Adapting and Pilot Testing a Nutrition Module Delivered With Virtual Human Technology for Colorectal Cancer Prevention
Phase: NA
Conditions: Colorectal Cancer
Sponsor: University of Florida

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PI Version: 05-24-2022 
University of Florida IRB-02 
Protocol Template Guidelines 
 
 
The “protocol” is similar in form to a brief research proposal. It should be as 
concise as possible.  It should, however, contain all information relevant to the 
proposed research project not specifically covered in the SmartForms. (Not every 
item will be relevant for every project, of course, and you may limit responses as 
appropriate in such cases, but if you’re uncertain as to what to include, be 
“inclusive” as that makes it less likely we’ll have requests for additional 
information.) 

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1. Background: 
 
• Colorectal cancer (CRC) accounts for about 8% of new cancer cases in 
the US.1 Alcohol and red/processed meat consumption are two diet-related 
risk factors for CRC.2–4 Evaluating nutritional status is considered a key 
component of the patient care process5 and when done effectively can help 
patients understand what foods increase CRC risk. Informing patients of 
personal nutrition risk factors for CRC may also help to stimulate accurate 
CRC risk perceptions and facilitate CRC prevention behaviors including 
screening. For some populations, including rural adults, technology can 
help address factors that contribute to CRC disparities such as low 
screening rates, poor diet, low literacy, and limited access to healthcare. 
 
• Innovative technology can facilitate communication of dietary risk factors in 
a medical setting, which is often difficult due to measurement challenges 
and barriers related to patient and provider characteristics. Physicians own 
interest in nutrition, hours of nutrition education received, and personal fruit 
and vegetable intake impact frequency of nutrition counseling with 
patients.7,8 Virtual heath assistants (VHAs) are human-like avatars that 
talk to and collect information from users in a web-based setting. There is 
growing evidence that using VHAs can facilitate discussions of stigmatized 
health information,9 offer advantages over traditional patient-provider 
settings,10 and integrate into existing healthcare systems.11  Furthermore, 
racial minorities and rural adults can benefit from innovative nutrition 
interventions for CRC prevention as they experience poorer adherence to 
dietary guidelines,12 higher incidence, morbidity, and mortality from CRC, 
and lower rates of screening compared to others.13,14 Thus, a strategic 
nutrition communication intervention using VHT is a promising approach for 
enhancing nutrition communication for CRC prevention. 
 
• This proposal is a subproject of a currently approved study (PI, Dr. Janice 
Krieger), titled “A Patient-centered Intervention Using Technology to 
Reduce Colorectal Cancer Disparities in Primary Care” (1R01CA207689-
01A1) (IRB#201702765 and IRB#201601642). The goal of the parent 
project is to test the efficacy of a patient-centered, tailored message 
intervention for increasing CRC screening among racial minorities and rural 
patients. Given the challenges of discussing nutritional risk in a clinical 
setting, the objective of this proposed subproject is to test if tailored 
nutrition-risk information delivered in a web-based platform increases 
perceptions of CRC risk and CRC prevention behaviors. 

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2. Specific Aims: 
 
• The goal of this proposed project is to adapt an existing CRC screening 
intervention to include a nutrition module that engages users with 
information about alcohol and red/processed meat consumption, and 
delivers tailored nutrition-risk messages to enhance CRC prevention 
outcomes.  
• The objective of this proposed project is to pilot test the adapted VHT-
delivered, tailored, nutrition-risk module to investigate mechanisms of 
efficacy for the adapted intervention including establishing preliminary 
estimates for CRC risk perceptions and CRC prevention behaviors. This 
information will be used to inform a larger trial. 
• The hypothesis is reporting dietary intake and receiving personalized 
nutrition-risk factors for CRC via a VHA will increase perceptions of CRC 
risk, CRC screening intentions, and information seeking behaviors (e.g. 
reducing alcohol, red/processed meat, how to order at home screening kit). 
• Aim 1: Modify an existing CRC intervention with a nutrition module where 
VHAs collect dietary intake information and give tailored visual feedback on 
nutrition risk factors for CRC. To increase patient engagement with 
nutrition-risk messages delivered in a virtual setting, we must first 
understand beliefs, experiences, and evaluations of nutrition-risk 
communication. We will engage in a cultural adaptation of an interactive 
nutrition module delivered by virtual health assistants (VHAs) to ensure 
acceptable social reactions to reporting dietary intake of alcohol and 
red/processed meat and receiving personalized feedback in the virtual 
setting. We will also conduct content adaptation of the module (tailoring 
language, visuals, and examples of food items). 
 
• Aim 2: Pilot test the VHA intervention to assess if the tailored nutrition 
module increases (2a) accurate risk perceptions for CRC (2b) intentions to 
screen for CRC (2c) and information seeking behaviors (e.g. how to reduce 
alcohol and red/processed meat intake, how to order home screening kit).  
3. Research Plan / Study Description: 
Aim 1 
Eligibility Criteria: 
• Eligible adults will be between 50-73 years old, proficient in English and 
geographically rural areas of north central Florida. We will enroll black, 
white, male and female participants. 

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Focus Group Structure: 
• Adults at risk for CRC will participate in focus groups with an estimated 6 
groups comprised of approximately 6 people. (N=36) 
• Focus groups will be conducted via an iterative cycle of adaptation based 
on participant feedback: 
-Cycle 1: FG 1 and 2 use storyboard exercise and discussion to inform 
initial content and message preferences for nutrition module PI meet 
with graphic designer/VH team to develop initial prototype 
 
-Cycle 2: FG 3 and 4 comment on developed first round stimuli from 
graphic designer/first prototype of module  PI meet with graphic 
designer/VH team to modify module 
 
-Cycle 3: FG 5 and 6 comment on module version 2 PI meet with 
graphic designer/VH team to update 
 
• Focus groups will take place in the community at an accessible location, 
take approximately two hours, and will be video and audio-recorded. 
• Due to Covid-19, as of Fall 2020 we will be conducting focus groups via 
zoom. 
• Trained researchers will conduct the focus groups using a semi-structured 
guide based on the Cultural Sensitivity Model (Resnicow, 2000). 
• Participants will answer questions to inform acceptability of messages and 
graphics to be delivered in the virtual setting related to CRC risk. Participant 
responses will help adapt the VHT nutrition module for cultural 
appropriateness, content, and framing of nutrition communication. 
• A questionnaire assessing participant characteristics, perceptions, and 
behaviors will also be administered. 
 
Individual Think-aloud Interview Structure: 
• A usability test of the nutrition module will be achieved by conducting 
individual, in audio and video-recorded think-aloud interviews (N=12) rooted 
in user-centered design principles. 
• Due to Covid-19, as of Fall 2020 we will be conducting interviews via zoom. 
• Think-aloud interviews will continue using the iterative process: 
-Cycle 4: TA 1-4 conducted on module version 3  PI review data, make 
decision about content/functionality, etc., and continue agile design 
method as needed through TA 5-8 and TA 9-12 
 
• Interviews will take place remotely, via zoom, take approximately one hour, 
and will be video and audio-recorded. 
• Facilitated by trained researchers, participants will test the VHA delivered 
intervention on a web-enabled device and will be encouraged to verbalize 
thoughts, questions, opinions and concerns about the module.  

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• Results from think-aloud interviews will inform final adaptations needed for 
the nutrition module prior to pilot-testing. 
• A questionnaire assessing participant characteristics, perceptions, and 
behaviors will be administered. 
 
Data and analysis 
• Focus group and interview data will be transcribed verbatim using secured 
transcription service DataGain, Inc. (reviewed by UF Integrated Risk 
Management and classified as low risk) and managed with qualitative data 
management software. The PI and trained members of the research team 
will analyze qualitative data using a constant comparative method and 
iterative process throughout data collection phase. 
• Transcripts will be analyzed for a priori and emergent themes relevant to 
nutrition module adaptations needed including but not limited to a) surface 
culture adaptations, b) deep culture adaptations c) cognitive adaptations d) 
affective-motivational adaptations. 
• Questionnaire data will be analyzed to summarize participant 
characteristics, perceptions, and behaviors. We will conduct descriptive 
statistics (e.g. Means, SDs) using quantitative data analysis software. 
• A member of the research team will store electronic data files (i.e. 
transcripts, audio and video files, data spreadsheets) on a password 
protected and encrypted server.  
 
Aim 2 
 
Eligibility Criteria: 
• Eligible rural (based on zip code) adults will be between age 45-73 years 
old, residents, who have not had CRC and who have not obtained CRC 
screening based on guidelines (i.e. <10 years for colonoscopy, <1 year for 
stool test, < 5 years for sigmoidoscopy). Participants should also answer 
“yes” to the question, do you have health insurance? We will enroll equal 
proportions of black, white, male and female participants. 
 
Pilot Test Structure: 
• We will enroll participants using Qualtrics Panels. Qualtrics Panels consist 
of U.S. adults who have agreed to participate in web administered surveys. 
• We will pilot-test the module using a 3-group randomized design with 30 
participants per group. Participants will be randomized to one of three 
groups: 1) high interactive VHA administered nutrition module, 2) low 
interactive VHA  module, or 3) attention control module. Each module will 
be approximately 5-10 minutes. 
• For group 1, the VHA will interactively collect nutrition information (alcohol, 
red meat, and processed meat intake) and report risk information back to 
users in visual and audio format. Group 2, will complete the current 
intervention module that includes items assessing alcohol and meat intake. 

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This module is consistent with Dr. Krieger’s ongoing clinical trial work. 
Groups 1 and 2 will receive CRC prevention messages including 
information about how to use a home FIT screening test (delivered by the 
VHA).  
• Group 3, the attention control group, will complete a non-CRC related 
module (e.g. recycling). 
• All groups will complete a questionnaire assessing outcomes of interest and 
participant characteristics.  
• All participants will access the intervention using an electronic link sent to 
them via email. 
• Participants will have option to receive additional information (see outcome 
3 below). Those participants will be directed to evidence-based cancer 
prevention resources housed on the secure web platform Wix.com.  
 
Data and analysis: 
• We will assess three main outcomes variables: 
• (1) Accurate risk perceptions for CRC (e.g. items measured on a 7-point 
Likert scale, “My chance of getting CRC are high”, “FIT screening 
decreases my chances of dying from cancer”).30  
• (2) Intentions to screen for CRC (e.g. items measured on a 7-point Likert 
scale “I want to get screened for colon cancer” or “I will talk to my doctor 
about colon cancer screening with FIT”).31 
• (3) Information-seeking behavior (e.g. assessed via clicks on links 
regarding “reducing alcohol/meat consumption”, “how to order a FIT kit” (for 
intervention groups) or “tips for recycling” (for attention control group). We 
will use the Qualtrics “event tracking” feature to track clicks (yes/no).  
• For outcomes (1) and (2) we will conduct one-way ANOVAS or Kruskal-
Wallis test on the difference between baseline and post-test to obtain 
estimates to inform the larger trial.  
• For outcome (3) we will use Pearson’s chi-square test or Fisher exact test.  
• Sample size was determined using a stepped rule of thumb based on an 
expected small effect size and 90% power for the future trial (Bell, 
Whitehead, & Julious, 2018). Based on this approach, if we expect a small 
effect size (.1-.3) at 90% power (for the larger trial) the pilot would require 
n=25 per arm to obtain estimates to inform larger trials sample size. Thus, 
n=30 per arm (N =90) is expected to give appropriate estimates to inform 
the larger trial. 
• Data will be de-identified, stored with participant IDs on UF secure server 
accessible from PI’s password protected computer, and analyzed using 
quantitative data analysis software for, preliminary estimates to plan a 
larger trial (e.g. confidence interval estimates, recruitment/response rates) 
and descriptive statistics to describe participant characteristics. 
• Descriptive statistics will be calculated for all variables including mean, 
standard deviation, median, inter-quartile range, minimum and maximum for 

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continuous variables and frequency and proportion for categorical variables. 
Graphical illustration will be provided if applicable. 
• Data analytics obtained from wix.com will be reviewed to understand use. 
Descriptive statistics on resources clicked and time spent on the site will be 
calculated. 
 
4. Possible Discomforts and Risks: 
 
• There are no potential risks of physical, psychological or economic harm 
associated with participant in this study.  
5. Possible Benefits: 
 
• While no direct benefits are expected, participants may benefit from 
learning about their health and ways to engage in health prevention 
behaviors relevant to nutrition and cancer screening.  
 
• The risks to subjects are reasonable in relation to the anticipated benefits 
due to the importance of the knowledge that will be gained from this research 
to benefit future populations.   
6. Conflict of Interest: 
 
• There are no real or potential conflicts of interest with any investigators with 
regard to this specific research project.