Colorectal NeoplasmsSSB and CRCNCT06669923
Understanding Sugar-Sweetened Beverages (SSB) and Colorectal Cancer (CRC)
A study testing iSIPsmarter Program and Patient Education in people with Colorectal Neoplasms, run by University of Virginia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- iSIPsmarter Program and Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 15 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging
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
- Being tested
- iSIPsmarter Program, Patient Education
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSIPsmarter ProgramBehavioural
Also called Sugary Drink Program
web-based behavioral intervention to reduce sugary drink intake
Patient EducationBehavioural
Also called Cancer Prevention Program
website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer)
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described Receives: Behavioral: Patient Education |
| Follow Up - iSIPsmarter Program Group | Experimental | Not described Receives: Behavioral: iSIPsmarter Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline sugar-sweetened beverages
Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz
Measured: 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.
Measured by comparing baseline physiological aging of right vs. left colon tissue biopsies with biopsies collected 6 months post-intervention.
Measured: Baseline, 6 months
Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 18 months.
Measured by comparing baseline physiological aging of right vs. left colon tissue biopsies with biopsies collected 18 months post-intervention.
Measured: Baseline, 18 months
Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI)
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)
Measured: Baseline, 9-weeks, 6-months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Nov 2029 (estimated)
- Study completion15 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, University of Virginia
- Investigators
- Li Li, MD, PhD, Principal investigator, UVA, Dept of Family MedicineJamie Zoellner, PhD, RD, Principal investigator, UVA, Dept of Public Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669923
- Sponsor's protocol ID
- HSR230101
- Acronym
- SSB and CRC
- Status last verified
- Mar 2024
- First submitted
- 29 Jan 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging
- ClinicalTrials.gov ID
- NCT06669923
- Acronym / sponsor ID
- SSB and CRC / HSR230101
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Nov 2029 (estimated)
- Study completion
- 15 Nov 2030 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSIPsmarter ProgramAlso: Sugary Drink Programweb-based behavioral intervention to reduce sugary drink intake | Behavioural | Follow Up - iSIPsmarter Program Group |
| Patient EducationAlso: Cancer Prevention Programwebsite with information about cancer screening and prevention (e.g. screening tests for seven types of cancer) | Behavioural | Follow Up - Patient Education Group |
Primary outcome
Change from baseline sugar-sweetened beverages
Time frame: Baseline, 9-weeks, 6-months, 18 months
Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Li, MD, PhD principal investigator
UVA, Dept of Family Medicine
Jamie Zoellner, PhD, RD principal investigator
UVA, Dept of Public Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing iSIPsmarter Program and Patient Education in people with Colorectal Neoplasms, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samyukta Venkatesh, BA (4342434983, qgf7up@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline sugar-sweetened beverages (time frame: Baseline, 9-weeks, 6-months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.