Delivering a Post-Partum Weight Loss Intervention Via Facebook vs In-Person Groups: a Feasibility Trial
Phase: NA
Conditions: Weight Loss, Diet Modification, Physical Activity
Sponsor: University of Connecticut

Study title: The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention 
Delivered Via Facebook or In-Person Groups 
 
NCT 03700736 
 
Study Protocol 
 
Date of document: 3/9/2020 
 
 
 

Page 1 of 19
IRB-1 Study Protocol
Protocol Version # and/or Date: 2020-03-09
Study Protocol Title: The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention 
Delivered via Facebook or In-Person Groups
Clinical Trial/GCP Training 
Is this a research study in which one or more human subjects are prospectively assigned1 to one 
or more biomedical or behavioral interventions2 (which may include placebo or other control) to 
evaluate the effects of those interventions on health-related biomedical or behavioral outcomes3 
(i.e a clinical trial)?   Indicate “yes,” “no,” or “N/A” in the space immediately below.
Yes.
Is the study fully or partially funded by the NIH?  Indicate “yes,” “no,” or “N/A” in the space 
immediately below.
Yes. NIH grant number R34HL136979.
Have the required key personnel completed Good Clinical Practice (GCP) Training?  Indicate 
“yes,” “no,” or “N/A” in the space immediately below. (Note that IRB approval will not be given 
for NIH funded clinical trials until all required key personnel complete the GCP training.)
Yes.
Research Plan
Purpose/Introduction: [State the reason for the study, the research hypothesis, and the goals of the 
proposed study as related to the research question(s). Provide a clear and succinct summary description of 
the background information that led to the plan for this project. Provide references as appropriate and, 
1The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that 
stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or 
other control) of a clinical trial.
2An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more 
health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; 
biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies 
to change health-related behavior (e.g., diet, cognitive/behavioral therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies.
3 3.Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect 
of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or 
negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or 
negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading 
comprehension and /or information retention, behavioral intervention for psychiatric symptoms); positive or negative changes to 
disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 2 of 19
when applicable, previous work in animal and/or human studies. Provide previous UConn protocol 
number, if applicable.]
The goal of this research project is to conduct a pilot randomized trial with 72 overweight or obese post-
partum women comparing delivery of a post-partum weight loss intervention via Facebook or in-person 
group sessions.
Post-partum weight retention contributes to obesity for many women,1-3 increasing risk for  
cardiovascular disease and other chronic diseases4 and complicating future pregnancies.5,6 While on 
average women retain 0.5-3 kg, as many as 50% of women retain ≥5 kg.2,7,8 Lifestyle interventions have 
shown to be modestly efficacious for post-partum weight loss in randomized controlled trials,9 yet 
interventions with numerous visits are logistically challenging for many post-partum women.10-16 
Innovative, efficacious, and cost-effective17,18 treatment models for post-partum weight loss that fit into 
the busy lives of new moms are needed.19
Facebook may be an efficient platform for delivering evidence-based weight loss programming to post-
partum women. Facebook is currently the most popular online social network,20 used by 81% of online 
moms.21 70% of Facebook users engage daily, including 43% multiple times per day,22 for upwards of 50 
minutes a day.23  Many women seek support about health and parenting from their Facebook network.21,24 
Interactions via Facebook are frequent, brief, and asynchronous, with women seeking support when they 
need it. Delivering interventions via Facebook allows us to connect with post-partum women where they 
are, more fully integrating into their lives and daily routines. Weight loss interventions that use Facebook 
appear promising.25-27 
We have developed a post-partum weight loss intervention based on the Diabetes Prevention Program,28 
tailored to needs of post-partum women and for delivery via Facebook. Participants receive counseling 
from a coach through posts and discussions via a private Facebook group. We conducted a one-arm pilot 
study of this intervention with 19 overweight or obese women (95% retention). Average weight loss was 
4.8% (SD: 4.2%), and 58% achieved clinically significant weight loss (i.e., ≥5%29,30). 88% said they 
would be likely/very likely to participate again if they had another baby, and 82% would recommend the 
program to a post-partum friend. While delivering the intervention via Facebook offers many advantages, 
we have no reason to believe it will be more efficacious than a traditionally-delivered intervention (i.e., 
via in-person group sessions), especially when intervention content is identical. Instead, we hypothesize 
that in a large trial delivery via Facebook will be at least non-inferior for weight loss compared to in-
person delivery, but superior in cost-effectiveness.
Additional preliminary data is needed to support the conduct of a large randomized non-inferiority trial to 
compare our Facebook-delivered post-partum weight loss intervention to in-person delivery of the 
intervention. In our pilot study, some intervention posts garnered low or no participant engagement. We 
have identified posts with low and high participant engagement, and will solicit feedback from women on 
how to make low engagement posts more engaging. As noted in the grant proposal (Section 3.B/Impact), 
the research described in this protocol is a step in a line of investigation to develop and test the efficacy 
and effectiveness of a Facebook-delivered post-partum weight loss intervention. Subsequent steps of this 
program of research include implementation in real-world settings. It is possible that the best model for 
widespread dissemination would be to develop a commercial product.
This project has three Specific Aims:
Aim 1: Feasibility. We will examine the feasibility of recruitment (especially the proportion of women 
unwilling to be randomized to either condition), sustained participation, contamination, retention, and 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 3 of 19
feasibility of assessment procedures, particularly measurement of cost-related data, in both treatment 
conditions. We will describe weight loss as an exploratory outcome.
Aim 2: Intervention refinement. In post-intervention focus groups, we will solicit women’s feedback on 
posts with low engagement, and will iteratively refine these posts to make them more engaging. 
Aim 3: Measuring time on Facebook. We will compare self-reported time spent on Facebook to 
participate in the intervention with application-tracked time on Facebook, changes in use, and time spent 
visibly engaging, to develop procedures for measuring time that balance accuracy and participant burden.
Please see the Specific Aims (page 1) and sections 3.A through 3.D.1.5 of the enclosed grant application 
(pages 2-7) for additional background information supporting the proposed research. The current protocol 
will cover research activities described as Phase 2 in the grant application; a separate protocol covers 
research activities described as Phase 1 (IRB # H17-203).
For EACH Participant Population State the Number of Participants to be Enrolled and Screened, if 
applicable: [State the total number of participants to be enrolled and, if enrolling more than one 
participant population, describe the total enrollment for each. Tip: consider attrition and the number of 
participants who may fail screening. Use of a range may provide flexibility.] Note that the range must be 
justified in the Justification of Sample Size section below.
N=72-125
Justification of Sample Size: [For qualitative and pilot studies, describe how the proposed sample size is 
appropriate for achieving the anticipated results. For quantitative studies, provide a power analysis that 
includes effect size, power and level of significance with references for how the sample size was 
determined. Explain the rate of attrition and possible number who fail the screening, with references as 
appropriate.]
The main purpose of the pilot trial is to examine the feasibility of recruitment (especially the proportion 
of women unwilling to be randomized to either condition), sustained participation, contamination, 
retention, and feasibility of assessment procedures, particularly measurement of cost-related data, in both 
treatment conditions, thus identifying modifications required before examining non-inferiority in a large 
randomized controlled trial. Leon, Davis, & Kraemer (2011) state “power analyses should not be 
presented in an application for a pilot study that does not propose inferential results.”31 As they and others 
recommend,31,32 we based the sample size on necessities for examining feasibility, thus identifying 
modifications required to the design of the trial or study procedures before conducting the subsequent 
full-scale non-inferiority trial. Conducting two waves allows us to iteratively refine how we deliver 
intervention content via Facebook, and each wave includes n=36 women allows us to assess the 
feasibility of recruitment and engagement under the conditions of the subsequent trial. While we will aim 
to maximize retention in both conditions, with retention of ≥80% to be acceptable, a priori, we decided 
that a retention rate in either condition lower than 60% would indicate that the non-inferiority trial is not 
feasible as designed. With n=36 per treatment condition, the 95% confidence interval (CI) for the 
estimated retention rate will be within ±13% if observed retention is 80%. Given n=36 per condition, the 
lower limit of the 95% CI for the observed retention rate in either treatment condition should not be lower 
than 60%. 
We will enroll up to 125 participants with the intention of randomizing 72 participants. As the current 
study is a feasibility study, we are unsure the proportion of enrolled (consented) participants who will be 
randomized, as some participants will fail to complete baseline measures or may be found to be ineligible 
after baseline assessments. 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 4 of 19
For EACH Participant Population State Describe the Study Population(s): [Describe the participant 
population(s) including gender, ethnicity, income, level of education and age range.] 
All participants will be adult women (aged 18 years or older). We anticipate minority enrollment of at 
least 30% as expected by the NIH/NHLBI. We are not targeting enrollment by income or level of 
education; we aim to recruit a diverse sample with respect to these characteristics. 
Enrollment of UConn Students and/or Employees: [Will UConn students be enrolled? If so, describe if 
these students include those who any key research personnel teaches, or for whom any key research 
personnel has responsibility. Will UConn employees be enrolled? If so, describe if these employees report 
to any key personnel. For each group, explain why this population is necessary to the study. Tip: 
convenience is not sufficient justification.]
UConn students and/or employees who any key personnel teach or who report to any key personnel will 
not be included; we will assess these relationships during eligibility screening. 
Enrollment of Key Personnel, Spouses or Dependents/Relatives: Will study key personnel, spouses of 
key personnel, or dependents/relatives of any key personnel be enrolled in the study? If so, describe and 
provide justification. 
No. We have included this as an exclusion criterion.
For EACH Participant Population Describe Recruitment Methods: [Specify each method and 
describe specific procedures for how participants will be identified and recruited. Attach copies of all 
advertisement/recruitment materials for IRB review. Describe how UConn Students/Staff and Key 
Personnel/Spouses/Dependents/Relatives will be identified and recruited, if applicable.] 
We will recruit post-partum women from the community. We will distribute flyers in local obstetric or 
pediatric clinics or practices (e.g., Women’s Ambulatory Health Services of Hartford Hospital), WIC 
offices, community organizations, and community venues and events. We will post study advertisements 
on craiglist.org and online social networks including Facebook, Instagram, and Twitter. We will contact 
the administrators of local Facebook groups to post our recruitment messages/images in their groups, as 
needed. We will connect with local businesses/organizations to have our ad/flyer emailed to their 
employees and/or students. We will submit announcements to be included in UConn distribution 
lists/newsletters such as the Daily Digest and the UConn Health Lifeline. 
We will also recruit women who are currently pregnant who are expected to deliver before mid-June 2019 
from the community as described above. Pregnant women will be asked to email us, call us, or complete a 
brief online form that includes their name, email address, phone number, and expected due date. 
Approximately 2 months after their expected due date, we will contact them about their interest in the 
study and if interested, screen them for eligibility. 
Additionally, potential volunteers will be contacted by ResearchMatch with IRB-approved recruitment 
content for this study, not including direct study contact information such as study phone number. When 
posting on Research Match we will specify women with BMI≥25 kg/m2 and aged 18-50 years, and set the 
geographic limits (50 miles) to prevent distribution of the recruitment message to individuals unlikely to 
be eligible for the study. Volunteers will have the option of replying ‘yes’ or ‘no’ through a set of quick 
links available in the recruitment message. If a volunteer chooses to respond in the affirmative, they will 
authorize ResearchMatch to release their contact information to the PI (or ResearchMatch designee) who 
will be responsible for managing that information according to institutional guidelines. 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 5 of 19
Recruitment flyers (“flyer” style with tear-away tabs and “pamphlet” style) and online recruitment 
messages/accompanying images are enclosed.
For EACH Participant Population Describe Screening Procedures, if applicable: [Describe when 
participants will be screened and how this will occur. Include copies of all screening forms and related 
documents. Describe procedures to notify participants of the screening result. Tip: if screening will be 
conducted online or by phone prior to consent, be sure to request a waiver of signed consent, if 
appropriate. Provide a copy of the screening instrument.] 
Research staff will screen potential participants for eligibility in person or via phone. Research staff will 
answer questions potential participants have about the research study at any point during the recruitment 
and screening process. For online recruitment specifically, staff will answer questions in the mode they 
are posed (e.g., email, reply to social media post) and include in the response an offer to talk with the 
individual via phone to answer any questions. In most cases, staff will notify participants immediately of 
the screening result. However, in some cases, staff will refer with the PI to determine the screening result 
(e.g., unclear whether medication is exclusionary) and call the participant as soon as possible but within 3 
days to inform them of the screening result. 
The eligibility screener is enclosed. We will assess whether potential participants are UConn students 
and/or employees who any key personnel teach or who report to any key personnel; such relationships 
will be exclusionary. We will also assess whether potential participants are key personnel, spouses of key 
personnel, or dependents/relatives of any key personnel; such relationships will be exclusionary. We will 
identify such exclusionary relationships using a two-step process: first, by asking potential participants to 
disclosure any known relationships during eligibility screening, and second, by review of potential 
participant name by study staff before randomization.
Screening will be conducted prior to consent; we request a waiver of signed consent.
Design, Procedures, Materials and Methods: [Describe the study design, including the sequence and 
timing of all study procedures. Experimental procedures should be clearly described and labeled as such. 
If the study uses control or experimental groups, or different treatment arms, clearly describe what 
participation will be like for each of the groups or study arms. Tip: describe procedures in the order 
conducted. The IRB strongly suggests that investigators incorporate flexibility into the study design to 
accommodate anticipated events (i.e. explain how missed study appointments can be made up by 
participants). If the research involves study of existing samples/records, describe how authorization to 
access samples/records will be obtained. If the study involves use of deception explain the reason why 
this is necessary. If applicable, describe the use of audiotape and/or videotape and provide justification for 
use. If this study offers treatment for the participants’ condition, complete the Treatment Study 
Supplemental Form (IRB-1C) and attach it to this application for review. If the study includes measures, 
survey instruments and questionnaires, identify each and, if available, provide references for the 
measures. Describe what they intend to measure (relate to purpose/hypothesis) and their psychometric 
properties (e.g., reliability and validity). Identify any that were specifically created for the study.]
Participation will include a baseline assessment, an orientation webinar, participation in a 6-month weight 
loss intervention, and follow-up assessments at 6 and 12 months. Study visits and in-person treatment 
sessions will take place in a private space (such as a conference room, exam room, or classroom) at 
UConn Storrs, UConn Hartford, the Hartford Public Library, Hartford Hospital, Women’s Ambulatory 
Health Services, or WIC offices. Overall, it is estimated that completing study assessments will take 
approximately 5-6 hours and participating in treatment sessions (in-person condition) or engaging with 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 6 of 19
the counselor and other participants online (Facebook condition) will take approximately 90 minutes per 
week over the 6-month intervention period.  
Baseline assessment. Staff will call and/or email participants within 3 days of their scheduled baseline 
assessment to remind them of the appointment. The baseline assessment will include informed consent 
measurement of height and weight, completion of a contact information sheet, and completion of 
additional measures which will be used to determine eligibility (screeners for depression and binge eating 
disorder). Study personnel will also help participants download My Fitness Pal app (all) and an app to 
track time on Facebook (Android users) and provide instruction of how to use these apps. For iPhone 
users, personnel will also show them how to locate Facebook app usage data using the battery settings. 
We expect the baseline study visit to take 30-45 minutes. Following the baseline assessment, research 
staff will fax the medical clearance form to participants’ primary care provider or OBGYN. After the 
baseline visit, staff will email participants a link to complete a survey via REDCap. A copy of the 
baseline survey is enclosed. We will email participants a $20 gift card after they have completed the 
baseline visit and online survey.
Orientation Webinar. Participants will complete a 60-minute orientation webinar. The purpose of the 
webinar is to educate participants about what research is, review study procedures, review importance of 
participation of enrolled participants, and to allow participants another opportunity to evaluate if joining 
this study is the right choice for them. This webinar is being conducted to improve study retention. The 
webinar moderator will record in REDCap tracking which participants completed the webinar. 
Pre-Randomization Survey. Following the orientation webinar, we will email participants a short online 
survey that includes Facebook time measures and completion of a randomization agreement. We will 
email participants a copy of the randomization agreement form for their records. A copy of the pre-
randomization survey is enclosed.
Participants will need to complete the telephone screening, baseline assessments (visit and survey), and 
orientation webinar, and pre-randomization survey before being randomized. 
Randomization. We will randomize participants 1:1 to the FB and IP conditions in randomly permuted 
blocks of size 4 and 6. Randomization will be stratified by weeks post-partum at enrollment (8 weeks to 
<6 months, 6-12 months) and smartphone type (iPhone vs Android) . 
Weight loss intervention. The 6-month intervention will include dietary and exercise counseling and tips 
to help participants meet their healthy lifestyle goals. Participants will receive personalized calorie and 
physical activity goals to help them achieve a healthy weight loss of 1-2 pounds per week. Breastfeeding 
women will receive daily calorie goals that will facilitate weight loss while accounting for energy needs 
to support lactation; weight loss expectations do not differ by breastfeeding status. Participants will be 
encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. While we 
will provide information about specific exercises designed to help with recovery from childbirth (e.g., 
pelvic floor exercises), participants will not be required to engage in any particular exercises or activity 
program. Counselors will encourage and support participants to make a plan for incorporating regular 
physical activity into their lives in a way (i.e., duration per session, frequency per week) that works for 
that individual woman. We will encourage participants to track their diet and exercise daily. We will 
encourage participants to use My Fitness Pal to track their diet and activity. In the in-person condition, the 
intervention will be delivered via weekly 90-minute group meetings for the first four months and then 
every other week in months 5 and 6. In the Facebook condition, the intervention will be delivered via a 
secret (private) Facebook group. See section 3.D.2.2.9 (3.D.2.2.9.1 through 3.2.2.9.6; pages 9-10) of the 
enclosed grant application for more details on the interventions. 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 7 of 19
Due to weather or to prevent spread of illness (e.g., coronavirus), we may hold intervention meetings for 
the in-person condition via video or telephone conference call.
Weekly time survey. Weekly, participants in both treatment conditions will complete a brief online 
survey to report current weight and time spent on Facebook. We expect the survey to take less than 5 
minutes. The survey will be administered via REDCap. A copy of the weekly survey is enclosed.
6-month follow-up assessment. At 6 months, women will participate in an in-person focus group 
session. We will email participants a link to complete an online survey before this visit. The survey will 
be administered via REDCap. Research staff will measure participants’ weight individually as women are 
arriving for the focus group. We will ask participants in both treatment conditions to elaborate on what 
motivated or hindered participation. Focus groups with women in the Facebook condition will explore 
their reactions to and ratings of the format of low or high engagement posts (same procedures as the pre-
trial focus group in Phase 1). For participants unable to attend the focus group session, we will schedule 
individual follow-up assessments and will conduct an individual interview (in-person or via phone) 
following the content of the focus group guide. We will audiotape the focus group and individual 
interviews. When scheduling the 6-month assessment, we will remind participants that we will audiotape 
the focus groups. For participants who are not comfortable with this discussion being audiotaped, we will 
schedule an individual visit and take notes during the interview. For follow-up assessments (both 6-month 
and 12-month), participants who are not willing to attend an in-person visit will be asked to self-report 
their current weight, and those who do not complete the survey online will be offered the option of 
completing the survey via phone. We expect that this study visit will take 1-1.5 hours and the survey will 
take 30-45 minutes. We will email participants a $40 gift card after they complete the study visit and 
survey. 
Due to weather or to prevent spread of illness (e.g., coronavirus), we may hold the focus group 
discussions via video or telephone conference call. In this case, participants would complete ratings of 
intervention posts via online survey. In the case of remote focus groups, we would ask participants to self-
report their weight and not require in-person visits.
12-month follow-up assessment. 12-month individual follow-up visits will include measurement of 
weight. Research staff will provide participants with instructions on how to remove the My Fitness Pal 
and time-tracking apps from their phones, and will assist participants with removal of these apps if 
desired. We will email participants a link to complete the survey at home following the 12-month follow-
up study visit. The survey will be administered via REDCap. We expect that the survey will take about 30 
minutes, and the visit will take about 15-45 minutes. We will email participants a $40 gift card after they 
complete the study visit and survey. 
Due to weather or to prevent spread of illness (e.g., coronavirus), we may participants to self-report their 
weight and not require in-person visits.
For all study assessments, research staff will call subjects who do not attend their scheduled in-person 
study visit to reschedule. Calls will follow the same calling procedures as the eligibility screen (see 
Eligibility Screen). We will reschedule the study visit a maximum of 5 times, with a maximum of 5 calls 
per scheduled visit before considering the woman lost to follow-up.  Women who do not complete the 
online surveys will be sent two reminder emails containing a personalized link, at least 24 hours apart. 
After 7 days, research staff will may participants who have not completed the measures online to provide 
the participant the option of completing any remaining measures over the phone. Calls will follow the 
same calling procedures as the eligibility screen (see Eligibility Screen). 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 8 of 19
Baseline, weekly, and follow-up surveys are enclosed. Data collection will include data to be collected in 
the subsequent non-inferiority trial (see Subsequent Clinical Trial Description, pages 14-16, of the grant 
application). In the baseline survey, participants will report relevant obstetric history,33 pre-pregnancy 
weight and gestational weight gain during the index pregnancy,34 contraception use, smoking/e-cigarette 
use, employment status, household composition, and other demographics. At each time point (baseline, 6-
months, 12-months), participants will complete measures of quality of life (PROPr),35,36 infant 
feeding,37,38 sleep (PSQI [partial]),39,40 depressive symptoms (EPDS),41 and social support for weight 
loss.42 At each follow-up, participants will also be queried about incident pregnancies as part of the 
participant survey. At 6 months, women in both conditions will rate their satisfaction with the 
intervention, how likely they would be to recommend it to a post-partum friend, and how likely they 
would be to participate again, and group cohesion.43 At 6 months, we will ask women whether they 
participated in other weight loss programs (online or in-person), sought weight loss support on Facebook 
or other online social networks,44 and if so, to what extent and reasons they sought this support. 
Data Analysis: [For all studies, specify the analytic techniques the researcher will use to answer the study 
questions. Indicate the statistical procedures (e.g. specific descriptive or inferential tests) that will be used 
and why the procedures are appropriate. For qualitative data, specify the proposed analytic approaches.]
We will use Research Electronic Data Capture (REDCap)45 for data collection and monitoring completion 
of study assessments. Datasets will be exported from REDCap and merged within SAS with cost-related 
data. PI Dr. Waring will supervise data management and quality control. We will use NVivo 11 (QSR 
International, Melbourne, Australia) to manage and analyze qualitative data and SAS 9.4 (SAS Inc, Cary, 
NC) to analyze quantitative data. 
Aim 1: Feasibility. We will examine the feasibility of recruitment (especially the proportion of women 
unwilling to be randomized to either condition), sustained participation, contamination, retention, and 
feasibility of assessment procedures, particularly measurement of cost-related data, in both treatment 
conditions. We will describe weight loss as an exploratory outcome.

Recruitment. Recruitment rates will be calculated from the number of patients approached and 
reasons for ineligibility and non-participation. We will report numbers and reasons for 
recruitment using a CONSORT diagram.46,47 

Sustained participation. We will calculate sustained participation as time to last intervention 
session attended in the IP condition and as time to last post, comment, or reaction (based on date 
of last post or comment reacted to) in the Facebook condition. In the Facebook condition, we will 
also calculate a secondary measure of sustained participation that includes last report of lurking.25 

Contamination. We will describe the proportion of participant in both treatment conditions who 
report participating in other weight loss programs (online or in-person), seeking weight loss 
support on Facebook or other online social networks44 at 6 months. We will also describe the 
extent of contamination and reasons women sought these extra sources of support using survey 
data and qualitative data from post-intervention focus groups. 

Retention. We will calculate retention as the proportion of participants who complete the 6- and 
12-month follow-up study visits in each condition and report this information using a CONSORT 
diagram46,47 

Feasibility of assessment procedures. We will examine the extent and mechanisms of missing 
data on each measure to be included in the subsequent non-inferiority trial. 

Weight loss. We will calculate percent weight change at 6 and 12 months by subtracting baseline 
weight from follow-up weights. We will define clinically significant weight loss as ≥5%.29,30 
Aim 2: Intervention refinement. In post-intervention focus groups, we will solicit women’s feedback on 
posts with low engagement, and will iteratively refine these posts to make them more engaging. We will 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 9 of 19
identify low- and high-engagement post using engagement data downloaded from Facebook. We will 
describe the total number of participant interactions (i.e., comments, reply-posts, and reactions) with 
counselor posts, overall and compare the number of interactions by post format (e.g., asking women to 
post a photo, informational without explicitly soliciting a response). We will also examine the number of 
comments/reply-posts and reactions separately, as post topics and formats may be differentially related to 
commenting versus reacting to posts.48 Following transcription of audio recordings of focus groups, Dr. 
Waring will lead a directed content analysis49 of responses to open-ended questions of how to make low-
engagement posts more engaging. We will also examine characteristics of posts that are rated as highly 
likely to engage women versus low-rated posts and will describe characteristics of posts that are judged as 
engaging (e.g., ask a question, include a picture) and a list of general characteristics of posts that are 
judged as not engaging (e.g., longer than 2 sentences, negative sentiment). Dr. Waring will develop an 
initial codebook based on the key questions in the focus group guide. We will revise the codebook to 
incorporate additional themes emerging during the initial review. The investigators will discuss initial 
results and finalize themes before final independent coding and consensus. We will calculate inter-rater 
reliability50 and will reach consensus on any discrepant coding through discussion. We will summarize 
women’s ratings of posts as mean (SD), or median (inter-quartile range) if ratings are not normally 
distributed.
Aim 3: Measuring time on Facebook. We will compare self-reported time spent on Facebook to 
participate in the intervention with application-tracked time on Facebook, changes in use, and time spent 
visibly engaging, to develop procedures for measuring time that balance accuracy and participant burden. 
We will compare self-reported time spent on Facebook to participate in the intervention with (1) 
application-tracked time spent on Facebook, (2) change in application-tracked time over the intervention, 
and (3) estimated time spent visibly engaging in the intervention using paired t-tests and Wilcoxon rank-
sum tests, as appropriate. We will also examine accuracy in reporting total time on Facebook at baseline 
and adjust self-reported time spent on Facebook to participate in the intervention accordingly. From these 
comparisons, we will develop procedures for measuring time spent on Facebook to participate in the 
intervention that maximize accuracy while not placing undue burden on participants nor changing their 
behavior as a result of surveilling their social media activities. 
Inclusion/Exclusion Criteria: [List ALL inclusion and exclusion criteria. Any proposed exclusion 
criterion based on gender (women of childbearing potential), age, or race must include justification for the 
exclusion. Describe the conditions under which participants may be removed from the study, i.e., 
noncompliance with study rules, study termination, etc.]
Only women will be included as the aim of this study is to refine a post-partum weight loss intervention.
Inclusion criteria. Women aged ≥18 years, 8 weeks to 12 months post-partum at enrollment, overweight 
or obese (BMI≥25 kg/m2) per measured height and weight at the baseline visit,  owns a scale (we will 
provide women with a scale if needed), comfortable reading and speaking English, owns an iPhone or 
Android smartphone, active Facebook user as defined as daily Facebook use and posts/comments at least 
weekly over the past 4 weeks, clearance from primary care provider or obstetrician/gynecologist, willing 
and able to participate in either treatment condition (Facebook or in-person), available to attend in-person 
meetings over the 6-month study period in Hartford, CT, 45 minutes or less to travel to intervention 
meetings, and willing and able to provide informed consent. 
Exclusion criteria. During screening procedures women who are key personnel on this study, a spouse, 
dependent, or relative of any key personnel, a UConn employee who reports to key personnel on this 
study, or a UConn student whom key personnel on this study teaches will be excluded from participation. 
Additionally, women who are currently pregnant or plans to conceive during the study period, current 
participation in a clinical weight loss program,  Type 1 or 2 diabetes, medical conditions or medications 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 10 of 19
affecting weight, incapable of walking ¼ mile without stopping, pain that prevents engagement in 
exercise, previous bariatric surgery, planned surgery during study period, plans to move out of the area 
during the study period, high depressive symptoms or suicidal ideation, positive screen for binge eating 
disorder (BED), failure to complete the baseline survey or orientation webinar. 
Participants will be withdrawn from the study if: they become pregnant, disrupt in-person groups, or 
repeatedly post inappropriate content on Facebook.
Potential Harms/Risks and Inconveniences: [Describe the potential risks to participants (and secondary 
participants, if applicable) and steps taken to minimize risks for each participant population.  Assess the 
likelihood of the risk occurring and, if it were to occur, the seriousness to the participant. Types of risks to 
consider include, but are not limited to: physical, psychological, social, legal, employment, and financial.  
Also describe any anticipated inconveniences the participants may experience (time, abstention from 
food, etc.).]
The possible risks of this study include an injury while being physically active, possible discomfort from 
completing questionnaires, and breach of confidentiality. Study activities do not differ from typical 
everyday activities of post-partum women (e.g., interacting with others on Facebook, using a mobile app, 
talking to other women) and/or activities done or recommended clinically and in line with national 
recommendations for weight loss during the post-partum period (e.g., eating a balanced nutritious diet, 
regular exercise, measurement of weight) and thus does not pose more than minimal risk/slight increase 
over minimal risk.
Participants will be screened for ability to engage in physical activity. Medical conditions 
preventing the increase of physical activity will be exclusionary. We will obtain medical 
clearance from each participant’s primary care provider (PCP) or obstetrician/gynecologist 
(OB/GYN) including clearance to participate in physical activity. Participants who experience 
discomfort will be asked to meet with their PCP /OBGYN prior to returning to physical activity. 
At the beginning of each study assessment, participants will be reminded that they do not have to answer 
any question they do not wish to, either in the focus group or surveys, and that they are free to leave at 
any time. The focus group leader will ask participants not to share information they learned about other 
participants during the group with others outside of the focus group. We will audio record the focus group 
discussion. We will ask participants to say their first name before she offers an opinion or answers a 
question. When we transcribe the audio recordings, we will remove participants’ name and enter study ID 
instead. All participant surveys will be completed via a secure web form via REDCap. Additional efforts 
to protect participant confidentiality are described below. 
For participants randomly assigned to the Facebook condition, information posted on Facebook is subject 
to Facebook’s terms of use and privacy policy, including terms of use for their website and mobile 
application. As all eligible participants already use Facebook, we will instruct participants to re-review 
these terms and the privacy policy. The Facebook group will be private (“secret”) and posts are only 
available to group members. We will ask participants not to post their locations or contact information 
when talking to other study participants. We will also ask participants not to disclose that they are in a 
research study to protect confidentiality of other participants and not to share posts of the Facebook group 
with people not in the group. Online social interactions will be monitored by study staff to help ensure the 
protection of privacy. Intervention counselors will log into Facebook daily to deliver the intervention, 
engage with participants, and monitor online social interactions.
We suggest My Fitness Pal as a tool to help participants track their dietary intake and physical activity. 
We will ask participants who have an Android phone to download a free, commercially available app and 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 11 of 19
report to us throughout the study how much time they are spending on Facebook. Information participants 
enter into an app or website or allow an app or website to access from their phone (such as My Fitness 
Pal) is subject to that company’s terms of use and privacy policy. We will instruct participants to review 
these terms and the privacy policy carefully before choosing to download and use the app or use the 
website. During the study, if we become aware of any changes made to applicable privacy policies, we 
will notify participants by email promptly that this has occurred and will encourage them to review their 
privacy settings. 
While not expected to be related to study participation, over the course of the study the research 
staff may become aware of depressive symptoms among our participants. The study assessment 
includes the Edinburgh Postnatal Depression Scale (EPDS), a screen for depressive symptoms for 
use during the post-partum period, and a modification of the SCID-I Binge Eating Disorder 
module. Elevated depressive symptoms, suicidal ideation, and positive screen for binge eating 
disorder are exclusionary. Research staff will alert participants that their scores make them 
ineligible to participate, and will let them know that when depression is very high, it’s best to 
focus on that first rather than focusing on multiple things such as depression plus weight loss. In 
the conversation for BED, we will let them know that the weight loss intervention is not an 
appropriate intervention because we don’t provide psychological help in the intervention, and 
receiving professional help, specifically cognitive behavioral therapy, will be more beneficial to 
them. We will offer to send a list of local resources to these participants. If suicidal ideation is 
present, the program director will call to assess safety and suggest professional help if needed as 
described below. Women who score 12 or greater (suggestive of high risk of clinical depression) 
and score negative on the EPDS suicide question (#10) will be encouraged to contact their 
provider to discuss their symptoms. After consulting with the PI, research staff will also contact 
the participant’s PCP/OBGYN and let her/him know that the participant’s score was suggestive 
of depression. Women who score positive on the EPDS suicide question (#10) will be considered 
at acute risk of injury or harm. In the unlikely event, the study PI Dr. Waring, clinical 
psychologist Co-I Dr. Pagoto, or project director Ms. Oleski will be contacted immediately and 
the participant will be assessed for the need for immediate referral for psychiatric evaluation. 
Urgent evaluation will be arranged for the participant as indicated, and the participants’ provider 
will be made aware of the situation. Staff will confirm participants’ contact information prior to 
each study follow-up assessment including contact information for their PCP/OBGYN. In the 
case that a participant’s EPDS score necessitates communication with her PCP/OBGYN and the 
participant reports not currently being under the care of either a PCP or an OBGYN, research 
staff will ask the participant whether she is being seen by another health care provider, and if so, 
ask the participant for contact information with the purpose of communicating with the provider 
about her depressive symptoms. In the case that the participant is not currently being seen by any 
health care provider, research staff will offer to send the participant information about mental 
health resources in her local area and will follow-up with the participant via phone and/or email 
until she has connected with a new healthcare provider, then contact the new provider per our 
protocol. Research staff will stop contacting participants after they have attempted to contact the 
participant on a maximum of 10 times over a maximum of 4 weeks. Participants will be made 
aware of this protocol in the original consent for the study. All referrals will be documented and 
reported to the study PI.
Inconveniences participants may experience include time spent to participate in the research. This 
includes time to travel to/from study assessments, and, for women randomized to the in-person 
condition, time to travel to/from the group meetings. We have planned study procedures to 
minimize the time needed by only collecting data needed to achieve study aims.
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 12 of 19
Participants may receive a benefit of weight loss, however since this is a research study this 
cannot be promised. If a participant expresses upset over lack of weight loss during the 
intervention period, research staff will encourage her to engage fully in the intervention and seek 
help from the counselor and other women in their group to make lifestyle changes supportive of 
weight loss. If a participant expresses upset with her weight loss following the intervention period, 
we will remind her that weight loss was not guaranteed, and encourage her to keep up with the 
healthy changes she made during the intervention or seek assistance with further weight loss from 
her PCP or OBGYN or by joining a formal weight loss program.
Benefits: [Describe anticipated benefits to the individual participants. If test results will be provided, 
describe and explain procedures to help participants understand the results. If individual participants may 
not benefit directly, state so here. Describe anticipated benefits to society (i.e., added knowledge to the 
field of study) or a specific class of individuals (i.e., athletes or autistic children).  Do not include 
compensation or earned course credits in this section.]
Participants may or may not benefit from participating in the trial. Benefits that could occur are losing 
weight through the exercise and lifestyle intervention. Results from this research will help refine the 
delivery of this intervention with the intent of increasing the efficacy of the intervention.
Risk/Benefit Analysis: [Describe the ratio of risks to benefits. Risks to research participants should be 
justified by the anticipated benefits to the participants or society. Provide your assessment of anticipated 
risks to participants and steps taken to minimize these risks, balanced against anticipated benefits to the 
individual or to society.]
This research does not involve more than minimal risk/slight increase over minimal risk. As 
described above, we will take steps to minimize these risks. Participants may derive direct benefit 
from participation. Additionally, results are intended to benefit future populations of post-partum 
women.
Economic Considerations: [Describe any costs to the participants or amount and method of 
compensation that will be given to them. Describe how you arrived at the amount and the plan for 
compensation; if it will be prorated, please provide the breakdown. Experimental or extra course credit 
should be considered an economic consideration and included in this section. Indicate when participants 
will receive compensation.]
Facebook, My Fitness Pal, and time-tracking apps we will recommend do not cost any money to use. We 
will encourage participants to check their data usage plan to ensure they are using the appropriate settings 
on their phone to minimize the use of their data so they don’t incur any charges due to any increased use 
of apps during participation in the study.
Participants will receive a $20 gift card after completing the baseline assessment (visit and 
survey) and a $40 gift card after completing each follow-up study assessment (6 months and 
12 months) to compensate them for their time, for a total of $100. Participants will be 
reimbursed up to $5 for parking or bus fare for each study visit (both conditions) and group 
intervention session (participants randomized to the in-person condition), as needed.
Data Safety Monitoring: [This is a prospective plan set up by the study investigators to assure that 
adverse events occurring during studies are identified, evaluated, and communicated to the IRB in a 
timely manner. Although the investigators initially propose a Data Safety Monitoring Plan (DSMP), the 
IRB must approve the plan and may require revision of the plan. A DSMP is required for all human 
studies at the University of Connecticut except for studies determined to be exempt from continuing IRB 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 13 of 19
review. For studies that present more than minimal risk to participants, the IRB will review and determine 
on a case-by-case basis whether a data safety monitoring board is most appropriate. Please refer to the 
IRB’s policy regarding data safety monitoring before completing this section - 
http://research.uconn.edu/policies-procedures. 
Issues that should be addressed in the DSMP include the following:
1.
frequency of the monitoring
2.
who will conduct the monitoring (Under UConn policy a student cannot be the sole person 
responsible for monitoring the data and safety of the protocol procedures)
3.
what data will be monitored (include compliance with approved IRB protocol)
4.
how the data will be evaluated for problems
5.
what actions will be taken upon the occurrence of specific events or end points
6.
who will communicate to the IRB and how communication will occur
7.
describe procedures to inform the sponsor
Sample response to issues listed above for minimal risk/slight increase over minimal risk – “Survey 
results will be monitored by the PI in conjunction with the student investigator once every two weeks 
(items 1, 2 and 3). Survey responses will be reviewed to monitor for clarity (i.e., the same question is 
skipped by 5 or more participants). In that case, the question will be revised and an amendment will be 
submitted to the IRB (items 4, 5 and 6).”
Every two weeks (item 1), the PI and research coordinator (item 2) will review survey responses 
and collection and storage of additional data (item 3) to insure compliance with study protocols 
(item 4). Any deviations to protocol or adverse event reported by participants will be reported to 
the IRB through the appropriate process via InfoEd (item 5) by the PI (item 6), and we will 
submit an amendment if appropriate (item 5). The report of adverse events is built into our 
tracking database. Staff will assess the presence of adverse events during all participant contacts. 
We will report to NIH any serious unanticipated harms or unexpected threat to privacy as 
appropriate (item 7). We will convene a Data Safety and Monitoring Board (DSMB) to monitor 
the safety of participants throughout the proposed research, in particular for the occurrence of 
adverse events (both serious and otherwise). See attached grant proposal section 6 (pages 30-31).
Privacy/Confidentiality Part 1: [Explain how the privacy interests of participants will be 
maintained during the study (note that privacy pertains to the individual not to the data). Describe how 
data will be coded. Do not use the any potentially identifiable information such as initials of participants 
as part of the code. If identifiable, sensitive information (illegal drug use, criminal activity, etc.) will be 
collected, state whether a Certificate of Confidentiality will be obtained. Be sure to state whether any 
limits to confidentiality exist and identify any external agencies (study sponsor, FDA, etc.) that will have 
access to the data. If participants will be screened, describe the plans for storage or destruction of 
identifiable data for those that failed the screening.]
Each participant will be assigned a unique study ID number that does not include any potentially 
identifiable information such as initials as part of the code. We will ask participants not to share 
information they learned about other participants during the group with others outside of the 
group. Investigators and research staff undergo training to help participants feel at ease with the 
study and to understand how their information will be protected. The research team will not 
access information about a participant after data have been collected except on an as-needed basis 
(such as to correct a telephone number).
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 14 of 19
During the study, should the research team become aware of any changes made to the privacy 
policies of Facebook, My Fitness Pal, or any time-tracking app recommended, research staff will 
notify participants that the policy has been updated and will encourage participants to review their 
privacy settings. The private (secret) Facebook group will be deleted by research staff 6 months 
after the last post or reply posted by a research participant. Photographs uploaded to Facebook by 
participants during the study will be accessible to participants as with any photo they upload to 
Facebook; research staff will not download participant photographs from Facebook when 
capturing engagement data. 
Data from ineligible participants: Contact information will be stored in a file with an indication that they 
are not eligible and reason(s) for ineligibility. After enrollment is complete, data collected from the 
screening, including reason ineligible, will be stored in a de-identified dataset.
The identified data will be kept in a locked cabinet and/or electronically using password-
protected and encrypted files. Any study documents containing identifying information or other 
sensitive data will be transported in a lockbox. Data from paper forms (e.g., eligibility screeners, 
contact information sheet, Facebook post rating forms) will be entered by research staff into 
REDCap. Study documents will be retained for at least 3 years after the completion of the 
research as required by Federal regulations. Downloaded datasets will be kept on password-
protected research drive accessible only by appropriate research staff. Study documentation will 
be kept on password-protected research drives and/or locked filing cabinets in the PI’s office. The 
link between identifiable information will be maintained in a REDCap database. Access to the 
REDCap database will be limited only to appropriate research staff. The link between identifiable 
information and de-identified study data will be deleted after all study procedures are completed 
and permanent de-identified study datasets have been created. The PI is responsible for the 
management of data.
Research staff will transcribe focus group discussions. During transcription of focus group 
audio recordings, participants’ names will be replaced with an identification number to 
permit linking of statements with de-identified survey data. Uniquely identifying statements 
(e.g., names of people or companies) will be masked during transcription. After the 
recordings have been checked for accuracy they will be deleted. Interview transcripts will be 
stored on a password-protected research drive accessible only be appropriate research staff. 
When the research results are published or discussed in conferences, manuscripts or grants, 
no information will be included that reveals patient identity.
The following security protocols will also be applied to all data: physical protections -- all 
recordings and data will be stored on secure servers behind firewalls. All hard copy files will be 
locked in secure cabinets; logical protections – all recordings and data will be password protected 
and/or encrypted; and access protections – access will be granted to data on a need to know basis 
only. All records consisting of personal identifiers will be destroyed upon completion of the study 
by shredding of the hard paper copy, redacting the PHI/PII from the hard paper copy, and/or 
destruction of the electronic files.
Privacy/Confidentiality Part 2: Complete the Data Security Assessment 
Form: [This form IS REQUIRED for ALL studies. The form is available here - 
http://research.uconn.edu/irb/irb-forms-infoed/. This form will be used to assess procedures for 
protecting confidentiality of data collected during the study and stored after closure. It will also be 
used to assess plans for storage and security of electronic data in accordance with University Best 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 15 of 19
Practices. Review the document proving tips to complete the form located at 
http://content.research.uconn.edu/pdf/storrs/rcs/irb/TipsDataSecurityAssessmentForm.docx. 
The Data Security Assessment Form is enclosed.
Informed Consent
As PI, you are responsible for taking reasonable steps to assure that the participants in this study 
are fully informed about and understand the study.  Even if you are not targeting participants from 
“Special Populations” as listed on page 4, such populations may be included in recruitment efforts. 
Please keep this in mind as you design the Consent Process and provide the information requested 
in this section.
Consent Setting: [Describe the consent process including who will obtain consent, where and when will 
it be obtained, and how much time participants will have to make a decision. Describe how the privacy of 
the participants will be maintained throughout the consent process. State whether an assessment of 
consent materials will be conducted to assure that participants understand the information (may be 
warranted in studies with complicated study procedures, those that require extensive time commitments or 
those that expose participants to greater than minimal risk).]
During eligibility screening, study staff will describe the study and answer any questions about 
participation. This process is intended to ensure that they understand the procedures, risks, and benefits 
involved in study participation. The consent process will take place at the baseline assessment. Ample 
time will be allowed for discussion or questions. Participants will be given enough time as needed to 
review the consent form and ask any questions prior to signing. Prior to signing the consent form, we will 
provide a verbal review of the consent form and allow time for questions to make that the participant 
understands all sections on the form and all aspects of study participation. This verbal review and 
questions will occur during screening, and we will provide the participant a copy of the consent form in 
advance of the baseline assessment either in hard-copy or via email. Before signing, research staff will 
verbally review the consent again and answer any questions before asking participants to sign. On the last 
page of the consent form the participant and the research staff member obtaining the consent will sign and 
date the form. We will ask participants to sign two copies of the consent form; following staff signature, 
we will provide participants with one of these copies.
Capacity to Consent: [Describe how the capacity to consent will be assessed for participants with 
limited decision-making capacity, language barriers or hearing difficulty. If a participant is incapable of 
providing consent, you will need to obtain consent from the participant’s legal guardian (please see the 
IRB website for additional information).]
All participants must be capable of providing informed consent. Eligible individuals must be able 
to complete the eligibility screening process in English and must endorse that they feel 
comfortable reading and writing in English in order to participate. The screening and consent 
process will include discussion of what participating in the study involves, including risks and 
benefits. If research staff conducting eligibility screening or obtaining informed consent has 
concerns about an individual’s ability to understand the study or her decision-making capacity, the 
case will be discussed with the PI who will determine whether the exclude the individual from 
participation on this basis. 
Parent/Guardian Permission and Assent: [If enrolling children, state how many parents/guardians will 
provide permission, whether the child’s assent will be obtained and if assent will be written or oral. 
Provide a copy of the script to be used if oral assent will be obtained.]
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 16 of 19
N/A.
Documentation of Consent: [Specify the forms that will be used for each participant population, i.e., 
adult consent form, surrogate consent form, child assent form (written form or oral script) or an 
information sheet. Copies of all forms should be attached to this application in the same format that they 
will be given to participants (templates and instructions are available on the IRB website).]
Written informed consent will be obtained. The consent form is enclosed. 
Waiver or Alteration of Consent: [The IRB may waive or alter the elements of consent in some 
minimal risks studies. If you plan to request either a waiver of consent (i.e., participants will not be asked 
to give consent), an alteration of consent (e.g., deception) or a waiver of signed consent (i.e., 
participants will give consent after reading an information sheet), please answer the following questions 
using specific information from the study:]
Waiver (i.e. participants will not be asked to give consent) or alteration of consent (e.g. use of deception 
in research):

Why is the study considered to be minimal risk?

How will the waiver affect the participants’ rights and welfare? The IRB must find that participants’
rights are not adversely affected. For example, participants may choose not to answer any questions
they do not want to answer and they may stop their participation in the research at any time.

Why would the research be impracticable without the waiver? For studies that involve deception,
explain how the research could not be done if participants know the full purpose of the study.

How will important information be returned to the participants, if appropriate? For studies that
involve deception, indicate that participants will be debriefed and that the researchers will be
available in case participants have questions.
Waiver of signed consent (i.e. participants give consent only after reading an information sheet):

Why is the study considered to be minimal risk?

Does a breach of confidentiality constitute the principal risk to participants? Relate this to the risks
associated with a breach of confidentiality and indicate how risks will be minimized because of the
waiver of signed consent.

Would the signed consent form be the only record linking the participant to the research? Relate this
to the procedures to protect privacy/confidentiality.

Does the research include any activities that would require signed consent in a non-research setting?
For example, in non-research settings, normally there is no requirement for written consent for
completion of questionnaires.
We request a waiver of written consent to conduct eligibility screening. We will obtain verbal 
consent to conduct eligibility screening. Following eligibility screening, eligible individuals who 
indicate that they wish to participate in the research study will be asked for their full names, phone 
number, and email address. Staff will inform participants that we call and/or email them the day 
before their baseline assessment to remind them of appointment and confirm that they intend to 
attend, and that we plan on leaving a message if we do not reach them by phone. Participants may 
choose not to provide a phone number or email address if they do not wish to, or may request that 
we not leave a message on the phone’s voicemail or answering machine. 
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 17 of 19
Why is the study considered to be minimal risk? The probability and magnitude of harm or discomfort 
anticipated from the screening process is not greater than those ordinarily encountered in daily life or 
during the performance of routine psychological examinations or tests.
How will the waiver affect the participants’ rights and welfare? Individuals may choose to not answer any 
eligibility screening questions they do not want to answer and may stop their participation in the 
eligibility screening at any time. However, all questions on the eligibility screener are required to 
determine eligibility for participation, so individuals who choose not to answer all questions will be 
excluded from further participation. 
Why would the research be impracticable without the waiver? Given the study procedures, it would not 
be practical to obtain written informed consent before screening interested individuals for eligibility. 
How will important information be returned to the participants, if appropriate? Following eligibility 
screening, we will ask ineligible individuals whether we may keep their answers to the eligibility 
screening questions. If they decline, we will destroy their information. See enclosed eligibility screener.
References / Literature Review:  
1.
Gunderson EP, Quesenberry CP, Jr., Lewis CE, et al. Development of overweight associated with 
childbearing depends on smoking habit: The Coronary Artery Risk Development in Young 
Adults (CARDIA) Study. Obes Res. 2004;12(12):2041-2053.
2.
Endres LK, Straub H, McKinney C, et al. Postpartum weight retention risk factors and 
relationship to obesity at 1 year. Obstet Gynecol. 2015;125(1):144-152.
3.
Rooney BL, Schauberger CW, Mathiason MA. Impact of perinatal weight change on long-term 
obesity and obesity-related illnesses. Obstet Gynecol. 2005;106(6):1349-1356.
4.
Pi-Sunyer FX. Medical hazards of obesity. Ann Intern Med. 1993;119(7 Pt 2):655-660.
5.
American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 549: 
obesity in pregnancy. Obstetrics and Gynecology. 2013;121(1):213-217.
6.
Catalano P, deMouzon SH. Maternal obesity and metabolic risk to the offspring: why lifestyle 
interventions may have not achieved the desired outcomes. Int J Obes (Lond). 2015;39(4):642-
649.
7.
Gore SA, Brown DM, West DS. The role of postpartum weight retention in obesity among 
women: a review of the evidence. Ann Behav Med. 2003;26(2):149-159.
8.
Gould Rothberg BE, Magriples U, Kershaw TS, Rising SS, Ickovics JR. Gestational weight gain 
and subsequent postpartum weight loss among young, low-income, ethnic minority women. Am J 
Obstet Gynecol. 2011;204(1):52 e51-11.
9.
Amorim Adegboye AR, Linne YM. Diet or exercise, or both, for weight reduction in women after 
childbirth. Cochrane Database Syst Rev. 2013;7:Cd005627.
10.
Montgomery KS, Bushee TD, Phillips JD, et al. Women's challenges with postpartum weight 
loss. Matern Child Health J. 2011;15(8):1176-1184.
11.
Carter-Edwards L, Ostbye T, Bastian LA, Yarnall KS, Krause KM, Simmons TJ. Barriers to 
adopting a healthy lifestyle: insight from postpartum women. BMC Res Notes. 2009;2:161.
12.
Groth SW, David T. New mothers' views of weight and exercise. MCN Am J Matern Child Nurs. 
2008;33(6):364-370.
13.
Mailey E, Huberty J, Dinkel D, McAuley E. Physical activity barriers and facilitators among 
working mothers and fathers. BMC Public Health. 2014;14(1):657.
14.
Graham M, Uesugi K, Olson C. Barriers to weight-related health behaviours: a qualitative 
comparison of the socioecological conditions between pregnant and post-partum low-income 
women. Matern Child Nutr. 2014.
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 18 of 19
15.
Evenson KR, Aytur SA, Borodulin K. Physical activity beliefs, barriers, and enablers among 
postpartum women. J Womens Health (Larchmt). 2009;18(12):1925-1934.
16.
Chang M-W, Nitzke S, Guilford E, Adair CH, Hazard DL. Motivators and Barriers to Healthful 
Eating and Physical Activity among Low-Income Overweight and Obese Mothers. Journal of the 
American Dietetic Association. 2008;108(6):1023-1028.
17.
Ramsey SD, Willke RJ, Glick H, et al. Cost-effectiveness analysis alongside clinical trials II-An 
ISPOR Good Research Practices Task Force report. Value Health. 2015;18(2):161-172.
18.
Ritzwoller DP, Sukhanova A, Gaglio B, Glasgow RE. Costing behavioral interventions: a 
practical guide to enhance translation. Ann Behav Med. 2009;37(2):218-227.
19.
Hutchesson MJ, Hulst J, Collins CE. Weight management interventions targeting young women: 
a systematic review. Journal of the Academy of Nutrition and Dietetics. 2013;113(6):795-802.
20.
Chasan-Taber L, Silveira M, Waring ME, et al. Gestational Weight Gain, Body Mass Index, and 
Risk of Hypertensive Disorders of Pregnancy in a Predominantly Puerto Rican Population. 
Matern Child Health J. 2016.
21.
Duggan M, Lenhart A, Lampe C, Ellison NB. Parents and Social Media. 2015; 
http://www.pewinternet.org/2015/07/16/parents-and-social-media/.
22.
Duggan M. Mobile Messaging and Social Media - 2015. 2015; 
http://www.pewinternet.org/files/2015/08/Social-Media-Update-2015-FINAL2.pdf.
23.
Owens JC. People spend more time with Facebook than actual friends 2016; 
http://www.marketwatch.com/story/people-spend-more-time-with-facebook-friends-than-with-
actual-friends-2016-04-27. Accessed 14 June 2016.
24.
Holtz B, Smock A, Reyes-Gastelum D. Connected Motherhood: Social Support for Moms and 
Moms-to-Be on Facebook. Telemedicine journal and e-health : the official journal of the 
American Telemedicine Association. 2015;21(5):415-421.
25.
Merchant G, Weibel N, Patrick K, et al. Click "like" to change your behavior: a mixed methods 
study of college students' exposure to and engagement with facebook content designed for weight 
loss. Journal of medical Internet research. 2014;16(6):e158.
26.
Napolitano MA, Hayes S, Bennett GG, Ives AK, Foster GD. Using Facebook and text messaging 
to deliver a weight loss program to college students. Obesity (Silver Spring, Md). 2013;21(1):25-
31.
27.
Herring SJ, Cruice JF, Bennett GG, Davey A, Foster GD. Using Technology to Promote 
Postpartum Weight Loss in Urban, Low-Income Mothers: A Pilot Randomized Controlled Trial. 
Journal of nutrition education and behavior. 2014.
28.
Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes 
with lifestyle intervention or metformin. The New England journal of medicine. 2002;346(6):393-
403.
29.
Mertens IL, Van Gaal LF. Overweight, obesity, and blood pressure: the effects of modest weight 
reduction. Obes Res. 2000;8(3):270-278.
30.
Wing RR, Lang W, Wadden TA, et al. Benefits of modest weight loss in improving 
cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes 
Care. 2011;34(7):1481-1486.
31.
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. 
J Psychiatr Res. 2011;45(5):626-629.
32.
Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res 
Methodol. 2010;10:1.
33.
Carter EB, Stuart JJ, Farland LV, et al. Pregnancy Complications as Markers for Subsequent 
Maternal Cardiovascular Disease: Validation of a Maternal Recall Questionnaire. J Womens 
Health (Larchmt). 2015;24(9):702-712.
34.
Institute of Medicine (IOM) and National Research Council (NRC). Weight Gain During 
Pregnancy: Reexamining the Guidelines. The National Academies Press;2009. 9780309131131.
UConn IRB Protocol H17-206 Approved August 10, 2020

Page 19 of 19
35.
Dewitt B, Feeny D, Fischhoff B, et al. Estimation of a Preference-Based Summary Score for the 
Patient-Reported Outcomes Measurement Information System: The PROMIS((R))-Preference 
(PROPr) Scoring System. Medical decision making : an international journal of the Society for 
Medical Decision Making. 2018;38(6):683-698.
36.
Hanmer J, Dewitt B, Yu L, et al. Cross-sectional validation of the PROMIS-Preference scoring 
system. PloS one. 2018;13(7):e0201093.
37.
Grummer-Strawn LM, Scanlon KS, Fein SB. Infant feeding and feeding transitions during the 
first year of life. Pediatrics. 2008;122 Suppl 2:S36-42.
38.
Lakshman RR, Landsbaugh JR, Schiff A, Hardeman W, Ong KK, Griffin SJ. Development of a 
questionnaire to assess maternal attitudes towards infant growth and milk feeding practices. Int J 
Behav Nutr Phys Act. 2011;8:35.
39.
Buysse DJ, Reynolds CF, 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality 
Index: a new instrument for psychiatric practice and research. Psychiatry research. 
1989;28(2):193-213.
40.
Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh Sleep Quality Index. 
Journal of psychosomatic research. 1998;45(1):5-13.
41.
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item 
Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150:782-786.
42.
Hwang KO, Ottenbacher AJ, Lucke JF, et al. Measuring social support for weight loss in an 
internet weight loss community. J Health Commun. 2011;16(2):198-211.
43.
Gesell SB, Barkin SL, Sommer EC, Thompson JR, Valente TW. Increases in Network Ties Are 
Associated With Increased Cohesion Among Intervention Participants. Health Educ Behav. 2015.
44.
Smith A. Mobile Access 2010. 2010; 
http://www.pewInternet.org/~/media//Files/Reports/2010/PIP_Mobile_Access_2010.pdf.
45.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data 
capture (REDCap)--a metadata-driven methodology and workflow process for providing 
translational research informatics support. J Biomed Inform. 2009;42(2):377-381.
46.
Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting 
randomized trials: explanation and elaboration. Annals of Internal Medicine. 2001;134(8):663-
694.
47.
Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated 
guidelines for reporting parallel group randomised trials. BMJ (Clinical research ed). 
2010;340:c869.
48.
Rus HM, Cameron LD. Health Communication in Social Media: Message Features Predicting 
User Engagement on Diabetes-Related Facebook Pages. Annals of behavioral medicine : a 
publication of the Society of Behavioral Medicine. 2016.
49.
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 
2005;15(9):1277-1288.
50.
Hallgren KA. Computing Inter-Rater Reliability for Observational Data: An Overview and 
Tutorial. Tutor Quant Methods Psychol. 2012;8(1):23-34.
UConn IRB Protocol H17-206 Approved August 10, 2020