Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women
Phase: NA
Conditions: Weight Loss, Weight, Body
Sponsor: University of Pittsburgh

Sleep GOALS (Goal-focused Online Access to 
Lifestyle Support) 
Protocol Number: SleepGOALS-01 
National Clinical Trial (NCT) Identified Number:  NCT05942326 
Principal Investigator: Marquis Hawkins, PhD 
 
Funded by: National Heart, Blood, and Lung Institute 
Version Number:  v.2 
28 August 2024 
 
 
 
Summary of Changes from the Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
Objectives and 
Endpoints 
Clarified operational definitions of 
feasibility and acceptability outcomes and 
associated benchmarks. 
To improve clarity and 
reproducibility of pilot outcomes 
without altering study objectives or 
endpoints. 
Statistical 
Considerations 
Expanded statistical analysis plan to 
include precision-based sample size 
justification and explicit definition of 
analysis populations. 
To align analytic methods with best 
practices for pilot randomized 
controlled trials. 
Study 
Intervention 
Refined description of intervention 
delivery, participant engagement tracking, 
and compliance monitoring. 
To enhance transparency of 
intervention implementation without 
changing content, dose, or duration. 
Safety Monitoring Clarified adverse event and unanticipated 
problem reporting and participant 
notification procedures. 
To ensure consistency with 
institutional and NIH guidance for 
minimal-risk behavioral trials. 
Assessments and 
Procedures 
Standardized terminology related to 
assessment timing (e.g., baseline 
 and post-intervention). 
To improve clarity and consistency 
across protocol sections. 
Multiple Sections 
Editorial and formatting updates to 
improve organization and alignment with 
NIH-FDA protocol template. 
Administrative updates only; no 
impact on study design or conduct. 
 

  
 
 
ii 
Table of Contents 
STATEMENT OF COMPLIANCE ................................................................................................ 1 
1 
PROTOCOL SUMMARY ................................................................................................... 1 
1.1 
Synopsis ....................................................................................................................... 1 
1.2 
Schema ........................................................................................................................ 2 
1.3 
Schedule of Activities (SoA) ....................................................................................... 2 
2 
INTRODUCTION ................................................................................................................ 3 
2.1 
Study Rationale ........................................................................................................... 3 
2.2 
Background ................................................................................................................. 3 
2.3 
Risk/Benefit Assessment ............................................................................................. 3 
2.3.1 
Known Potential Risks ................................................................................ 3 
2.3.2 
Known Potential Benefits ........................................................................... 4 
2.3.3 
Assessment of Potential Risks and Benefits ............................................... 4 
3 
OBJECTIVES AND ENDPOINTS ...................................................................................... 4 
4 
STUDY DESIGN ................................................................................................................. 5 
4.1 
Overall Design ............................................................................................................. 5 
4.2 
Scientific Rationale for Study Design ......................................................................... 6 
4.3 
Justification for Dose ................................................................................................... 6 
4.4 
End of Study Definition .............................................................................................. 7 
5 
STUDY POPULATION ....................................................................................................... 7 
5.1 
Inclusion Criteria ......................................................................................................... 7 
5.2 
Exclusion Criteria ........................................................................................................ 7 
5.3 
Lifestyle Considerations .............................................................................................. 7 
5.4 
Strategies for Recruitment and Retention.................................................................... 7 
6 
STUDY INTERVENTION .................................................................................................. 8 
6.1 
Study Intervention(s) Administration .......................................................................... 9 
6.1.1 
Study Intervention Description ................................................................... 9 
6.1.2 
Dosing and Administration ......................................................................... 9 
6.2 
Measures to Minimize Bias: Randomization and Blinding ......................................... 9 
6.3 
Study Intervention Compliance ................................................................................... 9 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL....................................................................................... 9 
7.1 
Discontinuation of Study Intervention ........................................................................ 9 
7.2 
Participant Discontinuation/Withdrawal from the Study .......................................... 10 
8 
STUDY ASSESSMENTS AND PROCEDURES ............................................................. 10 
8.1 
PRELIMINARY Efficacy Assessments .................................................................... 10 
8.2 
Adverse Events and Serious Adverse Events ............................................................ 10 
8.2.1 
Definition of Adverse Events (AE)........................................................... 10 
8.2.2 
Definition of Serious Adverse Events (SAE) ........................................... 10 
8.2.3 
Classification of an Adverse Event ........................................................... 11 
8.2.4 
Time Period and Frequency for Event Assessment and Follow-Up ......... 12 
8.2.5 
Adverse Event Reporting .......................................................................... 12 
8.2.6 
Serious Adverse Event Reporting ............................................................. 13 
8.2.7 
Reporting Events to Participants ............................................................... 13 
8.3 
Unanticipated Problems ............................................................................................ 14 
8.3.1 
Definition of Unanticipated Problems (UP) ............................................. 14 

  
 
 
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8.3.2 
Unanticipated Problem Reporting............................................................. 14 
8.3.3 
Reporting Unanticipated Problems to Participants ................................... 14 
9 
STATISTICAL CONSIDERATIONS ............................................................................... 15 
9.1 
Statistical Hypotheses ................................................................................................ 15 
9.2 
Sample Size Determination ....................................................................................... 15 
9.3 
Populations for Analyses ........................................................................................... 16 
9.4 
Statistical Analyses .................................................................................................... 16 
9.4.1 
General Approach ..................................................................................... 16 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) .......................................... 16 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ..... 16 
10.1.1 
Informed Consent Process ........................................................................ 16 
10.1.2 
Confidentiality and Privacy ...................................................................... 17 
10.1.3 
Protocol Deviations ................................................................................... 19 
10.1.4 
Publication and Data Sharing Policy ........................................................ 19 
10.1.5 
Conflict of Interest Policy ......................................................................... 20 
10.2 
Abbreviations ............................................................................................................ 20 
10.3 
Protocol Amendment History .................................................................................... 22 
11 
REFERENCES ................................................................................................................... 23 
 

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STATEMENT OF COMPLIANCE 
The trial will adhere to International Conference on Harmonization Good Clinical Practice (ICH GCP) 
guidelines, and all relevant state, local, and federal regulatory requirements. Investigators and clinical trial 
site staff funded by the National Institutes of Health (NIH) and responsible for conducting, managing, or 
overseeing NIH-funded clinical trials have completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent form, recruitment materials, and all participant materials were submitted 
to the University of Pittsburgh's Institutional Review Board (IRB) for review and approval. The protocol 
and consent form were approved before enrolling any participants. Any amendments to the protocol will 
be submitted to the IRB for review and approval prior to implementing the changes in the study. 
Additionally, all changes to the consent form will be reviewed and approved by the IRB; a determination 
will be made as to whether a new consent must be obtained from participants who provided consent using 
a previously approved consent form. 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Sleep GOALS (Goal-focused Online Access to Lifestyle Support) 
Study Description: 
This study will use a single-blind, parallel-arm, randomized controlled trial 
design. Participants will be randomized at a 1:1 ratio to the Sleep GOALS 
intervention or education control group. We will measure indicators of 
study feasibility and acceptability to identify and refine factors related to 
the conduct of the planned larger trial and intervention content and estimate 
the change in secondary outcomes. See Schema and Schedule of 
Activities, Sections 1.2 and 1.3, respectively.  
Objectives: 
 
Primary Objective: To determine the feasibility and acceptability of Sleep 
GOALS  
Secondary Objectives: To determine the preliminary efficacy of Sleep 
GOALS 
Endpoints: 
Primary Endpoint: The intervention’s feasibility (i.e., recruitment, 
enrollment, attrition rates, intervention engagement) and acceptability (i.e., 
participant ratings of the intervention delivery, curricula, action plans, 
intervention platform, and coaching) 
Secondary Endpoint: Weight loss and retention of pregnancy and 
postpartum weight gain 
Study Population: 
40 individuals from Allegheny County who are between 3+1 and 6+1 
postpartum, has a body mass index >25 kg/m2, self-report less than 150 
minutes of moderate-to-vigorous intensity physical activity (e.g., brisk 
walk) per week, self-report at least one sleep disturbance, and has Internet 
access. 
Phase: 
N/A 
Description of 
Sites/Facilities 
Enrolling Participants: 
Baseline and post-intervention assessments will occur at the Perinatal 
Health Behavior (PHB) Lab on the University of Pittsburgh’s campus, 100 
N Bellefield Ave, Pittsburgh, PA 15213. Post-intervention semi-structured 
interviews will take place in the PHB lab or Zoom, at the participant's 
preference. Baseline assessments will occur prior to randomization (Week 
0), and post-intervention assessments will occur immediately following 
completion of the 16-week intervention period (Week 16) 

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Description of Study 
Intervention: 
16-week online intervention that includes 1) informational videos that 
provide strategies to improve sleep, diet, and physical activity to achieve 
weight loss, 2) a lifestyle coach, 3) a commercial activity tracker (e.g., 
Fitbit Charge 5) to monitor sleep and physical activity, and 4) wireless scale 
(e.g., Aria) to monitor weight.  
Study Duration: 
The study will last 18 months from the time it opens enrollment until the 
data analysis is complete. 
Participant Duration: 
The participants will complete all study visits in 18 to 20 weeks. 
 
 
 
 
1.2 
SCHEMA 
 
Prior to  
Enrollment 
 
 
Visit 1 
Time Point 
 
 
 
 
 
 
 
 
Visit 2 
Time Point  
 
 
Visit 3 
Time Point 
 
 
 
1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
Procedures 
Screening,  
Day -7 to -1 
Enrollment/Baseline,  
Day -7 to -1 
Day 1 
Final Assessment,  
Day 112+8 
Eligibility determination 
X 
 
 
 
Informed consent 
 
X 
 
 
Randomization 
 
X 
 
 
Administer the intervention 
 
 
X-----------------------------------------------X 
Outcome Assessment 
 
 
 
 
Feasibility indicators 
 
X 
 
 
Acceptability indicators 
 
 
X-----------------------------------------------X 
Height and Weight 
X 
X 
 
X 
Descriptive characteristics 
 
 
 
 
Demographics 
X 
X 
 
 
Infant Feeding and Behavior 
 
X 
 
X 
Mental Wellness 
 
X 
 
X 
Total N=40:  Screen potential participants by inclusion and exclusion 
criteria; Obtain informed consent.  
Perform baseline assessments. 
See Section 1.3, Schedule of Activities 
Final Assessment 
see Section 1.3, Schedule of Activities> 
Follow-up assessments of study endpoints  
See Section 1.3, Schedule of Activities> 
Sleep GOALS 
N=20 
Education 
N=20 
Randomize 

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Treatment Expectations 
 
X 
 
 
Weight Goals 
 
X 
 
 
Social Support 
 
X 
 
X 
Social Determinants of Health 
 
X 
 
 
Health Behaviors 
 
 
 
 
Physical activity 
X 
X 
 
X 
Diet 
 
X 
 
X 
Sleep 
X 
X 
 
X 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
Pilot testing will help us identify and refine factors related to the conduct of the planned larger, definitive 
trial and estimate the change in secondary outcomes. 
 
2.2 
BACKGROUND  
• 
Postpartum weight retention and maternal obesity are associated with short- and long-term 
maternal morbidity and mortality risk. 
• 
The US Preventive Services Task Force recommends that clinicians offer or refer individuals 
with obesity to an intensive behavioral weight-loss intervention that addresses diet and physical 
activity 
• 
Most weight-loss interventions among postpartum individuals have followed these 
recommendations but have produced only modest effects and had substantial heterogeneity.  
• 
Sleep is independently associated with obesity and weight gain and bi-directionally associated 
with diet and physical activity. However, diet and physical activity interventions are rarely 
integrated with sleep interventions.  
• 
Integrating sleep interventions with diet and physical activity may enhance weight loss among  
postpartum individuals. 
  
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
We categorize the frequency of possible risk using the following categories: likely (occurs in >25% of 
people), common (occurs in 10-25% of people), infrequent (occurs in 1-10% of people), and rare (occurs 
in <1% of people). We will monitor the risk related to the intervention and data collection. 
Intervention-Related Risk:  
• 
The recommended physical activity may cause muscle soreness or fatigue (likely). There is the 
possibility that the following occurs during exercise: injury of a joint or muscle (common), 
broken bones (rare), falls from exercise equipment (infrequent). There is also the possibility of 
aggravating pre-existing problems (common), shortness of breath (common), abnormal blood 
pressure (common), fainting (rare), disorders of heart rhythm (rare), heart attack, stroke, or even 
death (rare). 
• 
The recommended weight loss may cause constipation (common) and dizziness upon standing 
(common). Rapid weight loss increases the chances of developing or enlarging gallstones (rare). 
Other risks include hypoglycemia (infrequent), light-headedness or weakness (common), and 
hunger (likely).  
• 
Wearing the wrist-worn activity monitor may cause some discomfort in the form of skin irritation 
(infrequent). 

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Data Collection Related Risk:  
• 
The potential risks of participating in this study include discomfort (rare) from answering 
questions, disclosure of postpartum depression or child neglect/abuse (infrequent), and breach of 
confidentiality (rare). 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
Participants enrolled in both intervention arms of the study may benefit from losing weight and learning 
strategies to improve weight-related behaviors, i.e., dietary intake, physical activity, and sleep. 
Participants enrolled in the Sleep GOALS intervention arm may benefit from having a lifestyle coach 
who can provide them with tailored information to support behavior change. Society may benefit from the 
study information because it will inform an intervention to improve maternal weight and health 
postpartum.   
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Postpartum weight retention (PWR) predicts weight gain and obesity development in women. PWR 
increases the risk of adverse maternal outcomes (e.g., preeclampsia, gestational diabetes) in subsequent 
pregnancies, additional weight gain, and long-term cardiovascular disease (CVD) development. The 
postpartum period is critical for engaging individuals in weight-loss interventions to prevent PWR and 
future CVD morbidity and mortality. Most weight-loss interventions among postpartum individuals have 
addressed diet and physical activity and have produced only modest effects. Poor sleep, common during 
the postpartum period, has rarely been addressed in standard weight loss interventions. Interventions that 
address poor sleep may enhance the efficacy of standard weight-loss interventions. The knowledge gained 
in this study will inform the refinement of a weight loss intervention for postpartum individuals that 
addresses diet, physical activity, and sleep. Iterative development of the intervention, which incorporates 
user feedback at various stages, is likely to increase the intervention's feasibility, acceptability, and 
efficacy. Participants will learn strategies for improving their sleep, diet, and physical activity and self-
select the activities that fit their circumstances. Given the minimal risks of the proposed assessments, the 
potential benefits to the individuals and society greatly outweigh the risks of conducting the proposed 
research.   
   
3 
OBJECTIVES AND ENDPOINTS 
Primary Outcomes: The primary outcomes are feasibility and acceptability factors relevant to conducting 
a subsequent efficacy trial, including the feasibility of recruitment, retention, and engagement (Table 5). 
To determine acceptability, we will ask participants to complete a modified Acceptability and Feasibility 
Questionnaire1 post-intervention. The questionnaire asks participants to provide answers on a 5-point 
scale (1=don’t agree at all to 5=totally agree) to 39 items about the intervention delivery (e.g., logical, 
understandable), curricula (e.g., was it logical, relevant, instructive), action plans (e.g., useful, easy to 
follow), and intervention platform (e.g., user friendly). We will also ask about the coaches' effectiveness, 
overall satisfaction with the intervention, and the likelihood they would recommend it to a friend. Items 
with an average score of <4 will be flagged for refinement. 
We will then conduct 60-minute semi-structured interviews with participants and coaches. The interviews 
will take place in person (PHB lab) or by video chat at the participant's preference. We will ask 
participants whether the content was understandable, the recommendations achievable, and what 
adaptations are necessary to improve low-scoring items. We will ask the lifestyle coach to discuss their 
experience and provide suggestions for improving the delivery of the material and their workflow. All 
interviews will be audio-recorded and transcribed by Qual EASE for qualitative analysis. The feedback 
will be used to refine the intervention’s content delivery, coach’s workflow, and training manual. 
Participants will receive $50 after each assessments and intervention participants will receive a $25 
honorarium for completing the post-intervention interview. 

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Secondary Outcomes: Weight will be measured with a digital scale, with the participant wearing light 
clothing and no shoes at baseline and post-intervention. We will estimate PWR as the difference in 
measured weight at post-intervention and self-reported pre-pregnancy weight.  
Analysis Plan: The primary study objective is to assess the feasibility and acceptability of Sleep GOALS. 
We will assess the feasibility of the intervention by estimating rates of recruitment, retention, and 
engagement (i.e., weekly logins; modules completed; daily self-monitoring of diet, physical activity, and 
sleep; weekly monitoring of weight using point estimates (means or sample proportions) and 95% 
confidence intervals). We will assess acceptability by estimating satisfaction rates on various intervention 
components (>4 Acceptability and Feasibility Questionnaire). Our benchmarks for feasibility are similar 
to those used in the original GOALS Lifestyle intervention. We will use a benchmark of 80% for all 
feasibility and acceptability measures. To assess the intervention's preliminary efficacy, we will calculate 
point estimates and confidence intervals for change in weight and PWR. We chose these weight measures 
as our secondary outcomes since they will be the primary outcome in the future R01. However, we will 
also explore changes in our proposed behavioral mediators, sleep, diet, and physical activity to inform 
power calculations for a fully powered study.  
We will conduct an exploratory analysis to determine how potential covariates (e.g., parity, breastfeeding 
status, postpartum depression, race/ethnicity, relationship status, and employment status) impact the 
intervention’s feasibility, acceptability, and preliminary efficacy. For example, in some studies, 
breastfeeding is associated with longer nocturnal sleep 2-4, but shorter nocturnal sleep in other studies.5 
Collecting data on breastfeeding and other covariates will provide preliminary data on how it impacts the 
intervention. 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
This study will use a single-blind, parallel-arm RCT design. Participants will be randomized at a 1:1 ratio 
to Sleep GOALS intervention (n=20) or an education control group (n=20). 
Domain 
Measure, Method of Assessment 
Benchmarks for Success 
Feasibility (Primary Outcome) 
Recruitment/Enrollment 
Total sample 
40 participants in 12 months 
Demographics of sample 
≥30% ethnic minority 
Retention 
Attrition Rates  
≤20% loss to follow-up 
Engagement 
Modules completed 
≥14 (~80%) modules completed within 
16 weeks 
Weekly self-monitoring of diet, sleep, and physical activity 
weekly 
≥14 (~80%) weeks, >1 day of monitoring 
Weekly weigh-ins 
≥14 (~80%) weeks, >1 day of weigh-ins 
Total time logged in 
  
Acceptability (Primary Outcome) 
Acceptability 
Acceptability of the intervention delivery; behavior change 
curricula; action plan; intervention platform 
>80% agree or totally agree with each 
Preliminary efficacy (Secondary Outcome)  
Weight 
Weight change 
>5% weight loss 
Postpartum weight retention 
<5 kg of weight retention 
The primary endpoints will inform factors related to the conduct of the study (i.e., feasibility) and the intervention content and delivery (i.e., 
acceptability) of the planned larger definitive efficacy trial. The secondary outcomes will provide estimates of the intervention’s effects on the 
primary outcome of the planned larger definitive efficacy trial 

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Sleep GOALS: We anticipate Sleep GOALS will be a 16-week intervention. However, the results of 
Aim 1 will determine the intervention length and core content. We will use a protocol Dr. McTigue and 
colleagues developed to adapt TSC to an online format and integrate it with the GOALS lifestyle 
intervention.6, 7 Briefly, in-person delivery of TSC has 3 components: 1) delivery of the core content, 2) 
providing tailored feedback, and 3) providing motivation and support. We will adapt the first component 
to an online format with 15-to-20-minute informational videos. The participants will view the material at 
their convenience, with new videos available weekly. The GOALS software will send weekly automated 
email reminders to review the new session materials. We will use a lifestyle coach to adapt the 2nd and 3rd 
components. Evaluating patient perspectives on the original GOALS lifestyle intervention found 
individualized lifestyle coaching, encouragement, and accountability helpful.8 The coach will be a 
master’s level student in a health-related program (e.g., physical activity and health promotion, nutrition 
and dietetics, etc.) with experience in weight-management counseling. As described in Aim 1, the coach 
will assist with developing Sleep GOALS to familiarize them with the intervention content. However, the 
coach will complete a 2-day training workshop using a similar training format as the GOALS Lifestyle 
intervention.7 The coach will help participants develop an individualized sleep treatment plan based on 
their baseline sleep assessment. For example, coaches will encourage participants to document challenges 
for sleep (e.g., infant sleep, lack of partner support) and identify one treatment strategy they deem feasible 
to implement each week. The coach will monitor participant progress and engagement weekly to revise 
the sleep treatment plan, diet, and activity as needed. Coaches will provide personalized feedback and 
encourage accountability and re-engagement through a secure messaging system in the Sleep GOALS 
platform.7 The PI will randomly check coach-participant communication weekly to ensure intervention 
fidelity. IF NECESSARY, the PI will meet with the coaches weekly to discuss challenges and participant 
communication. Lastly, participants will be given a wireless scale for self-monitoring weight and a Fitbit 
for self-monitoring sleep (daily minutes) and physical activity (daily steps, minutes). The Fitbit dashboard 
also allows participants to track dietary calories. Participants will receive instructions on how to sync the 
scale and Fitbit data with the Sleep GOALS platform. Participants will be asked to weigh themselves in 
light clothing at least once weekly.9  
Education Control: We used the Pragmatical Model for Comparator Selection in health-related behavioral 
trials to guide our control group selection.10 This model suggests utilizing a control group that is not likely 
to produce a change in the outcome for early-stage intervention development. We considered a no-
treatment comparator and wait-list control. Given the timeline and limited resources, we decided a wait-
list control is not feasible. We chose an education control because we decided the control should have 
some value to participants. Therefore, the control group will receive brochures from the American 
Academy of Sleep Medicine (e.g., sleep hygiene, sleep in women) and SNAP education connection (e.g., 
family-friendly activities, meal planning) after randomization is revealed.  
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Pilot testing will help us identify and refine factors related to the conduct of the planned larger, definitive 
trial and estimate the change in secondary outcomes. Given the timeline and limited resources, we 
decided a wait-list control is not feasible. We chose an education control because we decided the control 
should have some value to participants. Therefore, the control group will receive brochures with strategies 
to sleep better, eat healthily, be physically active, and lose weight.  
 
4.3 
JUSTIFICATION FOR DOSE 
Over the 16-week intervention, participants will have access to 16 (~20-minute) information videos, made 
available weekly. The intervention content will be delivered via a secure online platform. Participants can 
access the intervention content at their convenience, which increases the intervention’s feasibility for 
postpartum people with small children. The intervention 16-week are similar in dose to other weight loss 
interventions.  
 

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4.4 
END OF STUDY DEFINITION 
End of study is defined as completion of post-intervention assessments, which occur immediately 
following the 16-week intervention period (Week 16). 
 
5 
STUDY POPULATION 
We will enroll 40 primiparous adult individuals between 3+1 and 6+1 months postpartum with a body 
mass index >25 kg/m2. We chose this postpartum range because postpartum weight retention during this 
period is associated with the development of long-term obesity. Additionally, at 3 months postpartum, 
most infants experience rapid increases in nocturnal sleep; thus, many of our behavioral strategies for 
improving maternal sleep may be more feasible. Evidence suggests that addressing sleep in infants 
between 3 and 6 months can prevent longer-lasting sleep problems. Lastly, it is safe for most postpartum 
individuals to participate in an intervention involving physical activity during this period.  
 
5.1 
INCLUSION CRITERIA 
 
To be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Provision of signed and dated informed consent form, 
2. Stated willingness to comply with all study procedures and availability for the duration of the 
study,  
3. Primiparous, singleton pregnancy, 
4. Between 3+1 and 6+1 months postpartum, 
5. Has a body mass index >25 kg/m2, 
6. Physically inactive, defined as self-reporting <150 minutes/week of moderate-to-vigorous 
intensity physical activity, 
7. Endorse >1 indicator of poor sleep health based on the RU_SATED questionnaire, and 
8. Has smartphone and home Internet access 
 
5.2 
EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. current use of medications that affect weight (see Appendix 1), 
2. currently pregnant or plan to become pregnant during the study period (18 weeks), and 
3. participating in another weight loss intervention. 
 
5.3 
LIFESTYLE CONSIDERATIONS 
This study does not have any lifestyle restrictions.  
 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Recruitment Strategies 
All subjects will be recruited from Allegheny County using participant registries maintained by Pitt's 
Institute for Clinical and Translation Research (i.e., Pitt+Me, Pediatric PittNet, Women's Practice-Based 
Research Network). The respective registries will identify participants through: 
• 
Postings in practice waiting rooms 
• 
Personalizing mailing and emails about the study to women that meet eligibility criteria based 
upon ICD-9/10 diagnosis codes listed in their medical record (e.g., recent delivery), 
demographics (e.g., women aged at least 18 years) 
• 
Personalizing mailing and emails based on stated preferences (e.g., interest in weight loss 
interventions) 

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• 
A custom study web page that provides a lay description of the study, the eligibility criteria, 
compensation, and study team biographies 
• 
Facilitating collaborations between study staff and practicing physicians, including practices that 
serve a diverse sample of women 
• 
Advertisements on Facebook and Twitter 
Interested participants will be pre-screened for eligibility online or through a registry call center. Referrals 
to contact potentially eligible subjects will be delivered through an online portal. 
A research assistant will call women who agreed to be contacted to discuss the study purpose, procedures, 
risks, and benefits, screen for eligibility, and obtain verbal consent. Participants will be enrolled in the 
study once we obtain consent.  
Retention Strategies: 
 
The lifestyle coach will implement several strategies to increase engagement with the intervention 
protocol and re-engage participants who have not engaged with the online platform for two consecutive 
weeks. These strategies include: 
 
• 
Personalized reminders: Send friendly messages through the GOALS platform to participants 
who haven't logged in for two weeks. Personalize the reminders by addressing the participant by 
name and mentioning specific content they have missed or need to catch up on. 
• 
Motivational messages: Send motivational messages that highlight the benefits of the intervention 
and remind them of their goals and reasons for participating in the study. 
• 
Check-in calls: Reach out to the participant by phone to check in on their progress, address any 
barriers, and offer support. This personal connection can help re-engage participants and reinforce 
the importance of their involvement in the study. 
• 
Address technical issues: Some participants may be disengaged due to technical problems with 
the platform. Reach out to them to identify any issues they may be facing and provide assistance 
to resolve these problems. 
• 
Reinforce incentives: Remind participants of any incentives associated with study participation, 
such as financial rewards, access to additional resources, or entry into prize drawings. This can 
help motivate them to re-engage with the platform. 
• 
Monitor participant progress: Keep track of each participant's progress and send personalized 
feedback, praise, or encouragement based on their achievements. This can help maintain 
motivation and create a sense of accountability. 
• 
Revisit participant goals: Encourage participants to re-evaluate their weight loss and lifestyle 
goals and discuss any necessary adjustments with their lifestyle coach. This can help maintain 
motivation and ensure the intervention remains relevant to the participant's needs. 
 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
Sleep GOALS is a 16-week online lifestyle intervention integrating content on sleep, diet, and physical 
activity, supported by coaching. For the purposes of this trial and registry reporting, intervention duration 
is defined as 16 weeks for all participants. The Sleep GOALS intervention will include the following 
components: 

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• 
16 (~20 minutes) informational videos that provide strategies to improve sleep, diet, physical 
activity, and weight, delivered weekly through an online platform 
• 
Lifestyle coach to provide personalized feedback, encouragement, motivation, and accountability 
• 
A commercial activity tracker (e.g., Fitbit) to monitor sleep, diet, and physical activity 
• 
Wireless scale to track weight 
6.1.2 DOSING AND ADMINISTRATION 
The participants will view the informational videos at their convenience, with new videos available 
weekly. The GOALS software will send participants weekly email reminders to review the new session 
material and to track relevant behaviors (e.g., physical activity, sleep). 
 
6.2 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
We will use REDCap to generate the randomization plan. We will use blocked randomization (blocks of 
4) to ensure balanced intervention groups. The randomization plan results will be maintained in REDCap 
and only accessible by a lifestyle coach who will support participants in the intervention arm (further 
detailed below) but is not directly involved with data collection. Assignment allocation will be concealed 
from participants until after the baseline assessments. Investigators will remain blinded until post-
intervention data collection is complete. 
 
6.3 
STUDY INTERVENTION COMPLIANCE 
 
The GOALS platform contains built-in software to track compliance with intervention protocols. 
Specifically, the platform tracks the number of times they’ve logged into the system, the time spent in the 
system, the number of lessons viewed, workbook pages completed, self-monitoring, and communication 
with the lifestyle coach. The lifestyle coach will be instructed to reach out to participants if they have not 
logged into the system for two consecutive weeks to query challenges and provide encouragement to re-
engage.  
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION/WITHDRAWAL FROM THE STUDY INTERVENTION 
Participants may withdraw voluntarily from the study at any time by submitting a formal request to the 
study PI. We will still use data collected before the voluntary withdrawal. The PI may discontinue a study 
participant if there are changes to their eligibility status, including becoming pregnant or using 
medications that affect weight. Any new clinically relevant finding will be reported as an adverse event 
(AE). 
 
The data to be collected at the time of study intervention discontinuation will include the following: 
• 
Reasons for discontinuation 
• 
Timing of discontinuation 
• 
Adverse event details (if applicable) 
• 
Follow-up data (if applicable) 
• 
Documentation on each participant's last available data point(s), including sleep health, diet, 
physical activity measurements, weight, and any other relevant outcome measures 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 

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An investigator may discontinue or withdraw a participant from the study for the following reasons: 
 
• 
Pregnancy 
• 
If any clinical adverse event (AE) or other medical condition or situation occurs such that 
continued participation in the study would not be in the best interest of the participant 
• 
If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
The reason for participant discontinuation or withdrawal from the study will be recorded on the study 
discontinuation form. Subjects who sign the informed consent form and are randomized but do not 
receive the study intervention may be replaced.  Subjects who sign the informed consent form, are 
randomized and receive the study intervention, and subsequently withdraw, or are withdrawn or 
discontinued from the study not be replaced. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
PRELIMINARY EFFICACY AND COVARIATE ASSESSMENTS  
 
Assessments will be conducted at baseline (Week 0) prior to randomization and immediately 
after completion of the intervention (Week 16). Assessments will be conducted by a research 
team member in the PHB lab. Assessments should take 1-2 hours to complete. Participants will 
receive pre-visit instructions 3 days before their scheduled in-person visits. Assessments will 
consist of the following: 
 
• 
Height, weight & waist circumference: Height will be measured with a stadiometer at 
study enrollment (T0). Weight will be measured using a calibrated digital scale. Women 
will be measured in street clothes without shoes. 
• 
Demographic information: Age, race, ethnicity, income, educational background, 
employment status, health insurance status, marital status, family composition (e.g., 
number of adults and children in the household), smoking status, and current alcohol use. 
• 
Mental wellness: Participants will complete the Edinburgh Postnatal Depression Scale to 
measure the frequency of depressive symptoms. The Perceived Stress Scale will be used 
to measure perceived stress. 
• 
Infant sleep and eating. The Brief Infant Sleep Questionnaire - Revised (BISQ) Short 
Form will be used to assess infant sleep patterns. The infant feeding questionnaire to 
assessing infant eating patterns. 
• 
Social determinants of health: The Barkin Index of Maternal Functioning (BIMF) is a 20-
item self-report measure that was designed to assess overall functioning in the context of 
new motherhood. The EveryONE project social determinants of health screener to 
identify the social needs of participants.  
• 
Social support: The RAND social support survey helps identify the types of support 
available to participants. 
• 
Diet: The study will utilize the Automated Self-Administered 24-hour (ASA24) Dietary 
Recall System to collect information about what participants ate in the prior 24hours 
• 
Physical activity and sleep: Following the in-person visit, we will give participants an 
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days to assess their physical activity and sleep patterns. The Actigraph will be used solely 
for the purposes of physical activity and sleep measurement. This study will not test the 
efficacy of the device. During the 7 day assessment period, participants will complete a 
sleep diary to help us better interpret the monitor data. After the 7 day assessment, 
participants will mail the Actigraph and diary back to us in a pre-paid postage envelope. 
Participants will also complete a modified SASS-Y and PAQ questionnaires. 
   
8.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
8.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
 
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions. Important medical 
events that may not result in death, be life-threatening, or require hospitalization may be considered 
serious when, based on appropriate medical judgment, they may jeopardize the participant and require 
medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an 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. 
 
8.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
8.2.3.1 SEVERITY OF EVENT 
 
The following guidelines will be used to describe the severity of adverse events (AEs) not included in the 
protocol-defined grading system.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in low inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.  
Of note, the term “severe” does not necessarily equate to “serious.” 
 
8.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the PI, who 
examines and evaluates the participant based on temporal relationship and their judgment. The degree of 
certainty about causality will be graded using the categories below. In a clinical trial, the study product 
must always be suspect.  
 

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• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
8.2.3.3 EXPECTEDNESS  
 
The principal investigator will determine whether an adverse event (AE) is expected or unexpected.  An 
AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the study intervention. 
8.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-
UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits, community with the lifestyle coach during the intervention, and 
interviews. We will record all reportable events with start dates occurring any time after informed consent 
is obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation. We will assess and document AEs and SAEs at each study visits, inquiring about the 
occurrence of AEs and SAEs since the last visit, with a focus on any issues related to sleep, diet, physical 
activity, or weight loss. We will follow up on all events for outcome information until resolution or 
stabilization. 
 
8.2.5 ADVERSE EVENT REPORTING  
 
The investigator must record nonserious adverse events and report them to the sponsor within 24-hours of 
the PI learning about the event.  
 
8.2.6 SERIOUS ADVERSE EVENT REPORTING  
The PI will immediately report to the sponsor any serious adverse event, whether or not considered study 
intervention related, including those listed in the protocol, and must include an assessment of whether 
there is a reasonable possibility that the study intervention caused the event. Study endpoints that are 
serious adverse events (e.g., all-cause mortality) must be reported in accordance with the protocol unless 
there is evidence suggesting a causal relationship between the study intervention and the event. In that 
case, the investigator must immediately report the event to the sponsor. 
 
All serious adverse events (SAEs) will be followed until satisfactory resolution or until the site 
investigator deems the event to be chronic or the participant is stable. Other supporting documentation of 
the event may be requested by the study sponsor and should be provided as soon as possible. 
 
 
8.2.7 REPORTING EVENTS TO PARTICIPANTS  
We will inform participants of adverse events (AEs) that are related to the safety and welfare of the 
participants. To inform participants, we will take the following steps: 
 

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1. Assess the relevance and impact of the AE: Evaluate the AE to determine whether it has any 
direct implications for the participants' safety, welfare, or rights. If the AE is deemed relevant and 
important to the participants, proceed with informing them. 
2. Update the informed consent document: If the AE warrants a change to the study protocol, 
intervention, or the risks and benefits associated with participation, revise the informed consent 
document accordingly. Any changes must be approved by the Institutional Review Board (IRB) 
before sharing the updated document with participants. 
3. Prepare clear and concise communication: Develop a written or verbal communication that 
clearly explains the nature of the AE, its potential impact on participants, and any changes to the 
study protocol, procedures, or risks. Use plain language that is easily understood by the target 
audience and avoid jargon or technical terms. 
4. Choose an appropriate communication method: Depending on the nature and urgency of the AE, 
select an appropriate method to inform participants. This could include individual meetings, 
phone calls, emails, or letters. In some cases, a combination of methods may be necessary to 
ensure all participants are informed promptly. 
5. Provide an opportunity for questions and discussion: Allow participants the opportunity to ask 
questions, discuss their concerns, and seek clarification about the UP and its implications. This 
can be done during individual meetings, phone calls, or through written correspondence (e.g., 
email). 
6. Re-obtain informed consent, if necessary: If the AE has led to significant changes in the study 
protocol or risks, you may need to re-obtain informed consent from participants. Provide them 
with the updated, informed consent document, discuss the changes, and obtain their signature if 
they agree to continue participating in the study. 
7. Document the process: Keep a record of the steps taken to inform participants about the AE, 
including the date of communication, the method used, and any feedback or concerns raised by 
the participants. This documentation will be important for monitoring purposes and to 
demonstrate compliance with ethical guidelines and regulations. 
 
8.3 
UNANTICIPATED PROBLEMS 
 
8.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
participants or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
 
8.3.2  UNANTICIPATED PROBLEM REPORTING  
 

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The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and principal investigator (PI). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents a UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
UPs will be reported using the following timeline to satisfy the requirement for prompt reporting:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and study sponsor within 
48 hours of the investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB and sponsor within 5 business days of the investigator 
becoming aware of the problem.  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within 5 business days of the IRB’s receipt of the report of 
the problem from the investigator.] 
 
8.3.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
We will inform participants of unanticipated problems (UPs) that are related to the safety and welfare of 
the participants. To inform participants, we will take the following steps: 
 
1. Assess the relevance and impact of the UP: Evaluate the UP to determine whether it has any 
direct implications for the participants' safety, welfare, or rights. If the UP is deemed relevant and 
important to the participants, proceed with informing them. 
2. Update the informed consent document: If the UP warrants a change to the study protocol, 
intervention, or the risks and benefits associated with participation, revise the informed consent 
document accordingly. Any changes must be approved by the Institutional Review Board (IRB) 
before sharing the updated document with participants. 
3. Prepare clear and concise communication: Develop a written or verbal communication that 
clearly explains the nature of the UP, its potential impact on participants, and any changes to the 
study protocol, procedures, or risks. Use plain language that is easily understood by the target 
audience and avoid jargon or technical terms. 
4. Choose an appropriate communication method: Depending on the nature and urgency of the UP, 
select an appropriate method to inform participants. This could include individual meetings, 
phone calls, emails, or letters. In some cases, a combination of methods may be necessary to 
ensure all participants are informed promptly. 
5. Provide an opportunity for questions and discussion: Allow participants the opportunity to ask 
questions, discuss their concerns, and seek clarification about the UP and its implications. This 
can be done during individual meetings, phone calls, or through written correspondence (e.g., 
email). 
6. Re-obtain informed consent, if necessary: If the UP has led to significant changes in the study 
protocol or risks, you may need to re-obtain informed consent from participants. Provide them 
with the updated, informed consent document, discuss the changes, and obtain their signature if 
they agree to continue participating in the study. 

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7. Document the process: Keep a record of the steps taken to inform participants about the UP, 
including the date of communication, the method used, and any feedback or concerns raised by 
the participants. This documentation will be important for monitoring purposes and to 
demonstrate compliance with ethical guidelines and regulations. 
 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 
The aim of this study is to assess the feasibility and acceptability of the sleep GOALS intervention to 
identify the necessary adaptations for a larger efficacy/implantation study. We will not perform formal 
hypothesis testing.  
 
9.2 
SAMPLE SIZE DETERMINATION 
The primary aim of the pilot RCT is to obtain estimates of feasibility and acceptability to guide the 
planning of a larger efficacy trial and finalize the intervention’s content and delivery. With a sample size 
of 40 (20 in each group), we will have the ability to estimate 95% confidence intervals with acceptable 
precision (i.e., confidence interval width) of 0.31 for all feasibility and acceptability benchmarks for the 
entire sample and 0.44 for within-group estimates. As an exploratory aim, we will obtain estimates of 
variability for the change in diet, physical activity, sleep, and weight to guide sample size calculations for 
the larger trial. 
 
9.3 
POPULATIONS FOR ANALYSES 
For primary outcomes related to feasibility, we will include all randomized participants. For primary 
outcomes related to intervention acceptability, we will include all participants randomized to the Sleep 
GOALS intervention. For secondary outcomes, we will include all randomized participants (i.e., 
intention-to-treat) 
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
We will use descriptive statistics for primary and secondary outcomes.   
 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
The primary endpoints are the feasibility and acceptability of Sleep GOALS. We will assess the 
feasibility of the intervention by estimating rates of recruitment, retention, and engagement (i.e., weekly 
logins; modules completed; daily self-monitoring of diet, physical activity, and sleep; weekly monitoring 
of weight using point estimates (means or sample proportions) and 95% confidence intervals). We will 
assess acceptability by estimating rates of satisfaction on various components of the intervention (>4 
Acceptability and Feasibility Questionnaire). Our benchmarks for feasibility are similar to those used in 
the original GOALS Lifestyle intervention. We will use a benchmark of 80% for all feasibility and 
acceptability measures. To assess the intervention's preliminary efficacy, we will calculate point estimates 
and confidence intervals for change in weight and PWR. We chose these weight measures as our 
secondary outcomes since they will be the primary outcome in the future R01. However, we will also 
explore changes in our proposed behavioral mediators, sleep, diet, and physical activity to inform power 
calculations for a fully powered study.  
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status, postpartum depression, race/ethnicity, relationship status, and employment status) impact the 
intervention’s feasibility, acceptability, and preliminary efficacy. For example, in some studies, 
breastfeeding is associated with longer nocturnal sleep, but shorter nocturnal sleep in other studies. 
Collecting data on breastfeeding and other covariates will provide preliminary data on how it impacts the 
intervention. 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
Informed consent will be obtained during an in-person meeting in the PHB label. Informed consent will 
be obtained before baseline assessments.  
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED 
TO PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant, and written documentation of informed consent is required prior to starting 
intervention/administering the study intervention.   
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Consent forms will be Institutional Review 
Board (IRB)-approved and the participant will be asked to read and review the document. The 
investigator will explain the research study to the participant and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the participant’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants.  Participants will 
have the opportunity to carefully review the written consent form and ask questions prior to signing. The 
participants should have the opportunity to discuss the study with their family or surrogates or think about 
it prior to agreeing to participate. The participant will sign the informed consent document prior to any 
procedures being done specifically for the study. Participants must be informed that participation is 
voluntary and that they may withdraw from the study at any time without prejudice. A copy of the 
informed consent document will be given to the participants for their records. The informed consent 
process will be conducted and documented in the source document (including the date), and the form will 
be signed before the participant undergoes any study-specific procedures. The rights and welfare of the 
participants will be protected by emphasizing to them that the quality of their medical care will not be 
adversely affected if they decline to participate in this study. 
 
 
 
10.1.2 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
and the sponsor(s) and their interventions. This confidentiality is extended to cover baseline and post-
intervention assessments. Therefore, the study protocol, documentation, data, and all other information 
generated will be held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without the prior written approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor, and representatives of the Institutional 
Review Board (IRB) may inspect all documents and records required to be maintained by the investigator. 
 

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The study participant’s contact information will be securely stored on REDCap for internal use during the 
study. At the end of the study, all records will continue to be kept in on REDCap for as long a period as 
dictated by the reviewing IRB, Institutional policies, or sponsor requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be stored on REDCap. This will not include the participant’s contact or identifying information. Rather, 
individual participants and their research data will be identified by a unique study identification number. 
The study data entry and study management systems used by research staff will be secured and password 
protected.  
 
10.1.2.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
1. Data Collection Responsibilities 
a. Study Personnel: The research assistant or project coordinator will be involved in data 
collection under the supervision of the principal investigator. 
b. Training: The principal investigator will ensure all study personnel involved in data 
collection receive appropriate training on the study protocol, data collection instruments, 
data entry procedures, and ethical considerations (e.g., informed consent, confidentiality). 
c. Data Collection Instruments: Data collection will include physical measurements (i.e., 
measured height and weight), surveys and questionnaires, and semi-structured interviews. 
We selected previously validated interviewer-administered questionnaires relevant to the 
study objectives.  
d. Data Collection Procedures: Study data will be collected before randomization and post-
intervention by a study team member. The study team member will provide participants a 
QR code or HTML link to the self-reported surveys, which can be completed on the study 
computer or the participant's mobile device, at their preference.  
e. Quality Control: Implement quality control measures to ensure the accuracy, 
completeness, and consistency of data collection, such as periodic checks, data audits, or 
inter-rater reliability assessments. 
2. Data Management Responsibilities 
a. Data Entry: The project coordinator developed the REDCap database that will be used for 
data entry. Describe the procedures for entering data into the study database, including 
any software or platforms used, data entry formats, and procedures for verifying the 
accuracy of data entry. 
b. Data Storage: Study data will be stored on REDCap, an encrypted, secure server 
maintained by the University of Pittsburgh. Hard copies, if any, will be stored in a locked 
filing cabinet located in the PI’s university office, accessible only by authorized study 
team members.  
c. Data Access: Only study team members will have full access to the study data. We will 
adhere to NIH’s policy on dissemination of NIH-funded clinical trial information by 
taking the following steps: 
i. Registering the trial with ClinicalTrials.gov within 21 calendar days of 
enrollment of the first participant  

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ii. Submitting trial results to ClinicalTrials.gov no later than one year following the 
completion date of the study  
iii. Include a statement in our informed consent document that explains that this 
clinical trial is registered with ClinicialTrials.gov and that the results of the study 
(not including any identifying information) will be reported in accordance with 
the NIH dissemination policy for clinical trials 
iv. Working with the University of Pittsburgh's Office for ClinicalTrials.gov to 
ensure that all requirements within the policy are adhered to in a timely fashion 
v. Create a newsletter to share findings with our study participants 
vi. Submit abstracts to national scientific conferences and submit manuscripts for 
publication 
vii. Will make de-identifiable study data available to researchers upon request after 
primary outcome manuscripts are published. 
d. Data Monitoring: The PI will review data quality bi-monthly and ensure that there are no 
unexpected trends or safety issues. 
e. Data Cleaning and Validation: Data will undergo range checks for each variable, logical 
consistency checks, and manual outlier detection. Discrepancies will be resolved by 
referring back to the original data source. 
f. Data Analysis: See section 9.4 for details on the statistical analysis plan.  
g. Data Retention and Destruction: Study data will be retained for a period of 7 years post-
study completion, as per institutional guidelines. Following this period, hard copies will 
be shredded. 
 
10.1.2.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Conference on Harminosation (ICH) region and until there are no pending 
or contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform 
the investigator when these documents no longer need to be retained. 
 
10.1.3 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 

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It is the responsibility of the PI to use continuous vigilance to identify and report deviations within five 
working days of identification of the protocol deviation or within five working days of the scheduled 
protocol-required activity.  All deviations must be addressed in study source documents and reported to 
NIH.  Protocol deviations must be sent to the reviewing Institutional Review Board (IRB) per their 
policies. The site investigator is responsible for knowing and adhering to the reviewing IRB requirements. 
Further details about handling protocol deviations will be included in the MOP. 
 
10.1.4 PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data-sharing policies and 
regulations: 
 
The National Institutes of Health (NIH) Public Access Policy ensures that the public has access to the 
published results of NIH-funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-
Funded Clinical Trial Information and the Clinical Trials Registration and Results Information 
Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from 
this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results 
in peer-reviewed journals.  Data from this study may be requested from other researchers two years after 
the completion of the primary endpoint by contacting the PI, Dr. Marquis Hawkins.  
 
 
10.1.5 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical.  Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest 
will be required to have such conflicts managed in a way that is appropriate to their participation in the 
design and conduct of this trial.  
 
10.2 ABBREVIATIONS 
The list below includes abbreviations utilized in this template.  However, this list should be customized 
for each protocol (i.e., abbreviations not used should be removed, and new abbreviations used should be 
added to this list). 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 

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GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.3 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
 
Protocol 
Version 
Date 
Description of Change 
Brief Rationale 
2 
28 
August 
2024 
Clarified and expanded descriptions of 
feasibility and acceptability outcomes, 
including operational definitions and 
benchmarks for engagement, recruitment, 
retention, and satisfaction. 
To improve transparency and 
reproducibility of pilot feasibility 
outcomes without altering study 
objectives or endpoints. 
2 
28 
August 
2024 
Expanded statistical considerations to 
include precision-based justification for 
sample size and explicit definition of 
analysis populations (feasibility, 
acceptability, intention-to-treat). 
To align the statistical analysis 
plan with best practices for pilot 
randomized controlled trials and 
clarify analytic intent. 
2 
28 
August 
2024 
Refined description of intervention 
delivery, compliance monitoring, and 
participant engagement tracking. 
To provide greater clarity on 
intervention implementation 
while maintaining identical 
intervention content, dose, and 
duration. 
2 
28 
August 
2024 
Clarified adverse event and unanticipated 
problem reporting procedures and 
participant notification processes. 
To improve consistency with 
institutional and NIH guidance 
for minimal-risk behavioral trials. 
2 
28 
August 
2024 
Standardized terminology related to 
assessment timing (e.g., baseline and post-
intervention assessments). 
To enhance clarity and 
consistency across protocol 
sections without changing study 
procedures or participant burden. 
2 
28 
August 
2024 
Editorial updates, reorganization of 
sections, and formatting revisions to align 
with NIH-FDA protocol template. 
Administrative updates only; no 
impact on study design, 
outcomes, or conduct. 
 
 

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11 REFERENCES  
 
1. 
Vandelanotte C, De Bourdeaudhuij I. Acceptability and feasibility of a computer-tailored 
physical activity intervention using stages of change: project FAITH. Health Educ Res. 2003;18(3):304-
17. Epub 2003/06/28. doi: 10.1093/her/cyf027. PubMed PMID: 12828232. 
2. 
Doan T, Gardiner A, Gay CL, Lee KA. Breast-feeding increases sleep duration of new parents. J 
Perinat Neonatal Nurs. 2007;21(3):200-6. Epub 2007/08/19. doi: 10.1097/01.JPN.0000285809.36398.1b. 
PubMed PMID: 17700096. 
3. 
Doan T, Gay CL, Kennedy HP, Newman J, Lee KA. Nighttime breastfeeding behavior is 
associated with more nocturnal sleep among first-time mothers at one month postpartum. J Clin Sleep 
Med. 2014;10(3):313-9. Epub 2014/03/19. doi: 10.5664/jcsm.3538. PubMed PMID: 24634630; PMCID: 
PMC3927438. 
4. 
Blyton DM, Sullivan CE, Edwards N. Lactation is associated with an increase in slow-wave sleep 
in women. J Sleep Res. 2002;11(4):297-303. Epub 2002/12/05. doi: 10.1046/j.1365-2869.2002.00315.x. 
PubMed PMID: 12464097. 
5. 
Spaeth AM, Khetarpal R, Yu D, Pien GW, Herring SJ. Determinants of postpartum sleep duration 
and sleep efficiency in minority women. Sleep. 2020. Epub 2020/11/22. doi: 10.1093/sleep/zsaa246. 
PubMed PMID: 33220056. 
6. 
McTigue KM, Conroy MB, Hess R, Bryce CL, Fiorillo AB, Fischer GS, Milas NC, Simkin-
Silverman LR. Using the internet to translate an evidence-based lifestyle intervention into practice. 
Telemed J E Health. 2009;15(9):851-8. Epub 2009/11/19. doi: 10.1089/tmj.2009.0036. PubMed PMID: 
19919191. 
7. 
Simkin-Silverman LR, Conroy MB, Bhargava T, McTigue KM. Development of an online 
diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Diabetes 
Educ. 2011;37(2):263-8. Epub 2011/03/23. doi: 10.1177/0145721710396587. PubMed PMID: 21421991. 
8. 
Lyden JR, Zickmund SL, Bhargava TD, Bryce CL, Conroy MB, Fischer GS, Hess R, Simkin-
Silverman LR, McTigue KM. Implementing health information technology in a patient-centered manner: 
patient experiences with an online evidence-based lifestyle intervention. J Healthc Qual. 2013;35(5):47-
57. Epub 2013/09/06. doi: 10.1111/jhq.12026. PubMed PMID: 24004039. 
9. 
Madigan CD, Daley AJ, Lewis AL, Aveyard P, Jolly K. Is self-weighing an effective tool for 
weight loss: a systematic literature review and meta-analysis. Int J Behav Nutr Phys Act. 2015;12:104. 
Epub 2015/08/22. doi: 10.1186/s12966-015-0267-4. PubMed PMID: 26293454; PMCID: PMC4546162. 
10. 
Freedland KE, King AC, Ambrosius WT, Mayo-Wilson E, Mohr DC, Czajkowski SM, Thabane 
L, Collins LM, Rebok GW, Treweek SP, Cook TD, Edinger JD, Stoney CM, Campo RA, Young-Hyman 
D, Riley WT, National Institutes of Health Office of B, Social Sciences Research Expert Panel on 
Comparator Selection in B, Social Science Clinical T. The selection of comparators for randomized 
controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel. J 
Clin Epidemiol. 2019;110:74-81. Epub 2019/03/04. doi: 10.1016/j.jclinepi.2019.02.011. PubMed PMID: 
30826377; PMCID: PMC6543841. 
 
 
 

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Appendix 1 – Medication exclusion list 
 
Adipex-p 
Aldosterone 
Alli 
Beclomethasone 
Betamethasone 
Buprenorphine 
Carbamazepine 
Carbatrol 
Chlorpromazine Hydrochloride (CPZ) 
Clozapine 
Clozaril 
Cortisol 
Cortisone Acetate 
Deixtcirtucisteribe Acetate (DOCA) 
Depakote 
Dexamethasone 
Divalproex 
Equetro 
Eskalith CR 
Eskalith 
Fludrocortisone Acetate 
Gabapentin 
Haldol 
Haloperidol 
Hydrocortisone 
Insulin 
Lithium 
Lithobid 
Lomaria 
Meridia 
Methadone 
Methylprednisolone 
Neurontin 
Naloxone 
Naltrexone 
Olanzapine 
Orlistat 
Phentermine 
Prednisolone 
Prednisone 
Quetiapine 
Risperidone 
Risperdal 
ReVia 
Seroquel 

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Sibutramine 
Suboxone 
Subutex 
Tegretol XR 
Tegretol 
Thorazine 
Topamax 
Topiramate 
Triamcinolone 
Valproic Acid 
Vivitrol 
Xenical 
Zyprexa