Understanding Sugar-Sweetened Beverages (SSB) and Colorectal Cancer (CRC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iSIPsmarter Program, Patient Education.
- Who it may be relevant to
- Registry conditions: Colorectal Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging
Overview
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.
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)
Primary outcome measures
- Change from baseline sugar-sweetened beverages [Time frame: Baseline, 9-weeks, 6-months, 18 months]
Secondary outcome measures (3)
- Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 6 months. [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. [Time frame: Baseline, 18 months]
- Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) [Time frame: Baseline, 9-weeks, 6-months, 18 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06669923 · HSR230101