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

NCT06669923 | Not Yet Recruiting

• 1 other identifier: HSR230101
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Change from baseline sugar-sweetened beverages

  Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz

  Baseline, 9-weeks, 6-months, 18 months

Secondary Outcomes (3)

• Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 6 months.

  Baseline, 6 months

• Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 18 months.

  Baseline, 18 months

• Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI)

  Baseline, 9-weeks, 6-months, 18 months

Study Arms (3)

Baseline

NO INTERVENTION

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

Follow Up - Patient Education Group

SHAM COMPARATOR

Behavioral: Patient Education

Follow Up - iSIPsmarter Program Group

EXPERIMENTAL

Behavioral: iSIPsmarter Program

Interventions

iSIPsmarter Program BEHAVIORAL

web-based behavioral intervention to reduce sugary drink intake

Also known as: Sugary Drink Program

Follow Up - iSIPsmarter Program Group

Patient Education BEHAVIORAL

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

Also known as: Cancer Prevention Program

Follow Up - Patient Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• University of Virginia: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Patient Education as Topic; National Program of Cancer Registries

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Centers for Disease Control and Prevention, U.S.; United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government; Organizations; Health Care Economics and Organizations

Study Officials

• Li Li, MD, PhD

  UVA, Dept of Family Medicine

  PRINCIPAL INVESTIGATOR

• Jamie Zoellner, PhD, RD

  UVA, Dept of Public Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samyukta Venkatesh, BA

CONTACT

4342434983; qgf7up@uvahealth.org

Donna-Jean Brock, MA

CONTACT

434-962-5870; djbrock@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: November 1, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): November 15, 2029
• Study Completion (Estimated): November 15, 2030
• Last Updated: November 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share