Tailoring Online Continence Promotion for Women
Phase: NA
Conditions: Urinary Incontinence in Old Age, Fecal Incontinence in Old Age
Sponsor: University of Wisconsin, Madison

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tailoring Online Continence Promotion for Women 
 
NCT05183217 
4/19/2024 
 
 

~ i ~ 
 
 
 
 
 
 
 
Tailoring Online Continence Promotion for Women 
 
 
 
 
 
 
Protocol Number: MRR 2021-1555 
Principal Investigators: Megan Piper, PhD and Heidi Brown, MD, MAS 
 
 
 
Funding Source: National Institute of Diabetes and Digestive and Kidney Disease 
 
 
This document is confidential. 
No part of it may be transmitted, reproduced, published, or used by other persons without prior 
authorization from the Principal Investigator. 
 
 
 
Protocol Version History 
 
Protocol 
Version 
Version 
Date 
Summary of Revisions Made 
Rationale 
1.0 
11/05/2021 
Initial version 
 
2.0 
12/10/2021 
Revisions made after IRB pre-review 
 
3.0 
10/17/2022 
Updates needed due to Dr. Werner’s 
change in location and change in location  
 
4.0 
9/20/2023 
Final revisions before launch of 
recruitment and updates due to Dr. 
Brown’s change in institution 
 
5.0 
1/3/2024 
Increase enrollment number 
 
6.0 
1/6/2024 
Implementing a quality check to ensure 
participants are real participants 
 
7.0 
2/6/2024 
Enrollment criteria 
 
8.0 
4/19/2024 
Changes requested following post-
approval monitoring review of study 
 
 
 

- i - 
 
 
Table of Contents 
 
1.0 
STATEMENT OF COMPLIANCE ................................................................................................................ 1 
2.0 
LIST OF ABBREVIATIONS ........................................................................................................................ 2 
3.0 
STUDY SUMMARY ..................................................................................................................................... 3 
 
Synopsis .......................................................................................................................................... 3 
4.0 
KEY ROLES ................................................................................................................................................ 6 
5.0 
INTRODUCTION ......................................................................................................................................... 7 
 
Background ...................................................................................................................................... 7 
 
Rationale .......................................................................................................................................... 9 
6.0 
STUDY OBJECTIVES AND ENDPOINTS .................................................................................................. 9 
7.0 
STUDY DESIGN ........................................................................................................................................ 11 
 
General Design .............................................................................................................................. 11 
 
End of Study Definition .................................................................................................................. 12 
8.0 
PARTICIPANT SELECTION ..................................................................................................................... 12 
 
Inclusion & Exclusion Criteria ........................................................................................................ 12 
 
Vulnerable Populations .................................................................................................................. 12 
 
Participant Identification ................................................................................................................. 12 
 
Participant Recruitment .................................................................................................................. 13 
 
Remuneration and Retention Strategies ........................................................................................ 13 
 
Early Termination and Withdrawal ................................................................................................. 14 
9.0 
PROCEDURAL INTERVENTION .............................................................................................................. 14 
 
Study Procedural Intervention and Control Description ................................................................. 14 
9.1.1 
Description of Treatment Group Intervention .................................................................................................... 14 
9.1.2 
Description of Active Control Group .................................................................................................................. 15 
 
Method for Assigning to Treatment Groups - Randomization ........................................................ 15 
10.0 STUDY PROCEDURES ............................................................................................................................ 15 
 
Screening, Informed Consent, and Enrollment .............................................................................. 15 
10.1.1 
Screening .......................................................................................................................................................... 15 
10.1.2 
Informed Consent ............................................................................................................................................. 16 
10.1.3 
Enrollment ......................................................................................................................................................... 16 
10.1.4 
Screen Failure and Re-enrollment .................................................................................................................... 16 
 
Study Questionnaires and Surveys ................................................................................................ 16 
10.2.1 
Demographics Questionnaire ............................................................................................................................ 17 
10.2.2 
Pelvic Floor Muscle Exercise Frequency .......................................................................................................... 17 
10.2.3 
Fiber Food Frequency Questionnaire ............................................................................................................... 17 
10.2.4 
Fluid and Voiding Questionnaire ....................................................................................................................... 17 
10.2.5 
Geriatric Self-Efficacy Index for Urinary Incontinence ....................................................................................... 17 
10.2.6 
Generalized Self-Efficacy Scale adapted for MOM program ............................................................................. 17 
10.2.7 
Program-Specific Survey of Other Health Action Process Approach Components ........................................... 17 
10.2.8 
Barriers to Incontinence Care-Seeking Questionnaire ...................................................................................... 17 
10.2.9 
Barriers to Care-seeking for Accidental Bowel Leakage ................................................................................... 18 
10.2.10 International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form ........................ 18 
10.2.11 St. Mark’s Incontinence Score .......................................................................................................................... 18 
10.2.12 Pelvic Floor Impact Questionnaire Short Form ................................................................................................. 18 
10.2.13 12-item Short Form Health Survey (SF-12)....................................................................................................... 18 
10.2.14 Symptom Improvement and Program Satisfaction ............................................................................................ 18 
10.2.15 Behavioral Intention to Use Scale ..................................................................................................................... 18 

- ii - 
 
Study Calendar .............................................................................................................................. 18 
11.0 SPECIAL STUDY – QUALITATIVE INTERVIEWS ................................................................................... 19 
 
Assessments and Data Collection Procedures .............................................................................. 19 
 
Analytic Plan .................................................................................................................................. 20 
 
Qualitative Rigor ............................................................................................................................ 20 
12.0 DATA HANDLING AND RECORD KEEPING .......................................................................................... 20 
 
Data Collection and Database Management ................................................................................. 20 
 
Confidentiality and Privacy ............................................................................................................. 21 
 
Records Retention ........................................................................... Error! Bookmark not defined. 
 
Protocol Deviations ........................................................................................................................ 22 
 
Publication and Data Sharing Policies ........................................................................................... 22 
13.0 STUDY ANALYSIS ................................................................................................................................... 22 
 
Statistical Hypotheses .................................................................................................................... 22 
 
Sample Size Justification ............................................................................................................... 23 
 
Participant Population(s) for Analysis ............................................................................................ 23 
 
Statistical Methods ......................................................................................................................... 23 
13.4.1 
Primary Outcome Measures and Analysis ........................................................................................................ 23 
13.4.2 
Secondary Outcome Measures and Analysis ................................................................................................... 24 
 
Handling of Missing Data ............................................................................................................... 25 
14.0 RISK/BENEFIT ASSESSMENT ................................................................................................................ 25 
 
Known Potential Benefits to the Participants ................................................................................. 25 
 
Known Potential Risks ................................................................................................................... 26 
 
Risk/Benefit Analysis ..................................................................................................................... 26 
15.0 DATA AND SAFETY MONITORING ........................................................................................................ 26 
 
Data and Safety Monitoring Plan ................................................................................................... 26 
 
Safety Review Committee .............................................................................................................. 27 
16.0 REFERENCES .......................................................................................................................................... 28 

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Brown and Piper 
 
 
 
 
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1.0 
STATEMENT OF COMPLIANCE 
I confirm that I have read this protocol. I will comply with the IRB-approved protocol, and applicable 
regulations, guidelines, laws, and institutional policies.  
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitment.  
 
Name 
Signature 
Date 
 
 
_Heidi W. Brown, MD, MAS ____ 
_____________________________ 
_11/05/2021_ 
Principal investigator 
 
_Megan Piper, PhD______ ____ 
_____________________________ 
_9/20/2023_ 
Principal investigator 
 
 
____Not Applicable (NIDDK)__________ 
_____________________________ 
________ 
Sponsor 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2.0 
LIST OF ABBREVIATIONS 
 
BCABL 
Barriers to Care-seeking for Accidental Bowel Leakage 
BICS 
Barriers to Incontinence Care-Seeking Questionnaire 
BMI 
Body Mass Index 
CCC 
Clinical Coordinating Center 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMP 
Data and Safety Monitoring Plan 
EPI 
Estimated Percent Improvement 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GPI 
Global Perception of Improvement 
GSE-UI 
Geriatric Self-Efficacy Index for Urinary Incontinence 
HIPAA 
Health Insurance Portability and Accountability Act 
HSIRB 
Health Sciences Institutional Review Board 
ICIQ-UI SF 
International Consultation on Incontinence Questionnaire – Urinary Incontinence Short 
Form 
IRB 
Institutional Review Board 
MOM 
Mind Over Matter 
NDE 
Natural Direct Effect 
NIDDK 
National Institute of Diabetes and Digestive and Kidney Diseases 
NIE 
Natural Indirect Effect 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PFIQ-7 
Pelvic Floor Impact Questionnaire Short Form 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PSQ 
Patient Global Ratings of Satisfaction 
SMIS 
St. Mark’s Incontinence Score 
UW 
University of Wisconsin-Madison  
 
 
 

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3.0 
 
STUDY SUMMARY 
 Synopsis 
 
Full Title 
Tailoring Online Continence Promotion for Women 
Protocol Number 
MRR 2021-1555 
ClinicalTrials.gov 
Identifier & 
Summary 
NCT05183217 
This project seeks to understand whether, and how, tailoring an online continence 
intervention can increase engagement and uptake of health behaviors known to improve 
symptoms. 
Number of Site(s) University of Wisconsin-Madison 
Main Inclusion 
Criteria 
• 
Female, age > 50 years  
• 
Can read and write English 
• 
Can use email 
• 
Has access to Internet-connected device (such as a computer, tablet, or smart phone) to 
use an online program  
Main Exclusion 
Criteria 
• 
Women with medical conditions for which the intervention is not medically appropriate, 
including: 
− dementia  
− neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are 
contraindicated  
− hematuria or bloody stools within the last 6 months that have not been evaluated by a 
medical professional  
Objective(s) 
Primary Objective  
• 
To evaluate whether tailoring will increase engagement with online MOM. [Corresponds 
to Aim 1 of grant] 
Secondary Objectives  
• 
To evaluate whether tailoring will increase adoption and maintenance of health behaviors 
that promote continence. [Corresponds to Aim 2 of grant] 
• 
To determine the extent to which intervention engagement mediates the effect of tailoring 
on health behavior change. [Corresponds to Aim 3 of grant] 
• 
To determine the extent to which factors other than degree of intervention engagement 
mediate the effect of tailoring on health behavior change. [Corresponds to Aim 3 of grant] 
Endpoints 
Primary Endpoint 
• 
Proportion of participants who engage with online MOM (participation in at least one 
session per week during the first 4 weeks of the program) in the group with (test) and 
without (control) tailoring. [Aim 1 primary outcome] 
• 
Comparison of specific program use metrics (number of, minutes spent on, and average 
intervals between program sessions accessed weekly; number of and specific 
components accessed) between the two groups and cluster analyses will identify 
patterns of program use (such as tracking and reminders). [Aim 1 exploratory outcomes]  
Secondary Endpoints 

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• 
Proportion of participants in the treatment group compared to the control group who 
adopt consistent pelvic floor muscle exercises at 4 weeks, defined as self-reported 
performance of pelvic floor muscle exercises consistently (often or always) at 4 weeks 
after reporting inconsistent performance of these exercises at baseline. [Aim 2 primary 
outcome] 
• 
Proportion of participants in the treatment group compared to the control group who 
maintain exercise (reporting consistent exercise performance at two consecutive time 
points between 4, 12, and 24 weeks). [Aim 2 exploratory outcome] 
• 
Proportion of participants in the treatment group compared to the control group who 
adopt other health behaviors (fiber intake of at least 21 g; caffeine intake <205 mg/day, 
daily fluid intake between 60 and 100 ounces, and 6-9 voids per day) at 4 weeks, defined 
as exhibiting these behaviors consistently (often or always) at 4 weeks after reporting 
inconsistent performance of these behaviors at baseline. [Aim 2 exploratory outcome]  
• 
Proportion of participants in the treatment group compared to the control group who 
maintain other health behaviors (fiber intake of at least 21 g; caffeine intake <205 
mg/day, daily fluid intake between 60 and 100 ounces, and 6-9 voids per day), reporting 
consistent performance of these behaviors at two consecutive time points between 4, 12, 
and 24 weeks). [Aim 2 exploratory outcome] 
• 
Proportion of participants in the treatment group compared to the control group with a 
body mass index (BMI) >25mg/kg2 at baseline who report weight loss of at least 2 kg at 
12 or 24 weeks. [Aim 2 exploratory outcome] 
• 
Assessment of degree of program engagement (defined by program use data during the 
first 4 weeks) in relation to the intervention’s effect on adoption of pelvic floor muscle 
exercises at 12 weeks. [Aim 3 outcome] 
• 
Assessment of self-efficacy (comparing change in self-efficacy measures at 4 weeks 
relative to baseline [0 weeks]) in relation to the intervention’s effect on adoption of pelvic 
floor muscle exercises at 12 weeks. [Aim 3 outcome] 
• 
Assessment of incontinence symptoms and quality of life (comparing change in survey 
rating at 4 weeks relative to baseline [0 weeks]) in relation to the intervention’s effect on 
adoption of pelvic floor muscle exercises at 12 weeks. [Aim 3 outcome] 
• 
Assessment of barriers to care-seeking (comparing change in survey rating at 4 weeks 
relative to baseline [0 weeks]) in relation to the intervention’s effect on adoption of pelvic 
floor muscle exercises at 12 weeks. [Aim 3 outcome] 
Study Design 
This is a two-arm, parallel, randomized, controlled trial (RCT) comparing an online 
continence promotion program with standard weekly reminders (control arm) to an online 
continence promotion program with tailoring (treatment arm) to determine the impact of 
tailoring on program engagement. 
Study 
Intervention 
Women in the treatment arm will receive tailored content and digital reminders for 12 weeks 
based on their individual characteristics, symptoms, and behaviors assessed at baseline, 
with reassessment of key inputs every week resulting in re-tailored outputs.  
Total Number of 
Participants 
Up to 800 participants will be recruited for the main project. A subset of participants (N=36) 
will be invited to complete semi-structured qualitative interviews. 
Study Population 
Females aged 50 years and older in the U.S. who do not have medical conditions for which 
the intervention is not medically appropriate.  

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Statistical 
Methodology 
The proportion of participants in the treatment versus control group who achieve 
engagement (primary outcome) will be compared using binomial chi-squared test with type I 
error rate at 0.05. 
Estimated 
Participant 
Duration 
The duration of the study for each participant is approximately 24 weeks.  
Estimated 
Enrollment 
Period & Study 
Duration 
Study enrollment will occur over 12 months with the total expected duration of the trial to be 
18 months.  
 
 
 

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4.0 
KEY ROLES 
The following is a list of all key personnel and roles: 
 
Principal 
Investigators 
Megan Piper, PhD 
Professor 
Department of Medicine 
University of Wisconsin SMPH 
1930 Monroe Street, Suite 200 
Madison, WI 53711 
608-265-5472 
mep@ctri.wisc.edu 
 
Heidi Brown, MD, MAS 
Clinician Researcher II 
Kaiser Permanente Research  
Division of Health Services Research & Implementation 
Science 
3250 Fordham Street 
San Diego, CA 92110 
619-695-4714 
Heidi.w.brown@kp.org 
Participating 
Site(s) 
University of Wisconsin-Madison 
Madison, WI 53715-1507 
 
Kaiser Permanente Southern California 
San Diego, WI 92110 
Safety Review 
Committee 
Safety Review Committee 
University of Wisconsin-Madison SMPH 
Chair, Jane Mahoney, MD 
jm2@medicine.wisc.edu  
Study 
Monitoring 
Contact
 
 
Megan Piper, PhD 
Professor 
Department of Medicine 
University of Wisconsin SMPH 
1930 Monroe Street, Suite 200 
Madison, WI 53711 
608-265-5472 
mep@ctri.wisc.edu 
Funding 
Sponsor 
National Institute of Diabetes and Digestive and Kidney 
Diseases 
9000 Rockville Pike 
Bethesda, MD 20892  
NIH Point of 
Contact 
Julia Spencer Barthold 
Scientific Review Officer 
National Institute of Diabetes and Digestive and Kidney 
Diseases 
9000 Rockville Pike 
Bethesda, MD 20892 
301-435-0832 
julia.barthold@nih.gov 
Biostatistician 
Lu Mao, PhD 
Assistant Professor 
Department of Biostatistics and Medical Informatics 
University of Wisconsin SMPH 

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610 Walnut St, Room 207A  
Madison, WI 53726 
608-263-5674  
lmao@biostat.wisc.edu   
Data 
Coordinating 
Center 
University of Wisconsin-Madison 
610 Walnut St, Room 201 
Madison, WI 53726 
608-263-1706 
kamiller@biostat.wisc.edu 
Clinical 
Coordinating 
Center 
University of Wisconsin-Madison 
Madison, WI 53715-1507 
 
5.0 
INTRODUCTION 
 Background 
Incontinence is common, costly, and vastly undertreated in women. More than 60% of women age 65 
or older suffer from urinary and/or bowel incontinence, the combined annual cost of which exceeds $30 
billion in women aged 50 and older [1-3], and its prevalence is increasing, even in younger women [4]. In 
addition to negative impacts on quality of life, social isolation, and depression [3, 5-7], urinary and bowel 
incontinence increase risks for caregiver burnout, hospitalization, and nursing home placement [8-11]. 
Despite the existence of effective treatments [12-16], we found that over half of women with urinary 
incontinence and 70% of women with bowel incontinence do not seek medical care [17]. Incontinence 
interventions delivered in healthcare settings thus reach fewer than half of those in need.  
 
An in-person intervention delivered in community settings, Mind Over Matter: Healthy Bowels, 
Healthy Bladder (MOM) improves bladder and bowel incontinence and increases adoption and 
maintenance of pelvic floor muscle exercises in women age 50 and older [18]. This program was 
developed and tested during the PI’s career development award. Based on the Health Action Process 
Approach (Figure1) [19, 20], in-person MOM consists of three 2-hour sessions over 4 weeks during which 
eight to 12 women learn strategies to improve symptoms, set personal goals, and overcome barriers to 
success. The program is delivered in the community by a trained lay-facilitator and targets both urinary and 
bowel incontinence, which often co-occur. Key content includes instruction about behavior changes that 
improve both urinary and bowel incontinence (pelvic floor muscle exercises, fluid and fiber adjustments, 
weight loss, and toileting strategies). MOM is innovative because it targets both urinary and bowel 
symptoms, can be facilitated without health expertise, and incorporates a care-seeking tool designed 
specifically to overcome barriers previously identified by our team [21]. In a randomized, waitlist-control trial 
(N=121), MOM participants had eight-fold odds of improved urinary continence and three-fold odds of 
improved bowel continence compared to controls [18]. 
 
Although MOM is effective, its reach remains limited because of its in-person format. Community 
organizations’ staff and funding constraints limit their ability to offer resource-intensive, small-group 
programs [22]. We partnered with a state epidemiologic survey to identify women aged 50 and over with 
incontinence outside the healthcare setting and learned that only 17% would participate in a small-group 
program like MOM, whereas over 60% would participate in an online version, noting its superior 
convenience and privacy [23]. Community organizations can promote online programs using websites, e-
newsletters, and social media without consuming precious limited resources. 
 
With a pilot dissemination and implementation grant, we adapted the key components of the in-
person MOM program to an online setting (www.healthybowelandbladder.org).The online MOM 

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program reached 15 times as many women in 3 months as the in-person MOM program reached in an 
entire year. In our dissemination pilot study, there were 4,471 new visitors to the online program (94% 
female, 27% age 55-64, 60% > 65) over a 3 month time period, versus 282 participants in the in-person 
program over 12 months (April 2019-2020) (unpublished data). However, the average number of program 
sessions completed by online participants was 1, and the proportion of users in the pilot study doing pelvic 
floor muscle exercises consistently four months later was only 27% (28/102) (as compared to 63% four 
months after participation in the in-person MOM program) [18]. This finding is similar to findings by a 
Swedish incontinence research group examining an Internet program to improve urinary incontinence, 
where only 16% of users (27/166) who started the program completed it, and only 40% of those (11/27) did 
pelvic floor muscle exercises consistently [24]. Unfortunately, engagement with digital health interventions 
is dismally low across health conditions [25, 26].  
 
The potential public health impact of online programs is tremendous because of their relative 
scalability, reach, and cost-effectiveness, but they require optimization to maximize engagement 
and efficiency and preserve effectiveness of in-person programs. To increase engagement in other 
mobile/online interventions, daily digital triggers have been used [27, 28]. However, such digital triggers 
prompt some users to disengage, and can become subject to alert fatigue and habituation, depending on 
their timing, frequency, and content [29]. For example, in a mobile telehealth program for urinary 
incontinence specifically designed for U.S. women veterans (MyHealtheBladder) that involves daily 
motivational emails and program sessions, one-third of participants disengaged over 8 weeks [28]. In our 
qualitative interviews to understand barriers to engagement with online MOM, some users wanted email or 
text reminders, whereas others strongly felt such reminders would be intrusive (unpublished data). This 
sentiment was also described by Swedish women users of a mobile app (Tät) for stress urinary 
incontinence, which incorporates an optional reminder function as part of its program [30]. Similarly, while 
some online MOM users preferred the autonomy of the self-guided program, others wished for a guided 
experience where they would be directed to program features most relevant for them specifically. These 
diverse and conflicting user preferences and behaviors emphasize the challenges faced by one-size-fits-all 
interventions. In fact, NIDDK has convened multiple workshops in recent years focused on developing a 
science base to personalize urinary incontinence treatments [31, 32]. 
 
Tailoring, or personalization, improves engagement with and sustained participation in electronic 
health promotion interventions targeting conditions such as tobacco use, obesity, and diabetes. 
Tailoring delivers information that is customized to be personally relevant to the user, and thus more likely 
to be read, cognitively processed, and acted upon [34]. Information about the individual, or “input,” is used 
to select personalized content from an expert-developed database using a computerized algorithm [35]. 
Table 1. Model of tailoring depth applied to online MOM program (based on [33]) 
Level 
Input 
Tailoring Strategies 
Output 
Deep 
(Health 
Action 
Process 
Approach) 
[19] 
• 
Self-efficacy 
• 
Risk perception 
(and current 
symptoms) 
• 
Outcome 
expectations 
• 
Intentions 
• 
Barriers & 
resources 
• 
Content matching 
• 
Evaluative 
feedback 
• 
Personalizing 
sender, content, 
medium for 
triggers 
• 
Situation-specific 
action & coping 
plans 
• 
Digital triggers that 
align with user’s 
phase (motivational 
vs. volitional)  
Surface 
• 
Self-reported 
reminder 
preferences 
• 
Behavior tracking 
• 
Program use 
• Comparative 
progress  
• Trigger 
frequency, timing, 
intervals 
• 
Reinforce behavior 
& symptom tracking 
• 
Celebrate goal 
attainment  

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That individualized content, or “output,” is delivered to the individual user through multiple strategies and 
delivery modes, including digital triggers that can be further tailored in five domains (sender, medium, 
timing, frequency, and content) [29]. Table 1 depicts two tailoring levels: surface-level (based on 
observable factors) and deep (based on theoretical constructs) [33]. Tailoring improves engagement with 
and effectiveness of online programs promoting behavior changes related to physical activity, nutrition, and 
smoking cessation, especially when tailoring algorithms are informed by behavior change theory and 
conceptual models relevant to target outcomes [33-37].  
 Rationale 
Transdisciplinary, rigorous research is needed to individualize treatment for urinary incontinence, a 
specific priority for NIDDK. The proposed work harnesses expertise from investigators outside 
urology to study whether and how tailoring electronic continence interventions can increase their 
potential effectiveness and reach. Our team combines diverse expertise in human factors engineering, 
clinical and social psychology, health communication theory, dissemination and implementation research, 
and urogynecology to contribute critical insight about how tailoring principles, widely used in other 
electronic health interventions, can be most impactful for urinary and bowel continence promotion. We 
anticipate that our findings will be applicable to other electronic continence promotion interventions, and 
may inform other incontinence treatment interventions that include pelvic floor muscle exercises as a 
component. This small R01 grant will provide the preliminary data required for a subsequent large-scale 
trial examining the impact of a novel electronic continence promotion program on urinary and bowel 
incontinence symptoms and evaluating dissemination strategies. Our long-term goal is to discover and 
enhance solutions for incontinence in women and identify optimal methods for their dissemination outside 
the healthcare setting. This work is directly responsive to NIDDK’s mission to enhance science regarding 
personalized therapy for urinary incontinence. Furthermore, the intervention being studied targets another 
disease of interest to NIDDK: bowel incontinence. 
6.0 
STUDY OBJECTIVES AND ENDPOINTS 
 
Objectives 
Endpoints 
Primary 
To evaluate whether tailoring will increase 
engagement with online MOM. 
[Corresponds to Aim 1 of grant] 
• 
Proportion of participants who engage with 
online MOM (participation in at least one 
session per week during the first 4 weeks of 
the program) in the group with (test) and 
without (control) tailoring. [Aim 1 primary 
outcome] 
• 
Comparison of specific program use metrics 
(number of, minutes spent on, and average 
intervals between program sessions accessed 
weekly; number of and specific components 
accessed) between the two groups and 
cluster analyses will identify patterns of 
program use (such as tracking and 
reminders). [Aim 1 exploratory outcomes]  
Secondary 

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To evaluate whether tailoring will increase 
adoption and maintenance of health 
behaviors that promote continence. 
[Corresponds to Aim 2 of grant] 
• 
Proportion of participants in the treatment 
group compared to the control group who 
adopt consistent pelvic floor muscle exercises 
at 4 weeks, defined as self-reported 
performance of pelvic floor muscle exercises 
consistently (often or always) at 4 weeks after 
reporting inconsistent performance of these 
exercises at baseline. [Aim 2 primary 
outcome] 
• 
Proportion of participants in the treatment 
group compared to the control group who 
maintain exercise (reporting consistent 
exercise performance at two time points 
between 4, 12, and 24 weeks). [Aim 2 
exploratory outcome] 
• 
Proportion of participants in the treatment 
group compared to the control group who 
adopt other health behaviors (fiber intake of 
at least 21 g; caffeine intake <205 mg/day, 
daily fluid intake between 60 and 100 ounces, 
and 6-9 voids per day) at 4 weeks, defined as 
exhibiting these behaviors consistently (often 
or always) at 4 weeks after reporting 
inconsistent performance of these behaviors 
at baseline. [Aim 2 exploratory outcome]  
• 
Proportion of participants in the treatment 
group compared to the control group who 
maintain other health behaviors (fiber intake 
of at least 21 g; caffeine intake <205 mg/day, 
daily fluid intake between 60 and 100 ounces, 
and 6-9 voids per day), reporting consistent 
performance of these behaviors at two time 
points between 4, 12, and 24 weeks). [Aim 2 
exploratory outcome] 
• 
Proportion of participants in the treatment 
group compared to the control group with a 
body mass index (BMI) >25mg/kg2 at 
baseline who report weight loss of at least 2 
kg at 12 or 24 weeks. [Aim 2 exploratory 
outcome] 
To determine the extent to which 
intervention engagement mediates the 
effect of tailoring on health behavior 
change. [Corresponds to Aim 3 of grant]  
• 
Assessment of degree of program 
engagement (defined by program use data 
during the first 4 weeks) in relation to the 
intervention’s effect on adoption of pelvic floor 
muscle exercises at 12 weeks. [Aim 3 
outcome]  

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To determine the extent to which 
psychological variables and incontinence 
symptoms mediate the effect of tailoring 
on health behavior change. [Corresponds 
to Aim 3 of grant] 
• 
Assessment of self-efficacy (comparing 
change in self-efficacy measures at 4 weeks 
relative to baseline [0 weeks]) in relation to 
the intervention’s effect on adoption of pelvic 
floor muscle exercises at 12 weeks. [Aim 3 
outcome] 
• 
Assessment of incontinence symptoms and 
quality of life (comparing change in survey 
rating at 4 weeks relative to baseline [0 
weeks]) in relation to the intervention’s effect 
on adoption of pelvic floor muscle exercises 
at 12 weeks. [Aim 3 outcome] 
• 
Assessment of barriers to care-seeking 
(comparing change in survey rating at 4 
weeks relative to baseline [0 weeks]) in 
relation to the intervention’s effect on 
adoption of pelvic floor muscle exercises at 
12 weeks. [Aim 3 outcome] 
 
7.0 
STUDY DESIGN 
 General Design  
We will conduct a two-arm, parallel, randomized, controlled trial (RCT) comparing an online continence 
promotion program with standard weekly reminders (control arm) to an online continence promotion 
program with tailoring (treatment arm) to determine the impact of tailoring on program engagement. 
Women in the treatment arm will receive tailored content and digital reminders for 12 weeks based on their 
individual characteristics, symptoms, and behaviors assessed at baseline, with reassessment of key inputs 
every week resulting in re-tailored outputs. Participants (N=600) will be randomized and complete 
electronic surveys at enrollment, 4, 12, and 24 weeks. The primary outcome is the proportion of 
participants who engage with the program at least weekly in the first 4 weeks of the trial in the treatment 
versus control arms, with data collection continuing for 24 weeks to explore the impacts of tailoring over 
time. Cluster analysis based on machine learning principles will identify patterns of program use. 
Secondary outcomes will 1) compare the rates of adoption of pelvic floor muscle exercises (at 4 weeks) 
and maintenance (continuing to perform pelvic floor muscle exercises at 12 and/or 24 weeks) in the 
treatment and control groups and will explore differences in other continence-related behavior changes in 
these groups, and 2) will examine the extent to which program engagement in the first 4 weeks mediates 
the effect of tailoring on health behavior change at 12 weeks and will explore other potential mediators. To 
contextualize the findings from all 3 aims, a subset of participants (N=36) will be invited to complete semi-
structured qualitative interviews about their engagement with the program, their adoption of health 
behaviors, and their perceived barriers to and facilitators of engagement and behavior change (see section 
11.0).  
 

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 End of Study Definition 
A participant is considered to have completed the study when 30 weeks have elapsed from completion of 
baseline questionnaire (after electronically signing the informed consent form) (allows 6 weeks to capture 
final 24 week data).  
8.0 
PARTICIPANT SELECTION 
 Inclusion & Exclusion Criteria   
Eligibility will be determined by inclusion and exclusion criteria below. 
 
Inclusion Criteria  
1. Willing to provide informed consent. 
2. Female, age > 50 years. 
3. Can read and write English. 
4. Can use email. 
5. Has access to Internet-connected device (computer, tablet, or smart phone) to use the online 
program  
 
Exclusion Criteria 
• 
Women with medical conditions for which the intervention is not medically appropriate, 
including: 
• 
dementia  
• 
neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are 
contraindicated  
• 
hematuria or bloody stools within the last 6 months that have not been evaluated by a 
medical professional  
• 
Not suitable for study participation due to other reasons at the discretion of the investigators. 
  Vulnerable Populations 
Recruited participants may meet the definition of “older adults” (65 years of age or older) or “elderly 
individuals,” a vulnerable population. No other vulnerable populations will be recruited or eligible for the 
study. Women with medical conditions for which the intervention is not medically appropriate will be 
excluded (dementia, neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are 
contraindicated, recent hematuria or bloody stools that have not been evaluated by a medical 
professional). Specific efforts will be made to optimize recruitment of women in rural areas and 
underrepresented minority groups.  
 Participant Identification 
Potential participants may self-identify by responding to IRB-approved recruitment efforts, such as web 
postings, posters/flyers, social media ads, newsletter ads, mass mailings, email blasts, etc. IRB-approved 

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screening scripts, eligibility questionnaires, and email response templates will be utilized when 
communicating with potential participants who respond to these recruitment methods. 
 
Information collected is to be limited to protect the potential participant’s privacy and information collected 
from potential participants who fail pre-screening or decline to participate. Any information collected from 
potential participants who fail pre-screening or decline to participate will be stored anonymously (no 
identifiers retained). Indirect recruitment materials and response communications will not contain 
participant health information. 
 Participant Recruitment 
We will recruit participants using the methods we have used successfully in the past: email list solicitation, 
electronic dissemination by community agencies and paid advertisements on social media. All of the 
recruitment materials that the research team will use to recruit participants have been uploaded to 
ARROW. The research team will not recruit participants by phone. However, if individuals have questions 
regarding the study, they may contact the research team by phone or email. The research team will use the 
Basic Introductory Telephone Script guidance when communicating with participants via phone about the 
study.   
 
We have previously found that advertising via Facebook was particularly effective, supporting the feasibility 
of using these recruitment strategies for the proposed work. Program engagement was higher among 
those who enrolled in online MOM through a link on a community organization’s website (mean session 
time 6 minutes, 4.8 pages) than among those who clicked on a Facebook advertisement (mean session 
time 58 seconds, 1.7 pages).  
 
To optimize recruitment of women in rural areas and under-represented minority groups, we will specifically 
advertise with community agency partners that serve those communities. Each partner agency will 
disseminate recruitment advertisements and promote participation under its own banner, via the usual 
electronic and social media channels by which it routinely communicates with its constituents. Alongside 
targeted advertisements from the study team itself, this messaging from trusted sources will increase 
visibility and improve receptiveness among under-represented participants. Interested potential participants 
will visit the study website to be screened via electronic questionnaire and provide electronic informed 
consent before being directed to the baseline survey. 
 
Recruitment for this study will occur online, so targeted outreach to specific populations is not 
hindered by geography. Social media advertising will be focused on members in areas with a high 
prevalence of Black, Indigenous, and Persons of Color (BIPOC). We have successfully recruited research 
participants from rural areas in prior studies through partnerships with trusted community agencies that 
serve rural areas. We will expand our recruitment partnerships for this study to include community 
agencies that serve BIPOC, including financial compensation for their time and partnership. Outreach 
materials will reflect the diversity of those we hope to recruit.  
 Remuneration and Retention Strategies 
Participants will receive $25 after completing each survey (time 0, 4, 12 and 24 weeks). Surveys and 
payments will be emailed rather than embedded in the intervention so that payment is not misinterpreted 
as being related to program use. A subset will have the opportunity to be compensated an additional $25 
for completing a semi-structured interview (see Section 11.0). We will also distribute educational materials 
(infographic and video) via email and on the study website that build research literacy and inform 
participants of their power to improve the quality of the science by providing complete data. Using these 
strategies – payment after each survey and the educational materials – our attrition rate in the RCT of the 
in-person MOM program was only 6%. Education materials will not contain individual’s health information.  

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 Early Termination and Withdrawal 
Participants are free to withdraw from participation in the study at any time upon request.  
 
Participants who sign the electronic informed consent form and are randomized but do not receive the 
study intervention will be replaced. Participants who sign the informed consent form, are randomized and 
use the study program, and then subsequently withdraw, or are withdrawn or discontinued from the study, 
will be analyzed in the intent-to-treat arm.  
 
When participants withdraw, they will be instructed to no longer use the program and they will not receive 
additional communications from research personnel. 
 
All participants will be asked to complete an identity verification survey. The answers participants to provide 
to this survey will be compared to the information they provided in the screening survey. If participants 
answers significantly differ (ie. different name, different addresses, etc), the participant will be removed 
from the study. Participants will also be removed if they spent six minutes or less completing the baseline 
survey, if the phone number they provided is invalid, has a fraud score greater than 85, and is flagged as 
risky, and if the mailing address they provided is invalid. 
9.0 
PROCEDURAL INTERVENTION  
 Study Procedural Intervention and Control Description 
Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM; both arms). This online program has five 
key modules, each of which is subdivided into five sections (Figure 1). The Introduction module provides 
a program orientation and overview, including its evidence base and additional resources. “Exercises” 
contains pelvic floor muscle exercise regimens for specific skill levels and symptoms. “Bladder” covers 
types of urinary incontinence and behavior changes (weight loss, fluid modifications, toileting behaviors) 
that improve symptoms; “Bowels” covers constipation, bowel incontinence, fiber modifications, and 
toileting behaviors. “Care Seeking” provides information about healthcare providers and other available 
treatment options. Each module has five sections that build knowledge, self-efficacy, and skills to set 
action and coping plans relevant to a participant’s symptoms.  
Figure 1. Online Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM) Program 
Structure 
 
 
9.1.1 Description of Treatment Group Intervention 
Participants allocated to the test arm will receive an email inviting them to create a login and password 
to access the online MOM program content and will additionally receive tailored “output” (personalized 
cues, emphasis on relevant content, individualized and tailored reminders about their goals) based on a 
computer algorithm incorporating unique user “inputs” (individual factors). Inputs include: (1) program 
use data; (2) self-reported data (demographics, symptoms, communication preferences, risk 

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perception, outcome expectations, self-efficacy, motivation, intention, behaviors, barriers, and 
facilitators). Inputs will be reassessed every week for retailoring so that personalization evolves over 
the course of the intervention. Tailored output will include personalized action, coping, and tracking 
plans; digital triggers to engage with content specific to the user’s unique symptoms, behavioral 
intentions, and expected outcomes; periodic reminders in the user’s preferred format and frequency; 
and behavioral reinforcements and acknowledgements upon completion of recommended tasks and 
achievement of goals. For example, a smartphone user with stress urinary incontinence who set a goal 
of doing pelvic floor muscle exercises daily and has not accessed the program for two days might 
receive this email: “Is your action plan working? Click here for a refresher on the ‘Squeeze before you 
Sneeze!’ exercise,” sent at the same time of day when she has accessed the program previously.  
9.1.2 Description of Active Control Group 
Participants allocated to the active control group will receive an email inviting them to create a login and 
password to access the online MOM program. They will receive automated weekly reminders via email 
reminding them to re-visit the program, regardless of their individual user activity. 
 Method for Assigning to Treatment Groups - Randomization 
Randomization will be performed following identity verification completion. Participants will be blinded to 
their allocation. REDCap will randomize participants to one of the two study arms. The research team will 
not be blinded to participants study arm, as the research team must manually tailor weekly emails to 
participants allocated to the treatment arm. After a participant electronically consents and completes her 
identity verification, the study coordinator will confirm the participant is a real participant and determine 
what the next randomization allocation is, as made available by the statistician. The participant will receive 
an email with a link to the study website one week after completing their informed consent. She will also 
receive an email with instructions about how to save the program as an app on her mobile device. Those 
who do not access the website within three days will receive another email and then up to three telephone 
calls from the study team. The research specialist will offer assistance with signing into the program when 
calling. Only those participants who access and sign-up on the study website will be considered 
randomized. Participants must also complete a quality survey to confirm their identity. This short 
questionnaire will have participants confirm information that they provided in the screening questionnaire. 
Participants who are not able to confirm their identity will be removed from the study. If a participant was 
randomized prior to January 5th, 2024, they will be sent the identity verification survey and asked to confirm 
their identity. Participants who are going to be randomized after January 5th, 2024, will be asked to 
complete the identity verification prior to randomization. If the participant is not able to verify their identity 
and provide a valid phone number and mailing address they will be removed from the study. 
10.0 
STUDY PROCEDURES 
 
Screening, Informed Consent, and Enrollment 
10.1.1 Screening 
The study website will include information about the program and the research study itself including 
requirements for study participation. For potential participants who are interested in study participation, 
they will be directed to a screening webpage in which they will be asked their age, gender, whether 
they read and write English, if they have access to an Internet-connected device (like a computer, 
tablet, or smartphone), and whether they use email. If the study website begins to be infiltrated by bots, 
potential participants will be directed to email women.on.the.go@ctri.wisc.edu to schedule a phone call 
with a member of our study team before being sent a direct link to the screening webpage. They will 
also be asked if they have been diagnosed with the following medical conditions: dementia, neurologic 
or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated, or recent 

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(within last 6 months) hematuria or bloody stools that have not been evaluated by a medical 
professional. Potential participants who do not qualify for the study will be informed of that. Those who 
do qualify will be invited to participate and will be directed to an electronic informed consent form page.  
10.1.2 Informed Consent 
After participants screen into the study, the research team will immediately direct participants to the 
informed consent form. Participants will complete the informed consent electronically, with all consent 
information provided in the form. In compliance with university guidance on electronic informed 
consent, participants will be asked to type their name with an accompanying check box and statement 
noting an intent to affix a legal signature. The informed consent (informed consent form uploaded in 
ARROW) will provide participants with all study information. The informed consent process will make 
clear that participation in any and all aspects of the study are voluntary, and that participants may end 
their participation at any time. The informed consent process will include contact information for the 
principal investigator, Dr. Piper, who can be contacted if participants or potential participants have 
questions or concerns; However, we will also indicate that the PI and study team cannot decide if an 
individual is medically able to participate, and that it is up to individuals and their healthcare providers to 
decide whether they can do the exercises and make changes to their diets. Those with concerns will be 
encouraged to contact their healthcare provider.  
10.1.3 Enrollment 
A research participant will be defined as “enrolled” in the study when they meet the following criteria: 
• 
The participant has provided electronic informed consent.  
• 
The participant and study staff have completed all screening documentation. 
• 
The research team has verified that the participant meets all of the inclusion criteria. 
• 
The research team has verified that participant meets none of the exclusion criteria. 
• 
The participant has been assigned to the protocol by study staff.  
• 
The participant has completed the identity verification survey. Participants who were previously 
randomized who do not confirm their identity will be removed from the study. Participants who are 
eligible to be randomized after January 5th, 2024, must complete the identity verification survey and 
must not significantly differ in answer responses from the screening survey, per 8.6 prior to being 
randomized in the study.  
• 
The participant has spent more than six minutes completing the baseline survey. 
• 
The participant has a valid phone number, with a fraud score less than 85 and not flagged as risky. 
• 
The participant has provided a valid mailing address. 
• 
The participant has been randomized.  
10.1.4 Screen Failure and Re-enrollment 
Individuals who do not meet the criteria for participation in this trial (screen failure) will not be 
rescreened.  
 
Study Questionnaires and Surveys  
The following questionnaires and surveys will be administered at one or more times during the study. 
Participants will be sent questionnaires and surveys via their email address at baseline, and 4, 12, and 24 
weeks into the program. The study questionnaires will utilize the REDCap reCAPTCHA feature to ensure 
enrollees are not bots. The Study Calendar in section 10.3 details when specific questionnaires and 
surveys are administered.  

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10.2.1 Demographics Questionnaire  
Participants will be asked their age, race, ethnicity, height, weight, highest grade achieved, work status, 
marital status, living status, what other medical conditions they may have, and if they have health 
insurance and a primary care provider.  
10.2.2 Pelvic Floor Muscle Exercise Frequency 
Participants will be asked to answer the question, “How often do you do Kegel squeezes, or pelvic floor 
muscle exercises?”, on a 5-point Likert scale with the following descriptors—1: less than once per 
month; 2: a few times per month; 3: at least once per week; 4: several times per week; 5: almost every 
day. Participants will also be asked about number and type of panty liners, pads, or undergarments 
used daily, and the cost of these products weekly.  
10.2.3 Fiber Food Frequency Questionnaire 
Participants will be asked to individually estimate their daily fiber intake of specific foods on a scale 
from 1 (<1 severing per week) to 6 (2+ servings per day). Foods include fruit (not juice), green salad, 
potatoes or oatmeal, vegetables, vegetable juice, vegetable soup/stew, fiber cereal (Raisin Bran, Bran 
Buds, Fruit-n-Fiber), whole wheat/rye bread, brown rice, whole wheat pasta, barley, couscous, quinoa, 
and beans.  
10.2.4 Fluid and Voiding Questionnaire 
Participants will be asked to individually estimate their daily water, caffeinated beverage (coffee, tea, 
soda), and other decaffeinated beverage (milk, herbal tea, decaf) intake. Participants will also be asked 
to estimate their weekly intake of 8 ounce servings of alcohol and diet soda. The Bristol Female Lower 
Urinary Tract Symptoms-Filling Symptoms (BFLUTS-FS) and the Bristol Female Lower Urinary Tract 
Symptoms-Voiding Symptoms (BFLUTS-VS) will be used to assess urinary symptoms [38]. Participants 
will be asked about their bowel movements, including in the use of the Bristol Stool Chart [39].   
10.2.5 Geriatric Self-Efficacy Index for Urinary Incontinence 
The Geriatric Self-Efficacy Index for Urinary Incontinence (GSE-UI) [40] is a validated and clinically 
responsive [40, 41] instrument for older women with urinary incontinence. Participants select a 0-10 
score for each of the 12 items, with total scores ranging from 0-120. A higher score is indicative of a 
higher level of self-efficacy related to urinary incontinence. 
10.2.6 Generalized Self-Efficacy Scale adapted for MOM program 
In consultation with Dr. Ralf Schwarzer, Health Action Process Approach [19, 20] developer, we 
adapted the Generalized Self-Efficacy Scale [42] for behaviors related to continence promotion (such 
as pelvic floor muscle exercises). 
10.2.7 Program-Specific Survey of Other Health Action Process Approach Components 
Program-specific survey of other Health Action Process Approach components (risk perception, 
outcome expectations, intentions, action / coping plans, barriers, facilitators). 
10.2.8 Barriers to Incontinence Care-Seeking Questionnaire 
The Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) [43] contains 14-items framed on a 
4-point Likert scale and is validated in women with urinary incontinence. 

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10.2.9 Barriers to Care-seeking for Accidental Bowel Leakage 
The Barriers to Care-seeking for Accidental Bowel Leakage (BCABL) [21] has been validated by our 
team in women with bowel incontinence. BCABL contains 16 questions framed on a 4-point Likert scale 
with the following descriptors-1: strongly disagree; 2: somewhat disagree; 3: somewhat agree; 4: 
strongly agree.  
10.2.10 
International Consultation on Incontinence Questionnaire – Urinary Incontinence 
Short Form 
The International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-
UI SF) [44] is a widely used validated instrument with an established minimum clinically important 
difference [45]. Its score translates to mild (1-5), moderate (6-12), severe (13-18), and very severe (19-
21) symptoms of incontinence [46].  
10.2.11 
St. Mark’s Incontinence Score  
St. Mark’s Incontinence Score (SMIS) [47], also referred to as Vaizey Score, generates a scale 
between 0 (continent) and 24 (completely incontinent), and is widely used in urogynecology and 
colorectal surgery to assess bowel incontinence severity.  
10.2.12 
Pelvic Floor Impact Questionnaire Short Form 
The Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) [48]) is a widely-used validated instrument 
that assesses condition-specific quality of life. 
10.2.13 
12-item Short Form Health Survey (SF-12) 
The 12-item Short Form Health Survey (SF-12 [50]) is a validated questionnaire for patients 
with chronic conditions.  
10.2.14 
Symptom Improvement and Program Satisfaction  
The Symptom Improvement and Global Satisfaction Questionnaire is a validated three-item 
questionnaire that assesses global satisfaction and approximates symptom improvement that has been 
validated in other studies of conservative interventions to improve incontinence [49]. The items are 
Patient Global Ratings of Satisfaction (PSQ), Global Perception of Improvement (GPI), and Estimated 
Percent Improvement (EPI) [49]. PSQ is rated on a 3-point Likert scale with the following descriptors-1: 
completely; 2: somewhat; 3: not at all. GPI is rated on a 5-point Likert scale with the following 
descriptors-1: much better; 2: better; 3: about the same; 4: worse; 5: much worse. Participants EPI is a 
free-text response allowing for a numerical response between 0 and 100.  
10.2.15 
Behavioral Intention to Use Scale 
The Behavioral Intention to Use Scale was developed by our research team in expertise in 
human factors engineering. The questionnaire will ask participants if and how they will use the 
online program in the future to prevent and manage their incontinence symptoms. In addition, 
questions will ask participants how the research team can improve the online program to 
improve the experience for women who may use it in the future.  
 
Study Calendar 
The procedures/surveys performed at each time point are listed in the table below. Key measures related 
to health behaviors and incontinence symptoms are assessed at all four time-points. Data regarding core 

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constructs within the Health Action Process Approach will be assessed at baseline, 4 weeks (for the 
mediator analyses), and 24 weeks (final data collection time-point). Barriers to care-seeking for 
incontinence will be assessed at baseline and 24 weeks. Patient global ratings of satisfaction (PSQ), global 
perception of improvement (GPI), and estimated percent improvement (EPI) will be assessed at 4 weeks 
(conclusion of active program engagement) and 24 weeks (final data collection time-point). 
 
0 
4 w 12 w 24 w 
Screening/Review Eligibility Criteria 
X 
 
 
 
Informed Consent 
X 
 
 
 
Demographics 
X 
 
 
 
Behavioral Intention to Use Scale 
X 
X 
X 
X 
Health Behaviors 
Pelvic floor muscle exercise frequency 
X 
X 
X 
X 
Fiber food frequency questionnaire 
X 
X 
X 
X 
Fluid and voiding questionnaire 
X 
X 
X 
X 
Self-reported weight 
X 
X 
X 
X 
Core Constructs within the Health Action Process Approach 
Geriatric Self-Efficacy Index for Urinary Incontinence (GSE-UI) [40] 
X 
X 
X 
X 
Generalized Self-Efficacy Scale adapted for MOM program [42] 
X 
 
X 
 
Program-specific survey of other Health Action Process Approach 
components (risk perception, outcome expectations, intentions, action / 
coping plans, barriers, facilitators)   
X 
X 
X 
X 
Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) [43] 
X 
 
X 
 
Symptoms & Quality of Life 
International Consultation on Incontinence Questionnaire – Urinary 
Incontinence Short Form (ICIQ-UI SF) [44] (Urinary Incontinence) 
X 
X 
X 
X 
St. Mark’s Incontinence Score (SMIS) [47] (Bowel Incontinence) 
X 
X 
X 
X 
Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) [48] 
X 
 
X 
 
12-item Short Form Health Survey (SF-12) [50] 
X 
X 
X 
X 
Patient global ratings of satisfaction (PSQ), global perception of 
improvement (GPI), and estimated percent improvement (EPI) [49] 
 
X 
X 
X 
11.0 
SPECIAL STUDY – QUALITATIVE INTERVIEWS 
To contextualize the findings from all 3 aims of the grant, a subset of participants (N=36) will be invited to 
complete semi-structured qualitative interviews about their engagement with the program, their adoption of 
health behaviors, and their perceived barriers to and facilitators of engagement and behavior change. 
 
Assessments and Data Collection Procedures 
We will purposively sample to recruit participants for semi-structured qualitative interviews from three 
groups of anticipated user categories. These categories include: (1) frequent online program users (e.g. >3 
times per week) who adopt target health behaviors (N=12); (2) infrequent online program users (e.g. <3 
times per week) who adopt target health behaviors (N=12); and (3) users who neither engage with the 

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program nor adopt target health behaviors (N=12). Namey and colleagues found that a median sample size 
of 16 (range 11-26) achieves 90% saturation [51]; we will continue to conduct interviews until we reach 
saturation in each group [52]. Interviews will be conducted by phone or video conference and will be audio-
recorded and transcribed verbatim. Recordings and transcription files will be collected and recorded in 
REDCap and deidentified and stored on a secure department server.  
 
Analytic Plan 
Measures: The semi-structured interview guide will be developed using input from the transdisciplinary 
team, with question domains based on the objectives of each specific aim of the grant: 
• 
User experience, program engagement, barriers to and facilitators of engagement (Aim 1) 
• 
Behaviors changes made/attempted, barriers to and facilitators of behavior change (Aim 2) 
• 
Benefits and disadvantages of program, perceived impact on confidence, symptoms / quality of life, 
plans to seek care (Aim 3) 
Analysis: Telephone or video conference interviews will be recorded, transcribed, and uploaded to NVivo 
software (QSR International) for analysis. Qualitative analysis will complement quantitative findings by 
providing additional insight based on participants’ perceptions of using online MOM. We will use an 
inductive and deductive content analysis approach guided by the Health Action Process model [19, 20] and 
allowing key constructs to emerge from the data [53]. The research team will come to consensus on 
emergent codes and their definitions. Transcripts will be dual coded and agreement calculated. Qualitative 
analysis will be iterative; findings after five interviews will be brought to consecutive participants for 
member checking. Qualitative findings will be triangulated with quantitative analyses of online MOM 
program use data and self-report measures. 
 
Qualitative Rigor 
We will use Patton’s checklist [54] for ensuring and evaluating qualitative rigor across four criteria [55]. We 
will address (1) credibility, related to the quantitative method construct of internal validity, using strategies 
of member checking [56], methods and analyst triangulation [57], and deviant case analysis [56, 58]. We 
will address (2) transferability, the scope to which results are applicable to other contexts, by providing 
detailed descriptions of the context in which we are collecting data [59] and by purposively sampling to 
represent the range of diversity in engagement experiences [60]. We will address (3) dependability, or the 
ability to achieve consistent findings if the study is conducted as described, by creating and reporting a 
detailed audit trail of our process [61]. Finally, we will address (4) confirmability, requiring evidence for 
findings that come directly from participants rather than from a researcher’s bias, through triangulation of 
sources (interviewing multiple engagement perspectives) and analysts [57] as well as through 
multidisciplinary team reflexivity [56, 62].  
12.0 
DATA HANDLING AND RECORD KEEPING 
 
Data Collection and Database Management  
Study participants will need to create an account for our program, hosted by Orbita Inc. (formerly known as 
Wellbe, Inc.), providing their first name, last name, and email address. Individual program use data (Aim 1) 
will be collected from the user’s device and stored on Amazon Web Services (AWS) with failover at two 
data centers located 2,000 miles apart. Amazon provides a series of guarantees of reliability and security 
through a wide variety of certifications, including guaranteed uptime of 99.9%. Current copies of these 
certifications can be viewed at https://aws.amazon.com/compliance/. Data is encrypted in transit and at rest 
and governed by a set of security policies consistent with the HITRUST framework for healthcare data 
security. Amazon will not be able to access participant data stored on AWS. The research specialist will 

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receive a secure link daily provided by Orbita Inc. (formerly known as Wellbe, Inc.) and data from that 
secure link will be uploaded into the data repository in REDCap and then deleted. 
 
Engagement metrics will be derived from user device data monthly and merged with self-reported data. 
Participants will complete electronic surveys emailed via REDCap (https://redcap.ictr.wisc.edu) at baseline, 
4, 12, and 24 weeks to collect demographic and relevant health history data at baseline and the measures 
for Aims 2 and 3 at the intervals outlined in the Study Calendar (10.3).  
 
Study data will be organized by unique study identifier (ID) number and stored on REDCap and a 
password-protected server maintained by the Biomedical Computing Group in the Department of 
Biostatistics and Medical Informatics of UW-Madison for analysis. After participants complete the screening 
questionnaire, a unique study identifier (ID) number will be generated and documented in a linking file. The 
file linking study ID number to participant identifiers will be kept in REDCap and a password-protected file 
on a Department of Medicine secure server accessible only to the principal investigator and the research 
assistant who communicates with patients. All personnel with access to individual patient data will be 
trained in the maintenance of confidentiality of Protected Health Information as required by the Health 
Insurance Portability and Accountability Act (HIPAA) of 1996. The file linking study ID number to participant 
identifiers will be destroyed three years after study closure.  
 
 
Confidentiality and Privacy 
Participant confidentiality and privacy are strictly held in trust by the participating investigators, their staff, 
and the sponsor(s) and their agents. This confidentiality is extended to cover the clinical information 
relating to participants. Therefore, the study protocol, documentation, data, and all other information 
generated will be held in strict confidence. No information concerning the study or the data will be released 
to any unauthorized third party without prior written approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. 
 
All study staff engaged in the conduct of this project have completed training on the protection of human 
participants and the Health Insurance Portability and Accountability (HIPAA) Privacy Rule. In addition, all 
key personnel (i.e.., Principal Investigator, individuals involved in identifying/recruiting participants, 
obtaining electronic informed consent, or interacting and intervening with participants) have undergone 
Good Clinical Practice (GCP) training. 
 
Information about study participants will be kept confidential and managed according to HIPAA 
requirements. All participants will sign a combined electronic informed consent and HIPAA authorization 
form that includes specific privacy and confidentiality rights. Study data will be maintained per federal, 
state, and institutional data policies. 
 
The investigator(s) will ensure that the identities of participants are protected by using coded participant 
information. The log of participant identifying information that links participants to their study-specific 
identification number will be maintained by the investigators. The log and all study records will be 
maintained in locked rooms and access will be limited to essential study personnel. Electronic study 
records/files will be collected and stored on REDCap and/or a secure department server and accessed via 
networked computers that are password-protected with access provided only to authorized study 
personnel.  
 
Authorized representatives of the following groups may need to review this research as part of their 
responsibilities to protect research participants: representatives of the IRB and the National Institutes of 

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Health and federal oversight agencies, such as the Office for Human Subjects Protection (OHRP). The 
clinical study site will permit access to such records. 
 
Study staff may use e-mail to communicate with research participants, if the participant has agreed to using 
email in the Informed Consent form. The information contained in emails will be limited to research-related 
surveys and general questions. All emails to participants will be sent from UW/wisc.edu/Kaiser 
Permanente/Indiana University accounts; personal, home or Gmail email accounts will not be used. 
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be issued by the NIH. 
This certificate protects identifiable research information from forced disclosure. It allows the investigator 
and others who have access to research records to refuse to disclose identifying information on research 
participation in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, 
state, or local level. By protecting researchers and institutions from being compelled to disclose information 
that would identify research participants, Certificates of Confidentiality help achieve the research objectives 
and promote participation in studies by helping to assure confidentiality and privacy to participants. 
 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol or investigational plan 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the study 
site staff. As a result of deviations, corrective actions are to be developed by the site and implemented 
promptly.  
 
It is the responsibility of the Principal Investigator/site investigator/study staff to use continuous vigilance to 
identify and report deviations. The Principal Investigator is responsible for assessing whether the deviation 
constitutes noncompliance as defined by the reviewing IRB and if so, reporting it within the required time 
frame(s). The site investigator is responsible for knowing and adhering to the reviewing IRB requirements. 
 
Publication and Data Sharing Policies 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central 
(https://www.ncbi.nlm.nih.gov/pmc/) upon acceptance for publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted 
to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. 
Data from this study may be requested from other researchers 3 years after the completion of the primary 
endpoint by contacting the Study PI, Dr. Piper.  
13.0 
STUDY ANALYSIS 
 
Statistical Hypotheses 
• 
Primary Efficacy Endpoint(s):  

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Incorporating tailoring into online MOM will double the proportion of users who engage with the 
program, defined as at least four program sessions in the first 4 weeks of the trial, compared to the 
active control group (online MOM with weekly reminder emails and no tailoring). [Associated with Aim 1 
of grant] 
 
• 
Secondary Efficacy Endpoint(s): 
Tailoring will increase adoption and maintenance of health behaviors that promote continence. 
[Associated with Aim 2 of the grant] 
• 
Intervention tailoring will increase engagement with the online MOM program and that the increased 
engagement will result in behavior changes that improve continence. [Associated with Aim 3 of the 
grant] 
• 
Other mediating variables such as increased self-efficacy, decreased symptomatology, and decreased 
barriers to care-seeking will result in behavior changes that improve continence. [Associated with Aim 3 
of the grant] 
 
Sample Size Justification 
Our goal sample size for the quantitative analysis is based on the primary outcome of program 
engagement, defined for this purpose as participating in at least four online MOM sessions over the 4 
weeks following enrolment. We hypothesize that tailoring will double a woman’s likelihood of program 
engagement. We estimate that 15% of participants in the control group will meet this definition of 
engagement based on a similar proportion of real users engaging with an Internet program tested by a 
Swedish incontinence research group [24]; we estimate that 30% of participants in the treatment arm will 
meet this definition. To obtain 90% power with a type 1 error of .05, our goal sample size is 174 
participants per treatment arm. Assuming a 40% attrition rate, we will recruit 289 participants per arm. This 
attrition rate is between the rate of attrition in the RCT of in-person MOM (<5%), where participants were 
compensated following baseline assessment and final assessment, and the higher rate of attrition in our 
pilot dissemination study of online MOM (42%), where participants were not compensated until the final 
assessment. However, since this study is more similar to that of the online MOM program (this study is 
solely online), we have increased the attrition rate to 40% as we anticipate attrition to be more similar to 
that of online MOM.  
 
Participant Population(s) for Analysis 
• 
Primary analyses will be performed using Intention-to-Treat (ITT): all randomized participants 
• 
Other exploratory analyses will include: 
• 
Modified ITT: all randomized participants that received at least one dose of study intervention and/or have 
some particular amount of follow-up outcome data 
• 
Protocol-compliant Population: all randomized participants who received the required study intervention and 
complied with the protocol sufficiently to ensure that the data would be likely to represent the effects of the 
study intervention according to the underlying scientific model 
 
Statistical Methods 
13.4.1  Primary Outcome Measures and Analysis 
Measures. The primary outcome for this aim is engagement with the program, defined as participation 
in at least one session per week during the first 4 weeks of the participation. Additional engagement 
metrics include number of, minutes spent on, and average intervals between program sessions 
accessed weekly; number of and specific components accessed; and use patterns for specific program 
features (such as tracking and reminders). These metrics will be derived from user device data 
monthly. 

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Data Analysis. Summary statistics will describe and compare demographic and clinical characteristics 
in the treatment and active control groups. The proportion of participants in the treatment versus control 
group who achieve engagement (primary outcome) will be compared using binomial chi-squared test 
with type I error rate at 0.05. We will conduct exploratory analyses to determine whether individual 
difference variables such as race, educational attainment, and baseline incontinence symptoms 
moderate the effects of tailoring on engagement using chi-square analyses and by modeling interaction 
effects in Cox Regression. We will compare the number of and average intervals between program 
sessions, number of and specific pages viewed, minutes spent per week using the program (weeks 1 
through 24), and use of program features (such as tracking and reminders) between women in the 
treatment and control groups.  
To examine patterns of program engagement, we will use the processed data and characteristics to 
create categorizations leveraging two popular clustering models based on machine learning. Clustering 
is a type of unsupervised learning algorithm to partition data into groups (“clusters”) within which 
observations are similar to one another [63]. K-means clustering finds k clusters such that the total 
pairwise distance between each observation and its closest cluster centroid is minimized. Hierarchical, 
or agglomerative, clustering builds a hierarchy of clusters where the closest pairwise clusters are 
merged until there is only one cluster [63, 64]. Although we will not know a priori how the data will 
cluster, we will plan to use k-means and hierarchical clustering to group participants into: 1) 
“engagement types” based on program use metrics; 2) “behavior types” based on self-reported 
behavior data (described in Aim 2); and 3) “engagement-behavior types” based on both program use 
metrics and self-reported behavior data. 
13.4.2 Secondary Outcome Measures and Analysis 
13.4.2.1 
Secondary Outcomes Measures Associated with Aim 2 of the Grant 
Measures. Frequency of health behaviors known to improve continence (fluid changes, fiber 
optimization, voiding patterns) will be assessed via electronic survey at baseline, 4, 12 and 24 
weeks, using the same questionnaires we used in the RCT of the in-person MOM program [18]. 
The primary outcome for this aim is adoption of consistent pelvic floor muscle exercise at 4 weeks, 
defined as self-reported performance of pelvic floor muscle exercises consistently (often or always) 
at 4 weeks after reporting inconsistent performance of these exercises at baseline. Secondary 
outcomes include exercise maintenance (reporting consistent exercise performance at two 
consecutive time points between 4, 12, and 24 weeks) as well as adoption and maintenance of 
other health behaviors. Specific self-reported health behaviors of interest for exploration include: (1) 
daily fiber intake of at least 21g [65]; (2) caffeine intake <205 mg/day [66]; (3) daily fluid intake 
between 60 and 100 ounces; and (4) 6-9 voids per day. We will also compare the proportion of 
participants with a body mass index (BMI) >25mg/kg2 at baseline who report weight loss of at least 
2 kg at 12 or 24 weeks between the groups who did and did not receive tailoring [67]. 
Analysis. Summary statistics will describe and compare demographic and clinical characteristics in 
the treatment and active control groups. The proportion of participants in the treatment versus 
control group who adopt consistent pelvic floor muscle exercises between baseline and 4 weeks will 
be compared using the binomial chi-squared test with type I error rate at 0.05. Exploratory analyses 
will determine whether individual differences such as race, educational attainment, and baseline 
incontinence symptoms moderate the effects of tailoring on adoption of pelvic floor muscle exercise 
using chi-square analyses and by modeling interaction effects in Cox Regression. For secondary 
outcomes, the proportion of participants in the treatment versus control group who adopt or 
maintain a health behavior will be compared using similar analyses to those described for the 
primary outcome. 

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13.4.2.2 
Secondary Measures Associated with Aim 3 of the Grant 
Measures. The primary outcome for this aim is adoption of consistent pelvic floor muscle exercise 
at 12 weeks, defined as self-reported performance of pelvic floor muscle exercises consistently 
(often or always) at 12 weeks after reporting inconsistent performance of these exercises at 
baseline. The primary independent variable is allocation to the treatment (tailoring) or control arm.  
Potential mediators will include: 
• 
Program Engagement: High program engagement during weeks 0 – 4 as defined through 
cluster analysis described in Aim 1. 
• 
Self-Efficacy: Change in self-efficacy measures between baseline and 4 weeks on the 
surveys, GSE-UI and Generalized Self-Efficacy Scale. 
• 
Incontinence Symptoms and Quality of Life: Changes between baseline and 4 weeks on the 
surveys ICIQ-UI SF and SMIS (incontinence), and PFIQ-7 and SF-12 (quality of life). 
• 
Symptom improvement and program satisfaction: At 24 weeks, patient global ratings of 
satisfaction (PSQ), global perception of improvement (GPI), and estimated percent 
improvement. 
• 
Perceived barriers to care: Changes between baseline and 4 weeks on the surveys, BICS-Q 
and BCABL.  
Analysis. Mediation analyses as described by VanderWeele and Vansteelandt [68] will be 
conducted based on a regression model for behavior change (B) against the indicator of tailoring 
(T) and the multiple potential mediators M_1, …, M_K, i.e., B  T+M_1+…+M_K, along with K 
models for each mediator against tailoring, i.e., M_k  T (k=1,…, K). The natural direct effect 
(NDE) and natural indirect effect (NIE) through each of the mediators will be estimated and tested 
using proper linear combinations of the regression coefficients [68]. In addition to mediation 
analyses, summary statistics will describe changes in incontinence severity and impact over time in 
women who did and did not receive tailoring to inform design of a planned subsequent 
effectiveness trial. We will compare differences between 0 and 24 weeks in scores on instruments 
assessing barriers to care-seeking in the treatment and control groups and differences in program 
satisfaction and global perception of improvement between 4 and 24 weeks in the two groups. 
Continuous variables will be compared using the t-test and categorical variables using the chi-
square test, both with type I error rate at 0.05.   
 
Handling of Missing Data 
We will prevent and manage missing data according to the National Research Council’s Panel on Handling 
Missing Data in Clinical Trials guidelines. We will implement strategies that we have used successfully in 
the past (described in section 8.5) to minimize patient attrition (goal <20%). To evaluate missing data, we 
will conduct sensitivity analyses using methods appropriate for data missing at random [69] and for data 
missing not at random [70]. 
14.0 
RISK/BENEFIT ASSESSMENT 
 
Known Potential Benefits to the Participants 
There are no direct benefits of participation. The potential benefits to society include information about the 
acceptability, usability, and effectiveness of a digital version of an effective behavioral intervention to 
improve bladder and bowel incontinence. This research also collects information about which 
implementation strategy reaches the most women at risk for or experiencing incontinence.  

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Known Potential Risks 
There are no physical risks related to study participation, which entails completing several electronic 
questionnaires, and perhaps being invited to participate in a phone or video conference interview.  
  
There is a risk that patient information could become known to someone not involved in this study. If this 
happens, it could result in damage to the patient’s reputation, which could also affect relationships with 
family and friends, affect employment, or make it harder to get insurance or a job. 
 
There are several precautions that will be used to ensure that participant privacy is protected. The study 
questionnaires and interviews (for some) can be completed by participants in a private location of their 
choosing. (The eMOM intervention can also be completed in the locations of the participants' choosing.) 
Collection of sensitive information about participants is limited to the amount necessary to achieve the aims 
of the research. Data will be collected and stored by REDCap and then de-identified and stored on a 
secure department server. Patient contact information will be stored separately from study ID number, and 
all sensitive data collected will only be identified with study ID numbers. The electronic file linking study ID 
number and patient's identity will be stored in a password-protected data file on a secure shared drive 
accessible only to the principal investigator and research assistant. Participants will receive $25 after 
completing each survey (time 0, 4, 12, and 24 weeks) and after completing a semi-structured interview, if 
asked to participate in an interview. Surveys and payments will be emailed rather than embedded in the 
intervention so that payment is not misinterpreted as being related to program use.  
 
Risk/Benefit Analysis 
The risks associated with this study are minimal, and there are potential benefits to society, including 
information about the acceptability, usability, and effectiveness of a digital version of an effective behavioral 
intervention to improve bladder and bowel incontinence. 
15.0 
DATA AND SAFETY MONITORING  
 
Data and Safety Monitoring Plan 
The following Data and Safety Monitoring Plan (DSMP) pertains to all research to be supported under the 
PAS-20-160, Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK Award. This 
plan comprises research conducted directly by the University of Wisconsin-Madison (UW) investigators and 
all other personnel who are supported by these funds. All investigators must agree to comply with the 
procedures outlined in this DSMP. This DSMP does not reduce any investigator’s obligation to comply with 
the requirements of the UW Health Sciences Institutional Review Board (HSIRB). 
 
Monitoring the progress of trials and the safety of participants. The PI of the study will be responsible 
for routine monitoring of the progress of the research. This monitoring includes scheduled biweekly 
meetings with study staff and review of written documentation of all aspects of the research project. Data 
that are reviewed at these meetings include the number and type of participants enrolled, the number and 
reasons for exclusions from enrollment, the number of participants involved in each stage of the 
intervention, and any participant concerns or confidentiality issues. 
 
To facilitate participant safety, study participants must meet study inclusion and exclusion criteria. Should 
either excessive risk to study participants and/or lack of measurable benefit to study participants be 
determined, the study will be stopped and all participants notified in a manner appropriate to the nature of 
the risk and/or lack of benefit. 
 

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Plans for the reporting of unanticipated health events. This DSMP requires that investigators notify NIH 
and the University of Wisconsin IRB in a timely manner of the occurrence of any unanticipated health 
events, which are severe, unanticipated, and possibly related to study medication or protocol. 
 
This study does not involve pharmaceutical agents. Examples of a serious unanticipated health event 
would be untoward occurrences related to study participation that result in death, are life-threatening, 
require hospitalization or prolonging of existing hospitalization, create persistent or significant 
disability/incapacity, or involve congenital abnormality/birth defects. Unanticipated health events would also 
include less serious problems that merit reporting because they are severe, unanticipated, and possibly 
related to study participation. Any serious unanticipated health event will be queried and reported as 
required by IRB, NIH and/or FDA rules. The PIs will be responsible for the accurate documentation, 
investigation, and follow-up of all study-related unanticipated health events. 
 
Unanticipated health event assessment, recording, reporting, and investigation will be accomplished 
through staff training, structured/standardized assessments of untoward occurrences/events, and regular 
monitoring by the PI and research specialist. The Principal Investigator has ultimate responsibility for 
ensuring that unanticipated health events are detected and reported in a timely manner. Additionally, the 
IRB will receive an annual report of all serious unanticipated health events and unanticipated health events 
meeting the criteria listed above. 
 
Plans for assuring that any action resulting in a temporary or permanent suspension of an NIDDK-
funded clinical trial is reported to the NIDDK grant program director responsible for the grant. The 
NIDDK grant program director will be notified within 5 days if the PI deems it necessary to suspend the 
trial. In the case of a temporary suspension, the PI and Co-Is will develop a plan for continuation of the 
study and discuss this plan with the NIDDK grant program director in a reasonable time frame. 
 
Plans for assuring data accuracy and confidentiality and protocol compliance. The PI, supported by 
regulatory staff, will refine and monitor existing protocols for assuring data accuracy and protocol 
compliance. Such protocols will include data verification and protocol compliance checks. The Data 
Manager and IT Manager will also be responsible for ensuring that the data for the project are securely 
stored, that storage is in compliance with University and federal regulations and that no unauthorized 
persons have access (electronic or physical) to any participant-identifiable data. The UW Medicine 
Research Office will ensure that HIPAA regulations and guidelines are currently implemented and all study 
staff have completed approved human participants and HIPAA training programs. 
 
Safety Review Committee 
In addition to the protections outlined in the DSMP (above), this research conforms to the NIH definition of 
a clinical trial. The trial proposed in this R01 application is not multicenter in nature. The DSMP specifies 
overall monitoring that will be conducted by the PI. Their responsibilities include timely reporting of 
unanticipated health events and serious unanticipated health events. Every 6 months, the Program Project-
wide Safety Review Committee will convene to review the overall safety data, as well as data on safety 
summarized by treatment condition. The objective of these reviews will be to determine whether continued 
conduct of the trial poses no undue risk for participants. 
 
The Safety Review Committee will be chaired by Jane Mahoney, MD, a Professor in the University of 
Wisconsin-Madison Department of Medicine. Dr. Mahoney is a very experienced physician and clinical trial 
researcher with no involvement in any of this R01’s research activities. Dr. Mahoney will be joined on the 
committee by Justin Boutilier, PhD, Assistant Professor of Industrial Systems Engineering at UW-Madison 
and expert in data analysis related to machine learning; Angela Fidler Pfammatter, MS, PhD, an Assistant 
Professor of Preventive Medicine at Northwestern University and Clinical Health Psychologist with 
expertise in the development and testing of technology to influence health behaviors; and Kyle Rudser, 

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PhD, Associate Professor of Biostatistics at the University of Minnesota and expert in the design and 
monitoring of clinical trials. Drs. Boutilier, Pfammatter, and Rudser have no direct involvement with any of 
this R01’s research activities. The project team will provide support for these reviews including summaries 
of collected data. The PI will participate in these reviews and take lead responsibility for implementing any 
recommended changes in procedure or protocol. 
16.0 
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