Improving Care Giver Adherence to Recommended Infant Care Practices
Phase: NA
Conditions: Breastfeeding, SUID, SIDS
Sponsor: Boston University

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Improving Care Giver Adherence to Recommended  
Infant Care Practices  
(AKA SMARTER) 
 
ClinicalTrials.gov number: NCT04387552  
Protocol Version Number: V5.1 
Protocol Version Date: 5Nov24 
Funding Mechanism:  Eunice Kennedy Shriver National Institute of Child Health and Human 
Development (NICHD) grant #R01HD072815-06A1 
 
 
 
Principal Investigators: 
 
Eve R. Colson, MD, MHPE 
 
Washington University St. Louis 
eve.colson@wustl.edu 
Michael Corwin, MD 
 
Boston University 
mjcorwin@bu.edu 
Ann Kellams, MD 
 
University of Virginia School of 
Medicine 
ALK9C@hscmail.mcc.virginia.edu 
 
 
 
 
Statistical analysis plan- pages 38-41 
 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of Boston University. No part of it may be transmitted, 
reproduced, published, or used by other persons without prior written authorization from the study 
sponsor.

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Protocol Revisions and IRB Approvals 
 
Revision #1 
Protocol V 3.2 
IRB Approval Date: 20Dec2021 
Section 
Revision Description 
9.2.3 
1- If participant texts ‘stop’, they must reply to a stop confirmation text in order to stop 
TodaysBaby.  If they confirm stop will be withdrawn from study. 
 
2- Participants who respond to a study text indicating they are no longer pregnant, will 
receive a follow-up text asking them to confirm that they are no longer pregnant.  If they 
confirm they are no longer pregnant, participant will be withdrawn immediately. 
9.9 
Addition of a stop confirmation text to participants 
9.10 
Removed Amazon as gift card option.  Added CVS Pharmacy as gift card option.  Added 
Target as preferred gift card retailer. 
10.2 
Modified REDCap message for participants who respond anything other than “Never” to 
Q10 on EPDS.  Have added statement that survey responses are not monitored in real time. 
 
Revision #2 
Protocol V 3.3 
IRB Approval Date: 14Apr2022 
Section 
Revision Description 
7.2 
Exclusion Criteria updated to reflect that contraindication to breastfeeding and/or supine 
sleep position will not be assessed on initial eligibility screening.  It will be assessed at 30+1 
gestational weeks (via text query) and on the birth survey. 
9.10 
Reimbursements updated to reflect that participants will receive gift card for survey 
completion within 7 days of completing a survey. 
16.0 
Updated Pre-Observation Period weekly text messages.  Participant now receives on 
gestational week +0 instead of +1 (ex. 32+0) 
Added additional survey reminder text messages. 
 
Revision #3 
Protocol V 3.4 
IRB Approval Date: 01Aug2022 
Section 
Revision Description 
7.2 
Exclusion Criteria updated to reflect that participants who do not complete the Agile Health 
Onboarding process by 32+1 weeks gestation are not eligible for the study. 
9.8 
Early Terminations/Withdrawals section updated to indicate that participants will be 
ineligible for the study if they do not complete the following enrollment procedures by 32 
weeks plus 1 days gestation. 
9.9 
Updated follow-up section for participants Who text ‘Stop’  
• 
If participant has not undergone randomization #1 – they will be withdrawn from the 
study. 
• 
If participant has undergone randomization #1 – they will continue with the study and 
receiving any remaining study surveys via text or email.  
10.4 
Stopping Rules revised.  Added scenarios that participant will be withdrawn from study prior 
to undergoing randomization #1 
• 
Participant texts ‘STOP” and confirms they want to stop receiving the TodaysBaby 
program. 
• 
Participant informs study that they are no longer pregnant. 

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Revision #4 
Protocol V 3.5 
IRB Approval Date: 14Oct2022 
Section 
Revision Description 
5.0 
Updated Study Design: Data Collection Methods 
Have added a short TodaysBaby Program Discontinued Survey, for participant who elect to 
stop receiving the TodaysBaby Program via text, and are still enrolled in the study. 
 
9.9 
Updated follow-up section for participants who do not respond to text queries or open 
intervention videos. 
• 
If staff are unable to reach participant to follow-up by phone, they may attempt to 
contact participant via email (if email was provided at the time of enrollment).  Email will 
only be used if there is concern that participant is not receiving text messages. 
 
Updated follow-up section for participants Who text ‘Stop’  
• 
Participants who have undergone randomization #1, stop receiving the TodaysBaby 
program prior to their infant reaching 6 months of age, will be asked to complete a short 
TodaysBaby Program Discontinued Survey. 
 
 
Revision #5 
Protocol V 3.6 
IRB Approval Date: 11Jan2023 
Section 
Revision Description 
10.2 
Updated the response survey response participants receive if they respond anything other 
than ‘None’ on the EPDS Question 10 (thoughts of harming themselves). 
• 
Updated the Suicide and Crisis Lifeline information. 
• 
Added statement that a clinician from the study will call them to discuss their survey 
response. 
 
Revision #6 
Protocol V 4.0 
IRB Approval Date:   13Jun2023 
Section 
Revision Description 
5.B.c. 
Updated Randomization Section to include that randomization stratification will be 
assigned by State WIC region.   
5.C. 
Updated Study Team Institutional Roles and Responsibilities to include that study staff at 
UVA, WUSTL and UMASS Medical Center, may assist in participant recruitment at 
participating WIC centers and Federally Qualified Health Centers (FQHC). 
9.1.1 
Added that participants may be identified at participating FQHC. 
9.1.3 
Modified Participant ID # to indicate three-digit WIC Region number. 
10.2.C. 
Updated Safety Review section to indicate that clinicians following-up with a Spanish 
speaking participant because of a positive Q10 EPDS score, may use hospital interpreter 
services when following-up with participant. 
 
 

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Revision #7 
Protocol V 5.0 
IRB Approval Date:   06Dec2023 
Section 
Revision Description 
7.1 
Participant Inclusion Criteria has been updated 
Added: If potential participant is not enrolled in participating WIC Center they must have 
either Medicaid or no insurance 
10.2 
DSMP has been modified.   
Participants will have option to opt-out of receiving contact by the study physician if they 
respond positively on the EPDS to thoughts of harming themselves. 
 
We will add a statement at the beginning of the EPDS Section of the Baseline, Birth and 
Postnatal Surveys to inform participants that they may receive a call from study clinician to 
discuss some of their responses in this section. 
 
We have added an additional participant resource in the event of miscarriage, infant death 
or stillbirth.  https://www.postpartum.net/get-help/loss-grief-in-pregnancy-postpartum/ 
 
Revision #8 
Protocol V 5.1 
IRB Approval Date:    
Section 
Revision Description 
3.0 
Study Design: Study Team Institutional Roles and Responsibilities 
Starting 2025 – A UVA study coordinator will oversee the management of participant 
outreach and follow-up work that BU RAs are responsible for.  As part of this oversight the 
UVA Coordinator will have access to SMARTER participants reports and data through a 
secure VPN connection to the BU databases and the Agile Health platform. 
8.2 
DSMP has been modified.   
a. For participants who answer question 10 of the EPDS (thoughts of harming themselves) 
with any response other than 'never', and who do NOT opt-out of a follow-up call with a 
clinician, but who we are not able to reach after 3 attempts, we will now send them a text 
letting them know we were not able to reach them along with a link to resources if they 
ever should need them.   
 
b. For participants who answer question 10 of the EPDS (thoughts of harming themselves) 
with anything other than never, and who OPT OUT of a follow-up call with a clinician - we 
will now send them a text acknowledging their response and include a link to resources if 
they ever should need them.   
9.4 
Management of Information 
Starting 2025, a UVA coordinator will have access to participant data via a secure VPN 
connection to study databases housed on a secure BU server. 
 
 

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TABLE OF CONTENTS 
1 Background/Rationale & Purpose ........................................................................................................... 8 
1.1 Background Information ................................................................................................................... 8 
1.2 Rationale and Purpose ...................................................................................................................... 9 
2 Objectives ............................................................................................................................................... 12 
2.1 Study Objectives .............................................................................................................................. 12 
2.2 Study Outcome Measures ............................................................................................................... 12 
2.2.1 Primary Outcome Measures ....................................................................................... 12 
2.2.2 Secondary Outcome Measures ................................................................................... 12 
3 Study Design ........................................................................................................................................... 13 
4 Potential Risks and Benefits .................................................................................................................. 18 
4.1 Risks .................................................................................................................................................. 18 
4.2 Potential Benefits............................................................................................................................. 19 
4.3 Analysis of Risks in Relation to Benefits ......................................................................................... 19 
5 Study Participant Selection .................................................................................................................... 19 
5.1 Participant Inclusion Criteria ........................................................................................................... 19 
5.2 Participant Exclusion Criteria .......................................................................................................... 20 
6 Study Intervention .................................................................................................................................. 20 
7 Study Procedures ................................................................................................................................... 24 
7.1 Enrollment Procedures .................................................................................................................... 24 
7.1.1 Eligibility Screening ..................................................................................................... 24 
7.1.2 Informed Consent ....................................................................................................... 25 
7.1.3 Participant ID Number ................................................................................................ 25 
7.1.4 Enrollment Survey ...................................................................................................... 25 
7.1.5 mHealth Text Platform Access .................................................................................... 25 
7.2 Post Enrollment Procedures ........................................................................................................... 26 
7.2.1 Pre-Randomization/Limited Engagement Period ......................................................... 26 
7.2.2 Pre-Randomization/Engagement Observation Period ................................................. 27 
7.2.3 Ascertainment of Infant Birth or Fetal Demise Prior to Randomization #1 ................... 27 
7.3 Randomization Sequence #1 ........................................................................................................... 28 
7.4 Prenatal Intervention Period .......................................................................................................... 29 
7.5 Ascertainment of Infant Birth After Assignment to Prenatal Intervention ................................. 29 
7.6 Randomization Sequence #2 ........................................................................................................... 30 
7.7 Postnatal Intervention ..................................................................................................................... 30 
7.8 Early Terminations/Withdrawals .................................................................................................... 30 
7.9 Participant Follow-Up ...................................................................................................................... 31 
7.10 Reimbursements and Lotteries ..................................................................................................... 31 
8 Assessment of Safety and Data Safety Monitoring Plan (DSMP) ........................................................ 32 
8.1 Definitions ........................................................................................................................................ 33 
8.2 Safety Review ................................................................................................................................... 34 
8.3 Reporting Plans ................................................................................................................................ 36 
8.4 Stopping Rules .................................................................................................................................. 37 
9 Data Handling and Record Keeping ...................................................................................................... 37 

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9.1 Confidentiality .................................................................................................................................. 37 
9.2 Data Managed at Boston University ............................................................................................... 37 
9.3 Data Managed at Agile Health ........................................................................................................ 37 
9.4 ClinicalTrials.gov............................................................................................................................... 38 
9.5 Source Documents ........................................................................................................................... 38 
9.6 Study Records Retention ................................................................................................................. 38 
10 Statistical Plan ....................................................................................................................................... 38 
10. Study Hypotheses ............................................................................................................................ 38 
10.2 Sample Size Determination ........................................................................................................... 39 
10.3 Statistical Methods ........................................................................................................................ 39 
11  Ethics/Protection of Human Subjects ................................................................................................ 41 
12  Literature References .......................................................................................................................... 42 
13  Appendix 1 – TodaysBaby Intervention Videos ................................................................................. 48 
14  Appenix 2 – Schedule of Events .......................................................................................................... 50 
 
 

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List of Abbreviations 
Abbreviation 
Abbreviation definition 
AAP 
American Academy of Pediatrics 
BAA 
Behavioral Affective Associations Model 
EDD 
Estimated Due Date 
FQHC 
Federally Qualified Health Center 
ICP 
Infant Care Practices 
mHealth 
Mobile Health 
PMT 
Protection Motivation Theory 
SMART 
Social Media and Risk Reduction Training study 
SIDS 
Sudden Infant Death 
SUID 
Sudden Unexplained Infant Death 
TPB 
Theory of Planned Behavior 
WIC 
Supplemental Nutrition Program for Women, Infants, and Children 
SUPERSONIC 
Support via Online Social Networks to Promote Safe Infant Care Practices toward 
Reducing Racial Disparities in Infant Mortality 
 
Protocol Summary 
Title: 
Social Media and Risk Reduction Teaching Enhanced Reach (SMARTER) 
Population: 
Pregnant women from participating health or WIC centers who are less than 31 
weeks plus 6 days gestation, sample size=2,500, age = reproductive age  
Intervention: 
Prenatal Interventions: 
1) Infant care practices messaging with an emphasis on supporting best 
practices for infant feeding. 
2) Infant care practices messaging with an emphasis on supporting best 
practices for infant sleep. 
 
Postnatal Interventions: 
1) Infant care practices messaging with an emphasis on supporting best 
practices for infant feeding. 
2) Infant care practices messaging with an emphasis on supporting best 
practices for infant sleep. 
Objectives: 
Overall study goals are to improve adherence to safe sleep recommendations 
and improve rates of initiation and duration of any and exclusive breastfeeding.  
Design/Methodology: 
Prenatal randomization at 33 plus 6 days gestation to one of two study arms (in 
1:1 ratio): Prenatal Breastfeeding or Prenatal Safe Sleep;  
 
Postnatal randomization at birth ascertainment to one of two study arms (in 
1:1 ratio): Postnatal Breastfeeding; Postnatal Safe Sleep.   
Total Study Duration: 
Participants can enroll at any time prior to 31 weeks plus 6 days gestation. 
Study continues until participant’s infant is 6 months of age. Therefore, 
maximum total study duration may range from about 36 to 60 weeks 
depending on the gestational age at which the participant enrolls. 
Subject Participation 
Duration: 
Varies by participant between 8-12 months.   
 
 

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1 
Background/Rationale & Purpose 
 
1.1 
Background Information 
 
The SMARTER Study is the successor to the Social Media and Risk Reduction Training (SMART) study 
that was conducted by this study team from 2012 - 2018.  The SMART study was a randomized trial 
using mobile health (mHealth) strategies (those that use mobile communication devices [e.g., cell 
phones] to provide health services and information) to improve caregiver adherence to American 
Academy of Pediatrics (AAP) recommended infant care practices related to safe sleep.  
The SMART study sought to improve the design, implementation, and effectiveness of interventions 
to prevent Sudden Infant Death Syndrome (SIDS) and unintentional injury-related infant deaths 
associated with the sleep environment. 
 
These deaths, which we will refer to as sleep-related deaths, remain the leading cause of US 
postneonatal mortality,1 with ~3500 deaths each year. Many of these deaths are preventable by 
improving adherence to AAP safe infant sleep guidelines:2 infants should always sleep in the supine 
position, roomshare without bedsharing, avoid soft bedding, and use a pacifier when placed for 
sleep. In addition, the AAP recommends exclusive breastfeeding for the first 6 months and 
continued breastfeeding thereafter to 1 year, since breastfeeding is associated with many health 
benefits,8,9 including a decreased risk of SIDS.10   However, adherence to these recommendations 
continues to be suboptimal, particularly in low-income groups.3-6   
 
While the national Back to Sleep public health campaign was very successful in decreasing infant 
mortality from 1990 to 2000,1 adherence to supine sleep recommendations has plateaued since 
2001.11 Further, US public health efforts have been less successful in changing behaviors with 
regard to soft bedding and bedsharing.3,12 Rates of prone positioning, parent-infant bedsharing, and 
use of soft bedding are higher among those of lower educational and socioeconomic status.13-16 
Sleep-related infant deaths most commonly occur in the presence of multiple unsafe sleep practices 
(such as prone/side positioning, use of soft bedding, bedsharing, and pacifier non-use).17,18 
 
The benefits of breastfeeding increase with exclusivity and longer duration of breastfeeding. One 
study estimated that if 90% of infants were exclusively breastfed for 6 months, 911 US deaths, most 
of them in infants, would be prevented annually.19 Unfortunately, only 44% and 22% of US mothers 
are breastfeeding exclusively by 3 and 6 months, respectively, and only 31% are still doing any 
breastfeeding at 1 year.20 Certain groups, including mothers who are younger, have lower income 
and educational levels, or participate in the national WIC program have lower breastfeeding 
rates.21-25 Black women have lower breastfeeding initiation rates (59% in 2008, vs 75% White and 
80% Hispanic). At 6 and 12 months, rates decline to 30% and 13%, respectively.26 
 
The SMART study showed that a postnatal mHealth intervention improved safe sleep adherence by 
~10 percentage points compared to control, while in-hospital education alone did not. Further, our 
data suggest that low-income mothers represent a group that may benefit most from such an 
intervention. Prior to widespread dissemination, we believe that it is critical to replicate and expand 

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the successful postnatal intervention and to assess a prenatal mHealth intervention as a potentially 
more effective replacement for the in-hospital education.  
 
Assessing the intervention on a statewide basis in WIC centers will allow us to focus on low-income 
mothers, who are at high risk for both nonadherence13- 16 and infant mortality,27 and ultimately set 
the stage for large-scale implementation. 
 
This study will be conducted in compliance with the protocol, applicable regulatory requirements, 
and BMC/BU Medical Campus Human Research Protection policies and procedures. 
 
1.2 
Rationale and Purpose  
 
SMARTER is a randomized controlled trial (RCT) that will assess newly developed mHealth prenatal 
interventions to promote parental choices of best practices recommendations regarding infant 
sleep and feeding practices, while also providing an additional assessment of the simultaneously 
replicating and expanding on the SMART postnatal mHealth infant care practice interventions.  
SMARTER also assess Spanish language materials. 
 
Our history as a team of defining current practices with NISP (National Infant Sleep Position)3,11,12, 
SAFE (Study of Attitudes and Factors Effecting Infant Care Practices)28,29 and other studies,4,30-40 
followed by subsequent testing of a postnatal mHealth intervention (SMART) places us in a unique 
position to use what we have learned to enhance and refine the messaging, add the prenatal 
component, and study the interventions in a population at high risk for sleep-related death and low 
rates of breastfeeding, i.e., low-income women.  
 
In the sections below, we: 1) explain our rationale for focusing on WIC-eligible mothers as our 
target population, 2) describe the rationale for adding a prenatal intervention, 3) explain the 
rationale for selecting mHealth as our strategy, and 4) describe social marketing principles that 
inform our mHealth interventions. 
 
Rationale for Using WIC Centers for Recruitment:  Low socioeconomic status is a risk factor for 
sleep-related deaths,7,42 and Black infants, who are more likely to have low socioeconomic status,43 
are twice as likely to die from these deaths.44,45 The increased risk among these groups may in part 
be due to lack of adherence to recommended guidelines. Our data among low-income and Black 
mothers show that both groups are significantly less likely to place their infant supine,4,11,31,33 more 
likely to bedshare,3,45,46 more likely to use soft bedding,12 and less likely to exclusively breastfeed.28 
This may be due to specific beliefs and attitudes (e.g., infants are more likely to choke when 
supine11 or Breast Milk is no better than formula48), or a lack of appropriate role modeling by 
healthcare providers.31  
 
In our survey of low-income US mothers, only 42% reported receiving advice from nurses to place 
infants supine.31 However, these disparities may be amenable to change. We have shown that an 
intervention at WIC centers that addressed maternal concerns and misconceptions was effective at 
improving knowledge, changing attitudes, and modifying intention.49 In addition, our SMART 

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mHealth intervention improved safe sleep practices in these high-risk populations to levels 
comparable to the others. In the subgroup of SMART participants who were WIC recipients (51.6%), 
effect sizes were in general stronger; e.g., those who received both safe sleep interventions had a 
20 percentage point higher rate of supine placement than controls (93% vs 73%; a OR 5.2, 95% CI 
3.7-7.4). Effect sizes were also greater among WIC participants for roomsharing without bedsharing, 
and no soft bedding use. Thus, we have experience and demonstrated success with culturally 
competent messages that resonate with low-income mothers. 
 
WIC is a national program whose mission is to “safeguard the health of low-income women, infants, 
and children up to age 5 who are at nutrition risk by providing nutritious foods to supplement diets, 
information on healthy eating, and referrals to health care.”50 After May 2017, to be WIC eligible, 
one’s gross income must be ≤185% of US Poverty Income Guidelines.50 WIC eligibility is thus an 
easily verifiable proxy for income that does not depend on self-report. Almost 900,000 pregnant 
women (20.3% of whom are Black51) are enrolled in WIC annually, with >90% enrolling before 24 
weeks gestation.51 Thus, WIC centers are an efficient way to reach high-risk pregnant women in a 
systematic manner. A well-designed, targeted intervention utilizing what we have learned, which 
would be feasible to implement in WIC offices nationwide, could have broad implications for infant 
health and could potentially decrease the persistent income and racial disparities in postneonatal 
deaths and infant health. We have extensive experience working with WIC populations. We have 
recruited WIC patients for various studies, including an otitis media study,52 face-to-face 
interviews31 and interventions.39,40,48 We have current working relationships with statewide WIC in 
Virginia and Massachusetts, respectively. Both states have expressed support for this study.  34% 
and 24% of Virginia WIC recipients are Black and Hispanic, respectively; in Massachusetts, 22% and 
43% are Black and Hispanic, respectively. 
 
Rationale for interventions during the prenatal period 
The prenatal period provides a unique venue for intervention for several reasons.30,52 First, mothers 
experience excitement and anticipation, but are not yet exhausted and preoccupied with infant 
care, allowing an opportunity to absorb information. With regards to breastfeeding, most women, 
particularly WIC-eligible mothers, decide how they are going to feed their baby prior to birth;39 yet, 
women do not receive adequate prenatal education on breastfeeding.53  
 
Second, the safe sleep and breastfeeding practices that we are targeting should ideally start 
immediately after birth, and there is not always time to adequately reach everyone during the 
hospital stay prior to the first feedings and sleep periods. Thus, the hospital stay is not an optimal 
time to provide new information that could impact on decision-making; this may in part explain the 
lack of impact of our SMART in-hospital intervention. Third, knowledge, realistic expectations, and 
self-efficacy prior to the baby’s birth are associated with better breastfeeding outcomes,54-56 and we 
suspect that this may also be true for safe sleep outcomes. Finally, little is known about whether 
prenatal safe sleep education impacts sleep practices. Only 2 studies have reported prenatal safe 
sleep education; while both studies showed increased knowledge about safe sleep guidelines, there 
was no follow-up to look at actual practices after the infant’s birth.57, 58 
 
 

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Enhanced prenatal education increases breastfeeding rates,59 and for low-income women, both 
prenatal and postnatal interventions are needed.61 As there is little information regarding safe sleep 
education in the prenatal period, it will be important to test this strategy. SMARTER has the 
potential to enhance prenatal safe sleep and breastfeeding education with messages that target the 
specific barriers that low income women face, contain risk reduction information about conditions 
that uniquely affect them, and feature women of color as role models.  
 
Rationale for mHealth (mobile health) interventions in high-risk groups 
There is wide acceptance for accessing and receiving health information on mobile devices (e.g., 
smart phones).61-67 Systematic reviews of interventions using mHealth technologies found positive 
impacts on appointment attendance, immunization rates, medication adherence, and diabetes self-
management.68-70 In addition, the use of video health education has been effective in improving 
understanding, knowledge, and self-efficacy,71,72 and changing behavior,73,74 and are more 
appealing to patients than written pamphlets.71,72 Videos may also be a more effective means of 
providing health information to low-literate families. In addition to these studies, SMART 
demonstrated the effectiveness of a mHealth approach in changing infant care practices in the 
postnatal period. 99% of mothers approached had daily email or SMS access, and we demonstrated 
high engagement among mothers (>50% video view and query response rates),41 and increased 
adherence with safe sleep practices among those who received the safe sleep videos. Therefore, we 
believe that this mHealth approach, due to its accessibility, efficiency in delivering messages, 
capacity to reach low-literate populations, and demonstrated effectiveness in SMART will also be 
effective when used prenatally in SMARTER. 
 
Rationale for social marketing and culturally competent approaches in health promotion 
Social marketing is the use of commercial marketing concepts to design and implement programs to 
effect social change and is guided by the following principles: 1) the ultimate objective is to 
influence action; 2) action occurs when the target population perceives the benefits to outweigh 
the costs of the action; 3) programs are more effective when based on an understanding of the 
target population’s perceptions; 4) target populations are rarely uniform in perceptions and/or 
responses to social marketing efforts; 5) there are always behaviors that compete with 
recommended behaviors, and these must be understood and addressed; and 6) because of 
constant changes in the “marketplace,” there must be frequent monitoring in order to rapidly alter 
strategies as needed.76 Many health campaigns, however, have a one-size-fits-all approach (e.g., 
Back to Sleep), and thus are not necessarily effective in reaching all targeted audiences. 
 
Culturally and linguistically competent health promotion approaches respect cultural values, beliefs 
and practices of the target population; therefore, health promotion messages should ideally reflect 
these health beliefs and practices. This is often a challenge, as some beliefs and practices may be 
inconsistent with emerging knowledge of behaviors that support healthy outcomes. Culturally 
competent health promotion supports and honors those practices and beliefs that are protective or 
benign, and respectfully helps to identify and change those that have a negative health impact.77  
 
 

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Our interventions will incorporate techniques to favorably influence infant care practices, while 
respecting parental beliefs. Our goal is to build on the success of the SMART safe sleep and 
breastfeeding postnatal mHealth intervention, as well as the lessons learned in the SAFE, SMART 
and All Breasts Matters surveys, in order to incorporate a prenatal component, incorporate even 
more racial/ethnic and culturally competent messaging, and target the specific challenges of low-
income women. 
 
2 
Objectives 
 
2.1 
Study Objectives 
 
Aim 1: To assess the effectiveness of mHealth prenatal and postnatal interventions aimed at 
promoting safe sleep practices and breastfeeding. 
 
Aim 2: To assess social cognitive mediators of the intervention effects on infant care practices that 
may inform further refinements to optimize intervention effectiveness. 
 
2.2 
Study Outcome Measures 
 
2.2.1 Primary Outcome Measures 
 
The following primary outcome measures will be obtained by maternal survey completed 
between two and six months after infant date-of-birth: 
 
1. Usual infant sleep position in the previous two weeks 
2. Usual infant sleep location in the previous two weeks 
3. Soft bedding use in the previous two weeks 
4. Pacifier use in the previous two weeks 
5. Breast Milk feeding in the previous two weeks 
 
2.2.2 Secondary Outcome Measures 
 
The following secondary outcome measures will be obtained by responses to weekly text 
messages beginning on infant day of life two until six months of age. 
 
1. Age in weeks when Infant stopped supine sleep position 
2. Age in weeks when infant stopped room sharing without bed sharing 
3. Age in weeks when infant starts using soft bedding 
4. Age in weeks when infant Breast Milk feedings change 
 
 

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3 
Study Design 
 
A. Study Population 
SMARTER will enroll up to 2,500 pregnant women who are clients at participating FQHCs and WIC 
centers located throughout the United States, to achieve a target of randomization of 2,000 
women.   
 
B. Study Design 
The study will utilize a two-stage randomization approach in which pregnant women are 
randomly assigned to one of the two prenatal interventions (infant sleep practices messaging vs. 
infant feeding messaging) and then, at the time of birth ascertainment,  randomization to one of 
two postnatal interventions (infant sleep practice messaging vs. infant feeding messaging).  This 
will result in a classic 2 x 2 design where approximately 25% of participants will have been 
assigned to each of the four possible combinations of interventions (1 - prenatal sleep practices/ 
postnatal sleep practices; 2 - prenatal sleep practices/postnatal feeding practices; 3 – prenatal 
feeding practices/postnatal sleep practices; 4 – prenatal feeding practices/postnatal feeding 
practices).   This design will permit assessment of the impact of each intervention alone, as well as 
possible incremental effects of combinations of interventions. 
 
a. Development of Intervention 
There are three theoretical models that have informed the study design and intervention 
materials:  
• 
Theory of Planned Behavior (TPB) 
• 
Protection Motivation Theory (PMT) 
• 
Behavioral Affective Associations Model (BAAM) 
 
The Theory of Planned Behavior is our framework for understanding the factors that are 
important in influencing the health-related behaviors of interest.  According to the TPB, 
intention to perform a certain behavior is influenced by 3 main factors: a) attitudes and 
beliefs (e.g., baby might choke if he’s on his back); b) perceived social norms (e.g., my friends 
don’t put their babies on the back to sleep, so I won’t, either); and c) perceived control (e.g., I 
would put my baby on the back, but my mother takes care of her and likes the stomach). 
 
The Behavioral Affective Associations model, introduces the importance of affective 
(emotional) associations and cognitive beliefs as influences on behavior, and the PMT, which 
emphasizes perceived risk as a motivator.  
 
b. Delivery of Intervention to Participants via Short Message Service (SMS)  
The TodaysBaby Interventions will be delivered via SMS text message by Agile Health.  SMS 
allows for text messages (up to 140 characters in length) to be sent to participant’s mobile 
phone.  SMARTER participants will receive text queries and text links to TodaysBaby videos 
and study surveys. 
 
 

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All study text messages will be sent to participants between the hours of 9:00 AM and 9:00 
PM (participant local time).  Text messages will be sent at random times throughout the day 
with the majority of text messages being sent between 9-11 AM and 5-7 PM. 
 
c. Randomization 
Mothers will be randomized on an individual level in two stages (prenatal randomization at 34 
weeks plus 0 days gestation, and postnatal immediately upon birth ascertainment) such that 
participants are assigned to one of the 4 study groups (i.e. each of the four combinations of 
prenatal/postnatal interventions).  Randomizations will be stratified (by WIC center or State 
WIC region and pre-randomization participation level), and blocked (so that the number of 
mothers from each stratum within WIC center/region assigned to each of the study groups 
will balance after 4 or 8 mothers). Randomization will be based on computer-generated 
random numbers and stratified by WIC center/region and 2 categories of pre-randomization 
study participation (higher vs. lower engagement in mHealth activities during a 2-week 
window (32 weeks plus 0 days through 33 plus 6 days gestation)). This randomization 
stratification will help achieve balance in gestational age at enrollment, and balance across 
study groups in likely mHealth video viewing and exposure to breastfeeding counseling (which 
may differ by WIC center/region). We will also collect WIC site data with regards to 
breastfeeding support and safe sleep education, and query participants about what prior 
education they received from WIC. If there is a site effect, we will conduct exploratory 
analyses to assess any differences between sites.  
 
SMARTER will randomize participants at two study time points: 
 
• 
Randomization #1 (33 plus 6 days gestation) – Assignment to Prenatal TodaysBaby 
Intervention 
 
• 
Randomization #2 (immediately following infant birth) – Assignment to Postnatal 
TodaysBaby Intervention 
 
Participants must undergo randomization #1 in order to be eligible for randomization #2. 
 
Randomization will be based on computer-generated random numbers, block sizes of 4, and 
be stratified by WIC center/region, language, level of participant engagement during the 
Observation Period (viewing videos/responding to text messages).  
 
This randomization stratification will help achieve balance in gestational age at enrollment, 
and balance across study groups in likely post-randomization mHealth video viewing rates. 
 
 
 
 
 

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Blinding:  Investigators and study staff will be blinded to participant’s assigned prenatal and 
postnatal intervention.  Participant intervention arm will be maintained by the Boston 
University Database Programmer in a separate database.   
 
d. Data Collection Methods 
The TodaysBaby prenatal and postnatal mHealth interventions will be evaluated through 
initial and follow-up surveys and text messages.  
 
The surveys will assess both behavior change mechanisms/process constructs (risk 
perception, benefits/barriers, affective associations, efficacy, and intention), mood and 
anxiety.  Surveys and text messages will evaluate initiation and maintenance behavioral 
outcomes. 
 
Participant Surveys 
 
Participant surveys will be administered at various times throughout the study. 
 
Participants will be asked to complete five surveys during the course of the study.  A subset of 
participants will be asked to complete an additional short Breastfeeding Cessation Survey.   
 
In addition, participants who elect to stop receiving the TodaysBaby program, after 
completing randomization #1, will be asked to complete a short survey indicating why the 
stopped the TodaysBaby Program. 
 
i. Enrollment Survey 
Completed by participant after informed consent has been obtained and prior to the 
participant completing the mHealth on-boarding process via Agile Health.  Data collected 
includes: demographic information, household characteristics, and plan for infant feeding. 
 
ii. Baseline Survey 
   This survey will be completed when the participant is between 32 weeks plus 1 day 
through 33 plus 6 days gestation.  Data collected includes: past obstetrical history/delivery 
history, past breastfeeding history, ICP intention (breastfeeding, sleep position, sleep 

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location), TPB domains, affect, breastfeeding self-efficacy, past smoking history, PHQ-4 
ultra-brief screening scale for anxiety and depression. Mothers who screen positive on the 
PHQ-4 (score ≥3 for either depression or anxiety) will complete the Edinburgh Postnatal 
Depression Screen (EPDS). 
 
iii. Prenatal Intervention Survey 
This survey will be completed during the Prenatal Intervention Period.  This survey will be 
sent to participants after they have received the majority of the prenatal intervention.   
 
Data collected includes: ICP intention (breastfeeding, sleep position, sleep location), TPB 
domains, affect, breastfeeding self-efficacy, and participant assessment of TodaysBaby 
postnatal intervention. 
 
iv. Birth Survey 
This survey will be completed at the start of the Postnatal Intervention Period.  Data 
collected includes: information about the infant birth (ex. number of births, infant’s DOB), 
length of infant hospital stay, if infant has received any Breast Milk since birth, if 
participant plans to breastfeed infant, and the PHQ-4 ultra-brief screening scale for 
anxiety and depression. Mothers who screen positive on the PHQ-4 (score ≥3 for either 
depression or anxiety) will complete the EPDS. 
 
Participants who indicate that the baby they delivered first (index child) was not liveborn, 
will have an abbreviated survey.  The abbreviated survey will not include in the PHQ-4 and 
EPDS screening. 
 
v. Postnatal Intervention Survey 
This survey will be completed during the Postnatal Intervention Period, after participant has 
received all postnatal intervention videos. 
 
Data collected includes: brief obstetrical, delivery, and post-discharge, smoking history, 
ICP actual practice- (breastfeeding, sleep position, sleep location, sleep objects, sleep 
outfits, falling asleep with baby, smoking), ICP intention- breastfeeding, sleep position, 
sleep location, TPB domains, maternal work information, social determinants of 
health/discrimination/details on housing, breastfeeding initiation/cessation, participant 
assessment of TodaysBaby postnatal intervention, and the PHQ-4 ultra-brief screening 
scale for anxiety and depression. Mothers who screen positive on the PHQ-4 (score ≥3 for 
either depression or anxiety) will complete the EPDS. 
 
vi. Breastfeeding Cessation Survey 
Those participants who report, on the Postnatal Intervention Survey, that their infant 
received any Breast Milk (in the previous two weeks), will be asked to complete a short 
Breastfeeding Cessation Survey if they subsequently responds to two consecutive feeding 
plan practice/intent text queries indicating that their infant has only received formula for 

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the past seven days and the participant plans to only feed formula for the next seven 
days. 
 
vii. 
TodaysBaby Program Discontinued Survey 
Participants will be asked to complete this survey if the elect to stop the TodaysBaby 
program after they have completed randomization #1 and prior to their infant reaching six 
months of age.   
 
Participants can stop the TodaysBaby program by texting ‘STOP’ and confirming that they 
wish to stop receiving the program, or by calling/emailing the study office to request that 
program be stopped. 
 
Should a participant text ‘STOP’, they will receive a text asking that they confirm they 
would like to stop receiving the TodaysBaby Program.  If the participant confirms that they 
want to stop the TodaysBaby program, the will receive the following final text that 
contains a link to the TodaysBaby Program Discontinued Survey. 
 
You have stopped the TodaysBaby video/text program. You will continue to receive 
remaining study surveys and gift cards for completing surveys 
 
 You can stop your participation in the study anytime by calling 617-206-6269 or emailing 
tdybaby@bu.edu 
 
Please complete this short survey to let us know why you stopped the program <Link>  
 
Should a participant contact the study office by phone to indicate they would like to stop 
the TodaysBaby Program, study staff will complete the TodaysBaby Program Discontinued 
Survey over the phone. 
 
Should a participant contact the study office by email to indicate they would like to stop 
the TodaysBaby Program, study staff will confirm with the participant that they will stop 
receiving the TodaysBaby program and will send a link to the TodaysBaby Program 
Discontinued Survey via email. 
 
Study staff may reach out to participants by phone to request that the participant 
complete the survey. 
 
Survey data will be captured in the Boston University’s REDCap System.  REDCap has been 
selected for its’ mobile phone interface.  
 
Participants will have the option of completing surveys via the REDCap link or over phone with 
study staff.   
 
 
 

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Participant Text Messages Queries during Prenatal and Postnatal Interventions 
Participant will receive interactive text queries during the prenatal and postnatal 
interventions.  All participants will receive the same text queries at the same delivery cadence 
regardless of assigned prenatal or postnatal intervention. 
 
C. Study Team Institutional Roles and Responsibilities 
 
Boston University 
Is responsible for recruitment of WIC centers, FQHC and all study participants, management and 
analysis of all study data.  Boston University will oversee management and tracking of the 
mHealth delivery platform through Agile Health.  
 
Washington University in St. Louis, University of Virginia (UVA), and Other Investigators 
Investigators and colleagues are responsible for development of study materials (text messages 
and TodaysBaby videos) and will provide assistance with recruitment of WIC centers, FQHC, and 
data analysis.   
 
Study staff may assist with participant recruitment.  Staff may visit high-traffic WIC offices and 
FQHC and set-up a table in offices to be able to talk with patients/clients about the study and 
answer any questions, as assist interested participants with electronic screening, consent and 
sign-up if they are interested. 
 
Starting 2025 – A UVA study coordinator will oversee the management of participant outreach and 
follow-up work that BU RAs are responsible for.  As part of this oversight the UVA Coordinator will 
have access to SMARTER participants reports and data through a secure VPN connection to the BU 
databases and the Agile Health platform. 
 
Agile Health 
Agile Health is the mHealth delivery platform that will be used for this study.  Agile Health is an 
authorized Business Associate of Boston University. 
 
Agile Health is a mobile healthcare solutions provider dedicated to changing lives and improving 
healthcare outcomes. They leverage the mobile phone to: 1) engage members/patients in an 
intensive and highly personal process of behavior change, and 2) help clients and business 
partners fundamentally change the way they engage members/patients to deliver health 
improvement and care management services.  
 
4 
Potential Risks and Benefits 
 
4.1 
Risks 
 
Risk of loss of confidentiality  
To reduce the risks, appropriate measures will be taken to ensure confidentiality, including securing 
all data on secure websites, password-protected computers, and locked cabinets. Participants will 

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be reminded to take appropriate measures with their mobile phone when responding to study texts 
and completing study surveys. 
 
Risk of discomfort answering survey questions or text queries 
Participants will be informed that they do not have to answer any survey questions or text queries. 
Risk of psychological harm 
There is a minimal risk of psychological harm related to the nature of the questions and the content 
of the interventions, should mothers suffer either an adverse outcome, (e.g., mothers who 
experience infant loss may feel guilt, depression, or suicidal thoughts).   To reduce this potential 
risk, videos have been tested with study population, and messages in our interventions are 
accepted, well vetted public health messages that are endorsed by the American Academy of 
Pediatrics, Centers for Disease Control and Prevention, and other national health care 
organizations. 
 
Risks associated with participants being distracted if they to text while driving or walking 
To reduce this risk, participants will be reminded, during the consent process, to not text when 
driving or walking. 
 
4.2 
Potential Benefits 
 
Participants may benefit from participation by receiving up-to-date expert messaging about 
creating a safe infant sleep environment and infant feeding practices. 
 
4.3 
Analysis of Risks in Relation to Benefits 
 
The risks to subjects are low, and reasonable in relation to the importance of the knowledge that 
may reasonably be expected to result. 
 
5 Study Participant Selection 
 
5.1 
Participant Inclusion Criteria 
 
To be eligible to participate in this study, an individual must meet all of the following criteria: 
 
• 
Must be enrolled at a participating WIC center 
• 
If not enrolled in participating WIC Center must have either Medicaid or no insurance 
• 
Must be English or Spanish speaking 
• 
Must be pregnant and less than 31 weeks plus 6 days gestation 
• 
Must live in the United States 
• 
Must have SMS access (mobile phone) 
 
 
 
 

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5.2 
Participant Exclusion Criteria 
 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
 
• 
Not planning to live in same home as infant after birth. 
• 
Prenatal diagnosis expected to impact on infant care practices in a manner not compatible with 
study goals, including contraindications to breastfeeding.^^ 
• 
Prenatal diagnosis expected to impact on infant care practices in a manner not compatible with 
study goals, including contraindications to supine infant sleep positioning.^^ 
• 
Known or reported mental health or other issues that would preclude custody of the infant or 
being able to participate in the informed consent process. 
• 
Meets the definition of a minor according to applicable state law.** 
• 
Participants who consent to participation in the study, must complete the Agile Onboarding 
process before they reach 32+1 weeks gestation.## 
 
^^Contraindications to breastfeeding and supine sleep position will not be assessed on initial eligibility 
screening.  Contraindications will be assessed on enrolled participants at gestational age 30+0 (via text 
query) and on the Birth Survey.  Staff will follow-up with all participants who indicate a contraindication 
at these study time points to determine if participant should be withdrawn from study for not meeting 
eligibility criteria. 
 
**The study coordinating center (Boston University) will work with State WIC leadership to understand 
the laws surrounding the definition of a minor for research purposes.  If individuals < 18 who are making 
their own healthcare decisions are considered adults under state law the coordinating center will work 
with WIC State leadership to ensure any required State approvals (or review) are obtained.  
 
##In order to onboard to the Agile text message platform, participants must successfully enroll in the 
program.  Enrollment in the program consists of a) ensuring that their Smartphone can receive short code 
text messages; and b) texting ‘yes’ when prompted if they agree to enroll in program being delivered by 
text message.  Participants who do not complete the Agile onboarding process by the time they reach 
32+1 weeks gestation are no longer eligible for study. 
 
6 
Study Intervention 
 
This study consists of 4 interventions: 
 
Prenatal Interventions 
1. Infant care practices messaging with an emphasis on supporting best practices for infant feeding. 
2. Infant care practices messaging with an emphasis on supporting best practices for infant sleep. 
 
Postnatal Interventions 
1. Infant care practices messaging with an emphasis on supporting best practices for infant feeding. 
2. Infant care practices messaging with an emphasis on supporting best practices for infant sleep. 

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The TodaysBaby program consists of prenatal and postnatal videos, text message queries and 
information developed by the study team aimed at promoting adherence to AAP infant feeding and 
safe sleep recommendations.   
 
TodaysBaby videos will be delivered to participants via SMS text message link.  Videos range from 30 
seconds to 3 minutes and are designed to provide important information on specific safe sleep and 
breastfeeding infant care practices. 
 
The TodaysBaby program was initially developed by the study team for use in the SMART study and 
consisted of a postnatal intervention video/text curriculum only.   
 
The revised TodaysBaby program has been updated specifically for this study.  The revised 
TodaysBaby program includes a prenatal and postnatal curriculum.  TodaysBaby videos have been re-
designed and/or developed based on qualitative work completed in 2020 and 2021, which included 
focus groups and in-depth interviews with WIC clients and staff. 
 
The revised TodaysBaby program has been expanded to include translation of materials into Spanish, 
and the SMARTER study will include both English and Spanish speaking participants. 
 
A. TodaysBaby Curriculum Components 
 
a. TodaysBaby Safe Sleep Videos 
The TodaysBaby Safe Sleep Video Curriculum consists of 41 videos.  (See Appendix 1 for list of 
video topics). 
 
b. TodaysBaby Breastfeeding Videos 
The TodaysBaby Breastfeeding Video Curriculum consists of 41 videos. (See Appendix 1 for list 
of video topics). 
 
c. TodaysBaby Prenatal and Postnatal Intervention Text Queries 
 
i. Prenatal Intervention: Text queries will ask participants about their plan for sleep and 
feeding behaviors of interest (ex. Bedsharing, room sharing, breastfeeding) once their infant 
is born. 
 
ii. Postnatal Intervention:  Text queries will ask about sleep and feeding behaviors of interest 
(ex. Bedsharing, room sharing, breastfeeding). Queries will be formatted in a manner that 
asks participant about their practice for the past week and their intention for the coming 
week. 
 
All participants will receive the same text message queries regardless of assigned prenatal and 
postnatal interventions.   
 

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Feedback to Participants Based on Assigned Intervention   
 
i. Sleep Text Queries  
 
Participant Assigned to Prenatal/Postnatal Interventions with Sleep Emphasis: 
Participants will receive positive feedback (via text response) for responding to queries 
indicating that their plan/practice/intention aligns with AAP safe sleep recommendations.  If 
the plan/practice/intention does not align with AAP recommendations, participants will 
receive feedback that promotes AAP recommendations.   
 
Participant Assigned to Prenatal/Postnatal Interventions with Feeding Emphasis: 
Participants will not receive any positive or corrective feedback.  Participants will be 
thanked for providing their response. 
 
ii. Feeding Text Queries  
 
Participant Assigned to Prenatal/Postnatal Interventions with Feeding Emphasis: 
Participants will receive positive feedback (via text response) for responding to queries 
indicating that their plan/practice/intention aligns with AAP breastfeeding 
recommendations.  If the plan/practice/intention does not align with AAP recommendations, 
participants will receive feedback that promotes AAP recommendations.   
 
Participant Assigned to Prenatal/Postnatal Interventions with Sleep Emphasis: 
Participants will not receive any positive or corrective feedback.  Participants will be 
thanked for providing their response. 
 
B. TodaysBaby Prenatal Curriculum 
The TodaysBaby Prenatal Intervention will begin when the enrolled the participant reaches 34 
weeks plus 0 days gestation and continues until the birth of the participant’s infant. 
 
During this period, participants will receive: 
 
• 
Up to 25 Intervention specific videos and 2 Non-intervention videos 
• 
Infant care practice text queries and feedback 
• 
Birth ascertainment and informational text queries 
• 
Text link to the Prenatal Intervention Survey and several text survey reminders if survey is not 
completed. 
 
Participants will receive the same mHealth message and video cadence regardless of their 
assignment to the prenatal feeding or sleep interventions. 
 
Participants will receive a text link to the Prenatal Intervention Survey on gestational week 36 
weeks plus 1 day gestation.  Text reminders will be sent to participants on gestational weeks 

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36+3; 36+5; 37+2; 37+5, if the Prenatal Intervention Survey has not been completed.  Staff will 
also follow-up with participants by phone for incomplete survey as described in section 9.9. 
 
The Prenatal Intervention Survey must be completed prior to the start of the postnatal 
intervention.  If the survey is not completed by that time, it will be considered incomplete. 
 
C. TodaysBaby Postnatal Curriculum 
The TodaysBaby Postnatal Intervention will begin the day after the birth of participant’s infant 
and will continue until the infant reaches 6 months of age. 
 
During this period, participants will receive: 
 
• 
28 Intervention specific videos  
• 
Infant care practice text queries and feedback 
• 
Text message reminding videos can be viewed on study participant website 
• 
Text link to two study surveys:  Birth Survey and Postnatal Survey, along with several text 
survey reminders if surveys are not completed. 
 
Participants will receive the same mHealth message and video cadence regardless of their 
assignment to the postnatal feeding or sleep interventions. 
Participants will receive a text link to the Birth Survey on day 1 of the postnatal intervention.  Text 
reminders will be sent to participants on days 3, 6, 9, 13, if the Birth Survey has not been 
completed.   
 
Participants will have the option of providing the name of their baby on the birth survey if they 
would like future text messages to be personalized with their infant’s name.  
 
Participants will receive a text link to the Postnatal Intervention Survey on intervention day 60 of 
the postnatal intervention.  Text reminders will be sent to participants on intervention days 61, 
64, 71, 78, 85, 92, 113 if the Postnatal Intervention Survey has not been completed.   
Staff will also follow-up with participants by phone for incomplete surveys as described in section 
9.9. 
 
If the Birth Survey is not completed at the time the Postnatal Survey is sent to participant, it will 
be appended to the Postnatal Survey. 
 
Women whose pregnancy result in multiple births, will be asked to use the first born infant as the 
index infant for all study surveys and text queries. 
 
D. Participant Web Portal 
Participants will have access to a web portal where intervention specific videos will be maintained 
if they want to re-watch a video or share videos with others. 
 
 

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7 
Study Procedures 
 
7.1 
Enrollment Procedures 
 
Participant enrollment procedures consist of the following: 
• 
Eligibility Screening 
• 
Informed Consent 
• 
Assignment of Participant ID Number 
• 
Completion of Enrollment Survey 
• 
On-boarding to the mHealth messaging platform 
 
Participants must complete all enrollment procedures by 31 weeks plus 6 days gestation.  
Participants who do not complete all enrollment procedures by that time will be withdrawn from 
the study. 
 
7.1.1 Eligibility Screening 
 
Potential study participants will be identifed at participating WIC centers and FQHC.  WIC staff 
will introduce the study to pregnant WIC clients. Health Center and Hospital staff will introduce 
the study to all patients.  Flyers will be provided to WIC, Health Center and Hospital staff.  
These flyers provide contact information for Boston University study staff. Interested 
participants will be instructed to contact Boston University if they have any questions or are 
interested in the study.   
 
Potential participants will reach out to Boston University by scanning a study QR code (or 
entering a study URL into a web browser).  Potential participants will be directed to a study 
webpage where they can request to be contacted by study staff to discuss the study, or can 
complete eligiblity screening electronically to see if the are eligible to participate in the study. 
Participant Information obtained during screening process: Participants will review a brief 
screening information form and must agree to screening.  When participant has agreed to 
screening the following information will be obtained: 
 
• 
First/Last Name 
• 
Mobile Phone # 
• 
Alternate Phone #’s 
• 
Email Address 
• 
Home Address 
• 
Participant confirmation of eligibility criteria 
• 
Participant’s Expected Due Date (EDD) 
 
The EDD, defines the date on which the gestational age of the infant is considered to be 40 weeks 
plus 0 days.  The current gestational age for any prenatal date can then be calculated relative to 

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EDD, and this calculation will be used for assessing study eligibility and for the timing of all 
prenatal study procedures.   
 
Potential participants who screen as not eligible: will be informed that they do not meet eligibility 
criteria, and will be informed that they can call the study office if they would like to discuss 
eligibly with study staff. 
 
Participants who elect to complete screening electronically, without talking to study staff:  If a 
potential participant elects to complete screening without talking to a study staff, and does not 
complete the screening, study staff will attempt to contact the participant by phone to complete 
the screening. 
 
7.1.2 Informed Consent 
 
Potential participants will provide informed consent prior to being enrolled in the study.  There 
are two options to provide informed consent for this study. 
 
A. Talk with study staff over the phone and provide verbal consent. 
B. Provide consent electronically without the requirement of talking to study staff. 
 
7.1.3 Participant ID Number 
 
Each enrolled participant will be assigned a Participant ID number. Participant ID numbers will 
include: 
• 
A three-digit WIC Region number – Ex. 001 
• 
A two-character State Abbreviation – Ex. MA 
• 
4-digit sequential participant ID number starting at 1001 
 
Participant ID number will appear as WIC Region-State Abbreviation-Sequential ID (ex. 001-MA-
1001) 
 
7.1.4 Enrollment Survey 
 
Once informed consent has been obtained and participant ID number has been assigned, participants will 
complete a short Enrollment Survey.  This suvey can be completed electronically or over the phone.  The 
Enrollment Survey must be completed before the participant can onboard to the Agile Health mHealth 
platform. 
 
7.1.5  mHealth Text Platform Access  
 
Participants must complete an on-boarding process to the study mHealth platform to begin 
receiving study text messages. 
 

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The following participant information will be provided from Boston University to Agile Health for 
participant on-boarding: 
• 
First and Last Name 
• 
Gender 
• 
Mobile Phone Number 
• 
Zip Code 
• 
Language Preference (English or Spanish) 
• 
Participant Self-Reported EDD 
• 
Participant ID Number 
• 
Gift Card Preference 
 
The mHealth platform will send the participant a text message confirming they would like to enroll 
in the in the TodaysBaby program.  Participants will need to respond to the text to confirm they 
wish to enroll in program. 
 
As part of the onboarding procedures participants will receive a text messaging indicating they can 
text ‘stop’ at any time to discontinue receiving text messages (see section 9.8) 
 
7.2 
Post Enrollment Procedures   
 
The post enrollment study procedures can be divided into the following time periods:   
1) Pre-Randomization/limited engagement (enrollment through 31 weeks plus 6 days 
gestational age),  
2) Pre-Randomization/Engagement Observation (32 weeks plus 0 days through 33 weeks plus 
6 days),  
3) Prenatal Intervention (34 weeks plus 0 days through birth ascertainment),  
4) Postnatal Intervention (birth ascertainment until 6 months postnatal age).   
 
As noted above, during eligibility screening each participant will provide a self-report of their EDD.  
This EDD, will be the date used to calculate gestational age for all prenatal study procedures.  
 
7.2.1 Pre-Randomization/Limited Engagement Period 
 
The Pre-Randomization/Limited Engagement Period begins once participant has satisfied all enrollment 
procedures, and will continue until the participant is 31 weeks plus 6 days gestation. 
 
During this period, participant will receive one weekly text message/query.  The weekly text messages have 
been designed to a) keep participant engaged with study team by providing generic pregnancy information 
and text queries, and; b) re-visit several eligibility criteria, prior to the start of the Pre-
Randomization/Engagement Observation Period, in case anything has changed with the participant’s 
pregnancy that may make them no longer eligible for study participation. 
 

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If participant responds to text queries during this period, indicating they no longer meet eligibility 
criteria, study staff will call participant to confirm eligibility status and participant will be 
withdrawn. 
 
See Appendix 2 for Pre-Randomization/Limited Engagement Period Diagram. 
 
7.2.2 Pre-Randomization/Engagement Observation Period 
 
The Pre-Randomization/Engagement Observation Period begins when participant reaches 32 
weeks plus 0 days gestation and continues until participant reaches 33 weeks plus 6 days 
gestation.   
 
During this 14 day period, participants will receive 7 interactive non-intervention text queries, and text links 
to 4 non-intervention study videos.  These text queries and videos have been designed to a) provide 
participant with information about the TodaysBaby program, b) continue to ask non-intervention general 
pregnancy questions and; c) confirm that participant is still pregnant, and eligible for the study. 
 
The level of participant engagement with text queries and videos during this period during will be 
used as one of the strata in randomization sequence #1 and randomization sequence #2.  
Participants will receive a text link to the Baseline Survey when they reach 32 weeks plus 1 day 
gestation. Text reminders will be sent to participants on gestational weeks 32+3; 32+5; 33+0; 
33+3; 33+5, if the Baseline Survey has not been completed.   
 
The Baseline Survey must be completed prior to the start of the Prenatal Intervention.  If the 
survey is not completed by that time, it will be considered incomplete.  Staff will follow-up with 
participants by phone for incomplete survey as described in section 9.9. 
 
7.2.3 Ascertainment of Infant Birth or Fetal Demise Prior to Randomization #1 
 
Participants who inform the study team of a fetal demise or infant birth during the Pre-
Randomization/Limited Engagement and Pre-Randomization/Engagement Observation Periods 
(prior to randomization #1) will be withdrawn from the study.  Infant birth/fetal demise prior to 
randomization #1 will be ascertained as follows: 
 
a. Participant Texts ‘Birth’ to Study Team 
Participants will be informed during the consent process that they should text ‘Birth’ to let the 
study team know when they have given birth.  Participants will also be reminded (via text), 
during the Pre-Randomization/Limited Engagement and Pre-Randomization/Engagement 
Observation Periods, that they can text ‘Birth’ at any time. 
 
If a participant texts ‘Birth’ prior to randomization #1, they will immediately receive a text 
message asking to confirm that they have given birth.  If participant responds to this text and 
confirms they have given birth, they will be immediately withdrawn from the TodaysBaby 

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program and the study.  Study staff will attempt to call participant to explain why they have 
been withdrawn. 
 
If participant does not respond to the confirmation text, they will continue with the 
TodaysBaby program and study.  Study staff will attempt to call participant to confirm the 
birth and withdraw if necessary. 
 
b. Participants Call Study Office to Report Change in Pregnancy Status 
Participants will be informed during the consent process and on text queries sent on 
gestational weeks 14+1, 19+1, 25+1 that they should call the study office if there is a change 
in their pregnancy status during the Pre-Randomization/Limited Engagement and Pre-
Randomization/Engagement Observation Periods.   
Study staff will discuss change in pregnancy status with participant and determine if 
participant should continue or be withdrawn from the study. 
 
c. Text Queries During Pre-Randomization/Limited Engagement and Pre-Randomization/ 
Engagement Observation Periods 
During these period participants will receive three text queries (at 31+1, 33+0, 33+5, weeks 
gestation) to confirm if they are still pregnant.   
 
• 
If participant responds to any of the text queries indicating they are still pregnant they will 
continue with the study protocol. 
 
• 
If participant responds to text query and indicates they are no longer pregnant, they will 
immediately receive a text message asking to confirm they are no longer pregnant.  If 
participant responds to this text and confirms they are no longer pregnant, they will be 
immediately withdrawn from the TodaysBaby program and the study.  Study staff will 
attempt to call participant to explain why they have been withdrawn. 
 
If participant does not respond to the confirmation text, they will continue with the 
TodaysBaby program and study.  Study staff will attempt to call participant to confirm if 
they are still pregnant and withdraw if necessary. 
 
• 
If participant does not respond to ‘Are you still pregnant’ text queries, they will continue 
with study protocol. 
 
7.3 
Randomization Sequence #1  
 
Randomization sequence #1 will randomize participant to the TodaysBaby Prenatal Sleep emphasis 
or Prenatal Feeding emphasis interventions. 
 
Randomization sequence #1 will occur when participant has completed the Pre-
Randomization/Engagement Observation. 
 

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7.4 
Prenatal Intervention Period 
 
This period will begin when the participant is at 34 weeks plus 0 days gestation and will continue 
until ascertainment of participant’s infant birth.  (See section 8 for TodaysBaby Prenatal Sleep and 
Feeding Intervention descriptions) 
 
7.5 
Ascertainment of Infant Birth After Assignment to Prenatal Intervention 
 
Participants who give birth after completion of randomization #1 will immediately undergo 
randomization #2 (assignment to postnatal intervention).  Randomization #2 will occur regardless 
of how much of the prenatal intervention participant has completed.  
 
Infant birth after randomization #1 will be ascertained by: 
 
a. Participant Texts ‘Birth’ to Study Team 
Participants will be informed during the consent process that they should text ‘Birth’ to let the 
study team know when they have given birth.   
 
b. Prenatal Intervention Period 
During this period participants will receive birth ascertainment text queries on gestational weeks:  
35+0; 37+2,+4,+6; 38+1,+2,+3,+4,+5,+6; 39+0,+1,+2,+3,+4,+5,+6; 40+1,+2,+3,+4,+5,+6.  
 
• 
If participant responds to a birth ascertainment query indicating they have given birth, 
participant will immediately undergo randomization #2.   
 
• 
If participant responds to a birth ascertainment query indicating that they are still pregnant 
they will continue with the TodaysBaby Prenatal Intervention. 
 
• 
If, during gestational week 40 weeks plus 0 days through 40 weeks plus 6 days, participant 
responds to birth ascertainment query indicating they are still pregnant, they will continue 
to get daily birth ascertainment queries until they respond that they have given birth or 
there has been three consecutive days of no participant response to the birth ascertainment 
text queries.  After three days of no response, participant will automatically undergo 
randomization #2 and be assigned to the TodaysBaby Postnatal Intervention.   
 
• 
If participant does not respond to any birth ascertainment queries, the study team will 
attempt to contact participant by phone to confirm that participant is still pregnant.  If study 
team is unable to reach participant by phone, participant will automatically undergo 
randomization sequence #2 at 40 weeks plus 6 days gestation. 
 
 

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7.6 
Randomization Sequence #2 
 
Once infant birth has been ascertained, participant will undergo randomization sequence #2 and 
will be randomized to either the TodaysBaby Postnatal Sleep emphasis or TodaysBaby Postnatal 
Feeding emphasis interventions.   
 
7.7 
Postnatal Intervention 
 
The Postnatal Intervention Period will begin the day after randomization #2 and will continue until 
the infant is six months of age.  (See section 8 for TodaysBaby Postnatal Sleep and Feeding 
Intervention descriptions) 
 
7.8 
Early Terminations/Withdrawals 
 
A. Prior to Pre-Randomization/ Engagement Observation Period 
Participants will be ineligible for this study if they do not complete the following enrollment 
procedures by 32 weeks plus 1 days gestation: 
• 
Enrollment Survey 
• 
On-boarding to the study mHealth Platform   
 
B. Prior to Randomization Sequence #1 
Participants will be ineligible for this study for the following: 
• 
Study team is notified that participant no longer meets any eligibility criteria. 
• 
Study team is notified that participant is no longer pregnant (for any reason). 
• 
Study team is notified that participant no longer wishes to participate in study. 
 
C. After Randomization Sequence #1 
Participants will be withdrawn from the prenatal and postnatal interventions for the following: 
• 
Study team is notified that participant’s infant was born with contraindications to safe sleep 
or breastfeeding.   
• 
Study team is notified that participant no longer wishes to participate in study. 
 
D. Withdrawn Participants - Study Surveys 
As in drug intervention trials where a participant stops taking the study drug, participants, who 
withdraw from the TodaysBaby intervention after randomization #1, will continue to be 
followed for study outcomes.  Participants will stop receiving all prenatal and postnatal 
intervention content (videos and text messages).  Participants will continue to receive 
remaining study surveys.  In the event of an infant death or fetal demise all study procedures 
will be discontinued upon study staff learning of the event. 
 
Participants who do not complete the Baseline, Prenatal, and/or Birth** surveys will not be 
withdrawn from the study, as the Postnatal survey will include data on key final study outcomes. 
 

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** If a participant does not complete the Birth Survey, prior to administration of Postnatal Survey, 
the Birth Survey will be appended to the Postnatal Survey. 
 
7.9 
Participant Follow-Up  
 
A. Participants Who Do Not Respond to Text Queries or Open Intervention Video Links 
The study team will closely monitor participant’s interaction with text queries, videos and 
surveys.  If participant is non-responsive the participant will receive check-in text messages 
and/or phone call from the study team to make sure they are not having any technical 
difficulties with the mHealth Platform and to address any concerns or problems.  If study staff 
are unable to reach participants by text or phone, and there is concern that the participant is 
not receiving text messages, staff may contact participants by email (if an email address was 
provided during the enrollment process) 
 
B. Participants Who Text ‘Stop’  
Participants who text ‘Stop’ will receive a second text asking them to confirm that they want to 
stop the program.  If the participant does not confirm that they want to stop the program, they 
will continue to receive the TodaysBaby program. 
 
If a participant confirms that they want to stop they will stop receiving the TodaysBaby program 
(videos and text messages). 
• 
If participant has not undergone randomization #1 – they will be withdrawn from the study. 
• 
If participant has undergone randomization #1 – they will continue with the study and 
receiving any remaining study surveys via text or email.  
 
Participants will receive one final text message from within the Agile platform that confirms 
they have stopped the TodaysBaby program, that they will continue to receive study 
surveys, and request that they complete the TodaysBaby Program Discontinued Survey. 
 
C. Study Team Follow-Up With Participants by Phone 
There are multiple study scenarios where study staff may need to follow-up with a participant 
by phone (ex. incomplete surveys, check on birth status, etc.).  To ensure thorough follow-up for 
each situation, study staff will attempt to contact participants up to 6 times for each situation.   
 
7.10 Reimbursements and Lotteries 
 
A. Reimbursements 
Participants will receive up to $50 in electronic gift card as a reimbursement for their time for 
completing the following study surveys: 
Survey 
Gift Card Amount 
Baseline Survey 
$10 
Prenatal Survey 
$10 
Birth Survey  
$10 
Postnatal Survey 
$20 

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Participants will have the option of selecting an electronic gift card (eGift card) from the 
following National retail stores:  Target, Walmart, CVS Pharmacy.  Target will be the default gift 
card for all participants; However, participants will be able to choose a Walmart or CVS 
Pharmacy gift card. 
 
Participants can switch their desired gift card at any time by notifying study staff.  Participants 
may also request to receive a physical card via mail. 
 
eGift Cards will be sent to participants via text.  Participants will receive their gift card within 7 
days of completion of each survey. 
 
B. Monthly Lottery 
To encourage participants to respond to text queries and complete study surveys, participants 
will be eligible for a monthly lottery during the course of their participation in the study.  Each 
monthly lottery will consist of a $100 eGift Card to Walmart, Target, CVS Pharmacy. 
 
When a participant responds to a text query that begins with a ‘$’, they will receive one entry 
into the monthly lottery. 
 
When a participant completes any of the study surveys, they will receive three entries into the 
monthly lottery. 
 
Participants will be eligible to win up to four monthly lotteries during the course of their 
participation in the study.  Odds of winning the monthly lottery will depend on the number of 
entries received each month. 
 
Agile Health will be responsible for managing and conducting the lotteries.  Agile Health will 
provide Boston University with documentation of the date and URL of each eGift card texted to 
study participants. 
 
See the Appendix 2 for the schedule of events.  
 
8 
Assessment of Safety and Data Safety Monitoring Plan (DSMP) 
 
In this study, participants will receive health information about sleep or feeding beginning at 34 weeks plus 0 
days gestation and extending until their infant is 2 months of age. The risks in this study are minimal, and 
based on the investigators extensive experience, it is highly unlikely that there will be any adverse events (AE) 
or serious adverse events (SAE) related to participation in the study. 
 
 
 
 
 

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8.1 
Definitions 
 
The following definitions will be used in the assessment of safety: 
 
Adverse Event (AE) is any untoward or unfavorable medical occurrence in a human subject, 
including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, 
or disease, temporally associated with the subject’s participation in the research, whether or not 
considered related to the subject’s participation in the research. 
 
Serious Adverse Event (SAE) is any adverse event that  
(1) results in death; 
(2) is life-threatening; 
(3) results in inpatient hospitalization or prolongation of existing hospitalization; 
(4) results in a persistent or significant disability/incapacity; 
(5) results in a congenital anomaly/birth defect; or 
(6) based upon appropriate medical judgment, may jeopardize the subject's health and may 
require medical or surgical intervention to prevent one of the other outcomes listed in this 
definition (examples of such events include allergic bronchospasm requiring intensive treatment 
in the emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse).  
 
Life-threatening means that the event places the subject at immediate risk of death from the event 
as it occurred.  
 
Unanticipated Problem is defined as an event, experience or outcome that meets all three of the 
following criteria:  
• is unexpected; AND 
• is related or possibly related to participation in the research; AND 
• suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized.  
 
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 
 
Unexpected means the nature, severity, or frequency of the event is not consistent with either: 
• 
the known or foreseeable risk of adverse events associated with the procedures involved in the 
research that are described in (a) the protocol–related documents, such as the IRB-approved 
research protocol, any applicable investigator brochure, and the current IRB-approved informed 
consent document, and (b) other relevant sources of information, such as product labeling and 
package inserts; or 
• 
the expected natural progression of any underlying disease, disorder, or condition of the 
subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for 
the adverse event. 
 

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8.2 
Safety Review 
 
Both the risks listed in Section 6.1 and unknown risks will be monitored by the study Principal 
Investigators on an ongoing basis.   
 
The following Data Safety Monitoring Plan will be followed to monitor the safety of study 
participants: 
 
A. The principal investigators and co-investigators will be responsible for monitoring individual 
events and determining whether the study protocol needs modification to minimize risk.  
 
B. Dr. Corwin, the administrative PI, will review, collate and evaluate AEs on an on-going basis.  
Serious AEs will be reviewed within 24 hours of notification by research staff. Serious/life-
threatening events will be reported as required. 
 
C. A Data and Safety Monitoring Committee (DSMC), comprised of 3 individuals unaffiliated with the 
study, will monitor participant safety, data quality, and study progress. The DSMC will include 
experts in or representatives of the fields of pediatrics, clinical trial methodology, and/or 
biostatistics. The DSMC’s objective and external role will be to review recruitment, protocol 
deviations, protocol amendments, and all adverse events or complications related to the study; 
and to make recommendations for protocol changes if indicated. The DSMC will meet at least 
twice annually by teleconference and as needed should participant safety questions or other 
unanticipated problems arise. 
 
D. The Baseline, Birth and Postnatal surveys will screen for depression and anxiety.  Participants who 
screen positive on the PHQ-4 (score ≥3 for either depression or anxiety) will complete the 
Edinburgh Postnatal Depression Screen (EPDS). This 2-step approach will decrease survey burden 
for >80% of mothers, while still identifying those at risk.  
 
Participant EPDS scores will trigger messages as follows:  
 
a. Score 10-15 or higher will trigger a message within the survey with links to Postpartum 
Support International (which includes national and local resources), and a recommendation to 
talk to her health care professional;  
 
b. Score 16 or higher will trigger a more extensive message within the survey with the same links 
and a recommendation to call her health care professional today;  
 
c. Q.10 on the EPDS inquires about a participant’s thoughts about harming themself.  Should a 
participant response to this question be anything other than “Never” the following plan is in 
place: 
 
 
 
 

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The following message will display within the survey:  
 
“Pregnancy (-or- Giving birth) can be an emotional time, and you may feel stressed, 
anxious, or just not yourself. If you find that your mood changes during or after your 
pregnancy, we recommend reaching out to your healthcare provider for support.  You 
may also find support on-line at Postpartum Support International 
https://www.postpartum.net/get-help/help-for-moms/” 
 
 If you have thoughts or feelings of harming yourself there is hope and help! You should 
reach out for help immediately by calling your healthcare provider or 911.   
You can also contact the 988 Suicide & Crisis Lifeline by dialing 988 or 1-800-273-8255, 
which offers a free and confidential network of crisis centers nationwide 24 hours a day; 
7 days a week.  The 988 Suicide & Crisis Lifeline website is: www.988lifeline.org 
 
Your responses to the survey questions are not monitored in real-time.  That means it 
may take us several days or more to review your responses once you complete a survey.” 
 
A study doctor will try to give you a call in the next few days to discuss some of our 
responses to survey questions. 
 
Additionally, a research staff member (licensed physician), will attempt to follow-up with the 
participant by phone to recommend appropriate follow-up.  We will first reach out to the 
participant by text message to alert them to the clinician trying to speak with them, and allow 
the opportunity to opt out of this follow-up if they do not wish to speak to the study clinician.   
 
Should a participant opt-out of contact or the clinician is unable to speak with them after 3 
attempts the study team will send a text message to the participant acknowledging we were 
unable to reach them and include a link to resources if they ever should need them.  The 
resource link sent to participant is: https://www.postpartum.net/get-help/help-for-moms/ 
 
For Spanish speaking participants, the clinician may use hospital interpreter services for 
follow-up calls.  
 
Participants will be informed during the consent process, and again at the beginning of each 
EPDS survey section, that we plan to assess for mood and anxiety, and that a member of the 
research team may follow-up with them by phone. 
 
E. Should any member of the study research team identify that a participant’s physical or mental 
health could be compromised, including suicidal risk, the following procedures will be followed: 
 
a. If a participant expresses risk for harm while on phone with study staff, the team member will 
use the 3-way call feature to immediately connect the participant with the appropriate crisis 
hotline. 
 

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b. For non-urgent medical or psychiatric related issues, the participant will be referred to the 
participant’s primary care provider, if considered appropriate by study investigator(s). 
 
F. Should a participant experience prenatal or postnatal loss, the study research team will 
immediately express condolences and then ensure that all study procedures and interventions are 
discontinued as soon as we are notified. The study research team will provide information about 
grief and bereavement resources, if desired by the participant. 
 
• 
If infant death – First Candle  (https://firstcandle.org/) 
• 
If Stillbirth – Star Legacy Foundation (https://starlegacyfoundation.org/) 
• 
If miscarriage, infant death, or stillbirth - https://www.postpartum.net/get-help/loss-grief-in-
pregnancy-postpartum/ 
 
G. In the event that concern for child neglect or abuse is raised, the study research team members 
will immediately contact the investigators. Mandated reporting guidelines, including reporting to 
Child Protective Services, will be followed. 
 
H. Withdrawal of enrolled participants will be assessed on a case by case basis, depending on the 
situation and whether there are any potential risks to following the study protocol. The decision 
to withdraw a participant from the study and/or to halt data and/or sample collection for medical 
risk reasons will ultimately be made by the principal investigators. Should a participant who was 
assigned to either intervention develop an exclusionary condition, she will be given the 
opportunity to continue receiving the intervention text messages and videos if she feels that they 
are useful. 
 
8.3 
Reporting Plans 
 
The Principal Investigator at BMC/BU Medical Campus will report Unanticipated Problems, safety 
monitors’ reports, and Adverse Events to the BMC/BU Medical Center IRB in accordance with IRB 
policies: 
• 
Unanticipated Problems occurring at BMC/BU Medical Campus involving a fatal or life-
threatening event will be reported to the IRB within 2 days of the investigator learning of the 
event. 
• 
Unanticipated Problems occurring at BMC/BU Medical Campus not involving a fatal or life-
threatening event will be reported to the IRB within 7 days of the investigator learning of the 
event. 
• 
Reports from safety monitors with recommended changes will be reported to the IRB within 7 
days of the investigator receiving the report.  
• 
Adverse Events (including Serious Adverse Events) will be reported in summary at the time of 
continuing review, along with a statement that the pattern of adverse events, in total, does not 
suggest that the research places subjects or others at a greater risk of harm than was previously 
known. 
• 
Reports from safety monitors with no recommended changes will be reported to the IRB at the 
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8.4 
Stopping Rules 
 
A subject will be withdrawn from the study and all intervention and study procedures will be 
discontinued if: 
 
Prior to Randomization #1: 
• 
Participant texts ‘STOP” and confirms they want to stop receiving the TodaysBaby program. 
• 
Participant informs study that they are no longer pregnant. 
 
After Randomization #1 
• 
If the participant has informed the study team that their infant (Baby A if multiple birth) has 
died. 
 
9 Data Handling and Record Keeping 
 
9.1 
Confidentiality 
 
To ensure confidentiality the following procedures are in place: 
Each participant will be assigned a unique study ID number.  All study data will be managed at 
either Boston University or Agile Health only.  All study staff will receive training on confidentiality 
procedures. 
 
9.2 
Data Managed at Boston University 
 
Data managed at Boston University will be managed as outlined in the IRB application and approved 
by the BUMC/BU IRB.  Data will be managed and stored as required by Boston University 
institutional requirements.  Starting 2025, a UVA coordinator will have access to participant data via 
a secure VPN connection to study databases housed on a secure BU server. 
 
9.3 
Data Managed at Agile Health 
 
Their Agile Health platform is a rules-based engine that schedules and delivers text messages. It is 
an intelligent and responsive system that provides a highly personalized user experience. Their 
secure coaching dashboard can be viewed from any computer that will allow the study team to 
monitor incoming and outgoing messages in real-time, input participant personalization settings 
without the help of a programmer, and respond to participant inactivity. The Agile Health platform 
is HIPAA compliant, with all PHI/PII data encrypted in transit and at rest, and messages are 
delivered through a secure gateway in an encrypted format.  
 
Study participants who have been onboarded and consented through the Boston University REDCap 
system will be automatically enrolled in the Agile Health program through a secure API interface 
between the platforms. Only the minimum information necessary for Agile Health to deliver the 
personalized messaging protocols will be provided to Agile’s platform.  Additional data exchanges 
will take place between the platforms via secure API protocol to communicate when specific 

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activities have been performed by the study participant, such as watching a video, responding to a 
text message, indicating the birth of the child (by texting in BIRTH or responding via text to an 
explicit question about birth status), or completing the messaging curriculum. These exchanges are 
bi-directional in nature and are initiated by the platform in which the activity has taken place. 
 
9.4 
ClinicalTrials.gov 
 
This study is registered on ClinicalTrial.gov.  The study team will review and update the 
ClinicalTrials.gov listing on an annual basis and whenever any changes to the study protocol have 
been approved by the IRB. 
 
9.5 
Source Documents 
 
All data collected for the study will be via online surveys, text queries or documented by study staff 
during participant phone follow-up.  No data will be derived from medical records.   The surveys 
will be completed online with data going directly to into REDCap database.  Text message query 
responses will flow into the mHealth platform and will be forwarded to Boston University based on 
when the responses are needed (during data collection or after all data collections procedures 
have stopped).  
 
9.6 
Study Records Retention 
 
The BMC/BU Medical Campus IRB requires that documentation of informed consent of subjects be 
retained for at least seven years after the study is closed, unless the IRB waived the requirement 
for informed consent or documentation of informed consent. Such records may be preserved in 
hardcopy, electronic or other media form and must be accessible for inspection and copying by 
authorized individuals 
 
10 Statistical Plan 
 
Study records including documentation of informed consent of subjects will be retained for at least seven 
years after the study is closed, unless the IRB waived the requirement for informed consent or documentation 
of informed consent. 
 
10.1 Study Hypotheses 
 
Hypothesis (Aim1): For each recommended safe sleep practice (supine sleep position, roomsharing 
without bed sharing, avoiding use of soft bedding, and pacifier use), compared to mothers 
receiving only breastfeeding interventions, higher adherence will be reported among mothers 
receiving prenatal or postnatal safe sleep interventions and greatest adherence will be reported 
among mothers receiving both safe sleep interventions. 
 
Hypothesis (Aim1): For breastfeeding initiation and breastfeeding duration (for any and exclusive 
breastfeeding), compared to mothers receiving only safe sleep interventions, higher adherence 

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will be reported among mothers receiving prenatal or postnatal breastfeeding interventions and 
greatest adherence will be reported among mothers receiving both breastfeeding interventions. 
 
Hypothesis (Aim 2): The effect of the interventions on infant care practices will be mediated by: 
a) perceived risk for the health issue (e.g., infant death, lower IQ) associated with the infant care 
practice; b) cognitive constructs from the Theory of Planned Behavior (attitudes, subjective norms, 
perceived control); and c) affective associations with the infant care practice. 
 
10.2 Sample Size Determination 
 
We will enroll 2,500 participants and estimate that 2,000 participants will undergo randomization 
sequence #1, yielding randomization samples of 500 mothers in each study group. Based on our 
SMART experience, we anticipate 80% retention through the transition to the postnatal 
interventions, giving an analysis sample of 400/study group, or 1600 overall at the time of this 
transition, and retention of 80% from transition through the 2-6 month follow-up survey, for an 
analysis sample of 320/group or 1280 overall. Sample size considerations focus on Aim 1, the effect 
of intervention on safe sleep or breastfeeding outcomes. 
 
From our SMART study, the prevalence of safe sleep outcomes for mothers who did not receive any 
safe sleep intervention was ~70% for no soft bedding use and roomsharing without bedsharing, and 
80% for supine position; for mothers who did not receive any breastfeeding intervention, 
prevalence of any and exclusive breastfeeding at follow-up was ~75% and 35%, respectively. The 
odds ratio for the mHealth postnatal intervention was ~2.0 for both supine sleep and roomsharing 
without bedsharing, and 1.8 for no soft bedding use. The mHealth intervention did not have a 
significant effect on breastfeeding. In the absence of interaction, the current study is powered to 
detect an intervention odds ratio of 1.7, which corresponds to an increase in prevalence from 70% 
to 80%, or from 80% to 87%. For baseline prevalence of 70% and 80%, power of detecting an 
intervention odds ratio of 1.7 is 0.93 and 0.81 (adjusting for multiple comparisons and testing at the 
family-wise 2 tailed p<0.05 level). With a baseline prevalence of 70%, on odds ratio of 1.7 
corresponds to a 10 percentage point increase in prevalence. To detect interaction, stronger effects 
are needed. For example, the expected sample size gives 0.80 power to detect interaction for a 
scenario with prevalence in the no-intervention group of 70%, no effect of the prenatal intervention 
alone, a weak effect of the postnatal intervention alone (OR=1.5, corresponding to prevalence of 
78%), and a strong interaction effect (OR=2.5, corresponding to a prevalence for those receiving 
both interventions of 89%) (power for interaction determined through simulation). 
 
10.3 Statistical Methods 
 
Our study follows a 2x2 factorial design testing the effectiveness of the safe sleep and breastfeeding 
prenatal and postnatal mHealth interventions. Preliminary analyses will examine loss to follow-up 
from prenatal enrollment and intervention to transition to the postnatal intervention and 2-6 
month follow-up, both examining demographic characteristics related to drop out and comparing 
rates of follow-up across the 4 study groups. 
 

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Based on our experience with the SMART and All Breasts Matter studies, we do not anticipate 
problems related to follow-up; however, if there are problems, multiple imputation procedures will 
be used to account for potential drop out-related bias. We use the fully conditional specification101 
to multiple imputation, modeling dichotomous, multinomial, and continuous variables through 
logistic, multinomial logistic, and linear regression, respectively, with the number of imputation 
data sets based on the percent of missing data.102 As noted in the study overview, recruitment and 
sample size plans were developed based on estimates of loss to follow-up rates from previous 
studies.  
While group differences are not anticipated due to randomization, preliminary analyses will also 
compare demographic characteristics of mothers and infants across the four study groups, to 
identify demographic characteristics to be examined as potential confounders in our primary 
analyses. Finally, preliminary analyses will examine pre-intervention differences in the key decision-
making constructs. If pre-intervention differences are found, those differences will be controlled for 
in analyses. 
 
Data analysis for Specific Aim 1. The primary hypotheses for this aim are that, relative to control 
messaging, mothers receiving the risk reduction messaging will have higher uptake rates for each 
safe sleep outcome (hypothesis 1a), and each breastfeeding outcome (hypothesis 1b), and that 
receipt of both prenatal and postnatal interventions will be more effective than one intervention; 
breastfeeding messaging serves as the control for safe sleep outcomes, and safe sleep messaging 
serves as the control for breastfeeding outcomes. We will assess 4 different behavioral outcomes 
related to each intervention: 1a) safe sleep: supine position, sleep location of roomsharing but not 
bedsharing, no soft bedding use, and usual use of a pacifier (yes/no for all four), and 1b) 
breastfeeding: any breastfeeding (yes/no); exclusive breastfeeding for at least 8 weeks (yes/no); 
duration of any and duration of exclusive breastfeeding (time-to-event data modeled as days 
postpartum; we will be ascertaining breastfeeding behavior each week through 6 months using 
mHealth queries, as well as at the time of the 2-6 month survey).  
 
Dichotomous outcomes will be modelled through logistic regression, and time-to-event outcomes 
will be modeled through Cox proportional hazards regression. Mothers will be enrolled through an 
anticipated 10-20 WIC centers per state; since randomization is at the individual level, we don’t 
expect clustering by center to affect power, but we will control for clustering by WIC center by using 
the generalized estimating equation approach (GEE) with sandwich estimators for logistic 
regression and a marginal approach with a robust sandwich estimate for proportional hazards 
regression.103 For each outcome, we will first fit a multiplicative interaction model, with indicator 
variables representing the prenatal mHealth intervention, the postnatal mHealth intervention and 
their interaction. We will also include a variable for infant age at the 2-6 month survey (for 
dichotomous outcomes) to account for differences in age at follow-up. If the interaction term is 
significant, this model will be used to describe the effects of each intervention alone and in 
combination vs. those receiving both the pre- and post-natal control interventions. If the interaction 
term is not significant, we will fit a main effect model to test and describe the separate effects of 
the prenatal mHealth intervention and the postnatal mHealth intervention. The logistic and 
proportional hazards modeling approach allows us to control for potential confounding due to 
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age at interview. To acknowledge the multiple comparisons issue in evaluating the effectiveness of 
intervention on 4 safe sleep (or 4 breastfeeding) outcomes, we will use the Hochberg adjustment to 
maintain a family-wise 2-tailed alpha level of 0.05 when testing for intervention effects. 
 
Data analysis for Specific Aim 2. The primary hypothesis for this aim is that the impact of the 
intervention on behavioral outcomes will be mediated by effects on both cognitive and affective 
components of perceived risk. As for Aim 1, separate sets of analyses will examine effects of the 
safe sleep interventions on safe sleep outcomes, and the breastfeeding interventions on the 
breastfeeding outcomes. To test these hypotheses, we will first use the GEE logistic regression (for 
dichotomous outcomes) and marginal proportional hazards (for time-to-event outcomes) modeling 
approach described above to assess the effect of experimental condition on perceived risk. We will 
separately examine measures of risk conditioned on behavior (e.g., for safe sleep, risk of SIDS if 
baby placed prone) and not conditioned on behavior. To the extent that the intervention 
successfully communicates the risk message, the highest conditioned risk, for safe sleep outcomes, 
will be in the safe sleep pre/post condition and the lowest conditioned risk will be in the 
breastfeeding pre-post condition (e.g., mother will correctly understand and report that supine 
position lowers risk for SIDS). 
 
Primary analyses for Aim 2 will examine the mechanistic roles of risk perception, cognitive 
constructs, and affective constructs as motivators of behavior by testing whether the intervention 
effects tested in Aim 1 are mediated by changes in perceived risk. Our primary approach to 
mediation analysis will use causal mediation methods based on a counterfactual framework.102,103 
This approach is less susceptible to bias than traditional methods, allows for decomposition of 
effects into natural direct (effects of intervention on outcome that cannot be explained through the 
mediator) and indirect (effects of the intervention due to the effect of intervention on the mediator 
and the mediator on outcome) effects, and that it can be used with both dichotomous and time-to-
event outcomes.106 The extent of mediation is measured through an odds ratio (for dichotomous 
outcomes and logistic regression) or hazard ratio (for time-to-event outcomes and proportional 
hazards regression) and 95% confidence interval for the indirect effect. A limitation to the causal 
mediation approach is that current SAS macros do not account for clustering. As a secondary 
approach, if there is a strong cluster effect in our data, we will consider structural equation 
mediational models107 using bias corrected bootstrapped confidence intervals to test indirect 
effects, using the MPlus software package.108 
 
11 Ethics/Protection of Human Subjects 
 
This study is to be conducted according to applicable US federal regulations and institutional policies 
(which are based in federal regulations, guidance, and ICH Good Clinical Practice guidelines). 
 
This protocol and any amendments will be submitted to the Boston Medical Center and Boston 
University Medical Campus IRB, for formal approval of the study conduct. The decision of the IRB 
concerning the conduct of the study will be made in writing to the investigator.  
 

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All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision about their participation in this 
study. The consent form will be submitted with the protocol for review and approval by the IRB. The 
consent of a subject, using the IRB-approved consent form, must be obtained before that subject is 
submitted to any study procedure. Consent will be documented as required by the IRB.   
 
 
12 Literature References 
 
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change parents' minds? J Immigr Minor Health 2016;18:402-10. 
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39. Gurka KK, Hornsby PP, Drake E, et al. Exploring intended infant feeding decisions among low-income 
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Breastfeeding Initiation and Exclusivity during the Newborn Hospital Stay in a Low-income Population. J  
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41. Moon RY, Hauck FR, Kellams AL, et al. Comparison of Text Messages vs Email When Communicating with 
and Querying Mothers about Safe Infant Sleep. Acad Pediatr 2017;DOI 10.1016/j.acap.2017.06.004; available 
at http://dx.doi.org/10.1016/j.acap.2017.06.004. 
42. Blair PS, Sidebotham P, Berry PJ, Evans M, Fleming PJ. Major epidemiological changes in sudden infant 
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43. Costello EJ, Keeler GP, Angold A. Poverty, race/ethnicity, and psychiatric disorder: a study of rural children. 
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44. Mathews TJ, MacDorman MF. Infant mortality statistics from the 2006 period linked birth/infant death 
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45. United States Department of Health and Human Services (US DHHS), Centers of Disease Control and 
Prevention (CDC), National Center for Health Statistics (NCHS), Office of Analysis and Epidemiology (OAE), 
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46. Fu LY, Colson ER, Corwin MJ, Moon RY. Infant Sleep Location: Associated Maternal and Infant 
Characteristics with Sudden Infant Death Syndrome Prevention Recommendations. J Pediatr 2008;153:503-8. 
47. Hauck FR, Herman SM. Bed sharing and sudden infant death syndrome in a largely African-American 
population. Paediatr Child Health 2006;11:16A-8A. 
48. Kadakia A, Joyner B, Tender J, Oden R, Moon RY. Breastfeeding in African Americans may not depend on 
sleep arrangement: a mixed-methods study. Clin Pediatr (Phila) 2015;54:47-53. 
49. Moon RY, Oden RP, Grady KC. Back to Sleep: educational intervention with Women, Infants, and Children 
program clients. Pediatrics 2004;113:542-7. 
50. Women, Infants, and Children (WIC): About WIC. (Accessed June 16, 2017, at 
https://www.fns.usda.gov/wic/about-wic.) 
51. Thorn B, Tadler C, Huret N, et al. WIC Participant and Program Characteristics 2014. Prepared by Insight 
Policy Research under Contract No. AG‐3198‐C‐11‐0010. Alexandria, VA: U.S. Department of Agriculture, Food 
and Nutrition Service; 2015. 
52. Vernacchio L, Corwin MJ, Vezina RM, et al. Xylitol syrup for the prevention of acute otitis media. Pediatrics 
2014;133:289-95. 
53. Colson ER, Joslin SC. Changing nursery practice gets inner-city infants in the supine position for sleep. Arch 
Pediatr Adolesc Med 2002;156:717-20. 
54. Demirci JR, Bogen DL, Holland C, et al. Characteristics of breastfeeding discussions at the initial prenatal 
visit. Obstet Gynecol 2013;122:1263-70. 
55. Tully KP, Ball HL. Maternal accounts of their breast-feeding intent and early challenges after caesarean 
childbirth. Midwifery 2014;30:712-9. 
56. Hauck YL, Irurita VF. Incompatible expectations: the dilemma of breastfeeding mothers. Health Care 
Women Int 2003;24:62-78. 
57. O'Brien M, Buikstra E, Hegney D. The influence of psychological factors on breastfeeding duration. J Adv 
Nurs 2008;63:397-408. 
58. Ahlers-Schmidt CR, Schunn C, Lopez V, et al. A Comparison of Community and Clinic Baby Showers to 
Promote Safe Sleep for Populations at High Risk for Infant Mortality. Glob Pediatr Health 
2016;3:2333794X15622305. 

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59. Hesselink AE, van Poppel MN, van Eijsden M, Twisk JW, van der Wal MF. The effectiveness of a perinatal 
education programme on smoking, infant care, and psychosocial health for ethnic Turkish women. Midwifery 
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60. Rosen IM, Krueger MV, Carney LM, Graham JA. Prenatal breastfeeding education and breastfeeding 
outcomes. MCN Am J Matern Child Nurs 2008;33:315-9. 
61. Schreck PK, Solem K, Wright T, Schulte C, Ronnisch KJ, Szpunar S. Both Prenatal and Postnatal 
Interventions Are Needed to Improve Breastfeeding Outcomes in a Low-Income Population. Breastfeed Med 
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62. Smith A, Page D. U.S. smartphone use in 2015. Washington, D.C.: Pew Research Institute; 2015. 
63. Zallman L, Bearse A, West C, Bor D, McCormick D. Patient preferences and access to text messaging for 
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64. Person AK, Blain ML, Jiang H, Rasmussen PW, Stout JE. Text messaging for enhancement of testing and 
treatment for tuberculosis, human immunodeficiency virus, and syphilis: a survey of attitudes toward cellular 
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65. Kharbanda EO, Stockwell MS, Fox HW, Andres R, Lara M, Rickert VI. Text message reminders to promote 
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on influenza vaccination and educational text messages. Prev Med 2011;52:75-7. 
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69. Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. 
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70. Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health 
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13 Appendix 1 – TodaysBaby Intervention Videos 
 
TodaysBaby Safe Sleep Emphasis Videos 
 
Video Topic 
Prenatal 
Intervention 
Postnatal 
Intervention 
Prenatal Intervention-Congratulations 
X 
 
Back Sleeping Safest 
X 
 
Sleep Location Important 
X 
 
Health Babies Wake Easily/Often 
X 
 
Firm Mattress 
X 
 
Never too Late to Quit Smoking 
X 
 
Pacifier A (Should you give Baby) 
X 
 
Safe Sleep for Premature Babies 
X 
 
Good Sleeper 
X 
 
Babies Don't Just Sleep at Night 
X 
 
Breathe Better on Back 
X 
 
Pacifiers B (Pacifiers are Safe) 
X 
 
Prenatal Intervention Summary 
X 
 
Drugs & Alcohol During/After Pregnancy 
X 
X 
No Side Sleeping 
X 
X 
Good Airway – Open and Straight  
X 
X 
Calming a Fussy Baby 
X 
X 
Sleep Products 
X 
X 
Planning for Back to School/Work 
X 
X 
Swaddling/Sleep Sacks 
X 
X 
Flat Head/Tummy Time 
X 
X 
Overbundling 
X 
X 
Safe Baby Wearing Carriers! 
X 
X 
What its Really Like to be Postpartum** 
X 
X 
Take Care of Yourself** 
X 
X 
Postnatal- Intervention-Introduction 
 
X 
Postnatal-What You Will Learn 
 
X 
Roomshare not Bedshare 
 
X 
Won't Choke on Back 
 
X 
Why No Bedsharing 
 
X 
Bedding and Bumpers 
 
X 
Feed/Bed, Sleep/Crib 
 
X 
Good Sleepers 
 
X 
Comfortable on back 
 
X 
Pacifier C (Safe Sleep) 
 
X 
Smoking around baby not recommended 
 
X 
 Bedsharing – dangerous circumstances  
 
X 
Advice from Others 
 
X 
Pacifier D (Not Too Late) 
 
X 
Perinatal Mood and Anxiety** 
 
X 
Postnatal-summary-Thank you 
 
X 
 

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TodaysBaby Feeding Emphasis Videos 
 
Video Topic 
Prenatal 
Intervention 
Postnatal 
Intervention 
Prenatal Intervention-Congratulations 
X 
 
Your Body Knows What to Do 
X 
 
Good Start in Hospital/Breast Crawl 
X 
 
How to Know When Baby is Hungry 
X 
 
Good Latch 
X 
 
Output Patterns 
X 
 
Breastfeed for year 
X 
 
Breastfeeding Premature Babies 
X 
 
How Often To Feed Your Baby 
X 
 
Nutrition for Mothers 
X 
 
What to do When Baby is Fussy Baby 
X 
 
Avoid Nipple Pain Discomfort 
X 
 
Prenatal Summary-Your Journey 
X 
 
Busting Myths 
X 
X 
What if Baby Needs Supplementation 
X 
X 
How Long for Breast Milk to Come In 
X 
X 
Breastfeeding in Public 
X 
X 
Pumping Work/School 
X 
X 
Support From Friends 
X 
X 
Smoking and breastfeeding and Medications 
X 
X 
Advice From Others 
X 
X 
Breastfeeding is Convenient 
X 
X 
Feedings When Tired 
X 
X 
What its Really Like to be Postpartum** 
X 
X 
Take Care of Yourself** 
X 
X 
Breast Milk Best Milk 
 
X 
Nipple Pain Troubleshooting 
 
X 
Why Babies Cry 
 
X 
Baby Want to Eat all the Time 
 
X 
Worries About Supply and Weight Gain 
 
X 
Why Stick with Breastfeeding 
 
X 
Babies Should Wake Easily and Often 
 
X 
Worries About Milk Supply 
 
X 
Why Breast Milk is Best 
 
X 
Breastfeeding is Team Effort 
 
X 
Problems Breastfeeding 
 
X 
Keeping Toddlers Occupied 
 
X 
Back to School/Work 
 
X 
Late BF Stooling Pattern 
 
X 
Breastfeeding Save Time and Money 
 
X 
Perinatal Mood and Anxiety** 
 
X 
 
**videos shown to both intervention arms. 
 
 

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14 Appenix 2 – Schedule of Events 
Pre-Randomization/Limited Engagement Period 
 
Gest Wks 
Time Sent 
Text Message Topic 
9+0 
PM 
Message:  Morning Sickness 
10 +0 
PM 
Message: Feeling Tired 
11+0 
PM 
Message: Videos Begin 34 Wks 
12+0 
PM 
Message: Baby Size Plum 
13+0 
PM 
Message: Letting Family Know Pregnant 
14+0 
 PM 
Message: Welcome 2nd trimester 
15+0 
PM 
Message: Healthy Snacks 
16+0 
PM 
Message: WIC Offerings 
17+0 
PM 
Message: Normal Weight Gain 
18+0 
PM 
Message: Trouble Sleeping 
19+0 
PM 
Message: Child Birth Classes 
20+0 
PM 
Message: Halfway There 
21+0 
PM 
-$$-   Message: Sex of Baby 
22+0 
PM 
Message: Drink Water 
23+0 
PM 
Message: Feel Baby Kicks 
24 +0 
PM 
Message: You Are Doing Great 
25 +0 
PM 
Message: Exercise Can by Great for you and baby 
26+0 
PM 
-$$-   Message: Live in Same Home After Birth? 
27+0 
PM 
-$$-   Message: Change in Due Date? 
28+0 
PM 
Message: Baby Size Eggplant 
29+0 
PM 
Message: Third Trimester 
30+0 
PM 
-$$-   Message: Told Not to Breastfeed or Place on Back 
30 +0 
AM 
Message: Daily Text/Video Starts Soon 
31+0 
PM 
Message: Are you still pregnant? 
 
 
-$$- = Participant response to this text – they obtain entry into monthly lottery 
 
 
 
 
 
 
 
 
 

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Pre-Randomization/Limited Engagement Observation Period 
 
 
Gest Wk 
Time Sent 
Video Title, Text Message, Survey 
32 +0 
PM 
Video: What to Expect 
32 +1 
PM 
Baseline Survey Sent 
32 +2 
PM 
Message:  Reminder $ Texts 
32 +3 
AM  
Baseline survey REMINDER 
 
PM  
Video: Videos Start Soon  
32 +4 
PM 
Message: Pregnancy Challenges 
32 +5 
AM 
Message:  Visit TodaysBaby Website Yet? 
 
PM 
Baseline survey REMINDER 
32 +6 
PM 
 (No interactive text sent) 
33 +0 
AM 
Confirm Pregnant/Delivered Baby 
 
PM 
Baseline survey REMINDER 
33 +1 
PM 
Message: Favorite way to relax 
33 +2 
PM 
Video: Videos Tailored to Baby's Birth 
33+3 
AM 
Baseline survey REMINDER 
 
PM 
Message:  Prenatal Vitamins 
33 +4 
 
AM 
Video: Study Videos/ Website 
33 +5 
PM 
Message:  Confirm Pregnant/Delivered Baby 
 
PM 
Baseline survey REMINDER 
33 +6 
AM 
Message:  Do You Know Type ‘Birth’ Anytime? 
 
PM 
Message:  TodaysBaby Videos Start Tomorrow 
 
 
 
 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 52 of 64 
TodaysBaby/SMARTER Prenatal Intervention Curriculum 
 
Feeding Emphasis Cohort Video 
Sleep Emphasis Cohort Video 
Text Message to Both Cohorts 
Survey Link and/or Reminder to Both Cohorts 
 
Gest Wks 
Int Day 
Time 
Sent 
Video Title, Text Message, or Survey 
Video URL# 
34 +0 
(1) 
PM 
BF Video Title: BF-Pre-Intro-Congratulations 
Video URL#: 1010 
 
PM 
SS Video Title: SS-Pre-Intro-Congratulations 
Video URL#: 1051 
34 +1 
(2) 
AM 
Message:  Received First Video 
 
PM 
BF Video Title: BF-Body Knows 
Video URL#: 1011 
 
PM 
SS Video Title: SS-Back Sleeping Safest 
Video URL#: 1052 
34 +2 
(3) 
PM 
BF Video Title: BF-Busting Myths 
Video URL#: 1012 
 
PM 
SS Video Title:  SS-SMART-Good Sleeper 
Video URL#: 1064 
34 +3 
(4) 
AM 
Message: Feeding Plan 
 
PM 
BF Video Title: BF-Good Start 
Video URL#: 1013 
 
PM 
SS Video Title: BF/SS-Postpartum 
Video URL#: 1048 
34 +4 
(5) 
PM 
BF Video Title: BF-Baby Hungry 
Video URL#: 1014 
 
PM 
SS Video Title: SS-Calming Baby  
Video URL#: 1053 
34 +5 
(6) 
AM 
Message: Sleep Location (Bedsharing) 
 
PM 
BF Video Title: BF-Supplementation 
Video URL#: 1015 
 
PM 
SS Video Title: SS-No Side Sleeping  
Video URL#: 1062 
34 +6 
(7) 
PM 
BF Video Title: BF-Good Latch 
Video URL#: 1016 
 
PM 
SS Video Title: SS-Sleep Location  
Video URL#: 1054 
35 +0 
(8) 
AM 
Message: Birth Ascertainment 
 
PM 
BF Video Title: Output Patterns 
Video URL#: 1017 
 
PM 
SS Video Title: SS-Wake Easily/Often  
Video URL#: 1055 
35 +1 
(9)   
PM 
BF Video Title: BF-Breastfeed for year 
Video URL#: 1018 
 
PM 
SS Video Title: SS-Sleep Products  
Video URL#: 1056 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 53 of 64 
Gest Wks 
Int Day  
Time 
Sent 
Video Title, Text Message, or Survey  
Video URL# 
35 +2 
(10) 
AM 
Message: Sleep Position  
 
PM 
BF Video Title: BF-How Long Milk 
Video URL#: 1019 
 
PM 
SS Video Title: SS-Firm Mattress  
Video URL#: 1057 
35 +3 
(11) 
PM 
BF Video Title: BF-Breastfeeding Preemies 
Video URL#: 1020 
 
PM 
SS Video Title: SS-Quit Smoking  
Video URL#: 1058 
35 +4 
(12) 
AM 
Message: Sleep Location (Room Sharing)  
 
PM 
BF Video Title: BF-How Often To Feed 
Video URL#: 1021 
 
PM 
SS Video Title: SS-Pacifier A (Should you give Baby) 
Video URL#: 1059 
35 +5 
(13) 
PM 
BF Video Title: BF-Breastfeeding in Public 
Video URL#: 1022 
 
PM 
SS Video Title: SS-Drugs & Alcohol 
Video URL#: 1060 
35 +6 
(14) 
AM 
Message: Type Birth 
 
PM 
BF Video Title: BF-Pumping Work/School 
Video URL#: 1023 
 
PM 
SS Video Title: SS-Safe Sleep Preemies  
Video URL#: 1061 
36 +0 
(15) 
PM 
BF Video Title: BF-Support 
Video URL#: 1024 
 
PM 
SS Video Title: SS-Good Airway  
Video URL#: 1063 
36 +1 
(16) 
AM 
Message: Falling Asleep  
 
PM 
Prenatal survey – Sent 
36 +2 
(17) 
PM 
BF Video Title: BF/SS-Take Care 
Video URL#: 1050 
 
PM 
SS Video Title: SS- Back To School/Work  
Video URL#: 1065 
36 +3 
(18) 
AM 
Message: Study Website 
 
PM 
Prenatal survey REMINDER 
36 +4 
(19) 
PM 
BF Video Title: BF-Nutrition for Mothers 
Video URL#: 1025 
 
PM 
SS Video Title: SS- Babies don’t just sleep at night  
Video URL#: 1066 
36 +5 
 (20) 
AM 
Prenatal survey REMINDER 
 
PM  
Message: Soft Bedding 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 54 of 64 
Gest Wks 
Int Day  
Time 
Sent 
Video Title, Text Message, or Survey  
Video URL# 
36 +6 
(21) 
PM 
BF Video Title: BF-Fussy Baby 
Video URL#: 1026 
 
PM 
SS Video Title: SS-Breathe Better on Back 
Video URL#: 1067 
37 +0 
 (22) 
 AM 
Message – Birth Ascertainment 
37 +1 
 (23) 
PM 
BF Video Title: BF-Smoking 
Video URL#: 1027 
 
PM 
SS Video Title: SS-Swaddling/Sleep Sacks  
Video URL#: 1068 
37 +2 
 (24) 
 AM 
Message – Birth Ascertainment 
 
AM 
Prenatal survey REMINDER 
37 +3 
 (25) 
PM 
BF Video Title: BF-Advice From Others 
Video URL#: 1028 
 
PM 
SS Video Title: BF/SS-Take Care 
Video URL#: 1050 
37 +4 
 (26) 
AM 
Message – Birth Ascertainment 
 
PM 
Prenatal survey REMINDER 
37 +5 
 (27) 
PM 
BF Video Title: BF- Convenient 
Video URL#:  1029 
 
PM 
SS Video Title: SS-Flat Head/Tummy Time 
Video URL#: 1069 
 
AM 
Message – Birth Ascertainment 
37 +6 
 (28) 
PM 
BF Video Title: Ascertain Birth** 
Video URL#:  1005 
 
PM 
SS Video Title: Ascertain Birth** 
Video URL#:  1005 
 
AM 
Message – Type Birth 
38 +0 
 (29) 
PM 
BF Video Title: BF/SS-Postpartum 
Video URL#: 1048 
 
PM 
SS Video Title: SS-Pacifiers B (Safe) 
Video URL#:  1070 
38 +1 
 (30) 
AM 
Message – Birth Ascertainment 
 
AM 
Message – Birth Ascertainment 
38 +2 
 (31) 
PM 
BF Video Title: BF-Feedings When Tired 
Video URL#:  1030 
 
PM 
SS Video Title: SS-Overbundling 
Video URL#:  1071 
38 +3 
(32) 
AM 
Message – Birth Ascertainment 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 55 of 64 
Gest Wks 
Int Day 
Time 
Sent 
Video Title, Text Message, or Survey  
Video URL# 
38 +4 
AM 
Message – Birth Ascertainment 
(33) 
PM 
BF Video Title: BF-Nipple Pain Discomfort 
Video URL#:  1031 
 
PM 
SS Video Title: SS-Safe Baby Wearing Carriers! 
Video URL#: 1072 
38 +5 
 (34) 
AM 
Message – Birth Ascertainment 
38 +6 
AM 
Message – Birth Ascertainment 
(35) 
PM 
BF Video Title: BF-Pre-Summary-Your Journey 
Video URL#: 1032 
 
PM 
SS Video Title: SS-Prenatal-Summary 
Video URL#:  1073 
39 +0 
AM 
Text Message – Birth Ascertainment 
(36) 
PM 
BF Video Title: Break from Videos** 
Video URL#: 1006 
 
PM 
SS Video Title: Break from Videos** 
Video URL#:  1006 
39 +1 
 (37) 
AM 
Message – Birth Ascertainment 
39 +2 
 (38) 
AM 
Message – Birth Ascertainment 
39 +3 
 (39) 
AM 
Message – Birth Ascertainment 
39 +4 
 (40) 
AM 
Message – Birth Ascertainment 
39 +5 
 (41) 
AM 
Message – Birth Ascertainment 
39+6 
 (42) 
AM 
Message – Birth Ascertainment 
40+0 
 (43) 
AM 
Message – Birth Ascertainment 
40+1 
 (44) 
AM 
Message – Birth Ascertainment 
40+2 
 (45) 
AM 
Message – Birth Ascertainment 
40+3 
 (46) 
AM 
Message – Birth Ascertainment 
40+4 
 (47) 
AM 
Message – Birth Ascertainment 
40+5 
 (48) 
AM 
Message – Birth Ascertainment 
40+6 
 (49) 
AM 
Message – Auto tx to Postnatal intervention 
**non-intervention video 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 56 of 64 
TodaysBabys/SMARTER - Postnatal Intervention 
 
Feeding Emphasis Cohort Video 
Sleep Emphasis Cohort Video 
Text Message to Both Cohorts (-$$- Lottery Text) 
Survey Link and/or Reminder to Both Cohorts 
 
Gest Wks 
Int Day 
Time 
Sent 
Video title, Text Message, Survey 
Video URL# 
 
AM 
BF Video Title: BF-Breast Milk Best Milk 
Video URL#: 1033 
 
AM 
SS Video Title: SS-postnatal-intro-Choose  
Video URL#: 1075 
Wk 1/D1  
(1) 
PM 
-$$- Text Message – # Months Plan Breastfeeding  
 
PM 
BF Video Title: BF-Busting Myths  
Video URL#: 1012 
 
PM 
SS Video Title: SS-Postnatal-Intro-Keep Program  
Video URL#: 1074 
 
PM  
Birth Survey 
 
AM 
BF Video Title: BF-Nipple Pain Troubleshooting  
Video URL#: 1034 
 
AM 
SS Video Title: SS-Good Airway 
Video URL#: 1063 
Wk 1/D2  
(2) 
PM 
-$$-Message: Feeding Plan (Practice-Since Birth/Intent) 
 
PM 
BF Video Title: BF-Why Babies Cry  
Video URL#: 1035 
 
PM 
SS Video Title: SS-Roomshare not Bedshare 
Video URL#: 1076 
 
AM 
BF Video Title: BF-How Long Milk  
Video URL#: 1019 
 
AM 
SS Video Title: SS-Overbundling 
Video URL#: 1071 
Wk 1/D3  
(3) 
PM 
Message: Sleep Position (Practice-Since Birth/Intent) 
 
PM 
BF Video Title: BF-Baby Eats All Time 
Video URL#: 1036 
 
PM 
SS Video Title: SS- Won't Choke on Back 
Video URL#: 1077 
 
PM 
Birth Survey - Reminder 
 
AM 
BF Video Title: BF-Problems Breastfeeding  
Video URL#: 1043 
 
AM 
SS Video Title: SS-Why No Bedsharing 
Video URL#: 1078 
Wk 1/D4  
(4) 
PM 
-$$-Message: Sleep Location-Bed Sharing (Practice-Since Birth/Intent) 
 
PM 
BF Video Title: BF-Worries and Weight Gain  
Video URL#: 1037 
 
PM 
SS Video Title: SS-Bedding and Bumpers 
Video URL#: 1079 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 57 of 64 
 
Gest Wks 
Int Day 
Time 
Sent 
Video title, Text Message, Survey 
Video URL# 
 
AM 
BF Video Title: BF-Stick with Breastfeeding  
Video URL#: 1038 
 
AM 
SS Video Title: SS-Calming Baby 
Video URL#: 1053 
Wk 1/D5  
(5) 
PM 
Message: Decide When to Feed Baby 
 
PM 
BF Video Title: BF-Supplementation  
Video URL#: 1015 
 
 PM 
SS Video Title: SS-Feed/Bed, Sleep/Crib 
Video URL#: 1080 
 
AM 
BF Video Title: BF-Feedings When Tired  
Video URL#: 1030 
Wk 1/D6  
(6) 
AM 
SS Video Title: SS-SMARTER-Good Sleepers 
Video URL#: 1081 
 
AM 
Birth Survey Reminder 
 
PM 
Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk 1/D7  
(7) 
PM 
-$$-Message:  Soft Bedding (Practice /Intent) 
 
AM 
BF Video Title: BF-Babies Wake Often  
Video URL#: 1039 
Wk 2/D1 
(8) 
AM 
SS Video Title: SS-Comfortable on back 
Video URL#: 1082 
 
PM 
-$$-Message:  Falling Asleep (Practice Only) 
Wk 2/D2 
(9) 
PM 
Message: Feeding Plan (Practice /Intent)  
 
PM 
Birth Survey Reminder 
Wk 2/D3 
(10) 
AM 
BF Video Title: BF-Worries Milk Supply  
Video URL#: 1040 
 
AM 
SS Video Title: SS-No Side Sleeping 
Video URL#: 1062 
 
PM 
-$$-Message: Sleep Position (Practice/Intention) 
Wk 2/D4 
(11) 
PM 
Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk 2/D5 
(12) 
AM 
BF Video Title: BF/SS-Postpartum  
Video URL#: 1048 
 
AM 
SS Video Title: SS-Swaddling and sleep sacks 
Video URL#: 1068 
 
PM 
-$$-Message: Decide When to Feed Baby 
Wk 2/D6  
(13) 
PM 
Birth Survey Reminder 
 
PM 
-$$-Message: Sleep Location (Room sharing) (Practice/Intention) 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 58 of 64 
Gest Wks 
Int Day 
Time 
Sent 
Video title, Text Message, Survey 
Video URL# 
Wk 2/D7  
(14) 
AM 
BF Video Title: BF-Why Breast Milk is Best  
Video URL#: 1041 
 
AM 
SS Video Title: SS-Pacifier C (Safe Sleep) 
Video URL#: 1083 
 
PM 
Message:  Soft Bedding (Practice /Intent) 
Wk 3/D1 
(15) 
PM 
Message: Pacifier (practice) 
Wk 3/D2 
(16) 
AM 
BF Video Title: BF-Smoking  
Video URL#: 1027 
 
AM 
SS Video Title: SS- Smoking around baby not 
recommended 
Video URL#: 1084 
 
PM 
-$$-Message: Feeding Plan (Practice /Intent)  
Wk 3/D3 
(17) 
PM 
Message: Sleep Position (Practice/Intention) 
Wk 3/D4 
(18) 
AM 
BF Video Title: BF/SS-Take Care  
Video URL#: 1050 
 
AM 
SS Video Title: SS- bedsharing – dangerous 
circumstances 
Video URL#: 1085 
 
PM 
-$$-Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk 3/D5 
(19) 
11-1 PM 
Message: Decide When to Feed Baby 
Wk 3/D6  
(20) 
AM 
BF Video Title: BF-Team Effort  
Video URL#: 1042 
 
AM 
SS Video Title: BF/SS-Take Care 
Video URL#: 1050 
 
PM 
Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk 3/D7  
(21) 
11-1 PM 
-$$-Message:  Soft Bedding (Practice /Intent) 
Wk 4/D1 
(22) 
AM 
BF Video Title: BF- Convenient  
Video URL#: 1029 
 
AM 
SS Video Title: SS-Advice from Others 
Video URL#: 1086 
 
PM 
Message:  Study Website 
Wk 4/D2 
(23) 
11-1 PM 
Message: Feeding Plan (Practice /Intent)  
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 59 of 64 
Gest Wks 
Int Day 
Time 
Sent 
Video title, Text Message, Survey 
Video URL# 
Wk 4/D3 
(24) 
AM 
BF Video Title: BF-Back to School/Work  
Video URL#: 1045 
 
AM 
SS Video Title: BF/SS-Postpartum 
Video URL#: 1048 
 
PM 
-$$-Message: Sleep Position (Practice/Intention) 
Wk 4/D4 
(25) 
PM 
Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk 4/D5 
(26) 
AM 
BF Video Title: BF-Breastfeeding in Public  
Video URL#: 1022 
 
AM 
SS Video Title: SS-Sleep Products 
Video URL#: 1056 
 
PM 
-$$-Message: Decide When to Feed Baby 
Wk4 /D6 
(27) 
PM 
-$$-Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk4 /D7  
(28) 
AM 
BF Video Title: BF-Late BF Stooling Pattern  
Video URL#: 1046 
 
AM 
SS Video Title: SS- Back To School/Work 
Video URL#: 1065 
 
PM 
Message:  Soft Bedding (Practice /Intent) 
Wk5 /D1 
(29) 
PM 
-$$-Message:  Falling Asleep (Practice Only) 
Wk5 /D2 
(30) 
AM 
BF Video: BF/SS-Perinatal Anxiety  
Video URL#: 1049 
 
AM 
SS Video Title: SS-Safe Baby Wearing Carriers! 
Video URL#: 1072 
 
PM 
-$$-Message: Feeding Plan (Practice /Intent)  
Wk5/D3 
(31) 
PM 
Message: Sleep Position (Practice/Intention) 
Wk5 /D4 
(32) 
AM 
BF Video Title: BF-Keeping Toddlers Occupied  
Video URL#: 1044 
 
AM 
SS Video: BF/SS-Perinatal Anxiety 
Video URL#: 1049 
 
PM 
-$$-Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk5 /D5 
(33) 
PM 
Message: Decide When to Feed Baby 
Wk5 /D6 
(34) 
PM 
Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk5/D7  
(35) 
PM 
-$$-Message:  Soft Bedding (Practice /Intent) 
Wk6 /D1 
(36) 
PM 
Message: Pacifier 
Wk6/D2 
(37) 
PM 
Message: Feeding Plan (Practice /Intent)  
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 60 of 64 
Gest Wks 
Int Day 
Time 
Sent 
Video title, Text Message, Survey 
Video URL# 
Wk6/D3 
(38) 
PM 
-$$-Message: Sleep Position (Practice/Intention) 
Wk6 /D4 
(39) 
AM 
BF Video Title: BF-Save Time & Money 
Video URL#: 1047 
 
AM 
SS Video Title: SS-Drugs & Alcohol 
Video URL#: 1060 
 
PM 
Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk6/D5 
(40) 
PM 
-$$-Message: Decide When to Feed Baby 
Wk6 /D6 
(41) 
PM 
-$$-Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk6 /D7  
(42) 
PM 
Message:  Soft Bedding (Practice /Intent) 
Wk7 /D1 
(43) 
PM 
Message:  Website 
Wk7 /D2 
(44) 
PM 
-$$-Message: Feeding Plan (Practice /Intent)  
Wk7/D3 
(45) 
PM 
Message: Sleep Position (Practice/Intention) 
Wk7 /D4 
(46) 
AM 
BF Video Title: BF-Advice From Others 
Video URL#: 1028 
 
AM 
SS Video Title: SS-Pacifier D (Not Too Late) 
Video URL#: 1087 
 
PM 
-$$-Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk7 /D5 
(47) 
PM 
Message: Decide When to Feed Baby 
Wk7 /D6 
(48) 
PM 
Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk7 /D7  
(49) 
PM 
-$$-Message:  Soft Bedding (Practice /Intent) 
Wk8 /D1 
(50) 
PM 
Message:  Falling Asleep (Practice Only) 
Wk8 /D2 
(51) 
PM 
Message: Feeding Plan (Practice /Intent)  
Wk8/ D3 
(52) 
PM 
-$$-Message: Sleep Position (Practice/Intention) 
 
 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 61 of 64 
Gest Wks 
Int Day 
Time 
Sent 
Video title, Text Message, Survey 
Video URL# 
Wk8 /D4 
(53) 
AM 
BF Video Title: BF-Support 
Video URL#: 1024 
 
AM 
SS Video Title: SS-Flat Head/Tummy Time 
Video URL#: 1069 
 
PM 
Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk8 /D5 
(54) 
PM 
Message: Pacifiers 
Wk8 /D6 
(55) 
PM 
-$$-Message: Sleep Location (Room sharing) (Practice/Intention) 
 
Wk8 /D7 
(56) 
PM 
Message:  Soft Bedding (Practice /Intent) 
Wk9 /D1 
(57) 
PM 
-$$-Message: Decide When to Feed Baby 
Wk9 /D2 
(58) 
PM 
-$$-Message: Feeding Plan (Practice /Intent)  
Wk9/ D3 
(59) 
PM 
Message: Sleep Position (Practice/Intention) 
Wk9 /D4 
(60) 
AM 
BF Video Title: BF-Pumping Work/School 
Video URL#: 1023 
 
AM 
SS Video Title: SS-Postnatal-summary-Thank you 
Video URL#: 1088 
 
PM 
Postnatal Survey 
Wk9 /D5 
(61) 
PM 
Postnatal Survey Reminder 
Wk 10/D1 
(64) 
AM 
Postnatal Survey Reminder 
Wk 11/D1 
(71) 
PM 
Message: Feeding Plan (Practice /Intent) 
 
AM 
Postnatal Survey Reminder 
Wk 11/D4 
(74) 
PM 
-$$-Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk 12/D1 
(78) 
PM 
-$$- Message: Feeding Plan (Practice /Intent) 
 
AM 
Postnatal Survey Reminder 
Wk 12/D4 
(81) 
PM 
Message: Sleep Location-Bed Sharing (Practice/Intention) 
 
 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 62 of 64 
Gest Wks 
Agile 
Timing 
Time 
Sent 
Video title, Text Message, Survey 
Wk 13/D1 
(85) 
PM 
Message: Sleep Location (Room sharing) (Practice/Intention) 
 
PM 
Postnatal Survey Reminder 
Wk 13/D4 
(88) 
PM 
-$$-Message:  Soft Bedding (Practice /Intent) 
Wk 14/D1 
(92) 
PM 
-$$-Message: Sleep Location (Room sharing) (Practice/Intention) 
 
PM 
Postnatal Survey Reminder 
Wk 14/D4 
(95) 
PM 
Message:  Soft Bedding (Practice /Intent) 
Wk 15/D1 
(99) 
PM 
-$$-Message: Sleep Position (Practice/Intention) 
Wk 15/D4 
(102) 
PM 
Message: Feeding Plan (Practice /Intent) 
Wk 16/D1 
(106) 
PM 
Message: Sleep Position (Practice/Intention) 
Wk 16/D4 
(109) 
PM 
-$$-Message: Feeding Plan (Practice /Intent) 
Wk 17/D1 
(113) 
PM 
-$$-Message: Sleep Location-Bed Sharing (Practice/Intention) 
 
PM 
Postnatal Survey Reminder 
Wk 17/D4 
(116) 
PM 
Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk 18/D1 
(120) 
PM 
Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk 18/D4 
(123) 
PM 
-$$-Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk 19/D1 
(127) 
PM 
-$$-Message:  Soft Bedding (Practice /Intent) 
Wk 19/D4 
(130) 
PM 
-$$-Message: Sleep Position (Practice/Intention) 
Wk 20/D1 
(134) 
PM 
Message:  Soft Bedding (Practice /Intent) 
Wk 20/D4 
(137) 
PM 
Message: Sleep Position (Practice/Intention) 
Wk 21/D1 
(141) 
PM 
Message: Feeding Plan (Practice /Intent) 
Wk 21/D4 
(144) 
PM 
-$$-Message: Sleep Location-Bed Sharing (Practice/Intention) 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 63 of 64 
Wk 22/D1 
(148) 
PM 
-$$-Message: Feeding Plan (Practice /Intent) 
Wk 22/D4 
(151) 
PM 
Message: Sleep Location-Bed Sharing (Practice/Intention) 
Wk 23/D1 
(155) 
PM 
Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk 23/D4 
(158) 
PM 
-$$-Message:  Soft Bedding (Practice /Intent) 
Wk 24/D1 
(162) 
PM 
-$$-Message: Sleep Location (Room sharing) (Practice/Intention) 
Wk 24/D4 
(165) 
PM 
Message:  Soft Bedding (Practice /Intent) 
Wk 25/D1 
(169) 
PM 
-$$-Message: Sleep Position (Practice/Intention) 
Wk 25/D4 
(172) 
1PM 
Message: Feeding Plan (Practice /Intent) 
Wk 26/D1 
(176) 
PM 
Message: Sleep Position (Practice/Intention) 
Wk 26/D4 
(179) 
PM 
-$$-Message: Feeding Plan (Practice /Intent) 
Wk 26/D7 
6 Months  
(182 days) 
PM 
Message -  THANK YOU Study Complete 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

SMARTER Study 
 Version 5.1 
 
5November2024 
 
Page 64 of 64 
 
 
 
 
 
 
 
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