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

Официальное название

Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging

Обзор

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.

Вмешательства

• Поведенческое iSIPsmarter Program
  web-based behavioral intervention to reduce sugary drink intake
• Поведенческое Patient Education
  website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer)

Первичные конечные точки

• Change from baseline sugar-sweetened beverages [Срок оценки: Baseline, 9-weeks, 6-months, 18 months]

Вторичные конечные точки (3)

• Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 6 months. [Срок оценки: Baseline, 6 months]
• Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 18 months. [Срок оценки: Baseline, 18 months]
• Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) [Срок оценки: Baseline, 9-weeks, 6-months, 18 months]

Критерии участия

Baseline Study:

Критерии включения

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

Критерии исключения

• 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:

Критерии включения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06669923 · HSR230101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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