Building Habits Together: Feasibility Trial of an Integrated Mobile and Social Network Weight Loss Intervention
Phase: NA
Conditions: Obesity
Sponsor: University of Connecticut

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IRB-1 Study Protocol 
 
 
Protocol Version # and/or Date: 12/7/2021 
 
 
Study Protocol Title: Proof-of-Concept Study of an Integrated Mobile and Social Network Weight Loss 
Intervention  
 
 
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. 
 
No. 
 
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 
                                                 
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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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 this protocol is related to aim 1 of the grant application and includes a 6-week usability 
testing phase. 
 
Obesity and Cardiovascular Disease. Obesity affects 39% of US adults1 and is a significant risk 
factor for cardiovascular disease (CVD).2 Lifestyle interventions such as the Diabetes Prevention 
Program have shown strong efficacy for reducing CVD risk3,4 but have not been well-
disseminated due to the expense of the clinic-based model.5 Technology is changing how we 
deliver behavioral interventions by allowing patients to receive behavioral support in new ways. 
In spite of the promise, few fully-powered randomized trials have been conducted to test the 
efficacy of technology-based lifestyle interventions. This application is the culmination of several 
years of work by a team who has designed multiple technologies for obesity management.  
 
Technology-Delivered Interventions Fill An Important Treatment Gap. A recent systematic 
review of 21 technology-delivered lifestyle interventions based on the Diabetes Prevention 
Program (13 of which were randomized trials) revealed that efficacy is promising, but weight loss 
is less than that observed in clinic- delivered programs.6 The most common form of technology 
utilized in these programs was web-based platforms, but videoconferencing, interactive voice 
response phone calls, text messaging, and mobile applications were also used in some programs. 
This review concluded that studies including human counseling produced greater weight loss than 
fully automated programs and that participant engagement was a strong predictor of outcomes.6  
Increasing participant engagement may be key to improving outcomes, however it risks 
increasing counselor time which has implications for scalability. To advance this body of work, 
we aim to integrate technologies we developed to create a comprehensive technology-based 
weight loss program that maximizes meaningful participant engagement without increasing 
counselor time. Accomplishing this will require two things: 1) giving participants more 
technology-based assistance in behavior change strategies and 2) teaching participants how to 
mentor each other.  
 
Popular Mobile Technology Approaches to Weight Management Have Low Compliance. 
Although commercial weight loss apps have proliferated, systematic reviews have revealed they 
include very few evidence-based features7,8 and lack efficacy data.8 The cornerstone feature of 
most weight loss apps is self-monitoring (i.e., calorie tracking).7 A major problem with calorie 
tracking is compliance. In one study that prescribed a commercial weight loss mobile app to 212 
primary care patients, more than half (56%) didn’t use it in the first month and by six months 
only 16% were still using it.9 While studies routinely show that consistent use is associated with 
greater weight loss, consistent users are few and predictors of consistent use are high health 
literacy and being white, which has implications for health disparities.10 Mobile apps that assist 
users the many other behavioral strategies found in the DPP could be useful toward the goal of 
providing participants more assistance as they attempt to change their lifestyle behaviors. Our 
work shows that problem solving and stimulus control are two behavioral strategies that are 
amenable to mobile technology delivery.  
 
Problem Solving: A Staple Behavioral Strategy. Studies have established that problem solving 
is not only an active ingredient of behavioral weight loss interventions,11,12 but it is effective as a 
standalone intervention for weight loss maintenance13 and it is a strong predictor of weight loss 
outcomes.14 Problem solving is a counseling technique used to help patients identify barriers to 
behavior change and generate solutions to be iteratively attempted until barriers are overcome.15 

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In practice, the counselor works through 5 steps with the patient, including 1) identifying a barrier 
to behavior change, 2) brainstorming a list of solutions for overcoming the barrier with the 
patient, 3) having the patient select a solution he/she would be willing to try over the next week, 
4) making a plan to attempt the solution, and 5) evaluating the outcome and trying additional 
solutions until the problem is solved. At the end of every session of lifestyle interventions, 
patients are asked to identify barriers that are likely to arise as they attempt the homework 
assignment and they are then assisted in making plans to overcome those barriers.16 Additionally, 
an entire session of the DPP is devoted to problem solving skills.17 Given the systematic process 
of problem solving, it is conducive to being facilitated via mobile app. 
 
Peer Coaching: A Cost Saving Behavioral Strategy. Online social media platforms have 
frequently been used to deliver group-based behavioral weight loss interventions. Typically the 
way these work is that a social media platform’s private group function is used to convene a 
group and deliver a feed based on a behavioral weight loss program.18 Using the social media 
platform most popular with the target population is a way to get intervention content to people 
without requiring them to log into a novel platform or website. Using commercial social media 
platforms is also much cheaper than developing a novel platform. For example, the company 
Omada Health has raised $73M in 2019 for their online group-based counselor guided platform 
that delivers the DPP Lifestyle Intervention.19 Two meta-analyses revealed modest effects of 
online social network delivered weight loss interventions.20,21 In spite of the advantages of this 
modality of intervention delivery, participant engagement reported in studies is highly variable, 
with mean participant engagement ranging from once to 11 times per week.22-29 The latter was our 
study which was unique because our group was facilitated by a counselor who posted 
conversation threads from the DPP twice a day and hosted activities such as weekly goal setting, 
weigh-ins, and progress reports. Participant engagement in these studies appears to be related to 
1) whether the online platform was the sole intervention modality (vs just a place for participants 
to socialize) and 2) counselor activity, with studies reporting the lowest engagement posting only 
a single update per week.24,28 Studies reporting the highest engagement had the counselor posting 
updates daily or near daily.23,25-27 Even when the platform is the main intervention modality and 
counselors are very engaged, no studies have given participants direct guidance on how to best 
support and help each other.  
 
Conceptual Model. We now know that simply providing a means for participants to engage with 
each other in an online platform may not be enough to generate the type of interaction that 
facilitates behavior change. In traditional group therapy, a counselor actively guides the group in 
activities like brainstorming, problem solving, and sharing experiences. Online group-based 
interventions should apply principles of group psychotherapy to facilitate practice of behavioral 
strategies and group cohesion. For this reason, our proposed intervention has conceptual 
underpinnings in the group therapy literature. An APA Task Force conducted a review of specific 
elements of the therapeutic process30 concluded group cohesion is a key element in group 
therapy.31  Group cohesion is a reliable predictor of both retention and outcomes in cognitive 
behavioral group psychotherapies.31 To the extent that group members have the opportunity for 
in-session practice of behavioral skills with one another, group cohesion can be strengthened.30 
We know little about how to engage group members in skills practice in an online platform given 
the uniqueness of online interactions. Our mobile app and peer mentor training is specifically 
designed to prompt participants to practice problem solving skills with the group. Data from our 
previous work show that more frequent participant engagement of this type is associated with 
greater weight loss.  
 
Overall, obesity is a serious risk factor for cardiovascular disease2 but few people have access to 
behavioral treatments.32 Technology-delivered weight loss programs have the potential to 

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increase reach and early studies reveal modest impact.20 Less impressive outcomes have been 
produced by commercial weight loss mobile apps perhaps because they focus mostly on self-
monitoring which in spite of being an essential component of behavioral weight loss 
interventions, has poor efficacy as a standalone intervention.7,8 Comprehensive technology-based 
weight loss programs typically use online platforms to provide 1) technology supported dietary 
self-monitoring, 2) counseling in behavioral strategies, and 3) access to a peer group. In these 
models, the only technology-supported behavioral strategy is usually self-monitoring. The 
remaining behavioral strategies are the responsibility of counselors who provide personalized 
feedback. Technology that can assist people in the implementation of a wider range of behavioral 
strategies could increase the efficacy of technology-supported interventions. In separate studies, 
we developed and tested the feasibility of an online weight loss intervention and two mobile apps 
that help participants implement two behavior change strategies (problem solving and stimulus 
control). 
 
The goal of this study is to merge these technologies into a comprehensive technology-delivered 
weight loss intervention and add new features that were suggested during our user-centered 
design process. Aim 1 is the pre-pilot phase. The objective is to conduct a one-arm pilot of a 6-
week version of an online weight loss intervention paired with the Habit app and will evaluate the 
usability of the intervention in 20 adults with obesity. Usability is defined as use, acceptability, 
and burden of the mobile app features (dietary self-monitoring, slip tracker, and problem solving), 
and participant engagement in problem solving and peer mentoring.  
 
We hypothesize that the online weight loss intervention, by prompting group practice of 
behavioral skills, will result in greater peer-to-peer interactions, increased weight loss related 
problem solving skills, and greater group cohesion, which will in turn, produce greater weight 
loss relative to a standard online weight loss intervention. 
 
For EACH Participant Population State the Number of Participants to be Enrolled and Screened 
and/or the number of participant records reviewed (including, HIPAA covered health records and 
FERPA covered school records), if applicable:  [State the total number of participants/records 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 6-week usability testing phase is 20. It 
is estimated that we will screen 800 participants to achieve this recruitment goal. Since the initial 
contact is via an online link, there will be many incomplete responses driving up the number of 
screened-out participants.  
 
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.] 
 
We based the sample size of 20 on the number needed to allow sufficient diversity of participant 
experiences to identify usability issues.33 This number also is a critical mass for an online group-
based weight loss intervention to produce reasonable engagement, based on our experience. This 
sample size is consistent with recent pilot studies of similar interventions.23,34 No statistical 

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comparisons are being made which precludes the need to calculate a sample size estimation based 
on effect sizes. 
 
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 employees may be enrolled if they meet eligibility requirements and are 
interested in completing the study. Students and employees directly reporting to key personnel on 
this project will be excluded 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 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, if applicable.  Provide a 
copy of the screening instrument.]   
 
We are recruiting overweight and obese individuals of all races and ethnicities, income, and 
education levels between the ages of 18 and 65 years in the United States. Participants must have 
regular home Wi-Fi connectivity. 
 
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 via REDCap containing the initial screening questions. The survey will 
take 5 minutes. Participants will first be shown the information sheet and can elect to move on to 
the screening questions if they are interested. From there, they will then have the eligibility 
questions to complete. If they are eligible to proceed after completing the initial survey, they will 
be contacted by the study team to schedule a 15-minute telephone screening call to review the 
consent form, get screened for Binge Eating Disorder (BED), and provide contact information. 
We will not require PCP approval since we assess exclusionary medical conditions during the 
screening survey and again during the telephone screening. If conditions are reported, during 
either of these two assessments that might put the participant at risk during the intervention, they 
will be excluded. The next step in the screening process is to complete a set of online baseline 
surveys including demographics and depression severity lasting 20 minutes.  
 
Before participants are enrolled, they must next complete a 60-minute orientation webinar. The 
purpose of the webinar is to educate participants about what research is, review study procedures, 
how the intervention is going to work, 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 eligibility is 
determined from the screening call and baseline survey, participants will receive a link to access 
the webinar. Once the participants are logged into the webinar, the research coordinator will 
proceed with the slides. Toward the end of the slides, participants will have the opportunity to use 
the chat function to ask questions and discuss any concerns related to the program. The webinar 

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moderator will record in REDCap tracking which participants completed the webinar. After 
completion of the webinar, participants will receive a final email asking if they are still willing to 
participate.  
 
Participants will need to complete the initial screening survey, telephone screening, baseline 
REDCap survey, set-up the scale and log their first weight, and attend the orientation webinar 
before being enrolled into the 6-week usability testing intervention.  
 
Ineligible participants will be notified by the research assistant or coordinator that they do not 
meet criteria for the study. This will be communicated via e-mail if the reason is not sensitive (i.e. 
taking exclusionary medication). If the reason is sensitive (i.e., high depression score, presence of 
BED) staff will call them to let them know. In the conversation, staff will use a generic response 
about how their pattern of responses is not a match to our eligibility criteria (the examples are 
provided in additional documentation). If they want to know specifics as to why they were 
ineligible, staff will refer the participant to email the PI so they can have a more detailed 
discussion about eligibility. This is being done to avoid upsetting participants and letting Dr. 
Pagoto, a clinical psychologist, handle communication of more sensitive information.   
 
Once eligibility is determined after completing all screening procedures (initial screening survey, 
telephone screening call, baseline survey, and webinar), study staff will mail them a scale and 
then call to help them set up the scale and the apps, if they participant so wishes; they will also 
have the ability to set up the scale on their own. 
 
Study staff will use Google Voice to communicate with the study participants (our lab is still 
working remotely so we do not have access to our lab phones). This is an app that gives our staff 
a different phone number to protect their personal information due to their inability to divert 
UConn phone lines to personal phones. We will not be recording any phone calls with Google 
Voice. Participants will be able to reach out to investigators as easily as they can using standard 
calling. Participants do not need the app in order to contact the lab. It is important to note that 
some information may be retained on Google’s active servers temporarily for billing UConn staff 
or other business purposes, and residual copies may remain in Google’s backup systems. 
Anonymized copies of call record information, with no personally identifiable information, will 
be retained on Google systems to meet reporting and auditing requirements. However, this is no 
different than any standard phone plan. All information in the app pertaining to each participant is 
deleted after the study is over (text messages or call history). 
 
Anticipated Study Time Frame: [Describe the estimated time frame of the study from anticipated start 
to anticipated finish.  If the study will occur in more than phase include these in the time frame.  Use of a 
table is often helpful.] 
 
Project Time Frame: 
Aim 1 of this study, including recruitment, intervention, data cleaning and analysis will last for 
approximately 9 months. 
 
Participant Time: 
Participants will be in the study for approximately 8 weeks, which will include the screening 
phase, a 6-week intervention, and the follow-up survey, weigh-in, and focus group. 
 
Study Phase  
Approximate Time 
Initial Screening Survey (5 min) 
5 

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Telephone Screening (15 min) 
15 
Baseline (90 min total) 
Online survey (20 min) 
Orientation Webinar (60 min) 
Scale set-up (10 min) 
90 
Intervention  
Use of Facebook and diet entries (6 wks)/15 min/day (630) 
Optional weekly breakout sessions 45 min/week for 6 weeks (270) 
Weekly self-report app usage survey 5 min/week for 6 weeks (30) 
930 
Follow-up: 
     Weigh-in (5 min) 
Online survey (30 min) 
Focus group (60 min) 
95 
Total 
1,135 minutes  
(approx. 19 hrs) 
 
 
Design, Procedures, Materials and Methods:  [Describe the study design, including the sequence ll 
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, where they 
will be conducted and how long they will take to complete.  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 this study offers treatment for the participants’ 
condition, complete the Treatment Study Supplemental Form (IRB-1C) and attach it to this application 
for review.  Use of a table is often helpful here.   
 
Study design. Participation starts with an initial survey, telephone screening, and a baseline 
survey. Eligible participants will then complete an on-boarding process, which includes an 
orientation webinar and scale and app set-up. Participants will then complete the intervention for 
6-weeks. Finally, there will be a follow-up period starting after the intervention ends which 
includes a final weigh-in, online survey, and a focus group call with the study staff.  
 
Recruitment. As in our previous remote trials,35 online recruitment will be used with ads posted 
in Facebook groups and Craigslist throughout the US and Research Match which connects 
volunteers to research studies.36,37 To attract males we will also recruit on Reddit, where 74% of 
users are male.38 Study staff will post recruitment messages in large, public Facebook groups in 
cities and towns around the country with even distribution in urban, suburban, and rural areas. To 
bolster male recruitment we will recruit more aggressively on Reddit via paid ads and via relevant 
subreddits.  
A survey link will be included with our recruitment materials. Participants will be instructed to 
complete the survey to be considered for the study. Additional strategies that we may or may not 
use depending on recruitment flow include: 
- 
Electronic recruitment: online, Twitter, Instagram, newsletters, intranet messages, daily digest, 
emails and other online sources as we come across them;  
- 
Connecting with large businesses to get our ad and/or flyer e-mailed to their staff and students; 
- 
Qualtrics recruitment panel: Participants on the Qualtrics panel meeting inclusion criteria will be 
recruited for this study.  

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o On the first page of the survey, they will read a brief introduction about this project and if 
they complete the survey, they will receive Qualtrics incentives regardless of 
participation in this trial.  
o If they decide to hear more, they will click forward to the next page, which will be our 
information sheet.  
o If they would like to participate in the trial after reading that sheet, they will click 
forward to the next page and start the survey.  
o Participants who provide their email will be contacted by the study team for the telephone 
screening. 
 
To get a representative sample for this study, it is possible we will have to cap certain groups in 
order to allow room for other groups (i.e., stop enrolling white women in order to allow enrolling 
more males or other people of various ethnic/racial backgrounds). In that event, we will send 
participants generic wording via email (included in accompanying documents) letting them know 
that we are looking for people with specific characteristics and can only take a certain number of 
people who have similar characteristics. If they want a further explanation, we will refer them to 
email Dr. Pagoto to have a more detailed conversation about this decision.   
 
Screening. Please see the previous Screening Procedure section on page 5 and 6.  
 
Intervention. This 6-week online weight loss intervention involves 5 major components: 1) peer 
mentoring, 2) counselor-led DPP lifestyle intervention delivered via private Facebook group, 3) 
commercial app supported diet self-monitoring (MyFitnessPal), and the Habit app which includes 
slip tracking and problem-solving features, 4) Habit app integration with the Facebook group to 
stimulate peer-to-peer engagement, and 5) weekly weigh-ins. 
1. Peer Mentoring  
 
During the 6-weeks of the intervention, the program will have weekly breakout sessions for 
participants to join within the Facebook group. Each week, the counselor and/or study staff will 
schedule a 45-minute event within the Facebook group that will allow participants to RSVP to, if 
they so wish. When they click on the event on the day/time it was scheduled for, they will be 
brought to a video chat room within Facebook where everyone who joined can video chat 
together. The counselor and/or staff member will be leading each group. Each week will be based 
on a topic around achieving a healthy lifestyle (or barriers to achieving a healthy lifestyle). The 
participants will pick the topic for each week. In the beginning of each breakout session, the 
participants will introduce themselves. Then, the counselor will pose discussion questions related 
to the topic of the week to facilitate a discussion. The participants will then respond to questions 
and can take notes. At the end, the counselor will review the top solutions/responses that came 
up. The meeting will be recorded and posted in the Facebook group for those who missed. 
Facebook requires all attendees in the event to confirm they are okay with the recording. If they 
do not wish to be recorded, they will be able to leave the meeting and watch the video after it is 
posted in the group. The breakout sessions are optional. The point of these breakout sessions is 
for group members to peer mentor each other, connect on a topic, do some brainstorming, and get 
to know each other better.  
 
2. Facebook Group 
 
Participants will be asked to join a private Facebook group where they will receive weight loss 
counseling based on the Diabetes Prevention Lifestyle Intervention (DPP). The group leader will 
counsel participants toward achieving and maintaining the exercise and diet goals to lose weight. 

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The participants will also be asked to participate in the Facebook group by reading and engaging 
with the posts from the counselors. Additionally, they will be asked to engage with their fellow 
participants through comments, reactions, and posts. By interacting with other participant’s, they 
will be able to exercise the peer mentor training that they receive prior to the start of the 
intervention. The participants will be able to privately message their counselor if they do not want 
to share something with the group. A detailed description of the how the Facebook group will 
operate is below. 
 
The counselor will post twice a day in the private Facebook group. Each week’s content is based 
on the corresponding module of the traditional, in-person DPP 
(https://www.cdc.gov/diabetes/prevention/lifestyle-program/curriculum.html). The DPP assigns 
participants the goals of calorie tracking to achieve a calorie goal based on amount needed to lose 
1-2 pounds per week, developing a healthy diet consistent with the American Heart Association 
guidelines, engaging in 150-300 minutes per week of moderate intensity exercise (i.e. brisk walk 
at 2.5-4 mph, bicycling, gardening, dancing, water aerobics, canoeing, playing doubles tennis. 
etc.), developing a strength training regimen consistent with the National Exercise Guidelines, 
and losing 1-2 pounds per week. Goal setting happens on Mondays when the counselor posts 
asking participants to share their diet and exercise goals with the group. The counselor will 
suggest 2-3 goals each week—a behavioral goal (e.g., self-monitoring, slip tracking, problem 
solving), a diet goal (e.g., reduce added sugar) and an exercise goal (e.g., add 15 minutes of 
moderate intensity exercise on 3 days) to help participants progress toward the overall program 
goals. Weigh-ins happen on Fridays when the counselor posts asking participants to reply with 
their weight change in pounds for the week. This ensures participants are weighing themselves 
weekly and allows an opportunity for problem solving for participants not losing weight. Goal 
accountability happens each Sunday when the counselor posts asking participants to report how 
they did on the weekly goals. In between these key posts are posts related to the topic of the week 
(e.g., nutrition, making time for exercise) and posts relevant to the behavioral strategy of the 
week (e.g., slip tracking).  On the first day in the group the counselor will post a 5-minute 
problem solving video that teaches the process of problem solving, how the online weight loss 
program will help them implement this process, and their responsibility as a peer mentor. 
Additionally, the coach may post periodic videos of themselves or study-related content to 
facilitate with building a relationship with the participants and to assist with stimulating 
engagement. 
3. Mobile Apps 
 
Participants will be instructed to track their diet and exercise using MyFitnessPal for the first two 
weeks to achieve a negative energy balance at a level that produces 1-2 lbs of weight loss per 
week. They will then switch to the slip tracker within the Habit app for two weeks to gain an 
understanding of their diet and exercise slips and the contextual factors driving those slips. After 
that, they will then switch to the problem solver within the Habit app for the final two weeks to 
solve the problems they observed during slip tracking. This schedule was selected to avoid app 
fatigue and to give participants time to focus and practice each behavioral strategy without getting 
overwhelmed. However, if participants want to use the other features on unassigned weeks they 
may do so.  
 
MyFitnessPal.  
Participants will be given a calorie goal based on their BMI, gender, and activity level to produce 
a weight loss of 1-2 lbs per week. They will be asked to use MyFitnessPal to enter all of the food 
and beverages they consume and their exercise with the purpose of staying under the calorie goal.  
 

Page 10 of 26 
 
Habit App.  
Slip Tracking Feature. The slip tracker helps participants identify triggers of diet and 
exercise lapses that they can address with the problem solver. For diet slips, the user hits 
a button when they have a trigger and/or slip and then completes stress and hunger 
ratings and enters foods eaten and what they were doing at the time. At the end of the 
day, the user receives a notification asking if they missed recording any slips to ensure all 
slips were recorded. There will also be an exercise slip tracking feature. It will work such 
that at the beginning of the week, participants are asked to mark the days they plan to 
exercise on a calendar in the app. Then, the end of the day notification will ask the user if 
they exercised that day. If they did not exercise it counts as a slip and they will be asked 
to pick a day to reschedule. The user will also be asked the time they had planned to 
exercise and the activity that occurred instead (e.g., sleep, work, sedentary leisure 
activity). When participants browse their Exercise Slip History they can look for patterns 
in terms of when they are likely to skip exercise, the role of stress and poor sleep, and 
which activities they tend to do instead of exercise. This provides insights into what is 
obstructing their exercise intentions.  
 
Problem Solving Feature. Participants will be asked to do problem solving on Mondays 
of the assigned weeks. Once the user selects diet or exercise on the home screen, the next 
screen will ask them to identify a problem and then they will answer 3-4 questions before 
receiving tailored solutions. Once a solution is selected, they will schedule days and 
times to try it.  
 
Weekly Check-ins. The weekly check-in is part of the problem-solving feature. 
Participants report their weight and if they accomplished scheduled solutions. They can 
continue working on original solutions and/or to select new ones. Those wanting new 
solutions are brought to the list of solutions. Participants who lost no weight will be 
prompted to try a new solution. Participants who have lost no weight but have 
accomplished their solutions will be prompted to select a new problem to work through. 
This will prevent participants from putting more energy into solving problems that are 
not resulting in weight loss and to nudge them toward problems that are obstructing 
weight loss. If a participant hasn’t lost weight and has not executed their chosen 
solutions, they will be prompted to change the scheduling of the solution or to change the 
solution. This will help dislodge participants who are stuck. It might also prevent them 
from abandoning the app when a plan isn’t working by guiding them on what to do when 
stuck. The essence of problem solving is to keep iterating solutions until something 
works, so the app, like a therapist, keeps the participant moving through that process.  
 
4. Mobile App Integration with the Facebook Group 
 
Problem Sharing in the Group. When participants select a problem from the app but do not find a 
desirable solution, the app will provide an option for them to share the problem in the Facebook 
group. The prompt will provide language the user can edit as she/he sees fit: “I am working on 
[night time snacking]! I welcome ideas! Thanks!”  If so much problem sharing occurs in the 
Facebook group that it overwhelms the feed in the pre-pilot, we will place a limit on how often 
the app allows the user to share a problem.  
 
Sharing Plans to Implement Solutions in the Group. Participants can also share their chosen 
solution with the Facebook group by clicking a button that brings up a dialogue box to edit: “I 
plan on [bringing my lunch to work] this week. My reminders are set for [7pm Sunday – 
Thursday]. Ask me how I’m doing this week!”). Making a commitment in the group increases 

Page 11 of 26 
 
accountability. To prevent the feed from getting flooded with such posts, the app will only allow 
the user to share one plan per week.  
 
Sharing Successes in the Group. In the Habit app, when participants have successfully solved a 
problem and lost weight, they will have the opportunity to click a button to share to the Facebook 
group.  
5. Weigh-ins. 
Participants will receive a Fitbit Aria scale mailed to them by the study team. This will allow 
them to take their weight weekly and at assessments. Weight is logged directly from the scale to 
the Fitbit app. Using a Wi-Fi scale will allow for a standard weight measure for each participant 
with a higher level of accuracy than self-reported weight. 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. 
Study staff help the participants set-up their Fitbit scale if they need it and check their BMI once 
the scale is working. If a participant has a BMI under 25, we exclude them from the study, and 
allow them to keep their scale as compensation. At the end of the study participants will be 
allowed to keep their scale and instructed to change their Fitbit 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. If they choose not to share their login for the duration of the study, they 
will be allowed to upload screenshots of their weight to a secure REDCap link. Study staff will 
delete the screenshot from REDCap once the weight has been logged into the record. 
Follow-ups. Follow-ups are completed after the intervention ends. Participants will receive a link 
to an online REDCap follow-up survey during the 7th week after the start of the intervention. This 
survey will be a repeat of some of the measures assessed at baseline (indicated in the measures 
table below) and questions to solicit participants’ feedback on the program and app. The 
participants will also weigh-in one final time during the 7th week. Finally, the participants will 
schedule and attend a focus group call lead by study staff to get their feedback on their experience 
in the intervention.  
Adverse Events. Adverse events will be documented during the intervention and follow-up 
phases. AE’s will be formally assessed at follow-ups by asking a question in the REDCap survey. 
During the intervention AE’s will be documented when a participant reports it to the weight loss 
counselor or posts in the Facebook group. If it is reported during the intervention, the counselor 
will notify Kaylei Arcangel at UConn within 24 hours of learning of the event. UConn will then 
report it to the IRB (immediately if it’s serious, or at the time of annual renewal). If participants 
gain 5% or more weight during the intervention, this will be treated as an adverse event. The 
participant will receive a phone call from a UConn RC and they will be asked questions about 
what might be going on with their weight gain. We will also re-assess Binge Eating Disorder 
(BED) at this time. If BED is present, we will treat it as a study-related AE. We will only re-
assess BED once after the telephone screening, even if there are multiple AE’s for weight gain. 
Participants will not be removed from the intervention if they have 5% or more weight gain.  
[Describe study procedures for use of interviews or focus groups if applicable.  Include details such as 
how long each procedure will take to complete, who will be asked to participate in these procedures and 
where these procedures will be conducted.  Provide copies of interview and focus group questions/topic 
areas.] 
Focus groups. A focus group will occur in a WebEx setting starting in the 7th 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 
WebEx including 1-4 participants on each call. Any participants who are unable to attend the 

Page 12 of 26 
 
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. The focus groups will be recorded on WebEx and then will be 
transcribed using Otter.ai, a web-based transcription software. 
 After the study is over, we will be removing all members and all content from the Facebook 
group. 
[If the study includes measures, survey instruments and questionnaires (including the collection of 
demographic data), 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 and attach a copy for IRB review.] 
See below. 
 
Data Collected 
List of Measures 
Baseline 
6-week 
usability 
F/up 
Method 
Inclusion/Exclusion 
criteria 
Initial screening 
survey* 
X 
 
 
REDCap or 
Qualtrics 
BMI 
Height 
X 
 
 
REDCap 
Weight 
X 
 
X 
REDCap 
Demographics 
Income, 
employment, 
marital status, 
race/ethnicity, 
household 
composition* 
X 
 
 
REDCap 
Binge Eating 
Disorder 
SCID Eating 
Disorder 
Examination 
Questionnaire39 
X 
 
 
REDCap 
Depression 
Patient Health 
Questionnaire 
(PHQ-840 
X 
 
 
REDCap 
Weight Loss Problem 
Solving Skills 
Social Problem 
Solving 
Inventory-Revised 
(Modified for 
weight loss)  
X 
 
X 
REDCap 
Problem Sharing and 
Peer Mentoring 
Facebook 
Engagement 
 
X 
 
Grytics into REDCap 
App use 
App use data* 
 
X 
 
WPI server and 
REDCap 
Diet tracking 
Data extraction* 
 
X 
 
MFP records 
Usability Feedback  
Acceptability, 
satisfaction, 
burden*, and user 
engagement 
 
 
X 
REDCap and 
interview 
 
*investigator derived 

Page 13 of 26 
 
Psychometric properties for non-investigator derived measures: 
 
SCID Interview for BED: The SCID’s severity scales demonstrated substantial internal 
consistency (all Cronbach’s alphas >.80), test-retest reliability, concurrent, and predictive 
validity.39 
PHQ-9: The internal consistency reliability (Cronbach's alpha 0.89) and inter-rater reliability 
(intra class correlation coefficient, 0.94; 95% CI, 0.86-0.95) were high. PHQ-9 has good 
reliability and at cut off score ≥9, it has good validity to identify depression in primary care. 
Similarly, the PHQ-8, similar to PHQ-9 (with the omission of one question) is as useful as the 
PHQ-9 with strong validity and reliability 44, 45 
Social Problem-Solving Inventory-Revised: The internal consistency reliability (Cronbach’s α 
0.95) was high. The SPSI-R score was significantly associated (p < .05) with various subscales 
from calories, exercise, distress, and quality of life suggesting concurrent validity.43 
The User Engagement Scale Short Form (UES-SF): The UES-SF has shown to be statistically 
reliable (𝜔𝜔 = 0.88). Furthermore, each subscale highly correlates with the remaining items in the 
scale. This suggested that each subscale was suitable to accurately represent the value of the 
overall components from which the subscales were derived. Accordingly, these items were 
defined to be the UES-SF and were taken forward for evaluation.46 
[If applicable, describe the use of audiotape and/or videotape, provide justification for use and indicate if 
this is a requirement of participation.]  
 
The recording feature on WebEx webinars will be used for recording audio for the end-of-study 
focus groups. The recorded audio is necessary in order to turn the information said by participants 
into a transcript for analysis. This grant has an iterative process. The information we receive from 
participant’s feedback through the focus group help to inform the future phases of this study. The 
recordings are deleted once the transcription is finished. The transcription is anonymous and their 
names, if spoken during the call, are replaced with their REDCap ID number. We ask them to 
only say their first name if there are multiple people on the call in order to decipher who is saying 
what. If they are uncomfortable with using their name, we will provide an alias. During the initial 
screening, we will ask if they are comfortable being audio-recorded during a focus group call. If 
they select no, they will be excluded from the study. More information about the 
privacy/confidentiality of the recordings will be provided in the applicable section.  
 
[If the study involves use of deception or incomplete disclosure, explain the reason why this is necessary 
to answer the research question(s).  Complete the alteration of consent section below]   
 
N/A 
 
[Describe opportunities provided to participants to ask questions in order for them to make an informed 
decision regarding participation.]    
 
 
Participants are able to ask questions during the telephone screening and the webinar. They may 
also email the study team at any time.  
 
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 

Page 14 of 26 
 
be used and why the procedures are appropriate. For qualitative data, specify the proposed analytic 
approaches.] 
 
Proportion of participants meeting app use, engagement, acceptability, and burden targets will be 
calculated. We will summarize burden ratings as mean (SD). We will conduct thematic analyses42 
of interview data regarding likes/dislikes for each feature and the overall program. Drs Sherry 
Pagoto and Ran Xu will develop a codebook based on themes emerging during an initial review. 
The team will finalize themes before final independent coding and consensus. We will calculate 
inter-rater reliability and will reach consensus via discussion. We will summarize frequency of 
themes. We will use NVivo 12 (QSR International, Melbourne, Australia) to manage and analyze 
qualitative data and SAS 9.4 (SAS Institute Inc., Cary, NC) to analyze quantitative data. 
 
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.] 
 
Inclusion Criteria 
• 
18-65 years old; 
• 
BMI 27-45 kg/m2;  
• 
Wi-Fi connectivity at home (for Wi-Fi scale); 
• 
Logs into Facebook at least 5 days per week over the past 2 weeks; 
• 
Has posted/replied on Facebook at least twice a week in the past 2 weeks; 
• 
Able to participate in the study in English; and 
• 
Interested in losing weight 
 
Age justification: Children under 18 require different programming for weight loss and 
maintenance given their developmental needs. Weight loss is often not indicated for elderly adults 
and should be medically supervised.  
 
Exclusion Criteria 
• 
Under the age of 18 and over the age of 65; 
• 
BMI under 27 or over 45 at screening; then under 25 at the point of the first Fitbit Aria weight; 
• 
Does not have Wi-Fi connectivity at home; 
• 
Does not have a Facebook account; 
• 
Does not log into Facebook at least 5 days per week over the past 2 weeks; 
• 
Did not post/reply on Facebook twice a week over the past 2 weeks; 
• 
Not able to participate in the study in English; 
• 
Does not live in the United States; 
• 
Pregnant/lactating or plans to become pregnant during study period;  
• 
Bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression; 
• 
Had bariatric surgery or plans to have surgery during the study; 
• 
Currently taking medication affecting weight; 
• 
Chronic pain that interferes with the ability to exercise;  
• 
Type 1 Diabetes; 
• 
Type 2 Diabetes;  
• 
Unable to make dietary changes or increase physical activity; 
• 
Unable to walk ¼ mile unaided without stopping; 
• 
Currently smokes or vapes nicotine; 

Page 15 of 26 
 
• 
No phone connectivity at home and work; 
• 
Has a condition that precludes dietary changes (i.e. ulcerative colitis, Crohn’s disease, active 
diverticulitis, renal disease); 
• 
Meets criteria for severe depression on the PHQ-8 (score of >19) ; 
• 
Not interested in losing weight; 
• 
Does not currently own a smartphone; 
• 
Smartphone type and/or version not meeting app requirements; 
• 
Participated in previous weight loss studies under the PI; 
• 
Unable to attend the orientation webinar; 
• 
Did not complete baseline survey; 
• 
Has concerns about being in a Facebook group with other UConn faculty, staff, and students; 
• 
Had major surgery in past 6 months; 
• 
Has an implanted cardiac defibrillator or pacemaker 
• 
Did not complete screening and on-board processes of study; 
• 
Not willing to be audiotaped for focus groups; 
• 
Prisoner; or 
• 
Unable to provide consent 
 
[Describe the conditions under which participants may be removed from the study, i.e., 
noncompliance with study rules, study termination, etc.] 
 
Participants will be withdrawn from the study if: they choose to drop from participation, do not 
complete all screening/on-boarding procedures, post inappropriate content on the social network, 
or post inappropriate content during peer mentoring. 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. 
 
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.    
 
Possible risks for being in this study includes: Injury while exercising during the intervention, 
breach of confidential information during the intervention or focus group, and discomfort 
completing measures during the intervention or assessments, or using the app during the 
intervention. 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. Moderate-level 
physical activity is 3.0 - <6.0 METs, which includes activities such as brisk walk at 2.5-4 mph, 
bicycling, gardening, dancing, water aerobics, canoeing, playing doubles tennis. etc.). If 
participants were to be injured, the likelihood that the injury would be serious is also rare and 
unlikely. We also provide participants with information on exertion level and remind them to see 
medical attention if there is pain. Tracking data for the screening, intervention, follow-ups, and 
focus groups will be stored electronically in REDCap, a network secure data entry program; 

Page 16 of 26 
 
electronic data being collected from the app will be transmitted to WPI will be encrypted. During 
the focus groups participant may not keep what others say confidential. At the start of the group, 
we will remind participants that they may skip anything that they do not want to answer. 
Additionally, participants will be given the option to complete an individual interview in place of 
a focus group if they prefer more privacy. Participants will be informed that they may withdraw 
from the study at any time if they feel discomfort with any of the study procedures. We will use 
Otter.ai transcription software to produce transcripts. Otter.ai will not have access to identified 
data and will retain no ownership rights to the recordings or transcripts. Any privacy-related 
problems will be brought to the attention of the PI immediately. 
 
[Describe any anticipated inconveniences the participants may experience (such as:  their time, 
abstention from food, etc.).] 
 
Participants will be asked to dedicate about 14 hours of their time over the course of 8 
weeks to participate in this study. 
 
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.  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 changes as well as learning about peer mentoring. 
Through interacting with other participants and the coach, participants may also feel supported in 
their behavioral change efforts. 
 
[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).] 
 
Societal benefits include providing evidence to support an intervention delivery 
modalities that are 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. 
 
 
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.] 
 
The possible risks of the study (including injury during exercise, psychological discomfort 
completing measures and using the app, and breach of confidentiality) are minimal and 
are outweighed by the possible benefits to participants (weight loss). 
 
Economic Considerations:  [Describe any costs to the participants or amount and method of 
compensation provided.  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, study participation, 
and follow-up procedures. There is no cost to participants for participating in the study. 

Page 17 of 26 
 
Depending on smartphone data usage plan for each participant, usage charges may incur 
due to increased use of mobile apps. 
Participants will be paid in the form of online Amazon gift cards. Participants will receive 
$75 for completing the study. Payment will be in the form of an online gift card paid after 
the follow-up procedures are completed (weigh-in, survey, focus group). The procedures 
for each assessment will need to be completed before providing compensation. 
Additionally, participants may keep the study scale provided to them  
 
Participants who complete the Qualtrics initial screening survey, whether or not they 
participate in this study, will receive Qualtrics incentives.  Their incentives are based on a 
points system. Respondents accumulate points as they take surveys and then trade in 
points for E-gift cards to anywhere of their choice (amazon, walmart, target, etc.). The 
compensation Qualtrics provides is separate from the compensation for participating in 
the baseline and follow-ups of this trial. 
 
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 reviewed under the Exempt Criteria.  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 will 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).” 
 
The Data and Safety Monitoring Plan will include monitoring the study for the progress of recruitment 
and retention, and the occurrence of adverse events (both serious and otherwise), inclusion/exclusion 
criteria, adherence to study protocols, and data review (completeness/outliers).  
 
1. Frequency of monitoring 
 
The data report for the 6-week pilot intervention phase will be sent to the two safety officers once 
follow-ups have been completed. Recruitment is monitored daily during the recruitment phase. All 

Page 18 of 26 
 
surveys are monitored once submitted to REDCap within 48 hours. The Facebook group is monitored 
daily. Weigh-in submissions are monitored weekly. App usage is monitored weekly.  
 
2. Safety Monitoring Committee 
 
The two safety officers for this project will include faculty independent from the research team with 
expertise in clinical psychology, exercise and weight loss interventions, and an understanding of the 
types and severity of injuries commonly experienced during weight loss trials. The two safety officers 
will review the reports sent by the project director will use a checklist to document any corrective 
actions that should be communicated to the principal investigators, the University of Connecticut 
IRB, and the NIH.  In addition, the safety officers may include documentation on whether the 
principal investigators should provide follow-up to a participant. 
 
3. What data will be monitored: 
 
Recruitment rates and adherence to inclusion/exclusion criteria, and ethnic diversity goals: 
Recruitment progress, including baseline characteristics, will be reviewed. 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. Recruitment progress is monitored 
weekly and a final report will be provided in the DSMB report. 
 
Adherence to study protocols: 
Quality control will be conducted in all phases of the project. The Facebook group will be monitored 
daily for intervention protocol adherence. A final report will be provided in the DSMB report.  
 
Adverse events: 
The adverse event report will include a listing of all adverse events including duration, severity, 
seriousness, relatedness, action taken, and resolution. Adverse events are documented throughout the 
intervention and at follow-up. A final AE report will be provided in the DSMB report. In the event of 
a serious adverse event, the safety officers will be notified immediately. 
 
Participant retention 
Engagement will be tracked during the intervention, and completion of follow-ups will be 
documented. Participants will be reminded of upcoming study assessments. If a participant chooses to 
drop from the intervention, they will be given the option to skip the rest of the intervention, but still 
complete the follow-up. Retention is reviewed and discussed weekly throughout the study and at 
follow-up. A final retention and engagement report will be provided in the DSMB report. 
 
Data review (completeness/outliers): 
Reports will include completeness of data (visits completed, % of expected forms submitted, % of 
submitted forms passing edit); missed visits and missing information within visits; descriptive 
information for each endpoint (change in weight and physical activity) without statistical testing; and 
quality control analyses for primary outcome (change in weight). Data will be cleaned at the end of 
each phase (screening, intervention, and follow-up). A final data review reports will be provided in 
the DSMB report. 
 
4. Data evaluated for problems  
Data reports will be reviewed by the data manager, program director, statistician, and PI.  
 
5. Actions taken during certain occurrences 

Page 19 of 26 
 
Baseline participants who report conditions 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 of all adverse 
events during data review. Serious adverse events will be communicated immediately to the PI 
and safety officers. The NIH and UConn IRB will 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.  
 
6. IRB Communications 
The program director and research coordinator will communicate with the IRB. Communication 
will occur through emails, phone calls, and/or InfoEd as necessary.  
 
7. Informing sponsor procedures 
The sponsor will be notified within 48 hours for serious events that the IRB recommends we 
report.  
 
 
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.  Explain how long data will be kept in an identifiable format and how 
long de-identified data will be retained.  Explain how long the master key or audio or video recordings 
obtained, will be kept.  Consider whether keeping de-identified data will be retained indefinitely and 
whether participants may be contacted for a follow-up study (explain procedures to retain identifiable 
contact data is kept.] 
 
REDCap will be used for data entry and management. The database will be maintained on UConn 
servers where security will be maintained through access controls. Files will be managed by the 
data manager and research coordinators, 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 2-3 numerical characters representing the number of 
participants in the study. PHI fields will be stored in a separate REDCap form from other data 
collection forms. We will provide participant emails to our co-investigator at WPI. We will email 
the co-investigator a list of participant email addresses. Emails are needed to allow participants 
access to download the study app onto their phones. Emails will not be attached to the data that 
participants enter into the app. The participant accounts in the app will be attached to a unique 
app ID that the UConn staff can link to the REDCap study ID. WPI will not have access to the 
REDCap study ID, therefore app data will remain unlinked for WPI. Once participants download 
the app and confirm to the staff that it is downloaded and they can access the app, we will inform 
WPI to delete the list of email addresses from their records. WebEx recordings will be used to 
record the audio from the focus groups at the end of the study. The recordings will be maintained 
on UConn servers where security will be maintained through access controls. We will use Otter.ai 
transcription software to produce transcripts. Otter.ai retains no ownership rights to the recordings 
or transcripts. Staff will verify and edit the transcripts and then save the de-identified transcripts 
to the research drive on the UConn servers and delete the recordings from the drive and the 

Page 20 of 26 
 
Otter.ai platform. Please refer to these two sections of the terms of service and privacy policy: 
Terms of Service; Section 9 and specifically Section 9.3: https://otter.ai/terms: In summary, 
research team retains right to audio recordings and controls how the content is processed, 
transported, and distributed on the otter.ai platform. Once we delete the recordings from our trash, 
they are permanently deleted from platform. And from Section 2 of Privacy Policy: 
https://blog.otter.ai/privacy-policy/ “We train our proprietary artificial intelligence technology on 
aggregated, de-identified audio recordings. Only with your explicit permission will we manually 
review certain audio recordings to further refine our model training data.”. When the recordings 
are transcribed by study staff (RA’s), the names of the participants are replaced with ID numbers 
to anonymize the transcript. 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 5 years after completion of the study. 
 
Data from ineligible participants, including those excluded for having an exclusionary BMI from 
the Fitbit scale: 
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 
form and will be de-identified at the end of the study. 
 
If identifiable, sensitive information (illegal drug use, criminal activity, etc.) will be collected, state 
whether a Certificate of Confidentiality will be obtained.   
 
 
N/A 
 
Be sure to state whether any limits to confidentiality exist (e.g. mandated reporting) and identify any 
external agencies (study sponsor, FDA, etc.) that will have access to the data.   
 
Worcester Polytechnic Institute (WPI) will see participant emails and the app use data that is 
entered into the Habit app. Additionally, study staff from WPI will join the Facebook group to 
assist participants with any Habit app issues. They all have had CITI training at WPI, will be 
approved personnel, will not have access to study tracking/survey data, and will not have a link to 
study ID. Also, it is possible that participants in this study know each other. 
 
If participants will be screened, describe the plans for storage or destruction of identifiable data for those 
that failed the screening.] 
 
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 form and will be de-identified at the end of the study 
 
Privacy/Confidentiality Part 2:  Complete the Data Security Assessment 
Form:  [This form IS REQUIRED for ALL studies.  The form is available here - 
https://ovpr.uconn.edu/services/rics/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.   
 

Page 21 of 26 
 
 
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/permission Setting:  [Describe the consent/permission process including who will obtain it, 
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.   
 
A signed consent waiver is being requested for this study. Participants will review an 
informational page before completing the initial survey screener. At this point, they are able to 
contact the study staff with any questions they may have before continuing. Also, during the 
telephone screening, staff will review the informational page and ample time will be allowed for 
discussion or questions. Consent will be reviewed during the telephone screening by research 
assistants/coordinators trained in the consent process. 
 
State whether an assessment of consent/permission 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).] 
 
We will not perform an assessment to ensure participants understand the information, however 
we will conduct an interactive webinar to discuss any concerns 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, when 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.  For longitudinal studies, assent may happen 
at several points during the study.  ] 
 
 
N/A 
 
Documentation of Consent:  [Specify the forms that will be used for each participant population, i.e., 
adult consent form, surrogate consent form, parental permission sheet. child assent form (written form or 

Page 22 of 26 
 
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. 
 
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/incomplete disclosure 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. 
• 
Explain why the research could not be practicably carried out 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. 
• 
Explain why the research could not be practicably carried out without using identifiable 
private information and/or identifiable biospecimens.  
• 
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. 
• 
Indicate if the waiver/alteration as noted above is applicable to the entire study or to a portion 
of the study.  
 
Waiver of signed consent (i.e. , no signature, participants give consent only after reading an 
information sheet).  Tip:  if the investigator will obtain information through oral or written 
communication with the prospective participant or if the investigator will obtain private identifiable 
information or identifiable biospecimens by accessing records, then a waiver of signed consent is 
NOT required.,: 
 
This is being asked to conduct the initial survey online. 
 
• 
Why is the study considered to be minimal risk?  
 
The study is minimal risk because it includes surveys and a weight loss intervention. 
The weight loss intervention is commercially available.  
 
• 
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. 

Page 23 of 26 
 
 
• 
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 to communicate with participants throughout 
the study. 
 
• 
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.  
 
• 
Describe if the participants or their legally authorized representatives are members of a 
distinct cultural group or community in which signing forms is not the norm, the research 
presents no more than minimal risk of harm to subjects and there is an appropriate alternative 
mechanism for documenting that informed consent was obtained.  Not applicable to FDA 
Regulated Studies. 
 
N/A. 
 
 
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