iSIPsmarter Program
Behavioralweb-based behavioral intervention to reduce sugary drink intake
Other names: Sugary Drink Program
NCT Number: NCT06669923
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
web-based behavioral intervention to reduce sugary drink intake
Other names: Sugary Drink Program
website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer)
Other names: Cancer Prevention Program
Time frame: Baseline, 9-weeks, 6-months, 18 months
Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz
Time frame: Baseline, 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, 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, 9-weeks, 6-months, 18 months
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)
Contact information is provided by the study sponsor or research team.
Donna-Jean Brock, MA
CONTACT
Samyukta Venkatesh, BA
CONTACT
University of Virginia
Other
Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging
Acronym: SSB and CRC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07715903
Adenocarcinoma, Adrenal Cortex Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT07071454
Colonic Diseases, Colorectal Neoplasms
New York, United States
View Trial DetailsNCT07644910
Breast Diseases, Breast Neoplasms
View Trial DetailsNCT07623642
Adenocarcinoma, Biliary Tract Diseases
Beijing, Beijing Municipality, China
View Trial Details