Birth to Three - Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention
Phase: NA
Conditions: Caries,Dental
Sponsor: University of Iowa

Birth to Three – Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention 
Version 0.7
Protocol  
2 July 2024
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans – v4.0 2018-12-12 
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Birth to Three – Cavity Free: Effectiveness of a 
Psychoeducational Intervention for ECC Prevention 
 
Unique Protocol Identification Number: UH3DE029443 
National Clinical Trial (NCT) Identified Number: 05756413 
Principal Investigator: Karin Weber-Gasparoni 
Sponsor: University of Iowa 
 
 
Grant Title: Birth to Three – Cavity Free: Effectiveness of a 
Psychoeducational Intervention for ECC Prevention 
Grant Number: 22-031-E   
Version Number: 0.7 
July 2, 2024 
 
 
Summary of Changes from Previous Version: 
Version 
Number 
Date 
Affected Section(s) 
Summary of Revisions 
Made 
Rationale 
0.1 
08/04/21 Comments through Section 
7 
Melissa Riddle added 
comments to this draft, as 
the first NIDCR review 
of the protocol 
Comments are suggestions 
to consider, largely meant 
to follow the language and 
level of detail that is 
familiar to the NIDCR 
clinical team; let’s discuss 
any comments that don’t 
make sense or seem 
misguided 
0.2 
03/04/22 Changes made on 4.1 
Overall Design section 
Melissa Riddle and Elise 
Rice reviewed transition 
package with PI and 
CTRA during zoom 
meeting 
Clarification regarding the 
recruitment window of 
potential pregnant women  
0.3 
4/27/22 
Changes made on the 
following sections: 
Table of Contents; 5.2 
Exclusion Criteria; 
5.4 Screen Failures;  
University of Iowa IRB 
requested to remove 
exclusion criteria 
 
1) Mothers who deliver 
their child prior to their 
first study intervention 
visit – according to 
IRB, mothers no longer 
meet the inclusion 

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6.2.1 Interventionist 
Training and Tracking (e.g., 
Research Team Staff and 
WIC Clinic Staff) 
criteria of being 
pregnant to participate 
in the study. 
2) Children born with 
medical and/or special 
health care needs 
conditions that require 
specialized care and/or 
hospitalization 
preventing the mother 
to participate in study 
activities – according 
to IRB, this is the 
mother’s choice to 
withdraw from the 
study. 
 
0.4 
6/21/22 
Changes made on section 
7.2 Participant 
Discontinuation/Withdrawal 
from the Study 
Elise Rice in email dated 
6/20/22 requested a 
revision on section 7.2 to 
specify mother’s choice 
to withdraw from study if 
their child is born with 
medical and/or special 
health care needs 
conditions 
NIH team suggested the 
update on section 7.2 to 
match IRB request to 
change the exclusion 
criteria above to a 
participant 
discontinuation/withdrawal 
0. 5 
8/16/22 
Several sections 
Several revisions made 
Revisions made suggested 
by RHO 
 
 
 
 
 
0.6 
1/29/24 
Sections 4.3 and 6.1.2 
Clarified criteria for 
optional nature of the 
Year 1 Month 3 booster 
videos 
Revisions made suggested 
by RHO 
0.7 
2/9/24 
Sections 4.1, 5.1, 5.5, Table 
of Detailed Description of 
Study Procedures, Sections 
5.5. and 6.4, 10.1.5 updated 
Key Roles and Governance 
table 
 
 
Updated gestational 
window for recruiting 
moms from 32-36 wks, 
can start interventions 
earlier at 16 wks vs. 24. 
Updated widening of 1- 
and 9-month 
questionnaires to eight 
weeks. 
Updates of research team 
members, recruitment 
sites 
DSMB recommendations 
from 11/29/24 meeting 
 
 
 
 
General updates to study 

Birth to Three – Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention 
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0.7 
7/14/24 
Section 6.1.2 
Change language to 
reflect that “Visit 2, 3 and 
4 will be scheduled based 
upon the child’s DOB 
and will take place when 
the child is 
approximately 12, 24 and 
36 months of age.” 
 
Added language to reflect 
that according to 
informed consent 
approved by the UI IRB, 
“You (study participant) 
may feel uncomfortable 
in answering certain 
questions and you can 
choose to decline any 
aspect of the study at any 
time. You and your child 
may discontinue 
participating at any time 
without any negative 
consequences.” 
Therefore, participants 
may choose not to 
complete the one-month 
follow-up 
questionnaires,” which 
means that a protocol 
deviation does not occur 
when mothers do not 
complete the 1- and 9-
month follow-up 
questionnaires. 
 
Revisions made suggested 
by RHO 
 
 
 
 
 
 
 
Revision to address RHO 
Action Items #s 21 and 22 
dated 2024-7-11_12 
 
 
 
 
Table of Contents 
Statement of Compliance ............................................................................................................................................... 6 
Investigator's Signature .............................................................................................................................................. 6 
1 Protocol Summary ...................................................................................................................................................... 7 
1.1 Synopsis ............................................................................................................................................................... 7 
1.2 Schema ................................................................................................................................................................ 9 
1.3 Schedule of Activities ........................................................................................................................................ 10 
2 Introduction .............................................................................................................................................................. 11 
2.1 Study Rationale .................................................................................................................................................. 11 
2.2 Background ........................................................................................................................................................ 12 

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2.3 Risk/Benefit Assessment ................................................................................................................................... 15 
2.3.1 Known Potential Risks ............................................................................................................................... 15 
2.3.2 Known Potential Benefits ........................................................................................................................... 16 
2.3.3 Assessment of Potential Risks and Benefits ............................................................................................... 16 
3 Objectives and Endpoints ......................................................................................................................................... 17 
4 Study Design ............................................................................................................................................................ 23 
4.1 Overall Design ................................................................................................................................................... 23 
4.2 Scientific Rationale for Study Design................................................................................................................ 23 
4.3 Justification for Intervention .............................................................................................................................. 24 
4.4 End-of-Study Definition .................................................................................................................................... 24 
5 Study Population....................................................................................................................................................... 25 
5.1 Inclusion Criteria ............................................................................................................................................... 25 
5.2 Exclusion Criteria .............................................................................................................................................. 25 
5.3 Lifestyle Considerations .................................................................................................................................... 25 
5.4 Screen Failures .................................................................................................................................................. 25 
5.5 Strategies for Recruitment and Retention .......................................................................................................... 25 
6 Study Intervention(s) or Experimental Manipulation(s) ........................................................................................... 28 
6.1 Study Intervention(s) or Experimental Manipulation(s) Administration ........................................................... 28 
6.1.1 Study Intervention or Experimental Manipulation Description .................................................................. 28 
6.1.2 Administration and/or Dosing .................................................................................................................... 28 
Detailed Description of the Study Intervention ..................................................................................................... 30 
Detailed Description of the Study Procedures ....................................................................................................... 31 
6.2 Fidelity ............................................................................................................................................................... 31 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING ............................................................................. 31 
6.3 Measures to Minimize Bias: Randomization and Blinding ............................................................................... 32 
6.4 Study Intervention/Experimental Manipulation Adherence .............................................................................. 32 
6.5 Concomitant Therapy ........................................................................................................................................ 33 
6.5.1 Rescue Procedures ...................................................................................................................................... 33 
7 Study Intervention/Experimental Manipulation Discontinuation and Participant Discontinuation/Withdrawal ...... 34 
7.1 Discontinuation of Study Intervention/Experimental Manipulation .................................................................. 34 
7.2 Participant Discontinuation/Withdrawal from the Study ................................................................................... 34 
7.3 Lost to Follow-Up.............................................................................................................................................. 34 
8 Study Assessments and Procedures .......................................................................................................................... 36 
8.1 
Endpoint and Other Non-Safety Assessments ............................................................................................ 36 
8.2 Safety Assessments ............................................................................................................................................ 37 
8.3 Adverse Events and Serious Adverse Events .................................................................................................... 37 
8.3.1 Definition of Adverse Events ..................................................................................................................... 37 
8.3.2 Definition of Serious Adverse Events......................................................................................................... 37 
8.3.3 Classification of an Adverse Event ............................................................................................................. 38 
8.3.4 Time Period and Frequency for Event Assessment and Follow-Up ........................................................... 38 
8.3.5 Adverse Event Reporting ............................................................................................................................ 39 
8.3.6 Serious Adverse Event Reporting ............................................................................................................... 39 
8.3.7 Reporting Events to Participants ................................................................................................................. 40 
8.3.8 Events of Special Interest ........................................................................................................................... 40 
8.3.9 Reporting of Pregnancy .............................................................................................................................. 40 
NA ....................................................................................................................................................................... 40 
8.4 Unanticipated Problems ..................................................................................................................................... 40 
8.4.1 Definition of Unanticipated Problems ........................................................................................................ 40 
8.4.2 Unanticipated Problems Reporting ............................................................................................................. 40 

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8.4.3 Reporting Unanticipated Problems to Participants ..................................................................................... 41 
9 Statistical Considerations.......................................................................................................................................... 42 
9.1 Statistical Hypotheses ........................................................................................................................................ 42 
9.2 Sample Size Determination ............................................................................................................................... 42 
9.3 Populations for Analyses ................................................................................................................................... 43 
9.4 Statistical Analyses ............................................................................................................................................ 43 
9.4.1 General Approach ....................................................................................................................................... 43 
9.4.2 Analysis of the Primary Endpoint(s) .......................................................................................................... 43 
9.4.3 Analysis of the Secondary Endpoint(s)....................................................................................................... 44 
9.4.4 Safety Analyses .......................................................................................................................................... 45 
9.4.5 Baseline Descriptive Statistics .................................................................................................................... 45 
9.4.6 Planned Interim Analyses ........................................................................................................................... 45 
9.4.7 Sub-Group Analyses ................................................................................................................................... 45 
9.4.8 Tabulation of Individual Participant Data ................................................................................................... 45 
9.4.9 Exploratory Analyses.................................................................................................................................. 45 
10 Supporting Documentation and Operational Considerations .................................................................................. 46 
10.1 Regulatory, Ethical, and Study Oversight Considerations ............................................................................... 46 
10.1.1 Informed Consent Process ........................................................................................................................ 46 
10.1.2 Study Discontinuation and Closure .......................................................................................................... 47 
10.1.3 Confidentiality and Privacy ...................................................................................................................... 47 
10.1.4 Future Use of Stored Specimens and Data ............................................................................................... 48 
10.1.5 Key Roles and Study Governance ............................................................................................................ 48 
10.1.6 Safety Oversight ....................................................................................................................................... 51 
10.1.7 Clinical Monitoring .................................................................................................................................. 52 
Preparing for Audits by Regulatory Authorities ...................................................................................................... 52 
10.1.8 Quality Assurance and Quality Control .................................................................................................... 52 
10.1.9 Data Handling and Record Keeping ......................................................................................................... 53 
Long Term Storage of Forms .................................................................................................................................. 53 
10.1.10 Protocol Deviations ................................................................................................................................ 53 
10.1.11 Publication and Data Sharing Policy ...................................................................................................... 53 
10.1.12 Conflict of Interest Policy ....................................................................................................................... 54 
10.2 Additional Considerations ............................................................................................................................... 54 
10.3 Abbreviations and Special Terms .................................................................................................................... 54 
10.4 Protocol Amendment History .......................................................................................................................... 55 
11 References .............................................................................................................................................................. 56 
 
 
 

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STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with International Council on Harmonisation (ICH) 
Good Clinical Practice (GCP), applicable United States (US) Code of Federal Regulations 
(CFR), and the National Institute of Dental and Craniofacial Research (NIDCR) Terms and 
Conditions of Award. The Principal Investigator (PI) will assure that no deviation from, or 
changes to the protocol will take place without prior agreement from the funding agency and 
documented approval from the Institutional Review Board (IRB), except where necessary to 
eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct 
of this study have completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
INVESTIGATOR'S SIGNATURE 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
 
Date: 
 01/07/22 
Name*:  
 Karin Weber-Gasparoni, DDS, MS, PhD 
Title*:  
 Chair and Professor  
 
Investigator Contact Information: 
Affiliation*:   University of Iowa Department of Pediatric Dentistry 
Address:  
 202 Dental Science South, Iowa City, IA 52242-1001 
Telephone:   (319) 335-7486 
Email:  
 karin-weber@uiowa.edu 
 

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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title: 
Birth to Three – Cavity Free: Effectiveness of a Psychoeducational 
Intervention for ECC Prevention  
Grant Number: 
UG3DE029443  
Study Description: 
This study is considered a Stage II research study according to the 
NIH Stage Model1 and will implement an evidence-based 
behavioral intervention to help expectant mothers develop proper 
oral health habits early in their future child’s life. The central 
hypothesis is that a theory-based intervention approach facilitated 
by the self-determination theory (SDT) using videotaped messages 
and targeted to mothers of high-risk young children will promote 
an elevated sense of perceived autonomy, competence, and 
relatedness, which will in turn lead mothers to experience and 
demonstrate improved self-reported knowledge and behavior 
concerning their child’s oral health. Consequently, their child will 
have more positive oral health outcomes, indicated by lower levels 
of caries, dental plaque, and mutans streptococci (MS). 
Objectives*: 
Primary Objective: 1. To test the effectiveness of a multi-
component behavioral intervention for 
pregnant mothers on the subsequent oral 
health status of their children at ages 12, 
24, and 36 months. 
Secondary 
Objectives: 
2a. To test the degree to which the  
      intervention produces its effects on   
      children’s oral health status through its  
      mediating effects on mothers’ changes in  
      self-reported knowledge. 
2b. To test the degree to which the  
       intervention produces its  
       effects on children’s oral health status  
       through its mediating effects on mothers’ 
       changes in behaviors concerning their  
       child’s oral health (i.e., oral hygiene  
       habits, dietary habits, use of fluoride,  
       visits to the dentist, lift-the-lip to check  
       for early signs of cavities). 
2c. To test the degree to which the  
      intervention improves other  
      indicators of oral health status in children 
      (levels of salivary MS and visible dental  
       plaque scores among the children). 
 
 

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Endpoints:* 
Primary Endpoint: The primary outcome of interest is children’s 
caries status, as measured by the number of 
decayed, missing or filled surfaces using the 
d1d2-3 mfs scoring method. Both d2-3 and d1 
levels, derived from the d1d2-3mfs caries 
criteria, will be considered, reflecting 
numbers of affected (cavitated, missing due 
to caries or filled) surfaces with and without 
inclusion of non-cavitated (d1 “white spot”) 
lesions. 
Secondary 
Endpoints: 
Secondary outcomes will be changes in 
maternal knowledge and children’s oral 
health behaviors, as well as lower levels of 
dental plaque and MS. 
Study Population: 
The study sample will consist of 634 pregnant women enrolled 
from rural and urban Women, Infants and Children (WIC) 
Supplemental Nutrition Programs in different Iowa counties whose 
future child will be followed until they are 36 months of age. 
Phase* or Stage: 
Stage II  
Description of 
Sites/Facilities Enrolling 
Participants: 
The study sample will be drawn from 12 WIC clinic sites in 
different counties in Iowa with relatively large Hispanic and 
African-American populations. 
Description of Study 
Intervention/Experimental 
Manipulation: 
Pregnant mothers will be randomly assigned to either an 
experimental group (Group 1) where mothers will receive 
autonomy-supportive messages informed by the SDT or a control 
group (Group 2) where mothers will receive the same oral health 
care messages delivered using a neutral style. All mothers will be 
exposed to oral health messages – one during pregnancy, one later 
when their child is 12 months of age, and one when their child is 
24 months of age. Three months after receiving the oral health 
messages at each time point, mothers will be sent a follow-up 
booster message.  
Study Duration:* 
60 months 
Participant Duration: 
Approximately 42 months  
 

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1.2 SCHEMA 
 
 

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1.3 SCHEDULE OF ACTIVITIES 
 
 
Study time-points and 
corresponding 
activities for ALL 
study participants in 
the experimental and 
control groups 
 
Visit 1 
Prenatal 
 
Visit 2 
Age 1 to 2 
 
Visit 3  
Age 2 to 3 
 
Visit 
4  
Age 
3+ 
Visit 1 at 
WIC  
1-Month  
Follow-up 
3-Month 
9-Month 
Follow-up 
Visit 2 at 
WIC  
1-Month  
Follow-up
3-Month 
9-Month 
Follow-up 
Visit 3 at 
WIC  
1-Month  
Follow-up 
3-Month 
9-Month 
Follow-up 
Visit 4 at 
WIC 
Informed Consent 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group randomization 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mother demographic 
questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mother knowledge 
questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mother behavior 
questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention videotaped 
oral health message 
 
 
 
 
 
 
 
 
 
 
 
 
 
Internalization 
questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
Health care climate 
questionnaire (HCCQ) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Booster videotaped oral 
health message 
 
 
 
 
 
 
 
 
 
 
 
 
 
Child plaque sample 
 
 
 
 
 
 
 
 
 
 
 
 
 
Child dental exam: 
plaque, caries and tooth 
status recordings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Child behavior 
questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mother & child 
demographic 
questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mother behavior intent 
questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 INTRODUCTION 
2.1 STUDY RATIONALE 
Early childhood caries (ECC) is a serious problem, especially among low-income minorities. 
Although ECC is multifactorial, its primary cause is behavioral.2 Therefore, the solution, too, 
should be behavioral. However, healthy behavior change in very young children is a difficult 
problem that necessarily requires an indirect solution—to help very young children, we need to 
work with their primary caregivers, usually their mothers. To help mothers provide the high-
quality oral health care their young children need, we need to provide a great deal of 
understanding and support—partly because mothers do not yet know what to do (e.g., “Are sippy 
cups okay?”), but mostly because their young children routinely and emphatically resist oral 
health care behaviors (e.g., “I want the M&Ms, not the carrots!”). Many people face similar 
problems (e.g., smokers, exercisers, dieters), so SDT researchers developed and empirically 
validated a motivation-based explanatory model to help practitioners solve these difficult 
problems.3 The critical ingredients to catalyze volitional, long-lasting behavior change are the 
motivational experiences of (1) whole-hearted internalization of the recommended behavior 
change and (2) experiences of need satisfaction (i.e., autonomy, competence, relatedness) to 
support and maintain that behavior change. The critical social event that makes these 
motivational conditions possible is an autonomy-supportive relationship.4 The figure below 
provides the SDT framework to facilitate internalization and behavior change, and the next 
section outlines our research strategy to both empirically test this model and translate it into a 
low-cost behavioral intervention that can be used in WIC clinics and other public health settings 
across the nation to greatly reduce the burden of ECC among some of the most vulnerable 
populations.  
 
 

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2.2 BACKGROUND 
The etiology of ECC is multifactorial. Low socio-economic status is an ECC risk factor,5 but 
most ECC risk factors involve health behaviors,2 such as high frequency of sugar consumption, 
especially from added-sugar beverages and juice,6,7 poor oral hygiene,8-13 and early MS 
colonization which children acquire from their mothers.14-17 Caries rates of 35% to 56% have 
been reported for WIC-enrolled children under the age of three years.18 Nearly 34% of all 2- to 
5-year-old children living under the federal poverty level are affected by caries in the United 
States, with higher rates among minority children.19 Behavior-based risk factors (e.g., habitual 
sugar intake) place children at high risk for ECC. These risk factors are preventable, but the 
educational preventive messages that have been implemented for pregnant women and mothers 
have not been effective in increasing mothers’ oral-care behaviors or in decreasing their young 
children’s plaque, gingivitis or caries including some that have used videotaped messages.20,21 
 
This protocol tests the theory- and evidence-based motivational approach presented in the figure 
above. This approach and its behavioral strategies come from SDT.22,23 SDT is relatively unique 
among theories of motivation due to its focus on the quality, rather than the quantity, of 
motivation. Central to SDT is the distinction between self-determined or autonomous (i.e., high-
quality) and non-self-determined or controlled (i.e., low-quality) forms of motivation.23,24 Types 
of motivation differ from one another based on the degree to which actions are (or are not) fully 
self-endorsed by the individual. Autonomous motivation reflects freely chosen and fully or 
whole-heartedly self-endorsed reasons for engaging in a behavior, such as “I want to do this 
because it is important and very useful to me”.25 In contrast, controlled motivation reflects 
reasons for acting that are not self-endorsed and carry little personal ownership because one feels 
pressured into doing them, such as “This is something I should do, even though I don’t really 
want to” (internal pressure) or “This is something I have to do; it is required” (environmental 
pressure).23  
 
People acquire autonomous motivation to the extent that they internalize (and take personal 
ownership over) the recommended behavior change (e.g., brush your teeth, drink water instead 
of juice). The absence of internalization leaves only controlled motivation, which motivates 
temporary compliance rather than lasting behavior change.25 Thus, upon being exposed to a 
recommended behavior change, the critical motivational event that predicts volitional, lasting 
behavior change is internalization.26 The figure on the previous page explains the links among 
(1) receiving a recommended behavioral change request, (2) volitionally internalizing it to the 
point that it becomes one’s own way of behaving, and (3) lasting, volitional behavior change, 
even in the face of environmental challenges. The figure begins with autonomy support, which is 
the adoption of an understanding, mother-focused interpersonal tone.4 When a health care 
message is communicated in an autonomy-supportive way, the person offering the health care 
message works hard to take the mother’s point of view (e.g., “How do you feel about this 
recommendation?”), to provide explanatory rationales for their requests (e.g., “Juice will bathe 
your child’s teeth in sugar; this is why water is better.”), to acknowledge and accept the mother’s 
doubts and resistance to the difficult behavior change as okay and as understandable (e.g., “Yes, 
your child will protest, and the fussing will make this a difficult request for you to carry out.”), to 
rely on invitational language (e.g., “You might consider…”), and to display patience (e.g., “It 
may take many tries before your child begins to show the first sign of acceptance.”). These ways 
of communicating help the mother discover the value and personal utility within a new way of 

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behaving, and this sense of value or importance is what gets internalized. In our project, mothers 
will complete a questionnaire after receiving the videotaped oral health message, and this 
questionnaire will assess both perceived autonomy support and extent of internalization of the 
oral health message and its recommendations. Intervention-based research consistently shows 
that, when people have their autonomy supported while trying to learn and change their behavior, 
they experience not only greater internalization, but also greater psychological need satisfaction, 
more autonomous motivation, and a long list of adaptive behaviors, such as engagement, 
learning, skill development, achievement, prosocial behavior, and adaptive health-promoting 
behaviors.4,22,27-31  
 
As the person tries to work through the internalization experience, experiences of psychological 
need satisfaction are critical, because need satisfaction is the motivational fuel that drives the 
internalization process.32 For a mother to take in a recommended way of behaving as her own 
and to feel a sense of volition and personal ownership over that behavior, the communicated 
message needs to provide opportunities to feel the satisfaction of the three psychological needs 
of autonomy, competence, and relatedness.23 Autonomy is the psychological need to experience 
volition, personal ownership, and whole-hearted self-endorsement in one’s behavior (e.g., “Yes, 
I want to do this.”). Competence is the psychological need to experience effectance, mastery, and 
a sense of making progress in one’s interactions with the environment (e.g., “Yes, I can do this 
effectively.”). Relatedness is the psychological need to experience warmth, acceptance, 
closeness, connection, responsiveness, and reciprocal care and concern in one’s relationships 
(e.g., “Yes, I trust and feel close to this dentist.”).23,24 In our project, the questionnaire mothers 
complete will assess both extent of psychological need satisfaction and intention to engage in the 
recommended oral health behaviors. Once internalization has occurred, the behavior change 
needs to be maintained to bear its fruits (e.g., lower levels of dental plaque, MS, and caries). 
Lasting behavior change is difficult because mothers are busy, tired, and distracted and because 
their child complains, fusses, and resists the mother’s oral health care initiatives. To maintain 
such lasting behavior change, the mother needs the motivational support of ongoing 
psychological need satisfaction. While the mother is tired from working all day and trying to 
brush her fussing child’s teeth before bedtime, she critically needs to feel autonomy satisfaction 
(e.g., “Doing this is good; I want to do this.”), competence satisfaction (e.g., “Doing this makes 
me feel competent, effective as a mother.”), and relatedness satisfaction (e.g., “Doing this creates 
a high-quality relationship with my child.”). These experiences of need satisfaction 
motivationally support continual internalization and ongoing, persistent behavior change. In our 
project, mothers will complete a series of follow-up questionnaires (i.e., 6 months, 9 months) to 
assess the maintenance (and even increases) in their experiences of need satisfaction and 
intentions to engage in the previously recommended oral health care behaviors. In the medical 
field, autonomy-support facilitated perceived competence and autonomous motivation for long-
term health behavior change, which improved (a) adherence to exercise and subsequent weight 
loss among morbidly obese patients for over 23 months,27 and obese females for over 3 years;33  
(b) long-term medication adherence;34 (c) self-management, glycemic control, quality of life, and 
physiological outcomes among patients with Type 2 diabetes;24,35 and (d) medication taking and 
6-month tobacco cessation36 and 24- month prolonged tobacco abstinence.37 In the dental field, 
autonomy-support led to satisfaction of psychological needs, resulting in patients’ decreased 
plaque and gingivitis levels,38, 39 improved home brushing and flossing,38,40 increased fluoride 

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use,41 decreased frequency of sugar consumption,41 more positive dental health attitudes,38 and 
higher dental clinic attendance.40  
 
We believe that the SDT-based model proposed for this study provides an autonomy-supportive 
oral health care message targeted to mothers of high-risk children and therefore will promote 
greater autonomy, competence, and relatedness psychological need satisfaction. Because of this 
experience of need satisfaction while exposed to the videotaped healthcare message, mothers 
will be significantly more likely to identify with the message, internalize it, and accept its 
recommendations as their own. That acceptance and ownership will promote the mothers’ 
willingness to increase their oral health care knowledge, increase their willingness and intentions 
to engage in constructive oral health care behaviors, increase their actual oral health care 
parenting behaviors, and increase their parenting self-efficacy to carry out those constructive oral 
health care behaviors in a way that will produce desired oral health benefits for their children. 
According to SDT, the greater extent to which the autonomy-supportive message allows mothers 
to experience autonomy support and volitional internalization, the more positive will be the 
mothers’ post-message oral health care motivation (need satisfaction, autonomous motivation), 
knowledge and behavioral care for their children. These gains in the mother’s oral health care 
motivation, knowledge, behaviors, and self-efficacy will be the active ingredients during mother-
child interactions that produce longitudinal gains in the children’s oral health outcomes, as 
evidenced by lower levels of dental plaque, MS, and caries. In other words, mothers of high-risk 
children who receive our videotaped autonomy-supportive messages, compared to mothers of 
high-risk children who receive only a videotaped neutral message, will gain greater capacity and 
skills to provide their children with high-quality oral health care.  
 
The four-fold reasons why this SDT-based autonomy-supportive intervention will be effective 
(will increase mothers’ capacity to provide high-quality oral health care) are because (1) the 
recommended parenting knowledge and behavior will be communicated in a highly autonomy-
supportive way (i.e., take the mother’s perspective, encourage initiative, provide explanatory 
rationales, acknowledge and accept negative affect), (2) mothers will experience this autonomy-
supportive context as deeply need satisfying (i.e., mothers will feel high autonomy, competence, 
and relatedness satisfaction while learning about high-quality oral health care), (3) this 
experience of high need satisfaction will allow mothers to identify personally with the parenting 
message, internalize both the message and the recommended parenting behaviors, and accept the 
message and parenting behaviors as their own, and (4) mothers will learn how to apply all these 
constructive oral health care behaviors (e.g., daily brushing, no sugared beverages) toward their 
child’s oral health in an effective way. Given that the autonomy-supportive messages (videotape) 
help mothers gain a greater capacity to provide their children with high-quality oral health care 
(i.e., greater knowledge and parenting behaviors), mothers will be significantly more able to 
prevent caries in their children at ages 12, 24, and 36 months (the study’s primary outcomes), as 
well as promote their children’s improved oral hygiene (i.e., less plaque and less MS; the study’s 
secondary outcomes). 

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2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
The physical risks for children and mothers involved in this research are minimal and 
unexpected. Children will participate in a dental examination and plaque sampling at three time 
points (at approximately ages 12, 24, and 36 months). These exams and plaque sampling will be 
conducted by oral health providers trained in conducting dental exams on infants and toddlers, 
including managing uncooperative behavior during exams. While unlikely and rare, there is a 
risk of infection as a result of these procedures. Standard infection control procedures will be 
followed to minimize infection risk.  
 
Most other risks also are minimal and unexpected. As with all clinical research, breach of 
confidentiality of subject data is a risk, however, there will be study procedures in place to 
minimize this risk. Specifically, the risk to subject confidentiality will be minimized by assigning 
unique identification numbers to all subjects, and all study documents will use only these 
numbers to identify subjects. In this way, the name and contact information for all subjects will 
not be directly matched to the study data. A document that matches the contact information with 
study identification numbers will be maintained separately, with only the PI and research staff 
having access to this document. All study data will be stored on the secure server at the UI 
College of Dentistry. The data will be periodically backed up. A separate password will be 
created for the database and changed periodically. Only authorized individuals (e.g., PI and 
Clinical Trial Research Associate (CTRA)) will have access to the database. Paper-based 
questionnaires and other documents will be securely stored in locked cabinets in a locked office. 
Results of the study and study data will only be reported in aggregate form, so that individual 
subjects are not identifiable. A data safety monitoring plan will be in place to protect human 
subjects and assure confidentiality and data security. Additionally, participating women may feel 
uncomfortable answering some of the questionnaire questions, for example questions about 
feeding practices that do not adhere to the recommendations of the videotaped messages. 
Mothers will be reminded that their study participation is voluntary, and they may elect to skip 
any question(s) they do not feel comfortable answering.  
 
The one risk that is expected is that of children being upset and uncooperative during the dental 
exam and plaque collection procedures, given the young age of child participants (approximately 
12 months – 36 months of age). Study procedures are designed to maximize the comfort of 
children and mothers during these clinical procedures. Specifically, mothers will be present at all 
times during the child’s oral examination and it will be reinforced verbally that all procedures 
accomplished with their child are simple and safe. The tell-show-do technique will be used 
during all procedures in order to help relax the child and obtain his or her cooperation. The 
technique is simple and dictates that, before anything is done, the child is told what will be done 
and then shown by some sort of simulation exactly what will happen before the procedure is 
started. A puppet stuffed animal will be used to simulate the dental procedures to be done with 
the child. There are no alternative procedures; however, mothers will be assured that 
participation in this study is strictly voluntary. They and their children can choose to decline any 
aspect of the study at any time and may discontinue their participation at any time without any 
negative consequences. 

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2.3.2 KNOWN POTENTIAL BENEFITS 
Participating children will receive dental screenings by University of Iowa (UI) providers who 
are authorized, trained, and calibrated to make caries diagnosis. Mothers will receive oral and 
written information about their children’s caries status when they are ages 12, 24, and 36 months.  
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
The potential benefits of the study outweigh the risks. 

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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
To test the 
effectiveness of a 
multi-component 
behavioral intervention 
for pregnant mothers 
on the subsequent oral 
health status of their 
children at ages 12, 24, 
and 36 months. 
The primary outcome 
of interest is caries 
status. Caries status at 
each of the annual 
examinations will be 
expressed in terms of 
the number of 
decayed, missing or 
filled surfaces using 
the d1d2-3mfs scoring 
method, as well as 
crude, net and 
adjusted incidence 
rates.42,43 Both d1d2-
3mfs and d1mfs 
categories derived 
from the d1d2-3mfs 
caries criteria will be 
considered, reflecting 
numbers of affected 
cavitated (d2-3), 
missing due to caries 
or filled) surfaces 
with and without 
inclusion of non-
cavitated (d1 “white 
spot”) lesions. 
The caries criteria for 
scoring dental caries for 
the children were 
developed by members 
of the Iowa Fluoride 
Study44 and successfully 
adapted for caries 
epidemiological exams 
in young children in 3 
NIDCR Disparities 
Centers (Universities of 
California San 
Francisco, Colorado 
Denver and Boston).45-49 
According to SDT, the 
greater the extent to 
which the autonomy-
supportive message 
allows mothers to 
experience autonomy 
support and volitional 
internalization, the more 
positive will be the 
mothers’ post-message 
oral health care 
motivation (need 
satisfaction, autonomous 
motivation), knowledge, 
and behavioral care for 
their children. These 
gains in the mother’s 
oral health care 
motivation, knowledge, 
behaviors, and self-
efficacy will be the 
active ingredients during 
mother-child interactions 
that produce longitudinal 
gains in the children’s 
oral health outcomes as 
evidenced by lower 
levels of caries. In other 
words, mothers of high-
risk children who 
receive our videotaped 
autonomy-supportive 
message, compared to 
mothers of high-risk 
children who receive 
only a videotaped 
neutral message, will 
gain greater capacity and 
skill to provide their 
children with high-

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
quality oral health care. 
Consequently, their 
children will have lower 
numbers of decayed, 
missing or filled 
surfaces. 
Secondary 
(2a) To test the degree 
to which the 
intervention produces 
its effects on 
children’s oral health 
status through its 
mediating effects on 
mothers’ changes in 
self-reported 
knowledge. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2a) Maternal 
knowledge will be 
assessed through a 
series of questions 
using 5-point Likert-
type scale with 
anchors of “strongly 
disagree” to “strongly 
agree” on topics such 
as early childhood 
caries etiology (i.e., 
bacteria 
transmission), dietary 
habits (i.e., 
bottle/breast feeding, 
use of sippy-cup, 
juice consumption, 
snacks, etc.), oral 
hygiene habits (i.e., 
time of brushing, 
person responsible for 
brushing the child’s 
teeth, fluoride 
toothpaste use, etc.). 
These questions will 
be specific to the 
messages given at 
each of the three 
videotaped oral health 
messages time points. 
The pre-intervention 
self-reported 
knowledge 
questionnaires will be 
administered prior to 
watching the video 
(2a) The same 
questionnaires were 
used and validated in 
several previous 
research projects from 
the research team.10-13,50-
55  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2a) According to SDT, 
the greater the extent to 
which the autonomy-
supportive messages 
allow mothers to 
experience autonomy 
support and volitional 
internalization, the more 
positive will be the 
mothers’ post-message 
oral health care 
motivation (need 
satisfaction, autonomous 
motivation) knowledge. 
In other words, mothers 
of high-risk children 
who receive our 
videotaped autonomy-
supportive message, 
compared to mothers of 
high-risk children who 
receive only a 
videotaped neutral 
message, will 
demonstrate greater 
increases in knowledge 
scores. 
 
 
 
 
 
 
 
 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2b) To test the degree 
to which the 
intervention produces 
its effects on 
children’s oral health 
status through its 
mediating effects on 
mothers’ changes in 
behaviors concerning 
their child’s oral health 
(i.e., oral hygiene 
habits, dietary habits, 
use of fluoride, visits 
to the dentist, lift-the-
lip to check for early 
signs of cavities) 
 
 
 
 
 
 
 
 
 
 
messages at visits 1, 2 
and 3, and the post-
intervention 
knowledge 
questionnaires will be 
administered at one-
and nine-month 
follow-ups. 
*At the final visit 
(Visit 4), knowledge 
questions will assess 
the key topics 
discussed previously 
at all three time 
points. 
 
 
(2b) Maternal 
behaviors toward the 
child’s oral health 
will be assessed 
through a series of 
questions (i.e., visit to 
the dentist, detailed 
dietary and oral 
hygiene habits, etc.) 
that are pertinent to 
the behaviors 
recommended at each 
of the three 
videotaped oral health 
message time points. 
The pre-intervention 
self-reported behavior 
questionnaires will be 
administered prior to 
watching the video 
messages at visits 1, 2 
and 3, and the post-
intervention behavior 
questionnaires will be 
administered at one-
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2b) The same 
questionnaires were 
used and validated in 
several previous 
research projects from 
the research team.10-13,50-
55  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2b) According to SDT, 
the greater the extent to 
which the autonomy-
supportive message 
allows mothers to 
experience autonomy 
support and volitional 
internalization, the more 
positive will be the 
mothers’ post-message 
oral health care 
motivation (need 
satisfaction, autonomous 
motivation), behavioral 
care for their children. 
In other words, mothers 
of high-risk children 
who receive our 
videotaped autonomy-
supportive messages, 
compared to mothers of 
high-risk children who 
receive only videotaped 
neutral messages, will 
demonstrate more 
positive changes 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
 
 
 
 
 
 
 
 
 
 
(2c) To test the degree 
to which the 
intervention improves 
other indicators of oral 
health status in 
children (levels of 
salivary MSa and 
visible plaqueb scores 
among the children). 
and nine-month 
follow-ups. 
*At the final visit 
(Visit 4), behavior 
questions will assess 
the key topics 
discussed previously 
at all three time 
points. 
 
 
(2ca) Plaque samples 
will be obtained from 
all participating 
children at visits 2, 3 
and 4. Samples will 
be obtained by using 
sterile cotton swabs; 
all tooth surfaces will 
be swabbed. Cotton 
swabs will be 
immersed in sterile 
transport fluids and 
kept cold for transport 
to the microbiology 
labs.  Numbers of 
bacteria will be 
derived for each 
sample from these 
media following the 
standard matrix 
counting 
methodology of the 
spiral plating system. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2ca) The same protocol 
was used and validated 
in several previous 
research projects from 
the research team.10-13,50-
55 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
regarding behaviors 
towards their children’s 
oral health, such as more 
positive oral hygiene and 
dietary habits, use of 
fluoride, visits to the 
dentist, lift-the-lip to 
check for early signs of 
cavities, etc. 
 
(2ca) According to SDT, 
the greater the extent to 
which the autonomy-
supportive message 
allows mothers to 
experience autonomy 
support and volitional 
internalization, the more 
positive will be the 
mothers’ post-message 
oral health care 
motivation (need 
satisfaction, autonomous 
motivation), knowledge 
and behavioral care for 
their children. These 
gains in the mother’s 
oral health care 
motivation, knowledge, 
behaviors, and self-
efficacy will be the 
active ingredients during 
mother-child interactions 
that produce longitudinal 
gains in the children’s 
oral health outcomes as 
evidenced by lower 
levels of salivary MS. In 
other words, mothers of 
high-risk children who 
receive our videotaped 
autonomy-supportive 
messages, compared to 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2cb) Each child will 
be examined at 12, 24 
and 36 months of age 
(visits 2, 3 and 4) for 
visible plaque by one 
of the dentist-
examiners using a 
knee-to-knee 
technique. Visible 
plaque will be 
assessed first and 
recorded as present or 
absent for the 
maxillary and 
mandibular incisors 
and molars.  The 
number of maxillary 
and mandibular 
incisors and molars 
with plaque will also 
be recorded. 
 
 
 
 
 
 
 
 
 
 
 
 
(2cb) The same protocol 
was used and validated 
in several previous 
research projects from 
the research team. 10-
13,50-55  
 
 
 
mothers of high-risk 
children who receive 
only a videotaped 
neutral messages, will 
gain greater capacity and 
skill to provide their 
children with high-
quality oral health care. 
Consequently, their 
children will have lower 
levels of salivary MS. 
 
(2cb) According to SDT, 
the greater the extent to 
which the autonomy-
supportive message 
allows mothers to 
experience autonomy 
support and volitional 
internalization, the more 
positive will be the 
mothers’ post-message 
oral health care 
motivation (need 
satisfaction, autonomous 
motivation), knowledge 
and behavioral care for 
their children. These 
gains in the mother’s 
oral health care 
motivation, knowledge, 
behaviors, and self-
efficacy will be the 
active ingredients during 
mother-child interactions 
that produce longitudinal 
gains in the children’s 
oral health outcomes as 
evidenced by lower 
levels of visible plaque. 
In other words, mothers 
of high-risk children 
who receive our 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
videotaped autonomy-
supportive messages, 
compared to mothers of 
high-risk children who 
receive only a 
videotaped neutral 
messages, will gain a 
greater capacity and skill 
to provide their children 
with high-quality oral 
health care. 
Consequently, their 
children will have lower 
levels of visible plaque. 

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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
This UH3 clinical trial study constitutes a Stage II research according to the NIH Stage Model.4 
The study design specifies a two-arm, randomized controlled clinical trial to assess the 
effectiveness of autonomy-supportive videotaped oral health messages informed by SDT as a 
means of preventing ECC, as compared to the effects of exposure to neutral messages also 
delivered via videotape. The intervention is intended for use in public health settings attended by 
high-caries risk groups, and the proposed UH3 clinical trial will be conducted at several WIC 
clinic sites in different rural and urban counties in Iowa with relatively large Hispanic and 
African-American populations.51,52 
 
The study sample will consist of 634 pregnant women whose future children will be followed 
until they are 36 months of age. Pregnant women, between 12 and 36 weeks of the gestational 
period, 18 to 45 years old, and with no intention to move away in the next four years will be 
eligible to participate in the study. Recruitment will occur anywhere between 12 to 36 weeks of 
gestation. However, study interventions will only start between 16 to 36 weeks of gestation. If a 
pregnant woman is recruited between 16 to 36 weeks of gestation, the study procedures can 
begin immediately. If the woman is recruited between 12 to 15 weeks of gestation, we will 
schedule her an initial study visit for later, that is between 16 to 36 weeks of the gestation period. 
At their first study visit, informed consent will be obtained. After informed consent, they will be 
randomly assigned to one of two study groups: Group 1 (experimental (SDT) group) and Group 
2 (neutral control group). The primary outcome of interest will be children’s caries status. 
Secondary outcomes will be changes in children’s oral health behaviors conducive to better oral 
hygiene and dietary habits, as well as lower levels of dental plaque and MS.  
 
The central hypothesis is that a theory-based intervention approach using videotaped messages 
and targeted to mothers of high-risk young children will promote an elevated sense of perceived 
autonomy, competence, and relatedness, which will in turn lead mothers to experience and 
demonstrate improved self-reported knowledge, behavioral intention and subsequent behavior 
concerning their child’s oral health. Consequently, their child will have more positive oral health 
outcomes, such as lower levels of caries, dental plaque, and MS. We predict that the theory-
based intervention will enhance mothers’ oral health care knowledge (Hypothesis 1) and 
behavior toward their oral health and their child’s oral health (Hypothesis 2), relative to neutral 
messages, also delivered via videotapes. In addition, these hypothesized benefits will apply to 
both short-term (one-month) and long-term (nine-month) effects across each time point (prenatal, 
Age 1-2, Age 2-3, Age 3+). 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The strategy of providing caretakers with autonomy support has been shown to produce very 
large effect sizes across multiple domains.23,25,56 There is a need to evaluate the effectiveness of a 
theory-based intervention to alleviate the ECC burden using a psychological theory of 
motivation, such as SDT, proven useful in promoting behavior change in several domains.3,24,25,34 

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4.3 JUSTIFICATION FOR INTERVENTION 
The mode of our intervention delivery is through videotaped oral health messages presented 
through a link on a tablet at the WIC clinic sites or through a participant’s smart phone between 
site visits. This intervention delivery provides a cost-effective behavioral approach targeted to 
ECC prevention and does not depend on the availability of either dental and/or medical 
professionals to deliver the oral health messages. Empirical research, including our own 
preliminary work, has shown this particular video-based autonomy supportive intervention 
(SDT) to be accepted by WIC mothers and effective in ECC-prevention.50 Our prior focus 
groups reported that the video length along with images and messages were both appealing and 
understood by the WIC mothers. The mothers also felt the videotaped oral health messages 
represented different ethnic groups and reflected their own life experiences.  
 
The literature supports supplemental follow-up activities in boosting the original intervention 
experience to reinforce the oral health message.57 Therefore, mothers will receive a 3-month 
booster message via link through their smart phone after each oral health message received at 
their study WIC visits 1, 2 and 3. Viewing of the 3-month booster message is optional.  
 
The minimum-acceptable participation in order to have evaluable data on the study primary 
outcome would be the first and last visits. At the last visit, children will be examined for their 
caries status, therefore participation in this visit will be essential to assess the overall 
effectiveness of our intervention on ECC prevention. Ideally, the participants will complete the 
four WIC site visits, as well as study activities at 1-, 3- and 9 months post WIC visits to access 
their changes in knowledge and behavior towards their child’s oral health, as well as retention 
and continued use of the information presented at each intervention.  
4.4 END-OF-STUDY DEFINITION 
The end of the study is defined as the date when the last participating mother-child dyad 
completes study activities for the last visit (Visit 4). 

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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
1) WIC-participating pregnant women who are 18 to 45 years old. 
2) Between 12 and 36 weeks of the gestational period. 
3) Able to speak, understand and read English or Spanish 
4) No intention to move away in the next 4 years.  
5.2 EXCLUSION CRITERIA 
3) Mothers who deliver their child prior to their first study intervention visit. 
5.3 LIFESTYLE CONSIDERATIONS 
NA 
5.4 SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in this study and do not 
meet one or more inclusion criteria and/or do meet the exclusion criteria for participation in this 
trial (screen failure). Examples include a pregnant woman giving birth prior to the first 
intervention visit or not being fluent in either English or Spanish languages, in which case she 
would no longer be eligible for the study. Each potential screen failure will need to be 
determined on a case-by-case basis. 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
We plan to assess our recruitment rate during months three through 12 after the clinical trial 
starts. If the pace of recruitment is slow, we will increase recruitment days, advertise our study 
more aggressively through posters and media avenues, recruit participants from additional WIC 
sites, and/or consider increasing the incentives given to participating mothers and children. We 
will assess our retention rates annually at months 12, 24 and 36 of follow-up. If our follow-up 
exam rate is below the expectancy, then we plan to adopt the same methods described above for 
recruitment, as well as conduct the study at WIC sites that provide services on Saturday 
mornings.  With four dental examiners, we will be able to increase the number of exam days, 
allowing mothers more flexibility in scheduling their study visits, improving retention and 
helping us finish the study on time.  
 
Study staff will recruit subjects at all participating WIC sites on targeted clinic days. The CTRA 
and research assistants (RAs) will work to create schedules whereby specific days are chosen 
based on WIC site schedule and attendance patterns in order to maximize the number of WIC 
clients successfully recruited. Verbal and written information will be provided to prospective 
participants, and upon obtaining consent, subjects will be enrolled in the study. In some cases, 
for pregnant women who express interest but decline enrollment at that time, contact information 
will be gathered and follow-up emails/text messages and telephone calls made in an attempt to 
secure their enrollment in the study. In addition to the recruitment described above, WIC study 
staff will provide an informational brochure to each client who meets inclusion criteria, with 
WIC staff collecting names, home addresses/telephone numbers, and emails from interested 

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women (after the women give permission for sharing the information). The WIC staff will then 
forward this information to study staff who will call the mothers directly to 1) provide a brief 
overview of the study and introduce the potential risk and benefits of participation, 2) determine 
interest in study participation, and 3) if they are interested, schedule an initial appointment, at 
which time formal enrollment will take place and informed consent obtained. The study 
brochures and posters will be placed at the WIC sites will provide a QR code linking to a contact 
sheet that mothers can directly fill out to allow study team members to follow-up and contact 
them. 
 
In order to increase retention, every attempt will be made to maintain contact with all study 
participants during the clinical trial period through bi-annual study newsletters, multiple phone 
calls, texts, and emails, along with personal cards to provide valuable communication and 
continued support with the participants (i.e., congratulate mothers on the baby’s birth, mother’s 
and child’s birthdays, Mother’s Day, thank you notes, etc.). We will create social media contacts 
through a Birth to Three Cavity Free Facebook study account, and ensure all participants are sent 
individual, direct messages to prevent information sharing between participants. All of these 
efforts are crucial to maintaining our cohort of participants. 
 
For all study participants, phone, text, email and/or mail contacts will be made to schedule 
forthcoming assessment appointments and keep participants engaged in the study. Contacts will 
include newsletter with updates about the study, as well as thanking the participants. In order to 
enhance continuing participation in this study, the participants will be verbally encouraged to 
combine their regular WIC appointments with their visits for this study.  In addition, a phone call 
and text message through REDCap™ (Research Electronic Data Capture) will occur to every 
participant one week prior to each scheduled appointment to remind them about the time and 
location, as well as a text message a day before to confirm their appointment attendance. If a 
WIC appointment is missed, mothers will be allowed up to 2 months to reschedule any of the in-
person WIC site visits. If mother’s misses the 2-month time window, she will not be able to 
continue the follow-up questionnaires until the next yearly WIC visit.  
 
Mother’s will have up to eight weeks to complete the one- and nine-month questionnaires via 
REDCap™, with weekly reminders to complete them. If mothers do not complete the 
questionnaires after the first three reminders, REDCap™ will notify the study team, and an RA 
will contact the mother to complete the questionnaires. Non-responders will also be mailed paper 
copies of the questionnaires with a prepaid and self-addressed envelope to return once 
completed. 
 
Due to the time spent at each study visit (~1.5 hours) to complete all study procedures (i.e. 
consent forms, pre- and post-questionnaires, view video messages, dental examination, etc.), 
incentives for the subjects will include dispensing of toothbrushes, fluoride toothpaste and a 
small toy at each visit for the study children and a gift card to the study mothers. Monetary gift 
cards will be given to participants after completing study visits and returning questionnaires at 
each one- and nine-month time points as it follows: 
  
Visit 1 (Prenatal): $50 
 
1-month follow-up questionnaires: $20 

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9-month follow-up questionnaires: $20 
Visit 2 (age 1 to 2): $75 
1-month follow-up questionnaires: $20 
 
9-month follow-up questionnaires: $20 
Visit 3 (age 2 to 3): $100 
 
1-month follow-up questionnaires: $20 
 
9-month follow-up questionnaires: $20 
Visit 4 (age 3+): $125 
 
If needed, a no-cost extension to allow more time to complete the study will be sought. 

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6 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
This is a two-arm, randomized controlled clinical trial (NIH Stage II Research Model) 4 to assess 
the effectiveness of autonomy-supportive videotaped oral health messages informed by SDT as a 
means of preventing ECC, as compared to the effects of exposure to neutral messages also 
delivered via videotape. The intervention is intended for use in public health settings attended by 
high-caries risk groups. Enrollment may take as long as 18 months but is likely to require 
significantly fewer months to meet recruitment goals.54 Study participation will last 
approximately 3½ years. Subjects, clinical examiners and statistical analysts will be blinded with 
respect to treatment allocation; care will be taken to maintain allocation concealment. Treatment 
allocation will be based upon a randomization schedule (to groups 1 or 2 provided by 
REDCap™). In addition to the study CTRA, RAs will not be blinded, so that they can deliver the 
assigned intervention as a supervised exposure to prevent contamination, as a further measure to 
ensure rigor and transparency.  
 
6.1.2 ADMINISTRATION AND/OR DOSING 
• Mothers will be randomly assigned to either an experimental (SDT) group (Group 1) 
where mothers will receive SDT-informed autonomy-supportive messages or a control 
(neutral) group (Group 2) where mothers will receive the same oral health care messages 
delivered using a neutral style.  
• All mothers will be exposed to a series of three videotaped oral health messages - during 
pregnancy, and then when their child is 12 and 24 months of age.  
o The first videotaped message will be shown during the prenatal period and will 
cover a variety of oral health topics regarding the pregnant women’s own oral 
health, the impact of their general and oral health on their future child’s oral 
health, and oral health issues focused on specific needs for children 0 to 12 
months of age.  
o The second videotaped message will be shown when the child is 12 months of age 
and cover oral health issues focused on specific needs for children 12 to 24 
months of age.  
o The third videotaped message will be shown when the child is 24 months of age 
and cover oral health issues focused on specific needs for children 24 to 36 
months of age.  
• The oral health messages in all three videos for the experimental group (Group 1) will be 
informed by the SDT. All videos for the experimental (SDT) group (Group 1) will cover 
a variety of oral health topics: the impact of the mother’s oral health on their children’s 
oral health, process of tooth decay, oral hygiene practices, dietary habits that affect caries 
susceptibility, and checking the child’s teeth for early signs of cavities (white spot 
lesions). Throughout the videos, motivation messages will address the harm of 
inappropriate oral hygiene and dietary habits, challenges mothers face in caring for their 

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child’s oral health, and tips for positive oral health practices. These messages will be 
communicated in an autonomy-supportive way.  
• All videos for the control (neutral) group (Group 2) will cover the same dental content 
presented in the videotaped messages for the experimental (SDT) group (Group 1); 
however, the message will be delivered using a neutral style and will be simply 
informative.  
• Prior to watching the videotaped messages at visits 1, 2 and 3, participating women from 
both groups will complete a series of pre-intervention questionnaires regarding their own 
oral health and their (future) child’s oral health. The questionnaires will include 
information regarding the mother’s (1) demographics; (2) perceptions and status of their 
own oral health; and (3) pre-intervention self-reported knowledge and behavior 
concerning their own oral health (dietary/oral hygiene behaviors, frequency of visits to 
the dentist, etc.), as well as concerning their child’s oral health (child’s dietary/oral 
hygiene habits, etc.). 
• Immediately after viewing the videotaped oral health messages at visits 1, 2 and 3, 
participating women from both groups will complete two additional questionnaires to 
assess their perceptions of the degree of autonomy support of the videotaped messages. 
One questionnaire will assess the mothers’ perceived feelings of autonomy, relatedness, 
and competence (“health care climate questionnaire”), and the other will assess the 
mother’s internalization of the videotaped message (i.e., the degree to which mothers 
understood, agreed with, and perceived the oral health message as helpful and useful to 
them [“internalization questionnaire”]).  
• SDT proposes that, if the participating woman has internalized the message, the changes 
should be evident within a short period of time.7 Thus, participating women from both 
groups will be asked to complete post-intervention questionnaires at one-month follow-up 
after viewing the videotaped messages at visits 1, 2 and 3 designed to assess mothers’ 
changes in self-reported knowledge and subsequent oral health behavior towards their 
child’s oral health. According to the informed consent approved by the UI IRB, “You 
(study participant) may feel uncomfortable in answering certain questions and you can 
choose to decline any aspect of the study at any time. You and your child may 
discontinue participating at any time without any negative consequences.” Therefore, 
participants may choose not to complete the one-month follow-up questionnaires. 
• Booster messages will be sent to mothers at three-month follow-up after viewing the 
videotaped oral health messages at visits 1, 2 and 3 to help them overcome the difficulties 
of adopting the suggested behaviors. The booster messages for mothers of Group 1 will 
be autonomous-supportive, while neutral for mothers of Group 2. Viewing of the 3-
month booster message is optional. 
• In order to assess long-term behavioral changes, all study mothers will be asked to 
complete again the post-intervention questionnaires at nine-month follow-up after 
viewing the videotaped messages at visits 1, 2 and 3. According to the informed consent 
approved by the UI IRB, “You (study participant) may feel uncomfortable in answering 
certain questions and you can choose to decline any aspect of the study at any time. You 
and your child may discontinue participating at any time without any negative 
consequences.” Therefore, participants may choose not to complete the nine-month 
follow-up questionnaires. 

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• Each child will be examined at 12, 24 and 36 months of age (visits 2, 3 and 4) for visible 
plaque and dental caries by one of the examiners who will be blinded to participants’ 
group assignment. We will utilize the d1d2-3 mfs caries criteria for scoring dental caries 
for the children. 
• Plaque samples will also be obtained from all participating children at visits 2, 3 and 4. 
Numbers of MS will be derived for each sample through the standard matrix counting 
methodology of the spiral plating system. Plaque samples will be obtained by using 
sterile cotton swabs; all teeth surfaces will be swabbed. Cotton swabs will be immersed 
in sterile transport fluids and kept cold for transport to the microbiology labs. All 
laboratory procedures will be done by an experienced research scientist and under the 
overall guidance of Dr. Drake, Professor of Microbiology & Infectious Diseases. Dr. 
Drake will routinely audit the database and reconcile it to a logbook that has the 
identification numbers for the samples stored in the ultralow freezer on a monthly basis. 
Detailed Description of the Study Intervention 
This is a two-arm, randomized controlled clinical trial that will compare the efficacy of 
autonomy-supportive videotaped oral health messages framed by SDT to more traditional neutral 
videotaped messages. We intent to recruit pregnant mothers enrolled in Iowa Women, Infants 
and Children (WIC) Supplemental Nutrition Programs and follow them until their future child is 
36 months old. The primary outcome of interest will be children’s caries status.  Secondary 
outcomes will be changes in children’s oral health behaviors conducive to better oral hygiene 
and dietary habits, as well as lower levels of dental plaque and MS. 
 
Assuming an effect size (treatment difference) of 1.1 (standard deviation 3.45) for the number of 
cavitated, missing or filled lesions, Type I error level of 0.05, and 80% power, required sample 
size is 156 children per group at the three-year follow-up.  Given enrollment of 317 mother-child 
dyads for each group (SDT video or neutral control), and a conservative annual attrition rate of 
21%, 156 dyads per group (312 total) would be expected to complete three-year follow-up. 
Subjects, clinical examiners, and statistical analysts will be blinded with respect to treatment 
allocation. A block-level randomization scheme with a 1:1 allocation ratio will be used to 
determine interventions for individuals. Random block sizes of 2, 4, and 6 will be used to create 
the randomization scheme. Randomization will be stratified on primary language and site to 
ensure balance between the intervention groups. There will be 12 possible sites in the study. In 
addition to the CTRA, RAs will not be blinded so that they can deliver the assigned intervention. 
 
Enrollment may take as long 18 months. Study participation will last approximately 42 months. 
We intent to enroll 317 pregnant mothers for each group: Group 1 (experimental - SDT)/Group 2 
(neutral control). There will be four visits at the WIC clinics with three follow-ups after each 
WIC site visit. Outcomes will be measured at each study time points. Data will be collected in 
person at the WIC site visits and through completion of questionnaires through REDCap™ at 
follow-ups after each WIC visit. Visit 2, 3 and 4 will be scheduled based upon the child’s DOB 
and will take place when the child is approximately 12, 24 and 36 months of age.   Children will 
be examined (visits 2, 3 and 4) for visible plaque and dental caries by one of the study examiners 
who will be blinded to the participant’s group allocation. Plaque samples will also be obtained 
from all participating children at visits 2, 3 and 4. Numbers of MS will be derived for each 
sample through the standard matrix counting methodology of the spiral plating system. 

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Detailed Description of the Study Procedures 
The table below details the study procedures: 
6.2 FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
We will hold staff training sessions led by team experts to ensure accurate and complete data 
collection, storage, transportation, processing, and analyses (e.g., questionnaires, plaque 
collection). We will have backup plans to ensure data collection in case unanticipated problems 
arise (for instance, paper forms instead of REDCap™ for survey data collection due to internet 
issues). Participant-level checklists will be used to ensure that all necessary data elements are 
collected at each data collection visit. All data documents will be reviewed for completeness 
within 24 hours so that relevant corrections or unintentionally missing data can be collected. 
Data accuracy will be confirmed at the level of data collection by the CTRA. Any staff with 
Visit 
Time 
Window 
Purpose and Activities 
Location 
 
1.0 
 
Visit 1 
 
Day 0 
Enrollment, informed consent, group 
randomization, pre-intervention  
questionnaires, video 1 message, post-
video HCCQ and Internalization 
questionnaires 
 
 
WIC Clinic 
1.1 
1 month 
+8 weeks 
Post-intervention questionnaires 
Links via 
REDCap™ 
1.2 
3 months 
+6 months 
Booster video 1 message 
Links via 
REDCap™ 
1.3 
9 months 
+8 weeks 
Post-intervention questionnaires 
Links via 
REDCap™ 
 
2.0 
 
Visit 2 
 
1 year +2 months 
Pre-intervention questionnaires, video 2 
message, post-video HCCQ and 
Internalization questionnaires, child’s 
dental exam and plaque sample 
 
 
WIC Clinic 
2.1 
1 year & 
1 month 
+8 weeks 
Post-intervention questionnaires 
Links via 
REDCap™ 
2.2 
1 year & 
3 months 
+6 months 
Booster video 2 message 
Links via 
REDCap™ 
2.3 
1 year & 
9 months 
+8 weeks 
Post-intervention questionnaires 
Links via 
REDCap™ 
 
3.0 
 
Visit 3 
 
2 years +2 months 
Pre-intervention questionnaire data, 
video 3 message, post-video HCCQ and 
Internalization questionnaires, child’s 
dental exam and plaque sample 
 
WIC Clinic 
3.1 
2 years & 
1 month 
+8 weeks 
Post-intervention questionnaires 
Links via 
REDCap™ 
3.2 
2 years & 
3 months 
+6 months 
Booster video 3 message 
Links via 
REDCap™ 
3.3 
2 years & 
9 months 
+8 weeks 
Post-intervention questionnaires 
Links via 
REDCap™ 
4.0 
Visit 4 
3 years +2 months 
Post-intervention questionnaires, child’s 
dental exam and plaque sample 
WIC Clinic 

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consistent quality issues concerning data collection will receive feedback and be re-trained, as 
necessary. Staff training will include hands-on training, practice sessions, validation exercises to 
ensure accuracy, and certification. The CTRA will provide ongoing feedback to data collectors 
regarding data quality. 
 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
A block-level randomization scheme with a 1:1 allocation ratio will be used to determine 
interventions for individuals. Random block sizes of 2, 4, and 6 will be used to create the 
randomization scheme. Randomization will be stratified on primary language and site to ensure 
balance between the intervention groups. Subjects, clinical examiners, and data analyst will be 
blinded with respect to treatment allocation; care will be taken to maintain allocation 
concealment. However, the study CTRA and RAs will not be blinded so that they can deliver the 
assigned intervention as a supervised exposure to prevent contamination, as a further measure to 
ensure rigor and transparency. In addition, the study statisticians will be not be blinded in order 
to manage the dataset, check randomization, check the REDCap™, etc.  
6.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
When the participating pregnant WIC mother is randomly assigned to one of the two study 
groups through a randomization algorithm conducted through REDCap™, based on her language 
preference (English vs. Spanish), the subject will be linked to her assigned group and study 
activities in all time points throughout the duration of the study. In addition, the Data Base 
Manager and CTRA will keep a separate electronic log and verify any potential compliance 
issues through monthly data reports created by REDCap™. 
 
Participants will complete pre- and post-intervention questionnaires via REDCap™ at each of 
the four study visits at the WIC sites. In addition, participants will be sent links with follow-up 
questionnaires at one and nine months after each visit via texts/emails through REDCap™. 
Mother’s will have up to eight weeks to complete the one- and nine-month questionnaires. 
REDCap™ will send reminder text messages and emails at one week, two weeks and three 
weeks for non-responders of the one- and nine-month questionnaires. If mothers do not complete 
the questionnaires after the first three reminders, REDCap™ will notify the study team, and an 
RA will contact the mother to complete the questionnaires. Non-responders will also be mailed 
paper copies of the questionnaires with a prepaid and self-addressed envelope to return once 
completed. 
 
It is mandatory that study subjects participate in the first visit at the WIC site for enrollment, 
informed consent and randomization. In addition, in order to participate in all post-intervention 
activities (i.e., one- and nine-month questionnaires and 3-month booster message), it is 
mandatory that subjects complete the assigned group intervention activities at the WIC site visit. 
For example, if a study subject misses a WIC site intervention (visits 1, 2 or 3), they will not 
complete the post-intervention activities related to the missed visit but will be scheduled for the 
next WIC site time point intervention.  

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6.5 CONCOMITANT THERAPY 
Brief booster messages to help mothers overcome the difficulties of adopting the suggested 
behaviors will be sent via email and/or text link using REDCap™ at three-month follow-up after 
they view the videotaped messages at visits 1, 2 and 3. The booster messages for mothers of 
Group 1 will be autonomous-supportive, while neutral for mothers of Group 2.   
6.5.1 RESCUE PROCEDURES 
Mothers of children diagnosed with caries during the dental exam will be given a list of local 
dentists to further address their restorative needs. In the course of the children’s clinical exams, 
unexpected conditions might be identified (e.g., dental caries, acute infection, etc.). Should this 
occur, mothers will be given the following options: 1) to have their children evaluated on the 
same day on an emergency basis at the UI Department of Pediatric Dentistry, 2) to follow up 
with their respective local dental providers, or 3) to follow up with the UI Department of 
Pediatric Dentistry; appointments will be made within 1-4 weeks for further assessment and 
appropriate treatment. The clinical situation will dictate the urgency of the follow-up care. For 
example, participants with acute abscess will be strongly encouraged to receive immediate 
evaluation (e.g., urgent care clinic at UI Department of Pediatric Dentistry or same day visit with 
their local dentists). Participants with a condition that does not require immediate attention (i.e., 
asymptomatic dental caries, etc.) could have a longer wait period (e.g. follow up in 4 weeks). In 
the event that participants decide to follow up with their local dentists, they will be offered the 
option of a typed document detailing any concerns and oral exam findings. Otherwise, all 
information collected by the study will be de-identified and not shared with any outside sources. 

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7 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL 
MANIPULATION 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party. If the study is prematurely 
terminated or suspended, the PI will promptly inform study participants of changes to study visit 
schedule, the IRB and NIDCR, and will provide the reason(s) for suspension or termination.  
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Demonstration of efficacy that would warrant stopping    
• Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
• Data that are not sufficiently complete and/or evaluable 
• Determination that the primary endpoint has been met 
• Determination of futility. 
 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the funding agency, IRB or other relevant regulatory or oversight bodies. 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
If a participant does withdraw, or is lost to follow up, the Study Termination Case Report Form 
(CRF) will be completed and entered into REDCap™. The study team will document the reason 
for participant discontinuation and log the information into an excel file noting that participation 
is no longer active. Reasons for mothers to be withdrawn from the study or be lost to follow-up 
may include, but is not limited to mother and/or child moving out of the state, mother losing the 
child’s custody, mother opting to withdraw from study due to having a child born with medical 
and/or special health care needs conditions that require specialized care and/or hospitalization 
preventing participation in study activities, etc. 
7.3 LOST TO FOLLOW-UP 
A study WIC mother will be considered lost to follow-up if she is unable to be contacted by the 
study team to schedule and participate in their WIC site visit activities at year 2, 3 or 4. If 
participants miss WIC site visits 2 and/or 3, they can still return to the consecutive WIC site 
visit(s) but will not complete the post-intervention activities (1- and 9-month follow-ups and 3-
month booster message) related to missed WIC site visit(s). The study will not replace lost or 
withdrawn participants. 
 
The following actions must be taken if a participant fails to return to any of the WIC site visits: 
 
• The study team will attempt to contact the participant, reschedule the missed visit within 
two months, counsel the participant on the importance of maintaining the assigned visit 

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schedule and ascertain if the participant wishes to and/or should continue in the study; 
and 
• Before a participant is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the participant (where possible, three text messages, 
emails and telephone calls and, if necessary, a letter to the participant’s last known 
mailing address). These contact attempts will be documented in the participant’s study 
file.  
 
Should the participant continue to be unreachable, she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. 

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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Endpoints 
• The primary outcome of interest is caries status, which will be measured by the d1d2-
3mfscaries criteria for scoring dental caries for the children44,45-49 Both d1mfs and d2-3mfs 
scores derived from these criteria will be considered, reflecting numbers of affected 
(cavitated, missing due to caries or filled) surfaces with and without inclusion of non-
cavitated (d1 “white spot”) lesions. These caries outcomes will be assessed by dental 
examinations at 12, 24 and 36 months of age. Secondary outcomes of interest will assess 
changes in maternal knowledge and oral health behaviors through questionnaires via 
REDCap™, as well as children’s plaque and microbial outcomes through dental exams 
and plaque collection done by dental providers who will be blinded to study allocation.  
Screening and Enrollment 
• The PI and CTRA are responsible for tracking the screening, enrollment, and the number 
approached, refusals and reasons for refusal. The UI Institute for Clinical and 
Translational Science IT specialist along with the Database Manager will provide 
combined enrollment reports of all the WIC sites to the study team and NIDCR.  
Visit Procedure Completion  
• The study CTRA and RAs are responsible for collecting the data at the WIC sites during 
visits 1, 2, 3 and 4. Participants will view videos and complete questionnaires on 
tablets/i-pads through REDCap™. UI dental providers will conduct dental exams and 
collect plaque samples for all participating children. The REDCap™ system will ensure 
that once a study participant is randomly assigned to one of the two study groups, based 
on the participant language preference (English vs. Spanish), the participant will be 
linked to her assigned group and study activities in all time points throughout the duration 
of the study. In addition, the REDCap™ will also allow us to do complex and robust 
multivariate data checks, which will be critical for flagging the study team for potential 
issues within the data or potential process issues at the study sites. The Database Manager 
will provide reports of number of visits completed for each WIC sites.  
Retention and Attrition 
• The study PI and CTRA are responsible for tracking the recruitment, retention and 
attrition status throughout the study. Efforts will be made to assess reasons for dropouts.  
Data Entry Errors  
• The Database Manager is primarily responsible for identifying data entry errors in all 
WIC Sites. REDCap™ will notify the user during data entry of missing fields flagged as 

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required by data management, and manual queries may be created and issued by the Data 
Manager.  
Protocol Deviations/Violations  
• A protocol deviation is any noncompliance with the clinical study protocol or GCP. The 
noncompliance may be on the part of the subject, the investigator, or study staff. The 
study team will review protocol deviations on an ongoing basis and will implement 
corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. All protocol deviations and violations must be submitted to the UI IRB per its 
guidelines. 
• The CTRA and RAs will be responsible for tracking any deviations/violations. The 
Protocol Deviations/Violations Tracking Log will be completed and submitted with the 
report to the Data and Safety Monitoring Board (DSMB). Protocol violations or 
deviations that meet the definition of an Unanticipated Problem (UP) will be submitted to 
NIDCR and the Clinical Research Operations and Management Support (CROMS) 
contractor (rhoproductsafety@rhoworld.com). 
8.2 SAFETY ASSESSMENTS 
Safety monitoring for this study will focus on parameters that capture risks related to study 
participation. Therefore, the study will collect adverse events (including serious adverse events) 
and unanticipated problems (UPs) (Title 45 of the Code of Federal Regulations [CFR] Part 46) 
All UPs, AEs, and SAEs (as defined below) will be reported, from the time of signed informed 
consent to participant study completion or termination. 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
An adverse event (AE) is any untoward or unfavorable medical occurrence in a human 
participant, including any abnormal sign (for example, abnormal physical exam or laboratory 
finding), symptom, or disease, temporally associated with participation in the research, whether 
or not considered related to participation in the research. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
SAE is one that meets one or more of the following criteria: 
• Results in death 
• Is life-threatening (places the participant at immediate risk of death from the event as it 
occurred) 
• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect   
• An important medical event that may not result in death, be life threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical 
judgment, the event may jeopardize the study participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 

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8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
Each of the AEs and SAEs will be assessed based on the classification systems considering three 
factors: severity and expectedness of the event and relatedness to this study. Severity of the event 
will be determined using the classifications outlined below: 
• Mild - (e.g., signs or symptoms easily tolerated, are of minor irritant not causing loss of 
time from normal activities or oral function, and do not require therapy or medical/dental 
evaluation). 
• Moderate - (e.g., a low level of inconvenience or concern, may interfere with daily 
activities or functioning, improved by simple measures);  
• Severe - (e.g., interrupt normal daily activities, require systemic drug therapy or 
treatment, incapacitating in performing oral function). 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All AEs will have their relationship to study procedures, including the intervention, assessed by 
an appropriately-trained clinician based on temporal relationship and his/her clinical judgment. 
The degree of certainty about causality will be graded using the categories below.  
• Related – The AE is known to occur with the study procedures, there is a reasonable 
possibility that the study procedures caused the AE, or there is a temporal relationship 
between the study procedures and the event. Reasonable possibility means that there is 
evidence to suggest a causal relationship between the study procedures and the AE. 
• Not Related – There is not a reasonable possibility that the study procedures caused the 
event, there is no temporal relationship between the study procedures and event onset, or 
an alternate etiology has been established. 
All AEs and SAEs related to this study will be assessed to determine if a protocol amendment 
will be needed to prevent future occurrences.  Corrective and preventive actions will be initiated 
and the Program Officer at the NIDCR will be notified of these corrective efforts. 
8.3.3.3 EXPECTEDNESS 
Expectedness of each event will also be assessed to determine whether it is unexpected 
(e.g., nature not consistent with the intervention in the protocol, consent form, or other related 
materials) or expected (event is known to be associated with the provided intervention of this 
study).  
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
Any findings which consist of Adverse Events (AE), Serious Adverse Events (SAE) or Unexpected 
Problems (UP) will be documented on the appropriate Case Report Forms. All AEs, SAEs, UPs, 
regardless of severity, will be recorded. Potential untoward or unfavorable medical/dental 
occurrences that occur in a study participant, including any abnormal sign, symptom, or disease 
(including but not limited to dental pain, dental infection, trauma or other conditions that require 
immediate attention) that is temporally associated with the subject’s participation in the research 
study (whether or not considered related to the subject’s participation in the research) will be 
identified by all research team members at completion of each study visit and promptly reported 
to the PI. The PI will record the report on an adverse occurrence report sheet. The PI will also 
review all reports to determine whether the event is: 

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1) unexpected;  
2) related or potentially related to research study participation; and/or  
3) suggests that the research places subjects or others at a greater risk of harm related to the 
research than was previously known or recognized.  
 
If these three conditions exist, the occurrence will be considered an UP and will be reported to 
the IRB on the appropriate form and to the NIDCR per their required timeframes.  Unanticipated 
problems will be reported to the DSMB as part of the DSMB reports.  
 
Through these reviews of AEs and occurrences, the DSMB will consider whether cumulative 
data indicates the need to change the research design, to modify information presented to 
participants, or to terminate the project.  It is anticipated that the committee may decide that due 
to minimal risk in this behavioral study, there is not a risk for severe AEs that would require a-
priori stopping rules (this decision will be reviewed at least annually by the DSMB). Any action 
taken to suspend or terminate the project will be reported to the UI IRB, the NIH Office of 
Sponsored Projects, and the program directors at NIDCR.  New, scientific developments outside 
the study that may impact participant safety or the ethics of the study are considered in making 
these determinations.  In addition,  in following up AEs, SAEs, UPs, attempts will be made to 
obtain as much information as possible about event evolution and outcome. Every effort will be 
made to follow the subject until resolution of the event.  
8.3.5 ADVERSE EVENT REPORTING 
For all AEs that are deemed expected and/or unrelated to the study, a summary will be submitted 
to the NIDCR Program Officer with the annual progress report, as well as to the UI IRB at the 
annual continuing review. Adverse events will also be reported to the DSMB as part of DSMB 
reports.8.3.6 Serious Adverse Event Reporting 
Any AE meeting the specified SAE criteria will be submitted on an SAE form to NIDCR’s 
centralized safety system via Rho Product Safety. This report will be sent by fax or email. Once 
submitted, Rho Product Safety will send a confirmation email to the investigator within 1 
business day. The investigator should contact Rho Product Safety if this confirmation is not 
received. This process applies to both initial and follow-up SAE reports. 
SAE Reporting Contact Information: 
• Product Safety Fax Line (US):  1-888-746-3293 
• Product Safety Fax Line (International):  919-287-3998 
• Product Safety Email: rho_productsafety@rhoworld.com 
General questions about SAE reporting can be directed to the Rho Product Safety Help Line 
(available 8:00AM – 5:00PM Eastern Time):  
• US:  1-888-746-7231 
• International: 919-595-6486 
The study’s clinically responsible individual (the PI) will complete a SAE Form and submit via 
fax or email within the following timelines:  
• All deaths and immediately life-threatening events, whether related or 
unrelated, will be recorded on the SAE Form and submitted to Product Safety 
within 24 hours of site awareness. 

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• SAEs other than death and immediately life-threatening events, regardless of 
relationship, will be reported within 10 days of site awareness. 
All SAEs will be followed until resolution or stabilization. 
In addition to being reported to NIDCR, all SAEe will be reported to the UI IRB within 10 
business day of the investigator becoming aware of the event. The investigator will submit a 
Reportable Event form in the electronic IRB submission system at the UI. 
8.3.7 REPORTING EVENTS TO PARTICIPANTS 
If the study is prematurely terminated or suspended, study participants will receive written 
notification documenting the reason for the study changes. 
8.3.8 EVENTS OF SPECIAL INTEREST 
NA 
 
8.3.9 REPORTING OF PREGNANCY 
NA 
 
8.4 UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
The Office for Human Research Protections (OHRP) considers UPs involving risks to study 
participants or others to include, in general, any incident, experience, or outcome that meets all 
of the following criteria: 
• unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved research 
protocol and informed consent document; and (b) the characteristics of the participant 
population being studied; 
• related or possibly related to participation in the research (“possibly related” means there 
is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); and 
• suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
8.4.2 UNANTICIPATED PROBLEMS REPORTING 
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of 
an UP report form. We will include the following information when reporting an UP, or any 
other incident, experience, or outcome to the IRB: 
• appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
• a detailed description of the AE, incident, experience, or outcome;  
• an explanation of the basis for determining that the AE, incident, experience, or outcome 
represents an UP;  

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• a description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the UP. 
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:   
• UPs will be reported to the IRB within 10 business days of the investigator becoming 
aware of the event. The investigator will submit a Reportable New Information form in 
the UI (HAWK-IRB) electronic IRB submission system.  
• All UPs will be reported to appropriate institutional officials (as required by an 
institution’s written reporting procedures), the supporting agency head (or designee), and 
OHRP within one month of the IRB’s receipt of the report of the problem from the 
investigator. 
All UPs will be reported to NIDCR concurrently with reporting to the IRB. These reports will be 
made to NIDCR’s centralized reporting system via Rho Product Safety: 
• Product Safety Fax Line (US):  1-888-746-3293 
• Product Safety Fax Line (International):  919-287-3998 
• Product Safety Email: rho_productsafety@rhoworld.com  
General questions about UP reporting can be directed to the Rho Product Safety Help Line 
(available 8:00AM – 5:00PM Eastern Time):   
• US:  1-888-746-7231 
• International: 919-595-6486 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
If any unanticipated problems occur that may affect the participant’s decision to continue 
participation in the study, study participants will be notified. Safety monitoring for this study will 
focus on parameters that capture risks related to study participation. The study will collect UPs, 
including UPs that are also AEs and SAEs (Title 45 of the Code of Federal Regulations [CFR] 
Part 46). If the study is prematurely terminated or suspended, study participants will receive 
written notification documenting the reason for the study changes. 
 

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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
• 
Primary Efficacy Endpoint(s): 
o Lower caries incidence  
 
• 
Secondary Efficacy Endpoint(s): 
o Better knowledge, behavior towards the child’s oral health, and levels of salivary 
MS and visible plaque scores  
9.2 SAMPLE SIZE DETERMINATION 
Based on a sample size of 317, we should be able to entertain up to 31 covariates in a multiple 
regression model without jeopardizing model validity through overfitting (we note that this far 
exceeds the number of covariates targeted in this application, even allowing for reasonable 
examination of first-order interactions); this number would be smaller for logistic modeling, 
depending upon the distribution of the outcome variable. Finally, we note that modeling of 
outcomes such as clinical status and behavioral change can include covariates such as 
knowledge, behavioral intent, autonomy, competence, and relatedness. Such models incorporate 
the key aspects of the SDT intervention, can assist in the evaluation of the impact of SDT, and 
can offer validation of its application. The rich data set will permit formal evaluation of the 
validity of the theoretical basis of the proposed intervention, e.g., by evaluation of timing of 
behavioral change and whether it persists as prescribed by SDT, by assessing the relationships 
between outcomes and ratings of autonomy, competence and relatedness, and more 
systematically by use of mediation models.58-62 While every effort will be made to maximize 
retention as outlined below, missing data issues will be addressed via multiple imputation63,64 the 
importance and utility of this approach have been substantiated for intervention trials targeting 
early childhood caries.65 We will follow the general recommendations of Rubin66,67 and emulate 
the more specific aspects of execution of the caries-oriented analysis applied to these reported 
caries intervention trial data.65 The possibility of selective dropout between the two groups will 
be fully explored, as will characteristics associated with dropout; sensitivity analyses will be 
conducted to explore the potential impact on results. 
 
Power and Sample Size Considerations: Estimation of Detectable Effect Sizes  
 
For purposes of sample size calculation, the primary outcomes of interest are caries status as 
measured by the d1-2-3mfs and d2-3mfs indices at the third-year follow-up, i.e., at approximately 
three years of age; caries status at two-year follow-up represents a secondary outcome. Indices 
are derived from the modified d1d2-3mfs caries criteria. Required sample sizes are primarily 
based upon the experiences reported by Wagner et al,68 which were felt to provide the most 
appropriate estimates of effect sizes and variability after translation from the WHO caries 
criteria. Therefore, assuming an effect size (treatment difference) of 1.1 (standard deviation 3.45) 
for the number of cavitated, missing or filled lesions, Type I error level of 0.05, and 80% power, 
required sample size is 156 children per group at the three-year follow-up. Given enrollment of 
317 mother-child dyads for each group (experimental (SDT) video or neutral control), and a 
conservative annual attrition rate of 21%, 156 dyads per group (312 total) would be expected to 

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complete three-year follow-up. Based upon these sample sizes, we would have 93% power to 
detect a treatment difference of 1.7 (given s.d. of 4.35) if the caries index also included white 
spot lesions, based on the observations of Wagner et al.68 As described in the previous section, 
somewhat more optimistic retention rates may be realistically anticipated: if we assume an 
attrition schedule of 21% the first year and 15% for each of the two subsequent years, we would 
anticipate that initial recruitment of 317 dyads per group would result in about 180 dyads per 
group completing 3-year follow-up, corresponding to 85% power to detect a 1.1 difference in d2-
3mfs and 95% power to detect a 1.7% difference in d1d2-3mfs. Sensitivity analyses drew upon 
available data on children aged 26-30 months from our WIC-based studies in three Eastern Iowa 
Cities10,11,50-52,69 and the literature. Our studies10-13,49-54 suggest the standard deviation of both of 
these indices is slightly less than 3.0 surfaces, which would be expected to result in slightly 
higher power estimates that those given above; however, we will be drawing from a wider 
geographic area of the state, and somewhat greater variability has been reported for other WIC 
populations.70,71 We note that we have adequate power to detect smaller effect sizes than were 
noted at two years in the intervention trial of Harrison et al72 comparing the effect of 
motivational interviewing and control on ECC; moreover, they are similar to, or less than, the 
observed but non-significant differences for caries outcomes in a smaller study among First 
Nations children that also compared the effects of MI counseling vs. control.73 They will also 
provide some protection against loss of power should response rates be less than projected or in 
the case of misspecification of the statistical assumptions. 
9.3 POPULATIONS FOR ANALYSES 
Our primary population for analyses will be the intention-to-treat population. For a sensitivity 
analysis, the per-protocol population will also be considered. The per-protocol dataset includes 
subjects who complete the three visits and answer ‘yes’ to watching all booster messages.  
9.4 STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
Randomization 
A block-level randomization scheme with a 1:1 allocation ratio will be used to determine 
interventions for individuals. Random block sizes of 2, 4, and 6 will be used to create the 
randomization scheme. Randomization will be stratified on primary language and site to ensure 
balance between the intervention groups. There will be 12 possible sites in the study. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
Primary efficacy 
The primary outcome is caries status, measured by the d1d2-3 caries criteria for scoring dental 
caries in children developed by members of the Iowa Fluoride Study. Caries status as total counts 
of dmf surfaces will be calculated during yearly dental exams. These counts will be reported as 
means, medians, quartiles, standard deviations, and ranges for each intervention group. Data will 
be explored longitudinally using dmf surfaces at each age and dmf increments between ages. 
Analysis of caries outcomes will focus on Poisson and/or negative binomial modeling, possibly 
with variance inflation and zero inflation accommodation, as appropriate. To account for 
repeated longitudinal measurements, generalized estimating equations (GEEs) will be used to 
model these counts. A first-order autoregressive or AR(1) working correlation structure will be 

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assumed. The quasi-likelihood information criteria (QIC) will be used to compare models to 
select the best fit. The model will include age, gender, location (urban/rural), race, intervention, 
and mothers’ knowledge and behavior. These are all clinically important known covariates that 
are associated with caries status, and mothers’ intervention and behavior/knowledge are 
covariates of interest. These are planned covariates to include; however, if the number of 
covariates is limited by the sample size or infrequent observations of caries, we will use bivariate 
analyses to inform a more parsimonious final model. Results for the model will be presented as 
incidence rate ratios with 95% confidence intervals. Data will be analyzed on an intention-to-
treat basis with sensitivity analyses considering the per-protocol dataset. Missing data will be 
addressed via multiple imputation and sensitivity analyses will be conducted to explore potential 
impacts on results. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Secondary efficacy 
Secondary outcomes of interest include changes in knowledge and oral health behaviors of 
mothers, as well as plaque and microbial outcomes in children. Knowledge outcomes will be 
measured pre and post intervention via the score on the knowledge assessment. These measures 
will be considered as counts. GEE modeling will be used with Poisson or negative binomial 
distributions considered. Results will be presented as incidence rate ratios and 95% confidence 
intervals. 
 
Maternal change in behavior will be assessed via a set of behavioral questions asked at multiple 
time points. Each individual question will be dichotomized into improved vs. did not improve 
based on the answers given pre and post intervention. When analyzing single time points, logistic 
modeling will be used. To evaluate behavioral changes over time, GEE models with a logit link 
function will be used. Results will be presented as odds ratios and 95% confidence intervals.  
 
Visible plaque will be analyzed as the number of maxillary and mandibular incisors and molars 
with plaque at each visit. Analysis of plaque outcomes will focus on Poisson and/or negative 
binomial modeling, possibly with variance inflation and zero inflation accommodation, as 
appropriate. To account for repeated longitudinal measurements, GEE will be used to model 
these counts. Results will be presented as incidence rate ratios and 95% confidence intervals.  
 
Levels of salivary MS will be reported as numbers of bacteria from each visit. Log 
transformation will be considered if data is skewed, and GEE models assuming a normal 
distribution with an identity link will be used when analyzing multiple time points. Results will 
be presented as adjusted least squares means estimates and 95% confidence intervals.  
 
The same covariates as the primary endpoint will be used for both bivariate and multivariable 
modeling, subject to the constraint of 10 observations/events for every covariate included.  
Missing data may be addressed via multiple imputation. An AR(1) correlation structure will be 
assumed for all longitudinal models. QIC will be used for all model/covariate selection involving 
GEEs; AIC will be used for models calculated for single time points. Mediation analyses will 
proceed via Baron and Kenny’s74 steps for mediation analysis and significance will be calculated 
via Sobel tests.  

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9.4.4 SAFETY ANALYSES 
NA 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Baseline descriptive analysis 
For continuous demographic variables, the mean, median, and range will be calculated for each 
group (intervention and control). For categorical demographic variables, the frequency and 
percent of each category will be calculated for each group.  
9.4.6 PLANNED INTERIM ANALYSES 
Planned interim analysis 
No interim analyses are planned.  
9.4.7 SUB-GROUP ANALYSES 
To determine whether the effect of the assigned intervention is consistent across subgroups, 
similar models for both primary and secondary endpoints will be fit and estimated including but 
not limited to the following: 
   - Mother education level 
   - First time mother or not 
   - Mother income 
   - Mother race 
   - Mother oral health status 
   - Mother age (< 25 vs. 25 or older)  
No subgroup analysis by sex will be performed, as only pregnant individuals will be enrolled in 
the study.  
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Tabulation of individual participant data 
Data will be de-identified and presented anonymously. 
9.4.9 EXPLORATORY ANALYSES 
Exploratory analysis 
NA 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Prior to the beginning of the study, the PI must have IRB approval for the protocol and any 
informed consent forms. Any other information provided to the participants must have IRB 
approval. Only the PI or research team members approved by the IRB may administer consent. A 
person is qualified to administer consent only if he/she has received basic human subject’s 
protection training and possesses the requisite dental and/or medical training, knowledge of the 
protocol and familiarity with the clinical needs to be able to discuss the risks and benefits of the 
study with prospective participants.  
 
Informed consent is a process that is initiated prior to the individual agreeing to participate in the 
study and continues throughout study participation. Extensive discussion of risks and possible 
benefits of study participation will be provided to participants and their families. Consent in this 
study will be sought from all WIC-enrolled pregnant women interested in participating in the 
study. The consent of each pregnant woman will be obtained in a quiet private space by a trained 
research member. The consent form will be reviewed verbally. Throughout the consent process, 
the research member will ask the pregnant woman if she has any questions. The staff member 
will make sure the individual has adequate time to consider all options. If the individual appears 
to need more time to consider all options, staff will provide the option to participate at a later 
time. All pregnant women will be given the study staff’s contact information in case they decide 
to join the study. Informed consent will be administered electronically via REDCap™ web-based 
research software. 
  
The participant will be asked to sign the informed consent form electronically in 
REDCap™ prior to any study-related assessments or procedures. All participants will be given a 
copy of the signed form, either by email or printed on site directly following consent. Back up 
paper copies of all consent forms will be on hand in case of any power outages or Wi-Fi 
connectivity issues. Due to the child participants’ age, informed consent will be obtained from 
the mother of the future child participant.   
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Documentation of Consent – The ICH GCP guidelines require that the participant or legal 
representative receive a copy of the signed and dated consent document. In this study the study 
participants will be asked to sign and date the informed consent document electronically and will 
be provided with a signed and dated copy by email or a printed copy. The source documents will 
thus reside in REDCap™ and will indicate that the consent was signed, along with the date of 
signing.  
 

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Translation of Consent Documents – All participants need to be able to speak and read English 
or Spanish. Therefore, all materials, including consents, will be translated and made available in 
English and Spanish. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be prematurely terminated if there is sufficient reasonable cause. Written 
notification, documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party. If the study is prematurely terminated, the PI will promptly 
inform study participants, the IRB and NIDCR, and will provide the reason(s) for suspension or 
termination.  
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants. 
• Demonstration of efficacy that would warrant stopping.    
• Insufficient compliance of study staff to the protocol (i.e., significant protocol violations). 
• Data that are not sufficiently complete and/or evaluable. 
• Determination that the primary endpoint has been met. 
• Determination of futility. 
10.1.3 CONFIDENTIALITY AND PRIVACY 
Our research team will maintain rigorous protocols to ensure that data remain confidential. These 
methods include training of all research team members on issues of confidentiality and ethical 
research conduct, breaking the links between contact information and individual identifiers in the 
participant data, the use of secure passwords for access to data, and the use of secure filing 
cabinets. All researchers and staff will be required to keep all information collected by this 
project confidential. A REDCap™ program at the UI will maintain the list linking each 
participant with a unique identifier. This list will be maintained in a physically separate location 
from the research database(s) with the unique identifier. The PI will have ultimate responsibility 
for managing and maintaining the data. 
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, the safety and oversight monitor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a 
specific study participant will be held in strict confidence within the research team. No 
personally-identifiable information from the study will be released to any unauthorized third 
party without prior written approval of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
 
A study monitor, other authorized representatives of the IRB, may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, records for the 
participants in this study.  
 
The study participant’s contact information will be securely stored for internal use only during 
the study. At the end of the study, all records will continue to be kept in a secure location for as 

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long a period as dictated by the reviewing UI IRB, Institutional policies, or sponsor/funding 
agency requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at the Institute for Clinical and Translational Services 
(ICTS) at the UI using REDCap™. This will not include the participant’s contact or identifying 
information. Rather, individual participants and their research data will be identified by a unique 
study identification number. The study data entry and study data management system used by 
our research team will be secured and password protected. At the end of the study, all study 
databases will be de-identified and archived at ICTS. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
Stored specimens will be used for future studies. The participating child’s samples will be stored 
with a code which may be linked to the child’s name.  If the mother agrees during the informed 
consent for future use of her child’s samples but decide in the future that she would like to have 
it removed from future research, she should contact the PI.  However, if some research with the 
child’s samples had already been completed, the information from that research may still be 
used.  
  
All paper-based data at the UI will be stored in the PI’s locked private office within locked filing 
cabinets, including external hard drives with back up study data. Electronic data will be stored on 
the password-protected web-based REDCap™ site. No study data will remain on laptops after 
data collection visits end. All specimen and data will be stored for a minimum of six years upon 
study completion as dictated by the UI IRB. 
 
Subjects may refuse or withdraw consent for collected samples and data to be used for future 
studies as described in the consent form. IRB will review future studies, and protections of 
confidentiality for any future studies with the stored specimens and/or data. 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Role 
Responsibilities 
Principal Investigator 
Karin Weber-Gasparoni, DDS, MS, PhD 
Professor and Chair 
Infant Oral Health Program Director 
Department of Pediatric Dentistry 
University of Iowa College of Dentistry 
S202 Dental Science South 
Iowa City, IA 52242 
Office phone: (319) 335-7486 
Office fax: (319) 353-5508 
karin-weber@uiowa.edu 
 
• Study leadership 
• Study design 
• General study issues  
• Protocol questions 
• Reporting adverse events 
• Data analysis 
• Results interpretation 
• Dissemination of findings 
• Gold standard for calibration trainings 
• Write abstracts, presentations  
• Prepare manuscripts for publication 
Program Official 
Dr. Elise Rice 
•  Normal stewardship of the award 
• Provide scientific, programmatic, and 
technical aspects of this project 

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NIH NIDCR 
6701 Democracy Boulevard 
MSC 4878 
Bethesda, MD 20892 
United States 
(301) 594-4814 
elise.rice@nih.gov 
Project Scientist  
Dr. Melissa Riddle 
NIH NIDCR 
6701 Democracy Blvd  
MSC 4878 
Bethesda, MD 20892-4878 
United States 
(301) 451-3888 
riddleme@nidcr.nih.gov 
• Provide technical assistance, advice, and 
coordination above and beyond normal 
program stewardship for grants 
• Responsible for assessing the progress of 
the project toward the accomplishment of 
the goals and for recommending if further 
funds should be released to the project 
• Facilitate the establishment of contacts 
and collaborations between awardees and 
other persons or organizations whose 
participation will assist with the 
accomplishment of project goals  
NIDCR Medical Monitor  
Dr. Kevin McBryde 
National Institutes of Health (NIH) 
BG 1DEM RM 638 
6707 Democracy Blvd 
Bethesda, MD 20817 
Phone: (301) 594-0170 
Fax: (301) 480-8319 
kevin.mcbryde@nih.gov 
 
Co-Investigators 
• David Drake, PhD 
david-drake@uiowa.edu 
(319)-335-7384 
• Steven Levy, DDS, MPH 
steven-levy@uiowa.edu  
(319)-335-7185  
• Teresa Marshall, PhD 
teresa-marshall@uiowa.edu 
(319)-335-7190 
• John Warren, DDS, MS 
john-warren@uiowa.edu  
(319)-335-7205  
• Xian Jin Xie, PhD 
xianjin-xie@uiowa.edu  
(319)-335-7214 
• Advise on study design and operation 
• Aid in study protocols and instruments 
• Implement recruitment/retention 
strategies 
• Conduct dental exam calibration training 
• Data management, analysis, and 
interpretation 
• Write abstracts, poster presentations 
• Prepare manuscripts for publication 

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Clinical Trials Research Associate 
• Jennifer Bowman-Reif, MS 
jennifer-bowman-reif@uiowa.edu  
(319)-467-4930  
 
Research Assistants 
• Garrett Ormsby, BS 
garrett-ormsby@uiowa.edu  
(319)-467-4930 
• Ethan Heusel, BA 
ethan-heusel@uiowa.edu  
(319)-467-4930 
• Erin Striegel, BS 
erin-striegel@uiowa.edu  
(319)-467-4930 
• Project support & administration 
 
 
 
 
 
• Participant recruitment, enrollment, 
scheduling, and reminders 
• Data collection & management 
• Main contact and resource for 
participants 
• Resource to participants to answer 
questions and resolve problems for study 
subjects 
Consultants 
 
University of California, San Francisco 
• Stuart Gansky, DrPH 
stuart.gansky@ucsf.edu  
(415)-502-8094 
Australian Catholic University  
• Johnmarshall Reeve, PhD 
johnmarshall.reeve@acu.edu.au 
(612)-9739-2172 
 
 
 
• Assist with dental exam calibration 
training 
• Aid in creation of REDCap™ calibration 
data collection 
• Aid in study protocols and instruments 
related to the behavioral intervention 
(SDT) 
• Develop and monitor study fidelity 
• Collaborate with community partners 
with any study issues/concerns 
• Data interpretation 
• Write abstracts, poster presentations 
• Prepare manuscripts for publication 
Dental examiners 
• Amy Lesch, DDS, MS  
amy-lesch@uiowa.edu  
(319)-467-1464 
• Dental Hygienists (n=2) TBD  
• Principal investigator 
 
• Examine children for caries 
• Obtain plaques samples 
 
 
Data & Statistics Team 
• Xian Jin Xie, PhD 
xianjin-xie@uiowa.edu  
(319)-335-7214 
• Erliang Zeng, PhD 
erliang-zeng@uiowa.edu 
(319)-335-7302 
• Chandler Pendleton, MS 
chandler-pendleton@uiowa.edu 
 
• Data management and analysis 
• Monitor data quality 
• Advise on research design 
• Data analysis  
• Address any potential statistical issues 
• Data base manager: construct the 
database, edits, and randomization, create 
reports, provide training on queries and 

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(319)-467-3166 
 
report generation, export data, lock the 
database, and provide study close out 
materials. 
ICTS REDCap™ Senior IT Support 
• Joseph Spring, BS  
joseph-spring@uiowa.edu  
(319)-353-6299 
 
 
• Design and implementation of custom 
instruments in REDCap™ 
• Development of Alerts and Notifications 
to support the study 
• Development automation for sending of 
follow-up surveys based on timing of 
logic 
• Creating reports within REDCap™ for 
study team 
• Twilio 
• Multi language module 
• Randomization (variable number of sites) 
Laboratory Manager 
• David Drake, PhD 
david-drake@uiowa.edu 
(319)-335-7384 
 
Min Zhu 
Min-zhu@uiowa.edu 
(319) 335-6986 
 
• Plaque sample preparation 
• Processing of biomarker data 
• Lab safety, chemical inventory, and 
hazardous waste disposal 
• Record and interpret microbiological data 
• Responsible for salivary bacterial 
analysis 
WIC Clinic Staff 
• 
Cedar Rapids (3 sites) 
• 
Davenport (2 sites) 
• 
Muscatine (1 site) 
• 
Washington (1 site) 
• 
Clinton (1 site) 
• 
Dewitt (1 site) 
• 
Waterloo (1 site) 
• 
Dubuque (1 site) 
• 
Makoqueta (1 site) 
• 
Johnson (1) 
• 
UIHC (1) 
 
• 
Participant recruitment – WIC study staff 
will provide informational brochure to 
pregnant WIC clients interested in 
hearing about the study  
• 
WIC clinics will serve as study sites 
 
  
10.1.6 SAFETY OVERSIGHT 
The PI will be responsible for study oversight, including monitoring safety, ensuring that the 
study is conducted according to the protocol and ensuring data integrity. The interventions, 
outcome measures, and other assessments are of minimal risk to participants in the proposed 
study. Intervention participation and data assessments do not exceed the probability and 
magnitude of harm or discomfort anticipated during ordinarily encountered daily life or in the 
performance of routine oral or psychological examinations or tests. The PI will oversee 

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recruitment and consenting processes approved for participants and conduct the study using 
protocols that will be approved by the UI IRB. Systems will be in place to assure confidentiality 
and data security for data collection and storage. The PI and the CTRA will review the data for 
safety concerns and data trends at regular intervals and will promptly report to the IRB and 
NIDCR per their reporting requirements. 
 
In addition to the PI’s responsibility for oversight, study oversight will be under the direction of 
a Data and Safety Monitoring Board (DSMB) composed of members with expertise in 
obstetrics/gynecology, motivational interviewing and health disparities, pediatric dentistry, and 
biostatistics. Reports will be provided to the DSMB, including missing data, protocol deviations 
and safety data, screen fail, enrollment and withdrawal rates, etc.  If safety concerns arise, more 
frequent meetings may be held. The DSMB will operate under the rules of an NIDCR-approved 
charter that will be approved at the organizational meeting of the DSMB. At this time, most data 
elements that the DSMB needs to assess will be clearly defined. The DSMB will provide 
recommendations to the NIDCR. 
 
10.1.7 CLINICAL MONITORING 
Clinical site monitoring is conducted to ensure that the rights of human subjects are protected, 
that the study is implemented in accordance with the protocol and/or other operating procedures, 
and that the quality and integrity of study data and data collection methods are maintained. 
Monitoring for this study will be performed by NIDCR’s CROMS contractor. The monitor will 
evaluate study processes and documentation based on NIDCR standards and the ICH GCP.  
 
Details of clinical site monitoring will be documented in a Clinical Monitoring Plan (CMP) 
developed by the CROMS contractor, in collaboration with the NIDCR Office of Clinical Trials 
and Operations Management (OCTOM) and the NIDCR Program Official. The CMP will 
specify the frequency of monitoring, monitoring procedures, the level of clinical site monitoring 
activities (e.g., the percentage of subject data to be reviewed), and the distribution of monitoring 
reports. Some monitoring activities may be performed remotely, while others will take place at 
the study site(s). Staff from the CROMS contractor will conduct monitoring activities and 
provide reports of the findings and associated action items in accordance with the details 
described in the CMP. Documentation of monitoring activities and findings will be provided to 
the site study team, the study PIs, OCTOM, and the NIDCR. The NIDCR reserves the right to 
conduct independent audits as necessary. 
 
PREPARING FOR AUDITS BY REGULATORY AUTHORITIES 
The NIDCR reserves the right to conduct independent audits as necessary. Should independent 
monitoring become necessary, the PI will provide direct access to all trial related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by the sponsor/funding 
agency, and inspection by local and regulatory authorities. 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
All clinical site level quality management efforts will be supervised by the PI, aided by the 
CTRA and with input from the co-investigators. Details of the quality processes will be included 

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in the quality management plan. Research team will permit authorized representatives of NIDCR 
and regulatory agencies to examine (and when required by applicable law, to copy) research 
records for the purposes of quality assurance reviews, audits, and evaluation of the study safety, 
progress, and data validity. 
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data collection will be the responsibility of the clinical trial staff at the site under the supervision 
of the PI and CTRA. The PI will be responsible for ensuring the accuracy, completeness, and 
timeliness of the data reported. UPs must be reviewed by the PI. The research team will be 
trained on electronic data collection, particularly with regard to upholding the study intervention 
fidelity. In addition, proper training will be conducted among clinical examiners who will 
perform the dental exams and plaque collections, as well as among those involved in the storage 
and transport of plaque samples. 
 
The PI and co-investigators will be responsible for ensuring data integrity. Data management 
will be handled at the UI College of Dentistry by a dedicated database manager, who will 
construct the database, provide data entry training, create reports, and be responsible for data 
quality and management procedures, data edits, queries and report generation, exporting the data, 
locking the database, and providing study close out materials. The database will be established 
using REDCap™ (Research Electronic Data Capture), a reliable and secure web-based 
application developed at Vanderbilt University and supported by the UI. 
10.1.9.2 STUDY RECORDS RETENTION 
Study records will be maintained for at least six years, to comply with institutional policy, from 
the date that the grant federal financial report is submitted to the NIH or from the date of the 
final publication, whichever is later.  
LONG TERM STORAGE OF FORMS 
All final, cleaned data in REDCap™ will be exported to a CSV file and saved on the UI server. 
The REDCap™ database will be closed and archived and all user rights withdrawn. Data will be 
retained for at least 6 years from the end of the study.  
10.1.10 PROTOCOL DEVIATIONS 
A protocol deviation is any noncompliance with the clinical study protocol or GCP. The 
noncompliance may be on the part of the subject, the investigator, or study staff. The study team 
will review protocol deviations on an ongoing basis and will implement corrective actions when 
the quantity or nature of deviations are deemed to be at a level of concern. In addition, the study 
will notify the UI IRB and NIDCR, per their reporting requirements. 
10.1.11 PUBLICATION AND DATA SHARING POLICY 
The study will comply with 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 
within 12 months upon publication. The research team will be responsible for developing 

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publication procedures and resolving authorship issues. Manuscripts will be reviewed by all the 
co-authors before submission. Data will be shared no later than the acceptance for publication of 
the main findings from the final data set. 
10.1.12 CONFLICT OF INTEREST POLICY 
All study investigators will file conflict of interest and financial disclosure forms with the UI as 
needed or requested. 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
AE 
Adverse Event 
AR 
First-order autoregressive 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report Form 
CROMS 
Clinical Research Operations and Management Support 
CSV 
Comma-separated values 
CTRA 
Clinical Trial Research Associate 
dmf 
Decayed, Missing, and Filled Tooth 
DSMB 
Data Safety Monitoring Board 
ECC 
Early childhood caries 
GCP 
Good Clinical Practice 
GEE 
Generalized estimating equation 
HCCQ 
Health care climate questionnaire 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonisation 
ICTS 
Institute for Clinical and Translational Services 
IRB 
Institutional Review Board 
MS 
mutans streptococci 
NIDCR 
National Institute of Dental and Craniofacial Research 
NIH 
National Institutes of Health 
OCTOM 
Office of Clinical Trials and Operations Management 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
REDCap™  Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SDT 
Self-determination theory 

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SOA 
Schedule of Activities 
UI 
University of Iowa 
UP 
Unanticipated Problem 
US 
United States 
WIC 
Women, Infants and Children 
WHO 
World Health Organization 
 
10.4 PROTOCOL AMENDMENT HISTORY 
Version 
Date 
Description of Change  
Brief Rationale 
  
  
  
  
 
 
 
 
 
 

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NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans – v4.0 2018-12-12 
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69. Ghosheh J, Weber-Gasparoni K, Drake D, Warren J, Reeve, J, Xu J, Dawson D. Maternal 
behavioral changes in WIC toddlers facilitated by self-determination theory. 61st Annual 
session of the American Academy of Pediatric Dentistry, May 22-26, 2008. 
70. Weinstein P, Harrison R, Benton T. Motivating parents to prevent caries in their young 
children: one-year findings. J Am Dent Assoc. 2004;135(6):731-8. 
71. Ismail AI, Ondersma S, Jedele JM, Little RJ, Lepkowski JM. Evaluation of a brief tailored 
motivational intervention to prevent early childhood caries. Community Dent Oral 
Epidemiol. 2011;39(5):433-48.  
72. Harrison R, Benton T, Everson-Stewart S, Weinstein P. Effect of motivational interviewing 
on rates of early childhood caries: a randomized trial. Pediatr Dent. 2007;29(1):16-22. 
73. Harrison RL, Veronneau J, Leroux B. Effectiveness of maternal counseling in reducing 
caries in Cree children. J Dent Res. 2012;91(11):1032-07. 
74. Baron, R.M., & Kenny, D.A. (1986). The moderator-mediator variable distinction in social 
psychological research: conceptual, strategic, and statistical considerations. Journal of 
Personality and Social Psychology, 51(6), 1173-82.