Developing an Effective Online Social Network for Weight Loss
Phase: NA
Conditions: Weight Loss
Sponsor: University of Connecticut

2/3/2021 
IRB Protocol 
Study Title: “Facebook and Friends” Developing an Effective Online Social Network for Weight Loss
NCT02656680 

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IRB-1 Study Protocol
Protocol Version # and/or Date:  12/28/2020
Study Protocol Title: Developing an Effective Online Social Network for Weight Loss
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.
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, when applicable, previous work in animal and/or 
human studies.  Provide previous UConn protocol number, if applicable.]
Please note that the aim for this protocol falls under aim 3 in the grant application. Furthermore, this aim has had 
an NIH-approved revision since the original application. Dr. Pagoto is a paid consultant for Fitbit, Inc.
In addition, this protocol aligns with all 160 randomized participants in aim 3. 
Evidence-based lifestyle interventions are intensive, requiring multiple face-to-face visits over the course of 6-
months up to 2 years.1,2 Unfortunately, such interventions have not been widely implemented due to intensity and 
expense. Research shows that reducing intervention intensity (i.e., the number of visits/contact time) inevitably 
reduces weight loss outcomes.3 Inexpensive means of reducing intensity while preserving efficacy are needed to 
make a brief counseling model work.
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.
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Technology-Based Solutions:  Promising But More Data Needed In recent years, technology has been leveraged 
in various ways to change health behavior.4 Mobile technology is being applied to weight loss, although 
commercialization is far ahead of the science.  In a systematic review of mobile phone-based weight loss 
interventions, only 4 randomized trials were found.5 Three utilized text-messaging as an adjunct to other features 
including websites, counseling, and print materials. The two trials that integrated text-messaging with counseling 
had larger weight losses (4-4.5 kg) than the one that did not (1.5 kg), suggesting that technology may not entirely 
take the place of personal contact. The fourth trial tested a mobile phone-based dietary game designed to teach 
people about nutrition and weight loss. Findings revealed very modest weight loss (1.9 kg).  Surprisingly few 
NIH-funded studies of mobile-based weight loss interventions are underway.  More research is clearly needed to 
determine how to utilize mobile technology (beyond text messaging) to reduce the intensity of effective lifestyle 
interventions.
Commercial Mobile Applications are Plentiful But Reflect A Narrow Range of Behavioral Strategies. According 
to our recently published systematic review,6 commercial mobile apps for weight loss primarily include self-
monitoring and goal-setting (see Preliminary Studies section), but lack other key strategies frequently employed 
in behavioral weight loss interventions, such as stimulus control, nutrition education, problem solving, reducing 
negative thinking, stress management, social support, and relapse prevention.7 The focus of commercial weight 
loss apps on self-monitoring might limit their ability to improve upon traditional methods given a recent study 
showing that using mobile phones for dietary self-monitoring is no more effective at reducing caloric intake than 
paper-and-pencil methods.8 Without more interactive and “intelligent” capabilities that help patients overcome 
weight loss challenges, commercial apps are likely only going to benefit highly motivated individuals. Additional 
features may be needed for individuals who do not respond to self-monitoring and goal setting alone.
Why Self-Monitoring Is Not Enough In a Mobile Application. We tested a mobile application that includes self-
monitoring of diet/weight/physical activity, goal-setting, and social support. We found that such a mobile 
application when combined with a brief behavioral weight loss intervention did not improve upon the efficacy of 
a weight loss intervention that used traditional approaches to these strategies (e.g., paper and pencil diet records) 
(See Preliminary Studies section). We found that groups were alike in terms of the quantity and quality of 
problems they encountered as they tried to lose weight and the mobile application did not offer anything unique in 
terms of addressing the problems that arose. We then surveyed 11 professionals with experience delivering weight 
loss interventions, asking them to name the top weight loss challenges their patients report. The 3 most highly 
cited challenges were: finding time to exercise, resisting temptations, and stress. Of 77 responses, only 1 pertained 
to self-monitoring difficulties, which suggests that a mobile application that addresses a broad range of challenges 
could be useful.
Which Behavioral Strategies Are Conducive to Technology Delivery?  Stimulus control, problem solving, and 
social support are three behavioral strategies that have high potential for technology delivery. Stimulus control 
involves awareness and control of cues that trigger problematic behavior. Mobile technology can assist in this 
process by helping to identify cues and delivering intervention when cues are present. Problem solving is a 
systematic, iterative process by which 1) the patient is asked to identify problems that arise in relation to a 
particular goal, 2) solutions are brainstormed, 3) a solution is selected by the patient, 4) a plan is made to attempt 
the solution, and 5) the outcome is evaluated and other solutions are tried if necessary until the problem is solved. 
Mobile technology may be programmed to facilitate this process. Social networks may also assist problem solving 
by giving participants a venue in which to voice problems and share solutions at any time of the day or week. 
Finally, social support can be facilitated via social networks to the extent that users are connected to others who 
share common goals and experience. 
This study has several innovations that have the potential to shift current research and clinical paradigms forward. 
Online social networking in general is a novel, understudied weight loss tool. The 3 aims of the grant explore 3 
approaches to delivering these traditional behavioral strategies via technology. This current protocol represents 
aim 3: We will conduct two pilot randomized trials of 80 overweight and obese participants each to test the 
feasibility of a behavioral weight loss program delivered entirely via Facebook. The trials will be iterative, with 
findings from the first informing the intervention for the second. In the first, participants will be randomized to a 
condition which allows them to invite their Facebook friends who want to lose weight to the group if they so 
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choose, or a condition that only includes the original study participants.  Feasibility outcomes include engagement 
(frequency of likes/posts/comments, number of completed days of tracking), retention, acceptability, number of 
friends invited and weight loss. Post-intervention focus groups will gather feedback on the program. Baseline 
measures of gender, age, social media/technology experience, depression, and social anxiety will be used to 
predict social network acceptability, usage rates, and weight loss in the social networking condition.
 
The PI has extensive experience with behavioral weight loss interventions. In addition to 3 large RCTs she 
successfully adapted the DPP into a clinical program at UMass. She also implemented a behavioral weight loss 
program in a community mental health setting. 
Lifestyle Intervention in Co-Morbid Obesity and Depression. (R01 MH078012-02; PI: Pagoto). This 
randomized trial compared the effect of behavioral activation for depression plus behavioral weight loss 
intervention (BA) to behavioral weight loss intervention alone (BWL) on weight loss in 161 women with co-
morbid depression and obesity. Analyses revealed no differences between conditions in weight change at 6-
months (BA= -3.0%, SE= 0.66%; BWL= -3.6%, SE =0.62%; p =0.51) or 12-months (BA= -2.6%, SE=0.78%; 
BWL= -3.0%, SE=0.74%; p=0.71). However, the BA condition evidenced  greater improvement in Beck 
Depression Inventory-II scores at 6-months (BA mean change= -12.5, sd= .8; BWL mean change= -9.2, sd= .8; 
p=0.004) and 12-months (BA mean change= -12.6, sd= 1.0; BWL mean change= 9.6, sd= .9; p 
=0.045).  Retention rates at 6-months and 12-months were 90% and 85%, respectively.  
Translating the DPP Lifestyle Intervention into a Hospital-Based Weight Loss Program. Dr. Pagoto helped 
launch a group-based clinical weight loss program based on the DPP that has now been running for 7 years. The 
first 118 consecutive patients enrolled in the 16-week Core phase of the program lost an average of 4.5% (sd = 
3.5).  Mean attendance rate was 82%.
We plan to conduct a pilot randomized trial of a behavioral weight loss intervention with and without the social 
network to evaluate feasibility. Social network interactions will be content analyzed to identify the types that 
predict adherence and weight loss. We will also determine which individual difference factors predict who is 
most/least likely to benefit from online social networks. Finally, we will build a theoretical model of social 
support by evaluating to what extent 4 different social processes are associated with weight loss. We are 
comparing 2 conditions per wave in this study (there are 2 waves). Wave 1 includes randomization to: Facebook 
plus Friends (FB+friends) and Facebook without Friends (FB w/o friends). Wave 2 includes randomization to 
Facebook plus (FB+) and Facebook without (FB w/o).
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.
The total number of subjects that will be enrolled into the intervention will be 160. If each of the 40 participants 
randomized to FB+Friends condition invite 10 friends each that will increase the enrollment number to 560, 
however it is impossible to predict how many invites will come from each person since it is unlimited. It is 
estimated that we will screen 2000 participants to achieve the initial enrollment goal. Since the initial contact is 
via an online link, there will be many incomplete responses driving up the number of screened-out participants. 
The number of friends that these participants invite to the group is unknown since some may not invite any at all 
while others may invite as many as they wish. The FB+ condition will have a subset of approximately 70 
participant allowed into the group post-randomization. Given the 2000 participants needed to screen in order to 
achieve 160 randomized, the approximation of 400 invited friends and up to 70 post-randomized participants the 
total enrolled could be 2,470.
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 
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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 sample size was determined based on a balance between having a sufficient number of individuals to assess 
the feasibility of the intervention and resources allotted for the grant mechanism.
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.]  
We are recruiting men and women overweight or obese of all ethnicities, income and education levels between the 
ages of 18 and 65 in the United States. 
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.]
We will be recruiting overweight individuals between the ages of 18 and 65 from anywhere in the US. UConn 
students and employees may be enrolled if they meet eligibility requirements and are interested in completing the 
study. Since it is not essential that we recruit students and employees directly reporting to key personnel on this 
project, we will exclude them from participation. 
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
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.]  
A survey link will be included with our recruitment materials. Participants will be instructed to complete the 
survey to be considered for the study and will be recruited using the following online strategies:
-
Electronic  recruitment: online, Facebook, Twitter, newsletters, intranet messages, emails; 
-
Connect with large businesses to get our ad and/or flyer e-mailed to their staff and students;
-
Research Match (https://www.researchmatch.org/) volunteer database, as well as any other volunteer 
databases that are discovered during recruitment.
The friends that are invited to join the FB+friends Facebook group by their friends will be invited via a Facebook 
invite button.
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.]  
Participants will complete screening procedures online and over the phone since they may be located anywhere in 
the US, not just local. We will post online recruitment ads which will contain a link to an online survey containing 
the initial screening questions. The survey will first have a description of the study and will then have the 
eligibility questions. If they are eligible to proceed they will be contacted by the study team to book a telephone 
screening call. The next step in the screening process is to complete a set of online screening surveys including 
weight, height, physical activity, and social networking use. We will not require PCP approval since we assess 
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exclusionary medical conditions in the initial screening survey. If conditions are reported, during either of these 
two assessments that might put the participant at risk during the intervention, they will be excluded.
Before participants are randomized, they must complete an 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. After completion of the webinar, 
participants will receive a final email asking if they are willing to participate in the intervention.  For the post-
randomized participants in the FB+ condition, they will listen to the webinar during the screening call to expedite 
the process of getting them into the Facebook group. They will then receive the final email after they have 
completed their baseline survey. This will be mandatory in order to enter the group.  The webinar moderator will 
record in REDCap tracking which participants completed the webinar. 
Participants will need to complete the initial screening survey, telephone screening, a baseline survey, and 
orientation webinar before being enrolled into the intervention. 
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.]
Study design: Participation starts with an initial survey, telephone screening, and screening surveys. Eligible 
participants will then complete a webinar, 16-week intervention, and an end-of-study focus group and follow/up 
survey.
Randomization: Upon completion of all screening measures and webinar, participants in wave 1 will be 
randomized either: 1) a Facebook group allowing the invite of their friends (FB+friends); or 2) a Facebook group 
including only study participants (FB w/o friends). Participants in wave 2 will be randomized to either: 1) a 
Facebook group allowing additional participants between the weeks of 1-8 (FB+); or 2) a Facebook group 
including only the original group of 40 participants (FB w/o). The participants added during the weeks of 1-8 will 
not be randomized. They will follow the same screening process, but will be automatically assigned to FB+. 
Participants in wave 1 will be randomized 1:1 to the two study conditions in randomly permuted blocks of size 4 
and 6 using the ralloc program in Stata Randomization and will be stratified by gender (male vs. female) and 
baseline BMI (27.0-34.9 vs. 35.0-45.0). The randomization list was generated at the start of the study before 
randomization. The list is managed by the program director. Wave 2 will be randomized using the same 
stratification, using REDCap. Once a participant has been determined to be eligible, the program director will 
assign each participant to the next open assignment on the list. The program director will then tell the research 
assistant who will reach out to participants to inform them via e-mail of the condition assignment.  
FB+friends invite details: If they are assigned to the group including their friends, they have the opportunity to 
invite their friends to participate in the weight loss group if they are interested in losing weight as well. They will 
not have a limit as to how many friends they can invite. Facebook has a feature which will allow anyone to invite 
friends into a group. The private group for this condition is set to only let the admin (study staff) approve the 
friend-invite request.  The friends that are invited will not undergo the same procedures as the FB+friends study 
participants, but we will provide them with an informational sheet and collect minimal data from them.
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First, the participant will invite their friend into the group using the Facebook invite feature. Next, approval will 
remain pending until the admin e-mails the friend a survey that includes: an informational sheet, demographics, 
interest in losing weight, and a self-reported weight. Email is obtained by messaging the invited friend for their 
email. If that doesn’t work we will ask the friend who invited the participant. Once the survey is received, the 
admin will approve the invite. The admin will only e-mail the friend once to limit intrusion if they are not 
interested in joining the group.
The data that we’ll collect from friends includes:  demographics, interest in losing weight, self-reported weight 
when they join and at the end of the study, and their engagement data in the group.  They will not complete the 
same measures as the other conditions, or report weekly weight, or attend a focus group.
Intervention (16 weeks): 
Participants will receive a Fitbit scale to take their weight weekly and at follow-up. Weight is logged directly 
from the Fitbit scale to the participants’ Fitbit account. Participants will be asked to set up a Fitbit account for the 
study and share login with the study staff so that the staff can record the weight taken. At the end of the study 
participants will be allowed to keep their scale and instructed to change their password. If they already have a 
Fitbit account and choose not to create a 2nd one for the study, they may choose to share that login with the study 
staff. This method will allow for a standard weight measure for each participant with a higher level of accuracy 
than self-reported weight. 
All participants will receive weight loss counseling based on the Diabetes Prevention Program 
(https://www.cdc.gov/diabetes/prevention/lifestyle-program/curriculum.html) lasting 16 weeks and delivered 
online in a private Facebook group. The DPP content has been adapted to be delivered in an online setting. 
Participants will receive tips and guidance related to the intervention through Facebook posts in the private group. 
The goals for the intervention are a 7% weight loss and 175 minutes of moderate physical activity per week. Each 
participant will get an individualized calorie goal that would facilitate a 1-2 lb weight loss weekly. The Facebook 
group privacy settings will be set to the “secret” setting.  The group leader/coach will also counsel participants 
toward achieving and maintaining the exercise goal. 
We will also offer some optional fun activity-related activities such as: notifying participants of virtual walks, 
races, and health fairs; or staff sending out “challenges” for participants to try such as running a 5K race. Staff 
will post a “featured participant” each week if participants volunteer to be a featured participant. We would have a 
post with the participant’s picture and their story about why they want to lose weight, what they like, and anything 
else they would like to share.
Participants will also be encouraged complete diet and activity tracking using a tracker of their choice, such as 
MyFitnessPal. They may also share their diary with the interventionist to receive individualized feedback.
Focus Group Follow-up:
A focus group will occur in a conference call setting in the 17th week after the start of the intervention. The focus 
group will last for approximately 60 minutes and will include a discussion about likes and dislikes of the 
intervention. All focus groups will be conducted via conference call including 1-5 participants on each call. Any 
participants who are unable to attend the focus group will receive the focus group questions through an e-mailed 
survey. We will e-mail the survey twice. At the time of the 2nd e-mail, we will also call them to let them know to 
check their e-mails. If there is no response from the participant after the 2nd e-mail, we will make no further 
attempts to contact them.
Participants will also receive an online follow-up survey in the 17th week, which will be a repeat of the screening 
measures and a feedback survey.
We will also inform participants that they are welcome to continue to use the study Facebook group, although it is 
not part of the study procedures. We will inform them that we will continue to monitor the Facebook group and 
collect Facebook use data from users for another 12 months for any participants who continue to use it. Coaches 
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will not be participating or providing feedback to participants during this time. At the end of the intervention any 
participants still using the group will be asked if they would like to take over leading the group. We will continue 
to hold admin rights in order to extract data through 12 months, but at that time we will hand over administration 
rights to anyone who volunteers to take it on, and remove all study staff access.
Measures 
Data Collected
List of Measures
Screening 
Call
Baseline
During 
Intervention
F/up
Method
Height
X
REDCap
BMI
Weight
X
X (weekly 
via Fitbit)
X
REDCap
Demographics
Employment, marital 
status, race/ethnicity, 
household 
composition*
X
REDCap
 International Physical 
Activity Questionnaire9
X
X
REDCap
Depression
PHQ-9
X
REDCap
Binge Eating 
Disorder
SCID Interview11 for 
BED
X
Interview
Social support for 
weight 
management
WMSI13
X
X
REDCap
Social media use 
Social Media Use*
X
X
REDCap
Group engagement
Facebook data 
extraction
X
Facebook
Invited friends 
questions
Survey questions*
X
Intervention 
Feedback
Survey questions*
X
REDCap
* Investigator-derived items
Time Commitment:
Visit
Study 
Participants
Invited Friends
Initial Screening Survey (10 min)
10
5
Telephone Screening (20 min)
20
n/a
Baseline (35 min total)
Scale set-up (10 min)
Online survey (25 min)
35
n/a
Webinar (60 min)
60
n/a
Intervention 
Approx. 35 min/week for 16 weeks (approx. 10 hrs)
600
0-600*
Follow-up (85 min total)
Focus group (60 min)
Online survey (25 min)
85
5
Total
810 minutes 
(approx. 14 hrs)
10-610 minutes 
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*The length of intervention participation depends on when the friend got invited to the group. 
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.]
Social network participation analyses include frequency of tweets/per day. Repeated measures ANOVA will be 
conducted (baseline to 4-months) to determine if participant’s mean engagement per month changed over time. 
Descriptive analyses will assess acceptability at 4-months. Conditions will be compared on social support for 
weight loss at baseline and 4-months using mixed models (SAS PROC mixed). Sensitivity analyses will be 
performed for missing data. Participants’ comments will be content analyzed to identify the types of interactions 
that occurred, which will then be used to predict weight loss. All comments made by participants will be exported 
from Facebook for qualitative analysis. Separate mixed models will be used to examine whether the identified 
themes predict group adherence or weight loss.25, 26 Separate mixed models will be conducted to examine whether 
demographic factors, social media/technology experience, depression, and social anxiety predict: 1) acceptability, 
2) participation, and 3) weight loss. Potential covariates include: age and gender. We will not be testing whether 
social constructs mediate differences in weight loss between conditions in this feasibility study. Exploratory Aim. 
We will explore trends and condition differences at 4-months. Linear mixed models will be used to test the 
condition x time (baseline vs. 4-month) effect on weight, social support constructs and Facebook participation.
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.]
Smartphone users ages 18-65 with a BMI 27-45 will be recruited for this study.  Participants must log into a social 
media platform on a daily basis and engage (like, reply, post) at least 4 days per week. 
Age justification: Weight loss interventions intended for ages outside of the range (<18 or >65) require 
individualized attention from a physician and will not be appropriate to use the DPP. 
Inclusion Criteria: Participants must: be 18-65 years of age; have a BMI 27-45; and have daily internet access. 
Exclusion Criteria:
1)
Not posting on Facebook at least once per week; 
2)
Comments on someone else’s on post on Facebook less than once per week;
3)
Does not currently use a smartphone;
4)
Is not familiar with using phone apps;
5)
Pregnant/lactating;
6)
Meets criteria for severe depression on the PHQ-9 (score of >20)
7)
Had bariatric surgery or plans to during the study;
8)
Condition that precludes lifestyle changes (i.e. a condition that prevents physical activity increase or 
dietary changes);
9)
Medications affecting weight;
10) Incapable of walking ¼ mile without stopping;
11) Type 1 or 2 diabetes;
12) Participated in previous weight loss studies under the PI
13) Unable to attend the orientation webinar;
14) Has concerns about being audiotaped
15) Inability to provide consent;
16) Prisoners;
17) Non-English speaking
18) Has concerns about being in a Facebook group with other UConn faculty, staff, and students
19) Meets the criteria for Binge Eating Disorder
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20) Has had a weight loss of 5% or greater within the last 3 months
21) If they do not have Wi-Fi and cannot send us a picture of their weight from the scale 
Invited Friends of the subjects participating in the FB+friends condition: Must be: at least 18 years old, BMI 
of 25 or over, and have an interest in losing weight.
Participants will be withdrawn from the study if: they drop from participation, do not complete all screening 
procedures or post inappropriate content on Facebook. Participants reporting that they would like to withdraw 
from the study will be given the option to: 1) withdraw from all intervention-related activity and contacts, but still 
complete the final assessment or 2) withdraw from the study completely with no additional study contact. If a 
participant becomes pregnant during the study, they will be withdrawn from the intervention, but will be given the 
option still complete the follow-up assessments. If a participant is withdrawn, their invited friends will not be 
withdrawn unless they 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.).]
Possible risks for being in this study includes: Injury while exercising, breach of confidential information, and 
discomfort completing measures. The attempt to avoid risks to participants will be addressed by: suggesting 
moderate intensity exercise to avoid discomfort, pain, or injury. Participants reporting discomfort will be referred 
to their PCP. Injuries are unlikely to occur since we screen out medical conditions that could make someone prone 
to injury and we only suggest moderate activity. We also provide participants with information on exertion level 
and remind them to see medical attention if there is pain. Tracking data will be stored electronically in REDcap, a 
network secure data entry program; any data on paper will be stored in a locked file cabinet; and participants will 
be informed that they may withdraw from the study at any time if they feel discomfort with any of the study 
procedures. During focus group calls, participants may share information given by other participants. To avoid 
this we’ll ask that everyone on the call keeps the conversation confidential and if they choose to use and alias 
during the call, we can assign one to them so that the study team knows who they are, but the others on the call do 
not.
To maintain confidentiality, participants will be asked not to disclose that they are in a research study to protect 
confidentiality of other participants; posts from the participants will be continuously collected and monitored 
using computer programming and will address any issues related to privacy. We will do this by assigning a staff 
member to read and assess each interaction in the group on a daily basis. Any privacy-related problems will be 
brought to the attention of the PI immediately.
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 study. Benefits that could occur are losing weight 
through the exercise and lifestyle 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.]
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The possible risks of the study (including injury during exercise, psychological discomfort, and breach of 
confidentiality) are minimal and are outweighed by the possible benefits to participants (weight loss). Societal 
benefits include providing evidence to support an intervention delivery modality that is more conducive to 
settings like worksites, health plans, and clinics that serve large populations but have limited space, staffing, and 
resources for traditional in person interventions.
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.]
Economic burden to subjects includes the time needed for screening and study participation. There is no 
cost to participants for participating in the study. Depending on smartphone data usage plan for each 
participant, usage charges may incur due to increased use of mobile apps such as Facebook and My 
Fitness Pal.
Participants will be paid in the form of online Amazon gift cards. Participants will receive $40 for completing the 
study. Payment will be in the form of an online gift card paid after the follow-up survey. The procedures for each 
assessment will need to be completed before providing compensation. Additionally, participants may keep the 
study scale provided to them (value of $120).
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 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).”
A DSMP will be set up for this study and will convene before and after each recruitment wave. DSMP reports 
will be produced by the program director and data manager. Reports will be reviewed by the principal investigator 
and a statistician then will be sent to the safety officers on the board. 
Report type
Recruitment rates
Inclusion/exclusion
Demographics
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Adherence to study protocols
Adverse events
Participant Retention/Engagement
Data review (completeness/outliers)
Qualifications and responsibilities of the Safety Officer
The safety officers for this project are Dr. Kristin Schneider, Assistant Professor at Rosalind Franklin University, 
North Chicago, IL. Dr. Schneider has a degree in clinical psychology, experience in exercise and weight loss 
interventions, and an understanding of the types and severity of injuries commonly experienced during weight 
loss trials. Dr. Stanek has expertise in inference, mixed models, sampling, longitudinal data analysis, and cluster 
randomized trials. 
Recruitment rates and adherence inclusion/exclusion criteria, and ethnic diversity goals:
Recruitment progress, inclusion/exclusion criteria, and diversity goals will be reviewed at each meeting. This 
review will ensure that project deadlines are being met, that participants meet eligibility criteria, and that the 
ethnic diversity goals outlined in the grant proposal are being met.  
Adherence to study protocols:
The principal investigator will: direct creation of all study protocols and will be involved in trainings and 
supervision of all study staff. Quality control will be conducted in all phases of the project. The focus groups will 
be audio recorded. A 10% randomly selected sample of the recordings will be assigned to the an independent 
coder and project director for review. A summary will be provided to the safety officers and a checklist will be 
completed for each review.
Adverse events:
Participants who report conditions during the screening phase that could create a safety concern while receiving 
the intervention will be excluded. Adverse events that occur during the intervention will be assessed, recorded, 
and followed up until resolved. Safety monitoring procedures will be documented in a standard protocol and 
overseen by the PI and program director. Any adverse events will be immediately reviewed by the program 
director. The safety officers will be informed during monthly reports for all adverse events. Serious adverse 
events will be communicated immediately to the safety officers. The NIH and UConn IRB be notified 
immediately in the event of serious adverse event. Any death of a study participant will be reported to the NIH 
and UConn IRB whether or not it appears to be related to the study. 
The adverse event report will include a listing of adverse events including duration, severity, seriousness, 
relatedness, action taken, and resolution. This information will be presented unblinded. A significant increase in 
the rate of adverse events in one treatment group would be cause for concern for the safety of participants in the 
study. p to the safety officer. 
Participant retention
Engagement will be recorded throughout the study. If a participant chooses to drop from the intervention, they 
will be given the option to skip the rest of the intervention visits, but still complete the final assessment. 
Engagement data will be provided in a report to the safety officers.
Data Security: 
The databases will be maintained on UConn servers where security will be maintained through access controls. 
The program director will control the database and surveys and will allow access to necessary staff. Staff wanting 
access to identifiable data will need to: have prior IRB approval to be on the project, apply for a REDCap account, 
be approved by the program director, and utilize a password for login.
Data review (completeness/outliers):
Data reports will be reviewed by the data manager, project director, statistician, and PI. Reports will include 
completeness of data (visits completed, online engagement, % of expected forms submitted, % of submitted forms 
passing edit); missed visits and missing information within visits; descriptive information for each endpoint 
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(change in weight and physical activity) without statistical testing; and quality control analyses for primary 
outcome (change in weight).
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.]
REDCap will be used for data entry and management. Digital recorders will be used for recording audio from the 
end-of-study focus groups. The database and recordings will be maintained on UConn servers where security will 
be maintained through access controls.  Once recordings are saved on the server they are deleted from the 
recorder. Recordings are used for qualitative analysis. When the recordings are transcribed by study staff (RA’s), 
the names of participants are replaced with ID numbers to anonymize the transcript.  Files will be managed by the 
data manager and project director, who will control user access and rights. For each user, REDCap will require a 
REDCap profile, username and password to enter the program. Staff will only have access to the database if the 
data manager has given them access. UConn IRB and their representatives, and study personnel will have access 
to the research data, as will the study sponsor if requested. All participants will be assigned an ID number, which 
will link them to their study data. The ID number will be 3-4 numerical characters representing the number of 
participants in the study. PHI fields will be stored in a separate form from other data collection forms. Data will 
be completely de-identified once the last assessment is complete.  At this time the link between ID number and 
study data will be destroyed. Study data in the form of hard copies will be stored in a locked file cabinet managed 
by the program director and will be destroyed 3 years after completion of the study.
 
Data from ineligible participants:
Contact information will be stored in a file with an indication that they are not eligible. However the data 
collected from the screening, including reason ineligible, will be stored in a separate de-identified file.
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 
Practices.  Review the document proving tips to complete the form located at 
http://content.research.uconn.edu/pdf/storrs/rcs/irb/TipsDataSecurityAssessmentForm.docx.  
This form has been completed.
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).]
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A signed consent waiver is being requested for this study. Participants will review an informational page before 
completing the initial survey screener. At the beginning of the telephone screening, staff will review the 
informational page and ample time will be allowed for discussion or questions. 
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).]
To be able to actively participate in the study, participants must be adults without impaired decision 
making ability that are able to speak and read English. The consent process will include a discussion of the 
participants understanding of what participating in research means including their rights as a research 
participant, the protocol, as well as risks and potential benefits to participating in the study. If research 
personnel obtaining consent believes there is a concern regarding a participant understanding participation 
will be discussed with the program director who will determine whether to exclude the participants 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.]
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).]
An information sheet will be used for the study participants and an information sheet will be used for the invited 
friends.
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):
We are requesting a waiver of signed consent to be able to recruit participants across the US for an online study.  

Why is the study considered to be minimal risk? 
The survey is minimal risk because includes surveys and a weight loss intervention. 
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
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.
The ability to review the consent online will limit any risks of travelling to the study site needed to complete 
an in-person 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.
No. We also utilize contact information and Facebook names to communicate with participants throughout 
the study. We will use approved institutional data security procedures to protect this information.

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.  
No.
References / Literature Review:   
1.
McTigue K, Harris R, Hemphill MB, et al. Systematic evidence review. Screening and interventions for 
overweight and obesity in adults. Research Triangle Park, NC: Agency for Healthcare Research and 
Quality
U.S. Department of Health and Human Services;2003. No. 21.
2.
Diabetes Prevention Program Research G. The Diabetes Prevention Program (DPP): description of 
lifestyle intervention. Diabetes Care. 2002;25(12):2165-2171.
3.
Whittemore R. A systematic review of the translational research on the Diabetes Prevention Program. 
Translational Behavioral Medicine. 2011;1(3).
4.
Riley WT, Rivera DE, Atienza AA, Nilsen W, Allison SM, Mermelstein R. Health behavior models in 
the age of mobile interventions: Are our theories up to the task? Translational Behavioral Medicine. 
2011;1(53-71).
5.
Stephens J, Allen J. Mobile phone interventions to increase activity and reduce weight:  A systematic 
review. J Cardiovasc Nurs. 2012;epub ahead of print.
6.
Pagoto S, Schneider K, Jojic M, Debiasse M, Mann D. Evidence-based strategies in weight-loss mobile 
apps. Am J Prev Med. 2013;45(5):576-582.
7.
Venditti E, Kramer MK. Necessary components for lifestyle modification interventions to reduce 
diabetes risk. Current Diabetes Reports. 2012;12:138-146.
8.
Acharya SD, Elci OU, Sereika SM, Styn MA, Burke LE. Using a personal digital assistant for self-
monitoring influences diet quality in comparison to a standard paper record among overweight/obese 
adults. J Am Diet Assoc. 2011;111(4):583-588.
9.
I Booth, M.L. (2000).  Assessment of physical activity: An international perspective. Research Quarterly 
for Exercise and Sport, 71, S114-20.
10.
11.
First MB, Spitzer RL, Gibbon M, Williams JBW. Structured Clinical Interview for DSM-IV-TR Axis I 
Disorders, Research Version, Patient Edition. (SCID-I/P). New York: Biometrics Research, New York 
State Psychiatric Institute; 2002.
12.
13.
Rieder S, Ruderman A. The development and validation of the weight management support inventory. 
Eat Behav. 2007;8(1):39-47.
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