Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
Phase: NA
Conditions: Healthy Volunteers
Sponsor: Washington University School of Medicine

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 1 
Title: Communicating multiple disease risks: A translation of risk prediction science 
 
Short title: Comm multi disease risk Aim 2 
 
Date: May 4, 2017 
 
Protocol #:  201706063 
 
PI: Erika A. Waters, PhD, MPH  
314-747-5705 
Washington University School of Medicine 
Campus Box 8100 
660 S. Euclid Ave 
Saint Louis, MO 63110 
 
Co-I: Ying Liu, Graham Colditz 
 
Consultants: Linda Cameron, Integrity StL, Susan Gillham Design 
 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 2 
Contents 
 
Background and Rationale ................................................................................................................................ 3 
Objectives.......................................................................................................................................................... 4 
Eligibility Criteria ................................................................................................................................................ 4 
Registration Procedure ...................................................................................................................................... 5 
Research Plan ................................................................................................................................................... 5 
Statistical Considerations .................................................................................................................................. 8 
Study Procedure Calendar .............................................................................................................................. 11 
Drug Formulation and Procurement ................................................................................................................. 11 
Data and Safety Monitoring Plan ..................................................................................................................... 11 
Record Keeping ............................................................................................................................................... 12 
References ...................................................................................................................................................... 12 
Special Considerations .................................................................................................................................... 15 
List of Appendices ........................................................................................................................................... 15 
 
 
 
 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 3 
Background and Rationale 
RISK CALCULATOR (Parent grant) 
Epidemiology seeks to improve public health by identifying risk factors for cancer and other diseases and 
conveying that information to relevant audiences (e.g., physicians, the public).  The audience is presumed to 
understand and use that information to make appropriate decisions about lifestyle behaviors and medical 
treatments.  Yet, even though a single risk factor can affect the risk of multiple health outcomes, this 
information is seldom communicated to people in a way that optimizes their understanding of the importance of 
engaging in a single healthy behavior.[1]  Providing individuals with the ability to understand how a single 
behavior (obtaining sufficient physical activity) could affect their risk of developing multiple diseases could 
foster a more coherent and meaningful picture of the behavior’s importance in reducing health risks, and 
increase motivation and intentions to engage in the behavior. 
We will test the effectiveness of a risk calculator that conveys individualized risk estimates for colon cancer, 
heart disease, diabetes, stroke, and breast cancer (women) to socio-demographically diverse laypeople who 
do not get 150 minutes of moderate intensity physical activity per day.  Estimates of how the participant’s risk 
would change if they were to engage in at least 3 hours of moderate intensity activity per week will also be 
provided. 
MENTAL IMAGERY (Supplement) 
Although risk calculators can improve comprehension and produce favorable changes in health cognitions that 
lead to behavior change (e.g., accuracy of perceived risk, response efficacy, intentions), the effect of 
calculators on behavior itself is modest.[2-4]  However, the gap between intentions and behavior can be bridged 
via interventions that help people develop self-regulatory skills, such as developing action plans for how to 
achieve each step of the behavior.[5-8]  Mental imagery may be particularly useful in the development and 
realization of these plans.[5, 9, 10]   
We will adapt an existing and effective mental imagery-based self-regulation physical activity intervention[5] for 
incorporation into the working risk calculator and compare its effectiveness in increasing physical activity 
behavior to an active control that addresses sleep hygiene. 
RISK CALCULATOR AND MENTAL IMAGERY (Conceptual Model) 
The conceptual model was adapted from the Health Action Process Approach (HAPA).[8]  It asserts that 
behavior change occurs in two phases.  The motivation phase is most relevant for people who do not engage 
in the recommended behavior.  The goal of interventions that target the motivation phase – such as the risk 
calculator – is to increase intentions to engage in the behavior.  Risk perceptions are important in this phase 
because they raise awareness of the consequences of not engaging in the behavior.  Together with outcome 
expectancies (e.g., the expected consequences of engaging in the behavior, operationalized here as response 
efficacy), perceived severity of the health outcome, and action self-efficacy (i.e., confidence in one’s ability to 
initiate a new behavior), risk perceptions influence intentions to start the behavior change process.  Note that 
the risk calculator is not expected to increase action self-efficacy or perceived severity because it was not 
designed with a component to target those constructs. 
We enhanced the motivation phase of the conceptual model with additional components drawn from risk 
perception and communication research.  Comprehension of information was added because perceptions and 
comprehension are slightly different constructs that each have an important role in influencing health behavior 
and decisions.[11]  Worry, affective reaction to the information, affective attitudes to exercise, and anticipated 
regret were added because a growing body of research demonstrates that affect and emotion are integral to 
the formation of risk perceptions, in increasing motivation to change behavior, and in changing behavior 
itself.[12-17]  Demographics, numeracy, health literacy, and graph literacy were added because they are 
associated with the ability to understand and use health risk information.[18-20] 
According to HAPA, progression to the action phase is dependent upon factors not included in the motivation 
phase.  These new factors include developing action plans for engaging in the behavior, coping plans for 
overcoming barriers to action, maintenance self-efficacy (i.e., confidence in the ability to overcome barriers to 
acting), and recovery self-efficacy (i.e., confidence in the ability to recover from a relapse).  

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 4 
Objectives 
RISK CALCULATOR 
To compare the effectiveness of communicating personalized risk estimates via text, table, or risk ladder. 
Primary outcomes hypotheses and exploratory research questions 
H1:   Comprehension of risk information and intentions to increase physical activity will be higher 
among individuals who see multiple disease risks presented as a risk ladder than as text. 
RQ1: Prior research has shown that tables can be effective in communicating risk information.[21]  
Compared to the table, will the risk ladder elicit higher comprehension and intentions?  
Secondary outcomes hypotheses and exploratory research questions 
H2:   Any significant effect of the risk ladder on intentions will be mediated by comprehension, risk 
perceptions, response efficacy, worry, affective reactions to information, affective attitudes to 
exercise, and anticipated regret. 
H3:   Engagement in physical activity will increase from baseline to 90 day follow-up to a greater extent 
for individuals who see the risk ladder than those who see text only. 
H4:   Intentions will mediate any significant effect of the risk ladder on physical activity. 
RQ2: Compared to the table, will the risk ladder elicit higher risk perceptions, response efficacy, worry, 
affective reactions to information, affective attitudes to exercise, and anticipated regret? 
Sociodemographic exploratory research questions 
RQ3: Will education, race/ethnicity, numeracy, health literacy, and/or graph literacy moderate the effect 
of risk communication strategy on primary outcomes? 
MENTAL IMAGERY 
To test whether supplementing the risk calculator with a mental imagery-based self-regulation intervention will 
increase actual engagement in physical activity over time, and to explore several possible mechanisms. 
Primary outcome and exploratory research questions 
H5:   Engagement in physical activity will increase from baseline to 90-day follow-up only among 
individuals in the physical activity mental imagery intervention,[5, 7-9] not in the sleep hygiene 
imagery active control condition. 
RQ5: Will education, race/ethnicity, numeracy, health literacy, and/or graph literacy moderate the effect 
of mental imagery condition on behavior? 
Secondary outcomes and exploratory research questions 
H6:   Within the physical activity mental imagery condition, increases in activity from pre-intervention 
baseline to 90-day follow-up will be preceded by the following measures assessed at the week 4 
follow-up: action planning, coping planning, action self-efficacy, maintenance self-efficacy, 
recovery self-efficacy, affective attitudes to exercise, and perceived vividness of imagery.[5, 7-9, 16] 
RQ6: Within the physical activity mental imagery condition, the direction and magnitude of change in 
activity from pre-intervention baseline to week 1 follow-up will be preceded by the following 
measures assessed at the survey assessed immediately post-intervention: action planning, 
coping planning, action self-efficacy, maintenance self-efficacy, recovery self-efficacy, affective 
attitudes to exercise, and perceived vividness of imagery.[5, 7-9, 16]  Similarly, measures assessed at 
week 1 will predict change in behavior from week 1 to week 2; measures assessed at week 2 will 
predict behavior change from week 2 to week 3; and measures assessed at week 3 will predict 
behavior change from week 3 to week 4. 
Eligibility Criteria 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 5 
RISK CALCULATOR AND MENTAL IMAGERY  
Inclusion criteria are: 30-64 years of age, less than three relevant comorbidities (diabetes, heart disease, 
stroke and cancer, where cancer counts as 2 comorbidities for women but 1 for men due to the statistical 
properties of the risk calculator), having a SMS/text capable mobile phone that is not shared with anyone else, 
text messaging more than once a month, and not meeting national guidelines for aerobic physical activity (i.e., 
at least 150 minutes per week of moderate intensity aerobic physical activity).[22] 
Registration Procedure 
RISK CALCULATOR AND MENTAL IMAGERY  
Participants will be recruited from the Recruitment Enhancement Core (REC), reasearchmatch.org, the Health 
Communication Research Lab’s FReDa database, word of mouth, newspaper advertisements, and a database 
maintained by the Waters Lab.  REC will follow their established standard procedures by posting information 
about the study in BJC today (Appendix P: Aim 2, BJC Ad), on the REC website (Appendix T: Aim 2, Website 
posting), Facebook (Appendix R: Aim 2, Facebook Posting), Centerwatch (Appendix Q: Aim 2, Centerwatch 
Ad), and newspaper advertisements (Appendix CC, Newspaper Advertisement).  REC will forward interested 
participants’ contact information to the study team, who will make outbound calls to potential participants.  
Researchmatch.org will email registry members with information about the study (Appendix U: Aim 2, 
Researchmatch.org email), and offer participants a chance to contact the study team if they are interested in 
participating.  The study team will make outbound calls and emails to members of the HCRL FReDa database 
and Waters Lab database (Appendix N: Aim 2, Screening Call Script; Appendix O: Aim 2, Recruitment Email 
Script). 
In addition, we will also recruit participants in person at various locations around St. Louis.  The locations will 
be determined by the REC and will include publicly available places with private space available, like 
laundromats, libraries, and community centers.  In this case, research assistants will speak with potential 
participants in person to assess interest in the study.  If potential participants are interested in participating in 
the study, research assistants will go through appendix H, the eligibility screener.  If the participant is eligible, 
the study team member will record the participant’s contact information on Appendix I, the Contact Info Sheet.  
If the participant is able to conduct the data collection session immediately, the research assistant will continue 
on to begin the data collection session following Appendix W (Aim 2 Data collection session 1 guide).  If the 
participant is not able to conduct the data collection session immediately, we will schedule a time for the 
session at a later date, or offer times for walk-in sessions.  Study coordinators will schedule sessions to take 
place either at the Taylor Avenue Building (Wash U) or at a mutually agreed upon public place with adequate 
private space to conduct the interview (e.g. a meeting room at a library).  When the participant arrives for the 
session, the research assistant will explain the study procedures, obtain written consent, and begin data 
collection. 
 
We will enroll 500 participants.  Recruitment will be stratified based on race (at least 50% racial/ethnic minority) 
and education (at least 50% will have no college experience) to ensure adequate representation of populations 
that experience health disparities and, consequently, to increase relevance of the intervention to those groups. 
Research Plan 
RISK CALCULATOR AND MENTAL IMAGERY 
Design 
This study will use a 3 (risk presentation condition: text vs. table vs. risk ladder) x 2 (mental imagery condition: 
physical activity vs. sleep hygiene) experimental design.  Participants will be block randomized to ensure that 
each of the 6 experimental conditions has equal numbers of participants at the end of the study.  
Randomization will occur by the computer program after eligibility screening and consent, but prior to engaging 
in any study activities.   
Blinding 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 6 
The research staff will be blinded to participants’ risk presentation conditions, but they will unblinded to mental 
imagery condition.  This unblinding was the result of a combination of the block randomization (which 
prevented us from preparing packets of study materials ahead of time and assigning participants to condition in 
order of completion (e.g., A, B, C, D, E, F)), and the need for the goal cards and Baseline Survey 2 to include 
information specific to the mental imagery condition the participant was assigned to (see below). 
Procedure 
The procedures for the study will occur in 3 parts.  Part 1 is an initial 45 minute data collection session in 
person, followed by (Part 2) reminders and surveys conducted by Short Message Service (SMS) text 
messaging over the subsequent 4 weeks, and (Part 3) a final mailed survey on paper.  The last half of Part 1 
and all of Part 2 are adapted from prior research conducted by Linda Cameron for use with University of 
Auckland employees.[5, 9]  We worked closely with Dr. Cameron to adapt the interventions so they would be 
acceptable to our St. Louis community sample (e.g., minimize burden, reduce the need for Internet access, to 
accommodate cell phone plans that do not have unlimited text and/or data, etc).  This adaptation was 
performed in Spring 2017 and involved 3 sets of cognitive interviews, each set including 6-7 participants (Aim 
2, Part 1). 
Part 1, Baseline Intervention Administration and Data Collection.  Participants will complete all baseline 
activities in person with a research assistant.  After completing eligibility screening and informed consent 
processes, participants will use a smartphone provided by research staff to complete the risk calculator portion 
of the study.  The research assistant will enter the participant ID into the responsive website, and then the 
participant will provide information about their demographics, health behaviors, and personal and family health 
history (Appendix A Aim 2, Risk Display App Screens, pg. 2-34).  The website then provides participants with 
personalized risk results for their current activity level and how it would change if they began exercising 
regularly.  Results are displayed either as alphanumeric text, table, or risk ladder (Appendix A Aim 2, Risk 
Display App Screens, pg. 35-38).  Afterwards, the participant will complete Baseline Survey 1 independently on 
paper (Appendix C, Instructions Appendix HH).   
Immediately after completing Baseline Survey 1, participants will begin the mental imagery component of the 
study.  The research assistant will enter the participant’s personal phone number into the website so they can 
receive text messages for the next 4 weeks.  Then, participants will use the smartphone and headphones 
provided by the research team to listen to an audiorecording that walks the participant through how to set a 
physical activity or sleep goal and asks them to imagine themselves exercising or improving their sleep 
hygiene (Appendix A Aim 2, Risk Display App Screens, pg. 39-42; Appendices D and E, Mental Imagery audio 
recording scripts).  Participants will be asked to practice this mental imagery twice a day for 5 minutes each 
day the subsequent weeks.  The audio recording also instructs the participant to write down an exercise or 
sleep-related goal on a pamphlet provided by the research assistant (Appendix F, Pamphlet).  Participants will 
then complete Baseline Survey 2 independently on paper (Appendices L and M).  Based on the cognitive 
interviews conducted in Spring, 2017, Part 1 will take approximately 45 minutes.  Participants will receive a $20 
gift card to Schnucks for their time and effort. 
Part 2, SMS/Text Message Intervention and Data Collection.  Beginning at 7:00pm on the day the 
participant completes the Baseline/Part 1 activities, the participant will begin receiving text messages related to 
the study.  The first texts will welcome them to the study and provide information about how to contact the Lab, 
how to stop the texts from being sent, and how to access the audiorecording to which they were assigned 
(physical activity vs. sleep).  At noon on Mondays, Wednesdays, and Fridays, they will be sent 1 of 3 texts that 
remind them to practice the imagery presented in the audio recording twice daily for five minutes each time.  
These reminders will continue for 3 weeks.  Each week after the 3rd reminder they will receive a text message 
based survey.  A final text message based survey will be sent one week after the third text message based 
survey.  The content and schedule for the text messages and text surveys are found in Appendices X and Y 
(Text Message Reminders and Survey- Exercise, Sleep).  Each text message length is no more than 160 
characters, including spaces, to fit within the universal constraints of SMS messaging protocols.  This was 
done to avoid having 1 intended message being sent in multiple pieces.  The total participation time per week 
is estimated to be approximately 10 minutes.  Participants will earn a $10 gift card to Schnucks for each text 
message survey they complete.  This amount is intended to help offset the cost of text messages for 
participants who may not have unlimited text messaging. 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 7 
Part 3, Mailed 90-Day Follow-Up Survey.  Ninety days after Baseline/Part 1, participants will receive a 
final follow-up study survey (Appendix BB) in the mail along with a written survey invitation (Appendix AA). If 
participants do not complete the first mailed survey, we will follow-up with one reminder call (Appendix Z) and 
one additional mailed survey.  The survey is expected to take approximate 15 minutes.  Participants will 
receive a $20 gift card for Schnucks for completing the follow-up survey.  
Part 4, Follow-Up Phone Call.  Within one year of the final follow up period, we may contact up to 20 
participants by phone and ask them questions about their experience and thoughts on the study process 
(Appendix II).  If this occurs, the phone call will take approximately 10 to 15 minutes.  
Measures   
To reduce participant burden, we limit the number of survey questions by adapting single item measures used 
in nationally representative surveys and in published empirical research.  Many items are identical or very 
similar to the items in Aim 1 and Aim 2, Part 1 of the study.  All items for the proposed research, including items 
that were adapted or developed specifically for Aim 2, Part 2, underwent cognitive testing in either Aim 2, Part 
1 or in prior research studies conducted by the Waters Lab.  Adaptations to the items intended for use in the 
text messaging surveys (160-character limit) were made in close collaboration with Linda Cameron, who was 
the initial developer of the interventions.  Table 1 below provides each of the measures that will be assessed in 
each part of the survey.  
Table 1. Summary of Study Measures, in Order of Completion 
Questionnaire Name 
Timing 
Content 
Part 1: Baseline 
 
 
Eligibility Screener 
(Appendix H) 
Pre-randomization 
Age;[23] race/ethnicity;[23] education;[23] personal diagnosis of the 
target diseases;[24, 25] physical activity behavior;[26, 27] and cell phone 
access (developed in-house)  
Risk Assessment 
(Appendix A) 
Immediately following 
randomization to 1 of 
6 conditions in a 3 
(risk presentation: text 
vs. table vs. risk 
ladder) x 2 (mental 
imagery: physical 
activity vs. sleep 
hygiene) design 
Demographic, biological, and behavioral characteristics needed for 
the risk algorithm[28-30] 
Baseline Survey 1 
(Appendix C) 
Immediately following 
provision of 
personalized risk 
information 
Comprehension;[31] cognitive and affective perceived risk;[32] 
perceived severity[33] worry;[32] response efficacy;[34] action self-
efficacy;[35] affective reaction to the information;[36] affective attitude 
about exercise;[16] anticipated regret;[17] intentions to engage in 
physical activity in the next 90 days;[34] numeracy[37]; graph literacy;[20] 
health literacy.[38] self-reported health status;[24] work schedule;[39] 
sleep behavior.[9] Other items intended to be used as preliminary data 
in future studies examining possible defensive processing of 
personalized health risk information include: perceived accuracy of 
information;[4, 40] message acceptance;[41] defensive processing[42] 
time orientation,[43] and spontaneous self-affirmation.[32] 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 8 
Baseline Survey 2 
(Appendices L and M) 
Immediately following 
completion of the 
mental imagery 
activity.  The specific 
item wording is 
tailored based on 
which mental imagery 
condition is assigned 
(i.e., mental imagery 
vs. sleep), but the 
constructs assessed 
are the same for both 
conditions. 
Message acceptance,[41] perceived clarity and vividness of images;[5, 
9] and the following items obtained, developed, or adapted from:[5, 6, 9, 
34] action plan; coping plan; action self-efficacy; recovery self-efficacy; 
and maintenance self-efficacy.  
Part 2: Text 
Messaging 
 
 
Mid-Intervention Text 
Message Surveys 
(Appendices X and Y) 
1, 2, 3, and 4 weeks 
after Part 1 
Perceived clarity and vividness of images;[5, 9] and the following items 
obtained, developed, or adapted from:[5, 6, 9, 34] action plan; coping 
plan; action self-efficacy; recovery self-efficacy; and maintenance 
self-efficacy.  
Part 3: 90-Day 
Follow-Up 
 
 
Follow-Up (Appendix 
BB) 
90 days after Part 1 
Comprehension;[31] physical activity behavior,[26, 27] sleep behavior,[9] 
tobacco use,[27] and the same items as in Baseline Survey 2 
assessing intentions, action self-efficacy, cognitive and affective 
perceived risk, response efficacy, anticipated regret, and affective 
attitudes. 
Note: Race and education will be assessed during eligibility for recruitment stratification purposes only.  Baseline 
Survey 1 excludes characteristics that will be assessed in the Risk Assessment questionnaire. 
 
 
Statistical Considerations 
Preliminary Analyses 
We will begin by using descriptive statistics to understand the frequency and distributional properties of all 
items.  For variables with non-normal distributions, data transformations or non-parametric tests will be used 
for subsequent analyses.   
Cronbach  will be used to test the internal consistency of multi-item constructs in Baseline Survey 1 (i.e., 
cognitive and affective perceived risk; response efficacy; action self-efficacy; affective reaction to the 
information; affective attitude about exercise; anticipated regret; intentions to engage in physical activity, 
message acceptance), Baseline Survey 2 (i.e., message acceptance, perceived clarity and vividness of 
images), and the Follow-Up Survey (i.e., intentions, action self-efficacy, cognitive and affective perceived risk, 
response efficacy, anticipated regret, affective attitude about exercise).  Where  ≥ .70 we will create a scale 
by averaging responses to a given construct across diseases.  That average score will be used in subsequent 
analyses.  Comprehension, numeracy, and graph literacy will each be operationalized as continuous variables 
comprised of the number of items answered correctly. 
Next, we will verify that participant characteristics (i.e., demographics, personal diagnosis of one of the target 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 9 
diseases, self-reported health status, numeracy, health literacy, graph literacy, pre-intervention minutes of 
physical activity per week) are equivalent across experimental conditions by conducting t-tests, one-way 
ANOVAs, chi-square tests, or other tests, as appropriate.  If any differences are found, these variables will be 
included in subsequent analyses as potential covariates.  Personal characteristics will also be explored to 
determine if they are related to the outcomes of interest.  Any characteristic that has a significant association 
with the outcomes will be included in subsequent analyses as potential covariates. 
Main Analyses 
All hypotheses and research questions will be examined using separate analyses for each outcome variable.  
Assumptions of each type of test will be checked (e.g., assumptions of normality and homogeneity of variance 
for ANOVAs).  If there are violations, non-parametric tests will be used instead.  Sex will be a covariate 
because there are no valid prediction models for male breast cancer, so men will not be shown a breast cancer 
risk estimate.  The inclusion of other personal characteristics as covariates will be determined by the results of 
the preliminary analyses.  Tests of moderation will be conducted by creating interaction terms between the risk 
presentation condition or mental imagery condition variables, as appropriate, and the variable assessing the 
moderator of interest.  All statistical tests will be based on list-wise deletion except structural equation models, 
which can accommodate missing data. 
Mediation analyses will be conducted using structural equation modeling (SEM).  Full Information Maximum 
Likelihood estimation (FIML)[44] will be used to allow the inclusion of missing data.  Standardized estimates will 
be calculated and bias-corrected bootstrapping will be used to obtain the 95% confidence intervals.[45-48]  
Criteria assessing model fit will also be examined (e.g., Standardized Root Mean Square Residual ≤.08, 
comparative fit index ≥.95, root mean square error of approximation ≤.06).[49, 50]  Mediational analyses will 
examine each construct as an individual mediator first, and then as a multiple mediator model.  
Table 2 below describes the analyses that will be conducted for each hypothesis or research question. 
Table 2. Overview of Statistical Analyses 
  
Priority 
Statistical test(s) 
Outcomes 
Predictors/Mediators/Moderators 
Risk Calculator 
H1; 
RQ1 
Primary 
3 arm ANOVA, 2 
planned contrasts 
(risk ladder vs. text; 
risk ladder vs. 
table) 
Comprehension, intentions 
Predictor: Risk presentation condition 
 
H2 
Secondary 
SEM 
Intentions 
Predictor: Risk presentation condition 
(risk ladder vs. text) 
Mediators: comprehension, risk 
perceptions, response efficacy, worry, 
affective reactions to information, 
affective attitudes to exercise, 
anticipated regret 
H3 
Secondary 
3 arm ANOVA, 
planned contrast 
(risk ladder vs. text) 
Change in physical activity 
(mins/week at 90 days – 
mins/week at baseline) 
Predictor: Risk presentation condition  
H4 
Secondary 
SEM 
Change in physical activity 
(mins/week at 90 days – 
mins/week at baseline) 
Predictor: Risk presentation condition 
(risk ladder vs. text) 
Mediator: Intentions 
RQ2 
Secondary 
3 arm ANOVA, 
planned contrast 
(risk ladder vs. 
Risk perceptions, response 
efficacy, worry, affective reactions 
to information, affective attitudes 
Predictor: Risk presentation condition 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 10 
table) 
to exercise, anticipated regret 
RQ3 
Secondary 
3 arm ANOVA 
Comprehension, intentions 
Predictor: Risk presentation condition 
Moderators: Education, race/ethnicity, 
numeracy, health and graph literacy 
Mental Imagery  
H5 
Primary 
T-test 
Change in physical activity 
(mins/week at 90 days – 
mins/week at baseline) 
Predictor: Mental imagery condition 
RQ5 
Primary 
ANOVA 
Change in physical activity 
(mins/week at 90 days – 
mins/week at baseline) 
Predictor: Mental imagery condition 
Moderators: Education, race/ethnicity, 
numeracy, health and graph literacy 
H6 
Secondary 
Regression 
(physical activity 
mental imagery 
condition only) 
Change in physical activity 
(mins/week at 90 days – 
mins/week at baseline) 
Predictors: Week 4 action planning, 
coping planning, action self-efficacy, 
maintenance self-efficacy, recovery 
self-efficacy, affective attitudes to 
exercise, perceived vividness 
RQ6 
Secondary 
Regression 
(physical activity 
mental imagery 
condition only) 
Weekly change in minutes of 
physical activity, assessed by 4 
difference scores: Week1-
Baseline; Week2-Week1; Week3-
Week2; and Week4-Week3 
Predictors: For each weekly 
behavioral assessment, use the 
previous week’s measures of the 
following constructs: action planning, 
coping planning, action self-efficacy, 
maintenance self-efficacy, recovery 
self-efficacy, affective attitudes to 
exercise, perceived vividness. 
 
Sample Size Calculations 
We will enroll 500 participants at baseline.  This will enable us to test the primary hypothesis for each of the 
components of the study.  This calculation was based on the information below. 
RISK CALCULATOR 
Sample size was calculated to be able to detect an effect of risk presentation strategy on the primary outcome 
variables comprehension and intentions (Risk Calculator Hypothesis 1 and RQ1).  Based on a 2-sided test of 
means for 3 groups (ANOVA) at 80% power, =.05, df=2, and Cohen’s f effect size of 0.15 (approximately 
equivalent to Cohen’s d of 0.3),[51, 52] we anticipate needing 432 participants.  The effect size estimate was 
based on a study of personalized breast cancer risk and risk reduction communication that found an effect on 
intentions to increase physical activity of approximately f=0.25 and an effect on response efficacy of 
approximately f=0.20.[4]  However, most of those participants were white, highly educated, had high health 
literacy, and recruited from a breast health center.  Thus, we can expect the findings in our more diverse 
sample to be somewhat lower.  We chose f=.15 as a reasonable compromise because it represents slightly 
more than a minimal effect,[53] but is also logistically feasible.  To account for the possibility of 10% missing 
data in Baseline Survey 1, which assesses the constructs for the Risk Calculator Hypothesis 1, we would need 
to enroll 480 participants to obtain 432 completed surveys. 
MENTAL IMAGERY 
Dr. Cameron’s prior self-regulatory intervention accounted for approximately 20% of the unique variance in 
physical activity at 4-week follow-up.[5]  This is approximately equivalent to a Cohen’s d effect size of 1.0, which 
is considered a large effect.[53]  Because our follow-up is 90 days, we can expect that our effect size will be 
somewhat lower.  Other self-regulation interventions yielded smaller effects over varying timeframes (e.g., 
d=0.28-0.78).[7]  Thus, powering the study to detect an effect of d=0.30 of the intervention on behavior (Mental 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 11 
Imagery Hypothesis 5) would be conservative and reasonable.  Based on a 2-sided test of means for 2 groups 
(t-test) at 80% power, =.05, and Cohen’s d effect size of 0.30,[51, 52] we anticipate needing 352 participants at 
90-day follow-up.  To account for the possibility of 30% attrition rate due to our underserved sample 
(unpublished data), we expect needing to enroll 500 participants at baseline to achieve this goal. 
Study Procedure Calendar 
Table 3. Study Timeline 
  
Year 1 
Year 2 
Year 3 
Year 4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Startup (hiring, IRB amendments) 
X 
X 
X 
X 
X 
 
 
 
Biweekly research team meetings 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Aim 1, Part 1: modify and refine stimulus 
(includes cognitive interviews) 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
Aim 1, Part 2: refine, program, pilot test, 
and finalize questionnaires 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 1, Part 2: collect data (GfK) 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Aim 1, Part 2: analyze and interpret data 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
Aim 1, Part 2: disseminate results 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
 
Aim 2, Part 1: convert relative risk 
estimates to absolute risk estimates 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
Aim 2, Part 1: disseminate results 
 
 
X 
X 
X 
 
 
 
 
 
 
 
Aim 2, Part 1: write and verify the 
accuracy of the computer code used to 
calculate risk estimates and show the 
risk results displays (includes interviews) 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Aim 2, Part 2: Recruit participants and 
implement risk calculator and mental 
imagery interventions 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
Aim 2, Part 2: 90-day follow-up 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
 
Aim 2, Part 2: analyze data 
 
 
 
 
X 
X 
X 
 
 
Aim 2, Part 2: disseminate results 
 
 
 
 
 
X 
X 
 
Drug Formulation and Procurement 
Not applicable. 
Data and Safety Monitoring Plan 
RISK CALCULATOR AND MENTAL IMAGERY 
Voluntary participation 
We will protect against emotional discomfort by emphasizing that participation is voluntary.  Participants will 
provide informed consent.  They will be informed that participation is voluntary and that they can elect not to 
answer any question that makes them uncomfortable or withdraw at any time during the study without any 
penalty. Additionally, participants will be informed that all study data will be kept confidential and that all 
personal identifiers will be destroyed when the study is completed. 
Confidentiality and Data Security 
There are several layers of protection regarding confidentiality and data security. 
First, the study is undergoing a Washington University Information Security Office IRB Study Security review.  
A detailed description of our study’s confidentiality and data security features is described in that document. 
(see Appendix JJ).   

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 12 
Second, the websites that host the data (i.e., Amazon Web Services and Twilio) have extensive security 
precautions.  These precautions are being reviewed by the Information Security Office (see Appendices JJ, 
KK, and LL). 
Third, the study team will be alert for any potential breaches to prevent inadvertent release of confidential 
information.  If a potential breach in confidentiality occurs, the PI will work with the Institutional Review Board, 
HIPAA, and the Information Security Office according to their rules and regulations for such a situation. 
Fourth, all study data will be downloaded to WUSM servers on a daily basis.  Access to data will be password 
protected to restrict use by non-study personnel.  All data will be stored using ID numbers, not names. 
Participants’ responses to study questions will be coded to protect their confidentiality, and names will be kept 
separate from survey data.  Any data that is transported on portable storage devices will be encrypted. Hard 
copies collected at the in person recruitment locations will be transferred to storage by an RA in a closed 
envelope and will not leave sight of the RA until securely stored. All paper copies will be will be stored in a 
locked filing cabinet in a locked suite in an entry controlled building. No personally identifying information will 
appear in any presentations or publications that results from this study; only aggregated data will be 
disseminated. 
Record Keeping 
RISK CALCULATOR AND MENTAL IMAGERY 
Records will be maintained by the study coordinator and supervised by the PI.  All information will be recorded 
in password-protected databases and held on WUSM servers, which are encrypted and backed up nightly.  
The study coordinator will record the following pieces of information: 
• 
Participants’ contact information, which is needed for the text messaging and follow up activities (i.e., 
Parts 2 and 3). 
• 
Survey responses, which are linked to participants via an individual identifier but are not linked to 
names or contact information. 
Paper copies of study materials will be kept in a locked filing cabinet located within a locked office suite.  For 
additional information, see Data Safety and Monitoring Plan. 
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Special Considerations 
Not applicable. 
List of Appendices 
Appendix A, Aim 2, Risk App Screens 
Appendix C, Aim 2, Baseline Survey 
Appendix D, Aim 2 Mental Imagery Script- Physical Activity  
 Appendix E, Aim 2 Mental Imagery Script- Sleep Hygiene Appendix F, Aim 2 Pamphlet  
Appendix H, Aim 2 Intervention Screener  
Appendix I, Aim 2 Participant Contact Sheet  
Appendix J, Aim 2 Reminder Call Script  
Appendix K, Aim 2 Screening Log 
Appendix L, Aim 2 Baseline Survey 2 Physical Activity  
Appendix M, Aim 2 Baseline Survey 2 Sleep Hygiene  
Appendix N, Aim 2 Recruitment Call Script  
Appendix O, Recruitment Email Script  
Appendix P, Aim 2, BJC Ad  
Appendix Q, Aim 2, Centerwatch Ad Appendix R, Aim 2, Facebook Posting  
Appendix T, Aim 2, Website Posting  
Appendix U, Aim 2, Reaserchmatch.org email  
Appendix W, Aim 2 Data Collection Session 1 Guide  
Appendix X Aim 2 Text Messages- Exercise  
Appendix Y Aim 2 Text Messages- Sleep  
Appendix Z, Aim 2 Final Survey Reminder Call Script  
Appendix AA, Aim 2 Mailed Survey Invitation  
Appendix BB, Aim 2 Final Follow-Up Survey  
Appendix CC, Aim 2 Newspaper Advertisement  
Appendix DD, Aim 2 Request Letter for SSN  
Appendix EE, Aim 2 Gift card receipt 
Appendix FF, Aim 2 Flyer  
Appendix GG, Aim 2 Flyer Pull Tab  
Appendix HH, Aim 2 Instructions for baseline survey  
Appendix II, Aim 2 One year Follow Up Call Script with Questions  
Appendix JJ, Aim 2 IRB Study Security Review 20170503-01 

 
Communicating Multiple Disease Risk, Aim 2, Part 2 (Version 1) 16 
Appendix KK, Aim 2 Aws Security Whitepaper 
Appendix LL, Aim 2 Twilio Whitepaper Security-Architecture