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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2030-11-15

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Baseline

Baseline study collects baseline data and screens for potential participants for the follow-up study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Follow Up - Patient Education Group

Group Type SHAM_COMPARATOR

Patient Education

Intervention Type BEHAVIORAL

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

Follow Up - iSIPsmarter Program Group

Group Type EXPERIMENTAL

iSIPsmarter Program

Intervention Type BEHAVIORAL

web-based behavioral intervention to reduce sugary drink intake

Interventions

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iSIPsmarter Program

web-based behavioral intervention to reduce sugary drink intake

Intervention Type BEHAVIORAL

Patient Education

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Sugary Drink Program Cancer Prevention Program

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for a colonoscopy (large polyp removal)
* Patients 18+

* 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).

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:

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes