- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192071
Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention
November 29, 2023 updated by: University of Florida
Adapting and Pilot Testing a Nutrition Module Delivered With Virtual Human Technology for Colorectal Cancer Prevention
This study uses the opinions of adults between the ages of 45 and 73 years old to develop and test an interactive nutrition module for use in an existing colorectal cancer screening intervention using virtual human technology.
This study will contribute to knowledge of what messages and graphics promote understanding of cancer risk and promote screening.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Melissa Vilaro, PhD
- Phone Number: 352-273-3525
- Email: mgraveley@ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Recruiting
- University of Florida
-
Contact:
- Melissa Vilaro, PhD
-
Principal Investigator:
- Melissa Vilaro, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Eligible adults will be between 45 -73 years old,
- Proficient in English and
- Geographically residing in rural areas.
Exclusion:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: high interactive virtual human administered nutrition module
The virtual health assistant will interactively collect nutrition information (alcohol, red meat, and processed meat intake) and report risk information back to users in visual and audio format
|
Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer and dietary intake.
Interactive nutrition risk feedback will be customized based on user input.
Other Names:
|
Active Comparator: low interactive virtual human module
Complete the current intervention module that includes items assessing alcohol and meat intake.
|
Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer.
Minimally interactive risk feedback will be delivered.
Other Names:
|
Sham Comparator: attention control module
The attention control group, will complete a related module not related to colorectal cancer or nutrition
|
Participants engage with web-based content not related to colorectal cancer or nutrition.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk perceptions for colorectal cancer
Time Frame: up to 2 hours
|
Items measured on a 10-point Likert scale, (e.g.
"My chances of getting colorectal cancer are high")
|
up to 2 hours
|
Intentions to screen for colorectal cancer
Time Frame: up to 2 hours
|
Items measured on a 10-point Likert scale, (e.g.
"I want to get screened for colorectal cancer")
|
up to 2 hours
|
Information seeking behavior
Time Frame: up to 2 hours
|
Does participant click on link to more information.
The survey platforms event tracking feature will be used to track clicks (yes/no) for more information.
|
up to 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Melissa Vilaro, PhD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2020
Primary Completion (Estimated)
January 31, 2024
Study Completion (Estimated)
January 31, 2024
Study Registration Dates
First Submitted
December 6, 2019
First Submitted That Met QC Criteria
December 6, 2019
First Posted (Actual)
December 10, 2019
Study Record Updates
Last Update Posted (Estimated)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202301722
- 3R01CA207689-03S2 (U.S. NIH Grant/Contract)
- OCR27722 (Other Identifier: UF OnCore)
- IRB201902537 (Other Identifier: IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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