join ↗

The science

Registered title
Understanding Sugar-Sweetened Beverages (SSB) and Colorectal Cancer (CRC)
Phase
Not applicable
Study type
interventional
Conditions
Colorectal Neoplasms
What is tested
iSIPsmarter Program, Patient Education
Sponsor
University of Virginia
Ages
18 Years to no maximum
Dates
First posted Nov 1, 2024 · updated Nov 1, 2024

Registry 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.

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