An interventional study of iSIPsmarter Program and Patient Education in Colorectal Neoplasms, sponsored by University of Virginia. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by University of Virginia · Not applicable, Interventional, and Prevention
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 120 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Baseline Study:
Inclusion Criteria:
Exclusion Criteria:
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:
Baseline study collects baseline data and screens for potential participants for the follow-up study.
Behavioral: Patient Education
Behavioral: iSIPsmarter Program
web-based behavioral intervention to reduce sugary drink intake
Also known as: Sugary Drink Program
website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer)
Also known as: Cancer Prevention Program
Change from baseline sugar-sweetened beverages
Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz
Time frame: Baseline, 9-weeks, 6-months, 18 months
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.
Time frame: 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.
Time frame: 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)
Time frame: Baseline, 9-weeks, 6-months, 18 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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