Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)
Phase: NA
Conditions: Weight Loss, Postpartum Weight Retention, Hypertension in Pregnancy, Diabetes Mellitus in Pregnancy, Preeclampsia, Recruitment
Sponsor: University of Pennsylvania

Version 3, 8/31/2021 
1 
 
Postpartum weight loss for women at elevated cardiovascular risk: a 
randomized controlled trial 
 
Principal Investigator: 
Jennifer Lewey, MD, MPH 
 
 
 
 
Assistant Professor of Medicine 
 
 
 
 
Division of Cardiovascular Medicine 
 
 
 
 
Perelman Center for Advanced Medicine 
 
 
 
 
3400 Civic Center Boulevard, Pavilion 2 East 
 
 
 
 
Philadelphia, PA 19104 
 
 
 
 
Phone: 267-588-2327  
 
Co-principal investigator: 
Kelly Allison, PhD 
 
 
 
 
Professor of Psychology 
 
 
 
 
Department of Psychiatry 
 
 
 

Version 3, 8/31/2021 
2 
 
Protocol Outline 
 
1. Abstract 
2. Overall objectives 
3. Aims 
 
3.1 Primary outcome 
 
3.2 Secondary outcomes 
4. Background 
5. Study design 
 
5.1 Design 
 
5.2 Study duration 
 
5.3 Target population 
 
5.4 Accrual 
 
5.5 Key inclusion criteria 
 
5.6 Key exclusion criteria 
6. Subject recruitment 
7. Subject compensation 
8. Study procedures 
 
8.1 Consent 
 
8.2 Procedures 
 
8.3 COVID-19 precautions 
9. Analysis plan 
10. Investigators 
11. Human research protection 
 
11.1 Data confidentiality 
 
11.2 Subject confidentiality 
 
11.3 Subject privacy 
 
11.4 Data disclosure 
 
11.5 Data safety and monitoring 
 
11.6 Risk/benefit  
 
 
11.6.1 Potential study risks 
 
 
11.6.2 Potential study benefits 
 
 
11.6.3 Risk/benefit assessment 
 
 

Version 3, 8/31/2021 
3 
 
STUDY SCHEMA 
 
A. Enrollment strategies 
 
 
 
 

Version 3, 8/31/2021 
4 
 
B. Intervention allocation and follow-up 
 
 

Version 3, 8/31/2021 
5 
 
1. Abstract 
 
Two-thirds of women have overweight or obesity, and women of reproductive age have 
experienced the greatest increase in obesity rates of any group.(1) Obesity during reproductive 
years is a risk factor for pregnancy complications and higher risk of mortality later in life.(2) Women 
with cardiovascular (CV) risk factors, such as hypertension (HTN) or diabetes (DM) are at higher risk 
of obesity-related CV complications, as are women with pregnancy complications such as 
gestational hypertension, preeclampsia, and diabetes. The Diabetes Prevention Program (DPP) is an 
intensive in-person program resulting in sustained weight loss.(3,4) Behavioral weight loss (BWL) 
programs modeled after DPP and adapted to online platforms have shown success in different 
settings. An online behavioral weight loss program modelled after the DPP may be attractive to 
postpartum women, who may have difficulty attending in-person sessions due to competing 
demands of caring for a newborn.(5) The objective of this study is to use a randomized clinical 
trial to test the feasibility and effectiveness of a 16-week online behavioral weight loss program 
compared to usual care to promote weight loss in the postpartum period among women with 
CV risk factors. We will also be testing different behavioral strategies to recruit postpartum 
women to the study. We will be partnering with collaborators at the University of Connecticut 
(UConn) who have extensively evaluated this platform in different populations. 
 
2. Overall objectives 
The objective of this study is to evaluate the feasibility of an online behavioral weight loss 
program on weight loss among postpartum women at increased cardiovascular risk. A 
secondary objective is to evaluate the effectiveness of different behavioral strategies to recruit 
a diverse population of women to enroll in the study.  
 
3. Aims 
 
3.1 Aim 1: To understand feasibility and compare weight loss between postpartum 
women participating in an online behavioral weight loss intervention compared to usual care.  
 
3.2 Aim 2: To compare recruitment and enrollment strategies in enrolling postpartum 
women in a weight loss intervention.  
 
4. Background 
Pregnancy represents a life transition when many women become at risk for unhealthy lifestyle 
habits, such as excess weight gain and limited physical activity. At one year postpartum, nearly 
one-half of lower-income women will weigh 10 pounds more than their pre-pregnancy weight, 
and one-third will develop new overweight or obesity onset. Overweight and obesity are risk 
factors for cardiovascular risk (CV) factors, such as hypertension and diabetes, as well as 
maternal complications in future pregnancies.  
 
The Diabetes Prevention Program (DPP) is one of the most successful behavioral programs for 
weight loss and diabetes prevention, however the program is designed to be in-person which is 
challenging for many women with young children at home. Efforts to develop an on-line version 
of the DPP program have been successful in motivating weight loss among individuals from 

Version 3, 8/31/2021 
6 
 
diverse backgrounds and early research suggests that it may be modestly effective in 
postpartum women. Therefore, we propose a pilot feasibility study to examine opportunities to 
improve engagement in an online DPP program among postpartum women and measure 
preliminary efficacy by comparing it to usual care. 
 
5. Study design 
 
5.1 Design 
 
We will conduct a pilot two-arm randomized, controlled trial comparing the effect of an online 
BWL program (intervention) to usual care on weight loss after 16 weeks. The enrollment 
process and intervention will all be conducted remotely. All interested participants will be 
asked to complete a 7-day run-in period during which time they will complete surveys and 
submit a daily food log. Participants will be randomized 2:1 into the intervention and control 
arms, respectively. At the end of the 16-week intervention, participants will be asked to 
complete end-of-study surveys and complete an end-of-study virtual weigh-in. 
 
Study population 
We will recruit women who have recently delivered at the Hospital of the University of 
Pennsylvania or Pennsylvania Hospital. We will recruit women who are 6 weeks – 12 months 
postpartum at the time of study recruitment and have  1 CV risk factor.   
 
Trial arms 
Arm 1. Usual care: Participants will receive educational resources on weight loss and a digital 
scale. 
 
Arm 2. Online behavioral weight loss: Participants will receive educational resources on weight 
loss and a digital scale. Participants will participate in a “Weight Loss 101” virtual session, where 
they are introduced to successful components of weight loss. They will be enrolled in a 16-week 
online program that is based on the Diabetes Prevention Program (DPP) and involves weekly 
brief videos, a self-monitoring platform, and automated feedback.(3,6–8)   
 
Intervention 
Participants in all arms will attend a virtual Information session, undergo a 1-week behavioral 
run-in period, and attend a virtual Kick-off session. (see Study Schema). After completing these 
steps, all participants will be asked to complete a virtual weigh-in at the start and end of the 16-
week intervention. In addition, the intervention arm will receive: 
 
a. Weight loss and physical activity goals as part of the Weight Loss 101 session. All 
participants will be asked to lose 10% of their body weight, corresponding to 1-2 
lb/week over the 16-week study. Participants will be enrolled in the online behavioral 
weight loss program. The program involves the following components and described in 
more detail in Appendix 1: 
b. Weekly multimedia videos (lesson plan): These illustrated videos are < 5 minutes in 
length and include topics such as stimulus control, goal setting, and problem solving. 

Version 3, 8/31/2021 
7 
 
Each video is accompanied by online lesson plan that includes additional information 
and is posted every Monday morning. 
c. Self-monitoring platform (daily log): Participants are asked to track their daily weight, 
total calories, and exercise minutes and enter it on the website. These can be entered 
daily or at the end of the week. As long as values are entered before 11:59pm on 
Sunday night, the participant will receive automated feedback. 
d.  Automated feedback: Based upon the metrics entered into the daily log, participants 
will receive automated feedback by email on Monday morning with specific goal to work 
on each week. This may focus on reinforcing daily weights, encouraging adherence 
calorie or exercise goals, or resetting goals. The overall messaging of the automated 
feedback is supportive.  
e. Access to health coach: Participants will be able to contact study staff if they are 
encountering barriers to following the lesson plan or meeting their weight loss goals.  
 
 
5.2 Study duration 
This is a 16-week intervention that starts after the 1-week behavioral run-in and attending the 
Weight Loss 101 session. Overall duration of study from enrollment to final evaluation is 20 
weeks. 
 
 
5.3 Target population 
Postpartum women with overweight or obesity, age ≥ 18 years with  
1 CV risk factor, including chronic hypertension or diabetes mellitus, or a 
pregnancy complication placing them at increased CV risk, such as 
hypertensive disorder of pregnancy or gestational diabetes. 
 
 
5.4 Accrual 
The study population will be drawn from adult postpartum women at 
Penn (the Hospital of the University of Pennsylvania (HUP) or 
Pennsylvania Hospital (PAH)).  We will aim to randomize 60 
participants, 2:1 in the intervention and usual care groups (40 in the 
intervention and 20 in usual care). As some participants will be 
excluded during the run-in period (e.g. because they did not 
complete the daily food log or BMI < 27), we will plan to consent 85 
patients to reach our goal randomization.  Approximately 8,400 
deliveries occur annually at Penn. Assuming about 30% will have 
any hypertensive disorder or diabetes, 60% will have a BMI ≥ 27 
kg/m2, and up to 20% may be excluded for other reasons, we 
estimate that approximately 1,200 women will be potentially eligible (see Figure 1) 
 
 
5.5 Key inclusion criteria  
1) Age ≥18 years; 
2) Delivered a baby at HUP or PAH within 8 weeks-12 months prior to study enrollment;  
3) BMI ≥ 27 kg/m2  
Fig 1: Estimated sample size 

Version 3, 8/31/2021 
8 
 
4) Diagnosis of one of the following medical conditions: chronic hypertension, gestational 
hypertension, preeclampsia, eclampsia, gestational diabetes, or diabetes mellitus (type 
1 or 2) based on diagnosis codes in the EMR  
5) Has online access through smartphone or computer and has email address 
6) Ability to read and provide informed consent to participate in the study 
 
 
5.6 Key exclusion criteria  
1) Delivered prior to 32 weeks gestation in the EMR 
2) Documentation of fetal demise or neonatal demise in the EMR 
3) Currently pregnant or planning to get pregnant within the next 5 months 
4) Does not speak English  
5) Answers yes to any of the following questions: 
o Are you currently participating in any other weight loss or physical activity 
studies? 
o Do you have any medical conditions or other reasons why you could not 
participate in a 16-week weight loss or physical activity program? 
6) Participants will be excluded after completing the run-in period if they do not complete 
the daily food log or their baseline BMI is < 27 kg/m2 
 
6. Subject recruitment 
We will use EPIC to identify a cross-sectional cohort of potentially eligible patients. Given the 
lag time between identifying potentially eligible patients and enrollment, we will identify 
women with a delivery occurring between the time of the data pull and 365 days prior. We will 
identify women based on the inclusion and exclusion criteria above. In order to optimally 
recruit women with a BMI ≥ 27 kg/m2 at time of enrollment, we will use the following BMI 
criteria as documented in EMR: 
a. Pregravid BMI ≥ 30, regardless of delivery BMI 
b. Pregravid BMI 28-29.9 and delivery BMI ≥ 33 
c. If pregravid BMI missing, will include delivery BMI ≥ 33 
 
Potentially eligible patients will have their current address, phone number, email address, 
demographics, and clinical history abstracted. We will compare two approaches to patient 
recruitment (see study schema above, enrollment strategies) 
a. Email: For patients meeting inclusion criteria with a documented email address, 
we will randomize them to one of two recruitment emails that test behavioral 
approaches to engaging patients. Group 1 (reserved a spot) will receive an email 
notifying them that we reserved a spot for them in the upcoming online 
information session for a weight loss program designed for postpartum women. 
Group 2 (commit today) will receive an email asking participants if they are ready 
to commit to their health.  Participants will be able to click on an embedded link 
in the email which will take them to a secure Redcap survey that will allow them 
to sign up for the virtual information session. Once participants sign up, they will 
receive a text reminder prior to the information session with the Zoom link. See 

Version 3, 8/31/2021 
9 
 
Appendix 2 for text of recruitment emails. For participants who do not respond, 
a reminder email will be sent 48 hours after the initial email. 
b. Mailer: We will combine participants who received an email but did not respond 
and patients who do not have an email address documented in the EMR. We will 
then randomize them to one of two mailer strategies: study mailer alone versus 
mailer plus gift. The mailer alone group will receive a flyer and mailer that 
focuses on achieving a healthy lifestyle postpartum and explaining the weight 
loss study (see Appendices 3 and 4). The mailer plus gift group will receive a 
mailed package containing the flyer and mailer plus a baby bib inscribed with 
study logo. Recruitment materials will be sent in waves until the expected 
number of participants are enrolled.  
 
Patients will be able to sign up for the virtual information session hosted on Zoom through the 
study website (Redcap). Information on how to sign-up will be included on the mailer. In 
addition, patients will be able to call or text the study phone number to talk to a clinical 
research coordinator (CRC) in the Maternal and Child Health Research Center (MCHRC) to learn 
more about the study and/or sign up for an information session. We will try to accommodate 
patients who cannot make any of the scheduled sessions by scheduling additional sessions.  In 
order to sign up, participants will need to provide their name, contact information, and date of 
birth. 
 
As of 9/25/2021, we have reach target randomization using email recruitment alone. In order 
to compare the mailer versus mailer plus baby gift as outlined in Aim 2, we will continue 
recruitment using the mail strategy (see Study Schema, enrollment strategies above). When 
participants click on the Redcap link to sign up for a virtual information session, they will be 
informed that study enrollment is full. They will have the option to watch a 10-15 minute 
recorded video of study staff reviewing evidence based approaches to weight loss, which will be 
posted on the Recap website. 
 
7. Subject compensation 
All eligible participants will receive a scale if they complete the 1-week behavioral run-in period. 
Participants will receive $30 after completing the 16-week intervention, virtual weigh-in and 
exit survey at the end of the study. Compensation will be delivered via Greenphire ClinCard. 
 
8. Study procedures 
 
8.1 Consent  
Interested participants will sign up for and attend an online information session that will be 
conducted by research staff over Zoom. Prior to the information session, participants will be 
emailed a copy of the informed consent form. In order to achieve a goal of 10 participants per 
session, we will invite 15-20 individuals for each session. The research staff will present a 
PowerPoint via screen share that reviews study rationale, expectations, adherence to the run-in 
period and interventions, and assessments. Participants will be muted for the presentation. 
Participants can choose to have their video turned on or off for the presentation, however they 
will be asked to have their first name displayed on their Zoom window.  

Version 3, 8/31/2021 
10 
 
 
At the end of the presentation, the participants will be un-muted. Participants who are 
interested in enrolling and providing informed consent will be asked to stay on the Zoom call 
and make sure their video is turned on. Participants who are not interested in enrolling will be 
invited to leave the call. At this point, research staff will review the informed consent form and 
allow participants to ask questions. Once all questions are answered, participants who are 
interesting in providing informed consent will be asked to type their name in the chat box and 
indicate that they consent to participate. This will count as verbal consent provided in a group 
format. Documentation of verbal informed consent will be kept in the research record. 
Participants will be provided with details regarding how to contact the research team via phone 
at any time if they subsequently wish to withdraw from the study. Participants will be asked to 
electronically sign the consent form via Redcap when they receive the surveys as part of the 
behavioral run-in period and prior to randomization.  
 
8.2 Procedures 
a) Virtual information session: All potentially eligible and interested participants will first 
complete this session. At the end of the session, participants will provide verbal informed 
consent and will be invited to complete the behavioral run-in period.  
 
b) Behavioral run-in: participants will be emailed a link to a secure Redcap survey and asked to 
complete the following steps: 
 Electronic consent 
 Survey to determine eligibility 
 Profile with contact information, including correct address to send scale and contact 
preferences (email or text) 
 Online W9 form to facilitate delivery of incentives  
 Baseline demographic and study specific surveys (see Appendix 5) 
 
Participants will be asked to complete 5 days of food logging. Participants can log food in 
MyFitnessPal (MFP), a free app for food tracking, and share with research staff or they can keep 
a food diary on paper and send in screenshots via text or email. Participants who provide 
informed consent and complete the run-in period will be sent a digital scale along with 
handouts in preparation for the virtual kick-off session.  
 
c) Virtual kick-off session: Once participants have received the scale, they will be eligible to sign 
up for a virtual kick-off session, during which participants will be randomized. Participants can 
sign up through the study website (via Redcap) or by contacting a CRC. This session will be 
conducted by research staff over Zoom. Randomization will occur at the beginning of the 
session and participants will be placed in one of two breakout rooms for the intervention or 
control arm.  
 Control arm: study staff member will inform participants that they are in the control 
arm. 

Version 3, 8/31/2021 
11 
 
 Intervention arm: study staff will lead the Weight Loss 101 session. This session will 
review weight, calorie, and physical activity goals and evidence-based weight loss 
strategies, including food logging and daily weights. All participants will be asked to lose 
10% of their body weight, corresponding to 1-2 lb/week over the 16-week study. 
Participants will receive a brief introduction to the online BWL study website. The 
session will also include information about weight loss and exercise while breastfeeding.  
 
d) Virtual weigh-in: All participants will be asked to complete a virtual weigh-in on the Monday 
following the kick-off session. Their weight on the Monday morning will serve as their baseline 
weight for the program. Participants in both arms will be asked to take a photo of the scale with 
the morning weight and send it to study staff by text or email.  The number stays on the scale 
for 3 seconds after stepping off. 
 
e) Health coach: A study staff member will be trained as a weight loss coach by the PIs. If 
participants in the intervention arm are having trouble using the platform, reaching their 
weight loss goals, or have stopped logging into the platform, research staff will reach out to 
help triage and troubleshoot any barriers.  
 
g) At the end of the 16-week intervention, all participants will be asked to complete their final 
virtual weigh in and send a photo of the scale to study staff by text or email. At the end of the 
study, participants will be asked to complete an exit survey. In addition, participants will be 
offered an opportunity to participate in an online group feedback session on Zoom.  
Participants will receive $30 incentive for completing the final weigh-in and exit survey. 
Study staff will abstract clinically relevant data from the electronic medical record to collect 
data on demographics, clinical comorbidities, and health care utilization. The collection of these 
data will obviate the need to further burden participants by asking them additional questions 
during the survey periods.  
 
9. Analysis plan 
Primary outcomes include: 
 Enrollment rate, comparing email recruitment strategies (reserved a spot versus commit 
to health) and comparing mail strategies (mailer versus mailer plus gift) 
 Change in weight from baseline to 16-week follow-up  
 Proportion of participants losing  5% of weight  
 
Secondary outcomes: 
 Study completion rate between 2 arms 
 In the intervention arm, engagement with online BWL platform, including number of 
total logins, number of weeks with  1 login, number of weeks that calories, physical 
activity minutes, and body weight were reported for at least 5 of the 7 days 
 
Exploratory outcomes 

Version 3, 8/31/2021 
12 
 
 Differences in any of the primary or secondary outcomes according to race/household 
income 
 
To compare sample characteristics between arms we will use t-tests or Wilcoxon rank-sum 
tests for continuous variables and Pearson chi square tests or Fisher’s exact tests for categorical 
variables. Generalized linear mixed effects models will be used to assess for differences in 
weight, given repeated observations. We will use fixed effects to adjust for study arm, baseline 
weight, and calendar month, which may reflect seasonal variations that make weight loss 
harder or easier. We will conduct a number of sensitivity analyses to evaluate the robustness of 
our findings. All hypothesis tests will be two-sided using a two-sided alpha of 0.05 as our 
threshold for statistical significance. We will use Stata and/or SAS to analyze the data.  We will 
use multiple imputation for missing data.  
 
10. Investigators 
Jennifer Lewey, MD, MPH is the co-Principal Investigator (PI) and is an Assistant Professor of 
Medicine at the Perelman School of Medicine.  She is Director of the Women’s Cardiovascular 
Health Program. She has experience running lifestyle interventions among postpartum women. 
 
Kelly Allison, PhD is the co-Principal Investigator (PI) and is a Professor of Psychology in 
Psychiatry at the Perelman School of Medicine. She is Director of the Center for Weight and 
Eating Disorders. She has extensive experience designing and running behavioral weight loss 
clinical trials. 
 
Tricia Leahey, PhD is a co-investigator. She is Associate Professor in the Department of Allied 
Health Sciences and Co-Director of the Weight Management Research Group at the University 
of Connecticut (UConn). She developed the online BWL platform along with collaborators at the 
University of North Carolina.  
 
The Clinical Research Coordinator has experience with administering studies involving 
interventions with pregnant and postpartum populations and also has experience training 
Research Assistants to follow study protocols. 
 
11. Human research protection 
 
11.1 Data confidentiality 
Participants who are randomized into the online BWL program will be enrolled in the platform 
using the contact information (name, email address, and phone number) provided at the 
beginning of the study. The platform was designed by Dr. Tricia Leahey (co-I) and collaborators 
and is being provided to the Penn study team to use as part of the study at no cost. Research 
staff working with Dr. Leahey at UConn will be responsible for enrolling participants into the 
platform. Penn study staff will be provided a login and password to securely access any data 
entered into the platform by Penn participants. Penn study staff will not be able to enroll 
participants directly into the platform because this requires an administrator account, which 
would permit access to all studies that are ongoing within the platform at UConn. The 
participant information needed for enrollment (name, email, and phone number) will be 

Version 3, 8/31/2021 
13 
 
securely shared with the UConn research staff via a Penn Box link. Paper-based records will be 
kept in a secure location and only be accessible to personnel involved in the study. Computer-
based files will only be made available to personnel involved in the study through the use of 
access privileges and passwords. Wherever feasible, identifiers will be removed from study-
related information. Precautions are in place to ensure the data are secure by using passwords 
and encryption, because the research involves web-based surveys. 
 
 
11.2 Subject confidentiality 
Research material will be obtained from participant surveys and clinical data abstracted from 
the EMR.  All participants will provide informed consent for access to these materials. The data 
to be collected include demographic data (e.g., age, sex, self-identified race) and outcome data.  
Research material that is obtained will be used for research purposes only. The same procedure 
used for the analysis of automated data sources to ensure protection of patient information will 
be used for the survey data, in that patient identifiers will be used only for linkage purposes or 
to contact patients. The study identification number, and not other identifying information, will 
be used on all data collection instruments. All study staff will be reminded to appreciate the 
confidential nature of the data collected and contained in these databases.  
 
 
11.3 Subject privacy 
Enrollment will include a description of the voluntary nature of participation, the study 
procedures, risks and potential benefits in detail. The enrollment procedure will provide the 
opportunity for potential participants to ask questions and review the consent form 
information with family and friends prior to making a decision to participate. Participants will 
be told that they do not have to answer any questions if they do not wish and can drop out of 
the study at any time, without affecting their medical care or the cost of their care. They will be 
told that they may or may not benefit directly from the study and that all information will be 
kept strictly confidential, except as required by law. Subjects will be given a copy of the consent 
document. All efforts will be made by study staff to ensure subject privacy. 
 
 
11.4 Data disclosure 
The following entities, besides the members of the research team, may receive protected 
health information (PHI) for this research study in order to enroll patients in the online platform 
(intervention group only). These data will be limited to: participant’s name, email address, and 
cell phone number, in addition to any data entered into the online platform (limited to daily 
weight, caloric intake, and exercise duration).  
 
- 
The research team of Dr. Tricia Leahey (co-I) at the University of Connecticut 
 
 
11.5 Data safety and monitoring 
At the time of enrollment in the study, all patients are given anticipatory guidance on when to 
seek medical attention.  In addition, participants will be asked to report to the study team any 
episodes of shortness of breath, light-headedness, or other changes during periods of exercise.  
They will be instructed to call the study team.  The study coordinator will call the participant to 

Version 3, 8/31/2021 
14 
 
collect information regarding the issue and then the PI will review and determine whether it is 
ok to proceed, further investigation is needed, or the participant should stop the study.   
 
 
11.6 Risk/benefit  
 
 
11.6.1 Potential study risks 
To minimize the chance for serious and unexpected adverse events, study participants will be 
screened through exclusion criteria for any health conditions that may be exacerbated by 
participating in a physical activity study. The intervention tries to motivate a modest weight loss 
and increase in exercise that should pose little health risk to participants.  Participants are given 
guidance on when to seek medical attention and a reporting protocol is in place to capture any 
changes in symptoms with physical activity. Another potential risk of this study is a breach of 
participant confidentiality. We will minimize this risk by linking individual identifying 
information with participant ID numbers only in one single secure file that will only be accessed 
by the study team in the case of an adverse medical event, participant dropout, or if otherwise 
deemed necessary by the Principal Investigator. All other identifying information will be 
discarded after initial contact with the Study Coordinator. Due to the financial incentives in this 
study, we will be collecting social security numbers so that we can complete W-9 forms for 
participants. Social security numbers only will be used to generate W-9 forms and will be 
deleted once they are no longer needed. We will also collect home addresses to mail scales and 
incentive payments. Accidental disclosure of social security numbers could lead to identity 
theft. We will use commercial-grade encryption to protect social security information in transit. 
Names and addresses will be stored in encrypted databases. These data will be viewable only 
by the respective participants and the study coordinator. All other members of the research 
team will be able to view only participant ID numbers. There will be no functionality in the web 
application to export a dataset with identifiable information. Even the study arms will be 
identified by code letters until both the statistician and PI agree that analysis is complete. 
 
 
 
11.6.2 Potential study benefits 
Through participation in this study, each participant will have the potential to lose weight and 
increase their physical activity, which could improve their health and reduce their risk for future 
cardiovascular disease or other conditions such as diabetes and hypertension. If this approach 
is effective, it could have tremendous benefits for society if adopted on a wide scale to help 
women lose weight after delivering a baby. It is expected that other people will gain knowledge 
from this study and that participation could help understand how to effectively deliver a virtual 
program for weight loss in a variety of populations. Participants may also receive no benefit 
from their participation in the study. 
 
 
 
11.6.3 Risk/benefit assessment 
Anticipated risks of this study should be minimal and the risk/benefit ratio is very favorable. To 
minimize the chance for serious and unexpected adverse events, study participants will be 
screened through exclusion criteria for any health conditions that may be exacerbated by 
participating in a weight loss study.  
 
12. References 

Version 3, 8/31/2021 
15 
 
1.  Ladabaum U, Mannalithara A, Myer PA, Singh G. Obesity, abdominal obesity, physical 
activity, and caloric intake in US adults: 1988 to 2010. Am J Med. 2014 Aug;127(8):717-
727.e12.  
2.  Chen C, Ye Y, Zhang Y, Pan X-F, Pan A. Weight change across adulthood in relation to all 
cause and cause specific mortality: prospective cohort study. BMJ. 2019 Oct 16;367:l5584.  
3.  Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, et al. 
Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N 
Engl J Med. 2002 Feb 7;346(6):393–403.  
4.  Ali MK, Echouffo-Tcheugui J, Williamson DF. How effective were lifestyle interventions in 
real-world settings that were modeled on the Diabetes Prevention Program? Health Aff Proj 
Hope. 2012 Jan;31(1):67–75.  
5.  Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Muñoz-Christian K, et al. Effect of 
an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A 
Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2381–91.  
6.  Leahey TM, Subak LL, Fava J, Schembri M, Thomas G, Xu X, et al. Benefits of adding Small 
Financial Incentives or Optional Group Meetings to a Web-based Statewide Obesity 
Initiative. Obes Silver Spring Md. 2015 Jan;23(1):70–6.  
7.  Leahey TM, Thomas G, Fava JL, Subak LL, Schembri M, Krupel K, et al. Adding evidence-
based behavioral weight loss strategies to a statewide wellness campaign: a randomized 
clinical trial. Am J Public Health. 2014 Jul;104(7):1300–6.  
8.  Thomas JG, Leahey TM, Wing RR. An Automated Internet Behavioral Weight-Loss Program 
by Physician Referral: A Randomized Controlled Trial. Diabetes Care. 2015 Jan;38(1):9–15.