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
The science
- Registered title
- Understanding Sugar-Sweetened Beverages (SSB) and Colorectal Cancer (CRC)
- Trial ID
- NCT06669923 ↗
- 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.
