Mentoring in Mobile Health (mHealth) and Social Networking Interventions for Cardiovascular Disease Risk Reduction: Intervention Phase
Phase: NA
Conditions: Obesity
Sponsor: University of Connecticut

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UConn 
IRB-1 Study Protocol Form 
October 2021 
 
 
IMPORTANT - Please review the following items before you prepare the protocol application.  It 
will facilitate review of the study: 
• Review the Researcher’s Guide section of the OVPR website 
(https://ovpr.uconn.edu/services/rics/irb/researcher-guide/) for information and 
guidance concerning computer/internet-based research, consent, deception, 
recruitment/advertising, etc. 
• Review this form in its entirety before completing it.   
• Read each item carefully and provide the information requested where it is requested. 
• Please contact the Research Compliance Services at 6-8802/0986 or irb@uconn.edu 
with any questions.   
 
Protocol Version # and/or Date:  [The protocol version must be revised each 
time a modification is submitted to the IRB to change the protocol.] 
 
9/14/2023 
 
Study Protocol Title:  Mentoring in mHealth and Social Networking 
Interventions for CVD Risk Reduction: Intervention Phase 
 
Does this study involve one or more collaborating institutions, as listed on the 
IRB application in InfoEd?  
☒ No 
☐ Yes-> Please check the appropriate box regarding IRB review: 
 
  ☐ Each site has or will obtain their own local IRB approval (please upload available IRB 
approval letters with this submission).  
or 
 
  ☐ One IRB (sIRB) is being requested to serve as the IRB of record for this study. Identify:  
                    ☐ UConn   
                    ☐ External, identify:  
 
Clinical Trial/GCP Training 
Is this a research study in which one or more human subjects are prospectively 

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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?  
☐ No  
  ☒  Yes  This is a clinical trial 
 
Federal Funding requirement: 
Is this clinical trial funded by a federal department or agency (NIH, DoD, etc.)?  
☐ No/Not Applicable ☒ Yes  The Revised Common Rule requires that a federally-funded 
clinical trial consent form be publicly posted “after the clinical trial is closed to recruitment, and 
no later than 60 days after the last study visit by any subject.” Consent forms can be posted on 
Regulations.gov or ClinicalTrials.gov. For assistance with ClinicalTrials.gov, contact Ellen 
Ciesielski.     
 
NIH Funding requirements: 
Is this clinical trial fully or partially funded by the NIH?   
☐ No/Not Applicable ☒ Yes   
Have the required key personnel completed Good Clinical Practice (GCP) 
Training? 
 ☐ No ☒ Yes   
Is this clinical trial registered on ClinicalTrials.gov? 
 ☒ No ☐ Yes   
NIH-funded clinical trials must be registered within 21 days of enrollment of the first 
participant. Please contact Ellen Ciesielski for assistance.   
 
FDA requirement (all funding sources): 
Does this clinical trial evaluate at least one drug, biological, or device product 
regulated by the United States Food and Drug Administration (U.S. FDA)?  
                                                     
 
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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☒ No/Not Applicable ☐ Yes  Regardless of funder, federal law requires registration and 
results posting of this clinical trial in ClinicalTrials.gov.  Please see the ACT checklist to confirm, 
and contact Ellen Ciesielski for assistance.  
 
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):  
 
The behavioral strategy that most strongly predicts weight loss in behavioral weight loss 
programs is dietary tracking,1 a task that involves having participants record everything they 
consume (food and beverage) every day using a mobile app. Once participants lose weight, they 
can discontinue tracking and restart only when they begin to regain weight. However, dietary 
tracking is a burdensome task and adherence declines precipitously during a weight loss 
program, even long before participants have met their weight loss goals.2,3 Our data show that 
by the end of a weight loss program, only a small minority of participants are still tracking. 
Given how strong of a predictor of weight outcomes that diet tracking is, we need to identify 
ways to enhance tracking adherence. The goal of this study is to randomize participants into 3 
groups that vary based on their diet tracking prescription to explore ways to potentially 
improve adherence to dietary tracking.  
 
One way to increase adherence to diet tracking may be to schedule “breaks” in diet tracking. 
Breaks might not only ease the burden of diet tracking but also give participants a chance to 
practice healthy diet skills without tracking which might boost their confidence in their ability to 
eat healthy on their own. The drawback of tracking breaks though is that participants might 
lose their tracking momentum and have difficulty restarting after the break. No studies have 
examined different tracking prescriptions so we know very little about how people will respond 
to them. In the present study, we will conduct an 8-week weight loss intervention in which 
participants will take part of a Facebook Diabetes Prevention Program (DPP), weigh-ins, 
assessments and be randomized into 3 different tracking prescriptions, one being the 
traditional prescription of daily tracking and the other two involving different schedules of 
breaks.  
 
The Daily Tracking Group will be given the traditional prescription of tracking every day during 
the 8-week intervention. The 1 On/1 Off Tracking Group will be asked to track every day for a 
week, then to take a week off, and so on throughout the 8 weeks. This group will then track on 
weeks 1, 3, 5, and 7 for a total of 4 weeks of tracking. Although this group will only be tracking 
at the most 50% of the time, our previous study found that tracking 40% of the time was the 
threshold needed to lose ≥5% of weight which is the lower end of the program weight loss goal 
(5-10%). The 2 On/1 Off Tracking Group will be asked to track every day for 2 weeks, then to 
take 1 week off, and so on throughout the 8 weeks. This group will then track on weeks 1, 2, 4, 
5, 7, and 8, for a total of 6 weeks of tracking. Although this group will only be tracking at the 
most 67% of the time, our previous study found that tracking 67% of the time was the 

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threshold needed to lose ≥10% of weight which is the high end of the program weight loss goal 
(5-10%).  
All three groups will be asked to continue their schedule of tracking in the month following the 
8-week intervention (i.e., 12 weeks). We will compare groups on weight loss at 8 weeks, total 
days of tracking over 8 weeks, % who adhered to their prescription during the 8 week program, 
% who tracked <50% of the time, % who tracked >50% of the time, % who tracked >67% of the 
time, tracking burden, tracking enjoyment, intentions to continue tracking past 8 weeks, 
number of days tracked in the subsequent month, and weight loss at 12 weeks. Findings will 
inform a fully powered clinical trial of tracking prescriptions during a full-length weight loss 
program (6 months in duration).  
 
Provide a clear and succinct summary description of the background information 
that led to the plan for this project:  
 
Lifestyle interventions are effective at producing modest weight loss.4 One of the 
strongest predictors of weight loss is food tracking5, which involves logging all food and 
beverage consumed each day in an effort to stay within a daily calorie goal. Standard lifestyle 
interventions prescribe daily food tracking for the length of the program which can range from 
3-24 months6. This can be a taxing prescription that is not feasible to do long term for many 
people7. In a study of an 8-week mobile app-delivered lifestyle intervention, food tracking 
declined from six days per week at week 1 to two days per week at week 88. Another study of a 
12-week lifestyle intervention found that 68% of participants were consistently tracking in the 
first week, but this number fell to 21% by 12 weeks9.  Randomized trials of 6-month lifestyle 
interventions have reported mean tracking frequency of about 50% of intervention days8,10, 
which is far below the daily prescription. In spite of modest adherence to food tracking in 
lifestyle interventions, it remains a strong predictor of weight loss8. 
 Many studies show an association between food tracking and weight loss11-13, but it 
remains unclear how much tracking is necessary to achieve different weight loss milestones. 
Some studies have examined the association between various thresholds of food tracking and 
weight loss. For example, one study showed that tracking at least 6 out of 7 days on at least 9 
out of 12 of weeks of a lifestyle intervention was associated with greater weight loss and 
greater odds of losing clinically significant weight (i.e., ≥5%)9. Specifically, 48% of participants 
who met that tracking threshold lost ≥5% compared to 13% of participants who fell below that 
threshold. Another study classified participants in a 12-month lifestyle intervention as “rare 
trackers (n=25),” defined as having tracked <33% of days, “inconsistent trackers (n=5),” defined 
as having tracked between 33-66% of days, or “consistent trackers (n=15),” defined as having 
tracked >66% of days14. They found that consistent trackers lost significantly more weight than 
the other two groups and sustained their weight loss over time whereas the other two groups 
did not. Together, these studies suggest that the prescription to track everything all the time 
results in very few people actually doing so, but those who track one-half to two-thirds of the 
time appear to lose significantly more weight than those who track less.  
One approach to improving food tracking adherence is to reduce the burden of the task 
by simplifying the prescription. Simplification may involve reducing the frequency (e.g., 5 days a 

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week versus every day) or reducing the amount of intake to track (e.g., some foods/meals vs all 
foods/meals). To reduce burden, some studies had participants track diet patterns or servings 
of food groups (instead of calories) and others had participants track by taking photos of their 
food13. A recent systematic review found that 3 out of 4 studies using such abbreviated food 
tracking approaches reported an association between food tracking and weight loss13, which is 
evidence that the prescription of tracking everything all the time may not be necessary15. The 
only approach to tracking that was not associated with weight loss was where participants took 
photos of foods16, which suggests this approach may be too far afield from the traditional 
tracking method to produce meaningful impacts on weight.  
We recently conducted an analysis of 153 participants of a digitally delivered weight loss 
program and found that the optimum threshold of diet tracking that predicted ≥3%, ≥5%, and 
≥10% weight loss at 6 months was tracking on 28.5%, 39.4%, and 67.1% of intervention days, 
respectively. That participants could track about two-thirds of the time and still lose 10% of their 
baseline weight is an encouraging sign that perfect food tracking adherence is not necessary to 
be successful. Because participants can reach the weight loss goal while tracking 40-67% of the 
time, perhaps tracking prescriptions that match those levels would result in less burden and the 
same or higher success rate. The purpose of this study is to test this very question.  
 
Provide references as appropriate and, when applicable, previous work in animal 
and/or human studies:  
 
References are provided at the end of the protocol.  
 
Provide previous UConn protocol number, if applicable: 
N/A 
For each participant population proposed for this study, what is the total # of 
participants (or, for record reviews, total # of records) required to answer the 
study question: 
 
The total number of subjects that will be enrolled into the study is 108. It is estimated that we 
will screen ~1,500 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.  

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Leon et al state “power analyses should not be presented in an application for a pilot study that 
does not propose inferential results.”17 As they and others recommend,17,18 we based the 
sample size of 108 on necessities for examining feasibility thus identifying modifications 
required to the trial design or study procedures before conducting the full-scale factorial trial. 
Having 108 participants allows us to recruit online groups of 36, which our previous work shows 
is feasible and breeds regular engagement. 
 
Enrollment of UConn Students and/or Employees:   
Will UConn students be enrolled? 
☐ No ☒ Yes -> Is it possible that any of the listed study key research personnel teach, or are 
supervisors of, any of the students?   
☒ No   ☐ Yes -> Provide justification for inclusion of this population, provide name of 
the member of key personnel, and explain how undue influence and bias will be 
prevented:  
 
Will UConn employees be enrolled?  
☐ No ☒ Yes -> Is it possible that any of the employees report to one or more study key 
personnel?  
☒ No   ☐ Yes -> Provide justification for inclusion of this population, and explain how 
undue influence and bias will be prevented:  
 
UConn students and employees may be enrolled if they meet eligibility requirements and are 
interested in completing the study. Students or employees that report to, are taught by, or 
have supervisors on key personnel of this project will be excluded from participation. 
 
Enrollment of Key Personnel, Spouses or Dependents/Relatives:   
Will study key personnel, spouses of study key personnel, or dependents/relatives 
of any study key personnel be enrolled in the study?   
☒ No   ☐ Yes -> Specify, provide justification for inclusion of this population, and explain how 
undue influence and bias will be prevented:  
 
 
Recruitment procedures:  
For each participant population, provide full detail: 
 
How will the participants be notified or approached about the research 
(include copies of all recruitment tools, in any media)?  
 
Participants will be notified or approached about this research study through digital ads 
on various platforms (e.g., search engines, health websites, and social media platforms). 

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One method we may use will be in collaboration with a company called Build Clinical. 
Build Clinical is a technology company that enables academic researchers to engage the 
exact populations needed for a given study.19 Build Clinical will create the 
advertisements and landing page as well place the digital ads on the various platforms 
across the Internet. Participants will learn about the research study through these digital 
ads that will appear on the platforms they are on. If they are interested, they will click 
on the ad which will bring them to a landing page that will give them some more 
information about the study. From there, they can click on the link from the landing 
page which will bring them directly to the survey where they can read the information 
sheet in full and complete the eligibility survey if they wish to.  
 
Build Clinical’s privacy policy states that they utilize managerial, physical, and electronic 
safeguards intended to protect the data that they gather (Personal Data) from 
unapproved access, use or dissemination. They use Secure Socket Layer (SSL) for 
authentication and encrypted communications to ensure users' trust and confidence in 
their Website and Services and are HIPAA compliant.20 
 
Other recruitment methods we may use include strategies used in our previous remote 
trials.21 Similar to Build Clinical, with these strategies, the recruitment messages will 
include a link to the REDCap survey where they can read the information sheet in full 
and complete the eligibility survey if they wish to. Online recruitment may be used with 
recruitment messages posted on Facebook groups throughout the US. We will also use 
Research Match which connects volunteers to research studies.22,23 To meet our goal of 
reaching males, we may also recruit on Reddit, where 74% of users are male.24 Facebook 
group recruitment consists of study staff posting recruitment messages in Facebook 
groups. We have met recruitment milestones in our weight loss trials (N=161;25 
N=24026; N=32827). Additional strategies that we may or may not use depending on 
recruitment flow include: 
- 
Other online recruitment: Twitter, newsletters, intranet messages, listservs, 
Daily Digest, emails, and other online locations and platforms as needed  
- 
Connecting with large businesses to get our ad and/or flyer e-mailed to their 
staff and/or students 
- 
Qualtrics recruitment panel: Participants on the Qualtrics panel meeting 
inclusion criteria will be recruited for this study.  
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. 

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To get a representative sample for this study, it is possible we will have to cap certain groups to 
allow room for other groups (e.g., stop enrolling white women to allow enrolling more males or 
people of other 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.  As per the grant, the goal 
of the participant sample is to recruit 50% female and 50% male and anticipate enrolling 30% 
minority participants. Given that we will be recruiting online, we will not be bound to the racial 
and ethnic diversity in the local area. We will conduct online advertising in areas that have 
higher concentrations of ethnic minorities than the US generally so that we can meet our 
recruitment targets. Because recruiting a gender- and ethnically diverse sample for weight loss 
studies that do traditional local recruitment can be challenging, this study gives us an 
opportunity to hone an online recruitment strategy by evaluating the yields from ads in 
different geographical regions and cities.  
 
How will participant privacy be respected?  
 
During the recruitment process, we are unable to see who is viewing our advertisements on any 
platform, therefore their anonymity is respected. We may be able to see data such as how 
many people have clicked on an advertisement for example, but not who each person is. The 
entire process up until the eligibility screener is anonymous. We only email them to answer any 
questions they may have or respond about their eligibility status. Contact information is 
collected only after a participant reads through a simple information sheet and marks that they 
are interested in moving forward with the study. They do not have to provide the research 
team with any personal information until after they have made an informed decision after 
learning about the research study. The contact information will be stored in a REDCap 
database. If a prospective participant decides to email us before going through the REDCap link, 
we do not collect that information. We will simply reply to their email(s). If they request to have 
those emails removed from our inbox, we will delete all correspondence with them and only 
will collect their email address in REDCap if they decide to provide us with that information 
during the eligibility screening process.  
 
How will participants notify the study team of their interest in being in the 
study?   
 
 
With all above mentioned recruitment strategies, participants will be able to follow the link to 
the REDCap survey to complete the eligibility screening, except for BuildClinical. They will click 
on a link that will bring them to a landing page and the screening survey hosted by BuildClinical, 
which is HIPAA compliant. This eligibility survey will collect their contact information, so the 
research team has a way of contacting participants about eligibility. Participants will also be 

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able email us as our lab email will be posted on the landing page or within the recruitment 
wording/images we post online. 
 
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.  
 
This study will last for approximately 9 months from October 2023-June 2024. See approximate 
timeline below. 
 
The timeline is subject to change (depending on how study start up and recruitment goes). 
 
Participant Time. Participants will be in the study for approximately 4 months, which will 
include the screening/onboarding phase, an 8-week intervention, and the follow up 
assessments. 
 
Study Phase  
Approximate Time 
(min) 
Screening 
Initial Screening Survey (15 min) 
15 
Baseline 
Orientation Webinar (60 min) 
E-consent (10 min) 
Baseline survey (15 min) 
Scale and app set-up (10 min) 
95 
Weight Loss Program   
Online weight loss group and mobile app use (8-weeks)/15 min/day 
(840 min) 
840 
Study follow-up #1 (week 9) 
     Weigh-in (5 min) 
Online survey (15 min) 
Study follow-up #2 (week 12) 
Weigh-in (5 min) 
 
25 
Total 
960 minutes  
(approx. 16 hours) 
 
Oct 
Nov Dec 
Jan 
Feb 
Mar 
Apr 
May Jun 
Recruitment 
X 
X 
X 
 
 
 
 
 
 
Intervention 
 
 
 
X 
X 
 
 
 
 
Follow-ups 
 
 
 
 
X 
X 
 
 
 
Data management and analyses 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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Design, Procedures, Materials and Methods: 
Describe the study design, including all study procedures in the order they are 
being conducted, and scheduling/time required for each.   Experimental 
procedures should be clearly described and labeled as such.  If the study uses 
control or experimental groups, or different treatment arms, provide details for 
each.  Include flexibility in the study design where possible (e.g., timing of study 
visits should be reflected in terms of approximate, rather than a specific # of days 
apart, etc.) 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 for this section.  
Note:  
• 
Where platforms such as Zoom are being used, indicate if the use will be under UConn’s 
agreement/license with the vendor.  
• 
Be sure to provide copies of interview and focus group questions/topic areas with your 
submission.  
• 
If the study includes measures, survey instruments and/or questionnaires (including the 
collection of demographic data), identify each, specify if created for the study, and provide 
copies with your submission.  
• 
If applicable, describe and justify the use of digital and/or video recordings and indicate if this is 
a requirement of participation. 
• 
If the study involves use of deception or incomplete disclosure, include explanation of  why this 
intervention is necessary to meet the study aims, and complete the alteration of consent section 
later in this application.  
 
Study Design. Participation starts with a simple information sheet, online eligibility survey, 
orientation webinar, e-consent, and then another survey to collect baseline assessment data. 
Eligible participants will then complete an on-boarding process, which includes MyFitnessPal 
and scale set up. Participants will then be randomized (stratified by gender) and complete an 8-
week intervention, and then two assessments at 9-weeks (weigh-in, survey) and 12-weeks 
(weigh-in).  
 
Recruitment. We will post online recruitment ads that will contain a link to a simple 
information sheet and an online survey containing the screening questions. Ads that are done 
with Build Clinical will lead the participants to a landing page that will give them some more 
information about the study and then will have the link to bring them to the simple information 
sheet and survey. See the recruitment section (starting on page 6) for full recruitment details. 
 
Screening. Participants will complete screening procedures online since they may be located 
anywhere in the country. The screening survey will first have a description of the study and the 
data we will collect from them at that point (the simple information sheet). At the bottom of 
the information sheet, they can mark whether they are interested in participating or not 

Page 1 of 14 
 
 
interested. If they mark that they are interested, it will bring them to the screening questions to 
determine eligibility. The survey logic within REDCap will determine eligibility for participation 
based on participant responses. BuildClinical also had logic to determine eligibility. If they are 
ineligible, they will be notified after the survey is submitted. If they are eligible to proceed, they 
will be contacted by the study team via email to book a time to attend a live informational 
webinar.  
 
We will not require PCP approval since we assess exclusionary medical conditions during the 
screening process. If conditions are reported that might put the participant at risk during the 
intervention, they will be excluded.  
 
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 to evaluate if joining this study is the right 
choice for them. This webinar is being conducted to improve study retention. Participants will 
receive a link to access the webinar via WebEx (under UConn’s WebEx license). Once the 
participants are logged into the webinar, the research coordinator/assistant 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 
moderator will record in REDCap tracking which participants completed the webinar. After 
completion of the webinar, participants will receive an email to go over any questions they may 
have had during the webinar and a link to the online consent form.  
 
As a result of the COVID-19 Pandemic, our lab is working remotely. Therefore, any phone calls 
or texts made to participants while our team members are working from home will be 
conducted via Google Voice. 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 standard calling. Participants do not need the app to 
contact the lab. Researchers will retain the call history and text message exchanges for the 
duration of the study within the Google Voice app. Call history and text messages will be 
deleted once the study is over. If something sensitive is shared by a participant, we will delete it 
right away and save it in the R Drive or REDCap if it is relevant to the study. Team members 
using Google Voice to communicate with participants will ensure their phones are properly 
maintained during the study for security and privacy purposes. 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.  
 
Baseline. Participants that decide to complete the online consent process will be sent the 
online baseline survey about demographics, nutrition literacy28, depression, and history of 

Page 1 of 14 
 
 
weight loss attempts and use of diet tracking and diet tracking apps. Participants who do not 
consent will be brought to a landing page thanking them for their time learning about the 
study, but they will no longer be eligible to participate beyond that point. 
 
After the baseline survey is completed, for those that are still eligible, UConn will ship a study 
scale to the participants. Once the participants receive their scale, UConn staff will give the 
participant an option to set it up themselves or schedule a call to help them set up the scale 
and ensure that it is working, and we can access their data. UConn staff will then collect a 
baseline weight from participants to confirm their BMI for eligibility reasons.  
 
After the BMI has been confirmed, UConn staff will do a final eligibility check, going through all 
previous steps done by the participant and double-check to confirm that they are eligible. If 
they are not, UConn staff will notify them via email. If they are eligible, UConn staff will engage 
in a series of emails with the participants to help them set-up the study app and confirm they 
are working. If the participant prefers, the set-ups can be done over the phone as well. 
 
Participants will need to complete both surveys (screening and baseline), webinar, consent, set-
up the scale and provide the study team with a baseline weight to confirm BMI (done with scale 
we ship to them), and set-up all study apps before being randomized into the trial. Participants 
will be randomized into one of two groups. 
 
Ineligible participants will be notified either automatically or by the research 
assistant/coordinator via email that they do not meet criteria for the study. Staff will use a 
generic response about how their pattern of responses does not match 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. 
For participants who score a 20 or higher on the PHQ-8, they will be contacted via email to let 
them know they are ineligible and to provide them with a list of resources/support (attached in 
study documents) for their symptoms of depression if they want to utilize those options. It’s 
important to note that a high score on the PHQ-8 only indicates the presence and severity of 
symptoms of depression, but not an actual diagnosis. 
 
Intervention. All participants will join an 8-week counselor-led (counselors go through the DPP 
lifestyle coach training) Diabetes Prevention Program (DPP) lifestyle intervention in a private 
Facebook group. Depending on which group participants are randomized to will determine 
which Facebook group they join. The DPP content will stay the same across all groups. 
Participants will also be asked to track their diet and exercise on MyFitnessPal as part of the 
program. Participants will be randomized into one of three groups that differ regarding dietary 
tracking. Group One will be called the Daily Tracking Group and will be asked to track their diet 
every day in the program. Group Two will be called the 1 On/1 Off Tracking Group and will be 
asked to track every other week which would result in 4 weeks of tracking and 4 weeks off from 

Page 1 of 14 
 
 
tracking. Finally, Group Three is called 2 On/1 Off Tracking Group and will be asked to track for 
2 weeks, then they will get a 1-week break and repeat that pattern until the end of the 
program.  
 
Facebook Groups. The DPP lifestyle intervention will be delivered within all three counselor-led 
Facebook groups 
with twice daily 
pre-programmed 
posts as in our 
previous studies 
(see 4 sample 
posts 
below).27,29,30,31 
All Facebook 
groups will be on 
the “private” 
setting which 
means only group 
members can see 
the group and its 
content. Each 
week’s content is 
based on the 
corresponding 
module of the DPP. The DPP assigns participants the goals of 1) calorie tracking to achieve a 
calorie goal based on amount needed to lose 1-2 pounds per week, 2) developing a healthy diet 
consistent with the American Heart Association guidelines, 3) engaging in 150-300 minutes per 
week of moderate/vigorous intensity exercise (i.e., brisk walk at 2.5-4 mph, bicycling, 
gardening, dancing, water aerobics, canoeing, playing doubles tennis. etc.) or 75-150 minutes of 
vigorous exercise (e.g., jogging at 6mph, soccer game, shoveling, playing a tennis singles game, 
etc.), 4) developing a strength training regimen consistent with the National Exercise 
Guidelines, and 5) losing 1-2 pounds per week. Goal setting happens on Mondays when the 
counselor posts diet and exercise goals with the group. The counselor will give the group 
different sets of 2 goals each week—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. On Fridays, the counselor posts a weigh-in post 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 those 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 recurring posts are 
posts that reflect the DPP module for the week (e.g., nutrition, making time for exercise). Many 
posts contain links to our Pinterest page which includes recipes, meal plans, and workouts 
tailored to dietary preferences (e.g., vegetarian) and cultural influences (e.g., African American, 

Page 1 of 14 
 
 
Latinx). Participants also have the opportunity to send their counselor private messages if they 
don’t want to post in the group. Additionally, the coach or study team members may post 
periodic videos of themselves or study-related content to facilitate building a relationship with 
the participants and to assist with stimulating engagement. The coach/study team will also post 
about MyFitnessPal to give them tips/tricks with their tracking and remind the relevant groups 
which weeks they are tracking and are not tracking. The counselors may attempt to re-engage 
any participants who stop commenting or reacting in the Facebook group by tagging them in a 
post, private messaging, emailing, or calling them. 
 
MyFitnessPal. All participants regardless of which group they are randomized into will be asked 
to use MyFitnessPal, the differences in the groups are the rate of which they track. Participants 
will be given a calorie goal based on their BMI, gender, age, and activity level to produce a 
weight loss of 1-2 lbs. per week.  On days they are tracking, they will be asked to enter all the 
food and beverages they consume and their exercise with the purpose of staying under or at 
the calorie goal. Participants will use the free version of MyFitnessPal for this study. 
 
Weigh-ins. Participants will receive a Wi-Fi 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 an app designed for the scale. 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 scale to the participants’ account. Participants will be asked to set up 
an account for the study and share login with the study staff so that the staff can record the 
weight taken. Study staff will help the participants set up their scale if they need it and check 
their BMI once the scale is working. If a participant has a BMI under 27, 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 password. 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/Assessments: The follow-ups/assessments will occur at the 9 and 12-week marks 
after the intervention has begun. At the 9-week mark (the week after the program ends), 
participants will receive a link to an online REDCap survey. 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. Then, at both the 9 and 12-week assessments, the participants 
will also weigh in. At the 12-week assessment, we will also collect their MFP diary entries, but 
that does not require the participant to do anything. Participants will be compensated 
(compensation explained in Payment/Course Credit to Participants section) for completing 
these assessments.  
 
Adverse Events: Adverse events will be documented during the intervention and assessments. 
AE’s will be formally assessed during the 9-week assessment by asking questions in the REDCap 
survey. During the intervention, AE’s will be documented when a participant reports it to the 

Page 1 of 14 
 
 
weight loss counselor or posts it in the Facebook group. If it is reported during the intervention, 
the counselors will notify a research coordinator within 24 hours of learning of the event. The 
study team will then report it to the IRB (immediately or at the time of annual renewal 
depending on the AE). 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 and/or email from a 
research coordinator, and they will be asked questions to figure out the cause of their weight 
gain. We will also assess Binge Eating Disorder (BED) at this time. If BED is present, we will treat 
it as a study-related AE. We will only assess BED once, even if there are multiple AEs for weight 
gain. Participants will not be removed from the intervention if they have 5% or more weight 
gain. If a participant is losing twice the weekly goal, which is 4 pounds of weight loss a week, 
consistently for 3 or more weeks in a row, then we will contact them to find out how they are 
accomplishing that and determine whether they are doing anything that is unsafe. If it is 
determined that they are losing weight in an unsafe manner, we will record that as an AE and 
the PI will have a discussion with them privately about healthy weight loss and how to do so in 
a safe manner moving forward. If after that conversation, they are still consistently losing 4 
pounds of weight loss a week (for another 3 weeks or more in a row), we will remove them 
from the study and refer them to the National Eating Disorders Association helpline 
(https://www.nationaleatingdisorders.org/help-support/contact-helpline).  
 
Measures: See table below. 
Data Collected 
List of Measures 
Screening/ 
Baseline 
8-week 
Intervention 
F/up 
#1 
F/up 
#2 
Method 
Inclusion/Exclusion 
criteria 
Initial screening 
survey* 
X 
 
 
 
REDCap or 
Qualtrics or 
BuildClinical 
BMI 
Height 
X 
 
 
 
REDCap 
Weight 
X 
X 
X 
X 
REDCap 
Demographics 
Marital status, 
education, 
race/ethnicity, 
sexual orientation, 
work status, 
household income, 
household 
members* 
X 
 
 
 
REDCap 
Nutrition Literacy  
The Nutrition 
Literacy Assessment 
Instrument (NLit)28 
X 
 
X 
 
REDCap 
History of Weight 
Loss 
Weight loss 
attempts* 
X 
 
 
 
REDCap 

Page 1 of 14 
 
 
 
* = investigator derived 
** = as needed for AEs 
 
The Nutrition Literacy Assessment Instrument: The NLit demonstrated both factor validity and 
reliability (0.97, CI =0.96–0.98) as well as test-retest reliability (0.88, CI=0.85–0.90).28 
 
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.32 
 
Patient Health Questionnaire (PHQ)-8: The PHQ-8 is an 8-question measure like PHQ-9 (with 
the omission of one question). The Cronbach’s α for the PHQ-8 was 0.88 which demonstrates 
good reliability and a Spearman coefficient of 0.616 which demonstrates good convergent 
validity when compared to the PHQ-9.33 Together, this data shows the PHQ-8 is as valuable as 
the PHQ-9. 
 
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.  
 
Use of diet tracking* 
Use of diet tracking 
apps* 
Binge Eating 
Disorder 
SCID Eating Disorder 
Examination 
Questionnaire32 
 
X** 
X** 
 
REDCap 
Depression 
Patient Health 
Questionnaire (PHQ-
833) 
X 
 
 
 
REDCap 
Engagement 
Facebook 
Engagement* 
 
X 
 
 
Grytics into 
REDCap 
Diet tracking 
Data extraction* 
 
X 
 
X 
MFP records 
Diet Tracking 
Acceptability (0-10 
scales) 
Difficulty* 
Time Consuming* 
Helpfulness* 
 
 
X 
 
REDCap  
Intervention 
Feedback 
Burden* 
Contamination*  
 
 
X 
 
REDCap 
Adverse Event 
Assessment 
Adverse Events* 
 
 
X 
 
 

Page 1 of 14 
 
 
Intervention prescription. We will report the % of participants meeting the prescription. % of 
participants who are high trackers (tracked >70% of the time), medium trackers (tracked 40-
69% of the time), and low trackers (tracked <40% of the time). 
Recruitment. We will report numbers and reasons for exclusion using a CONSORT diagram and 
we will compare recruitment sources by gender and race/ethnicity yields.   
Retention. We will calculate retention as the proportion of participants who complete the 
follow-up assessments in each condition and report this information using a CONSORT diagram. 
Engagement. Number of Facebook reactions (e.g., like, care, wow, etc.), replies, posts, and polls 
per participant during the program. 
Diet tracking prescription acceptability. We will report on the difficulty level, time consuming, 
and helpfulness of tracking prescription, as well as intentions to keep tracking in the next 
month. 
Nutritional Literacy. We will report on the % who are considered likelihood of poor nutrition 
literacy, possibility of poor nutrition literacy, and likelihood of good nutrition literacy. 
History of Weight loss attempts, diet tracking and diet tracking apps. Using descriptive 
statistics, we will summarize those who have a history of weight loss attempts, and use of diet 
tracking and diet tracking apps. 
Amount of tracking. We will report the amount of tracking participants did throughout the 
intervention as well as one month following the intervention. 
Contamination. We will report the percentage of participants that used any outside programs 
that provided weight loss coaching or another app to help with weight loss/exercise. 
Burden. Using descriptive statistics, we will summarize burden scores in both treatment 
conditions. ANOVAs will be used to compare conditions on burden.  
Weight loss. We will calculate weight change from baseline to 8 weeks as well as baseline to 12-
weeks. As this pilot trial is not powered to detect differences, average changes will not be 
compared by treatment condition. 
 
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 rationale 
for the exclusion.   
 
Inclusion Criteria 
• 18-65 years old 
• BMI 27-45 kg/m2  
• Wi-Fi connectivity at home 
• Logs into Facebook at least 5 days per week over the past 2 weeks 
• Able to participate in the study in English 
• Interested in losing weight 
• Lives in US 
 

Page 1 of 14 
 
 
Age justification: Children under 18 require different programming for weight loss and 
maintenance given their developmental needs. Weight loss is for elderly adults should be 
medically supervised, something this study is not offering. 
 
Exclusion Criteria 
• Pregnant/lactating or plans to become pregnant during study period 
• Reports having bipolar disorder, substance abuse, psychosis, an eating disorder, or 
severe depression 
• Had bariatric surgery or plans to have surgery during the study 
• Currently taking medication affecting weight 
• Has lost ≥5% of weight in past 3 months 
• Is participating or intends to participate in another weight loss program during the study  
• 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 twice a week or more 
• Has a digestive disorder/condition that precludes dietary changes  
• Meets criteria for severe depression on the PHQ-8 (score of >19) 
• Does not currently own a smartphone 
• Participated in previous weight loss studies under the PI 
• Unable to attend the orientation webinar 
• Had major surgery in past 6 months and have not been cleared by their doctor to 
resume physical activity and diet changes 
• Plans to have major surgery in the next 6-months  
• Has an implanted cardiac defibrillator or pacemaker 
• Did not complete screening and on-board processes of study (screening survey, 
webinar, e-consent, baseline survey, app set-up, scale set-up, etc.) 
• Is a student and/or staff of the PI. 
 
Removal from Study 
Describe the conditions under which participants may be removed from the 
study, e.g., noncompliance with study rules, study termination, etc.  
☐ N/A 
 
Participants will be removed from the study if: 1) they do not complete all screening, baseline, 
and on-boarding procedures (two surveys, consent, webinar orientation, app set-up, and scale 
set-up, join the Facebook group), 2) become pregnant during the study period, 3) post 
threatening or disturbing content in the Facebook group (e.g., bullying/harassment of others, 
hate speech, violent/graphic content, violating privacy of others etc.), and 4) if they choose to 
withdraw their participation from the study. Participants reporting that they would like to 

Page 1 of 14 
 
 
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 asked to 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. For 
each risk, you must assess the likelihood of occurrence, and, if it were to occur, 
the associated severity. Types of risks to consider include, but are not limited to: 
physical, psychological, social, legal, employment, and financial.    
☐  N/A (no foreseeable risks anticipated) or,  
Describe any anticipated inconveniences the participants may experience (such as:  
their time, abstention from food, etc.): ☐ N/A 
 
Potential risks for being in this study includes injury while exercising and/or cardiovascular 
event, accidental exposure of personal information, and discomfort with study procedures (e.g., 
feeling uncomfortable with some questions asked on a survey or something someone said in 
Facebook group). The attempt to avoid risks to participants will be addressed by focusing 
mainly on suggesting moderate intensity exercise to avoid discomfort, pain, or injury. We do 
provide guidance on vigorous activity for those participants who prefer that type of exercise 
and/or are already doing it prior to joining the study in accordance with the National Exercise 
Guidelines. We also provide images or links on how to do exercises properly to avoid pain or 
injury. Participants reporting discomfort will be told to go see their PCP. Injuries are unlikely to 
occur since we screen out medical conditions that could make someone prone to injury. To 
avoid accidental exposure of personal information, tracking data will be stored electronically in 
REDCap, a network secure data entry program, in the UConn-supported R drive, or OneDrive 
which is secure. Only those who have IRB approval to work on the study will have access to the 
R drive and REDCap database for this study. To avoid discomfort during study procedures, 
participants will be informed that they may withdraw from the study at any time if they feel 
discomfort with any of the study procedures or if they don’t want to answer a question on a 
survey, they can skip it. The likelihood of each of these risks happening is rare since we take 
steps to prevent these from happening and if they were to happen, the severity would be likely 
be minor.  
 
Benefits: 
Describe anticipated benefits to the individual participants.  If test results will be 
provided, describe, and explain procedures to help participants understand the 
results.  Identify who provides results to participants.  If individual participants 

Page 1 of 14 
 
 
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 exercise and lifestyle changes and improvements in mental, physical, 
social, and emotional health. Through interacting with other participants and the counselor in 
the Facebook group, participants may also feel supported in their behavioral change efforts. 
Participants will also receive weighing scales that they are able to keep at the end of the study. 
 
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 more sustainable yet still 
effective ways to help people achieve healthy lifestyle goals and improve the outcomes 
of their health. 
 
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 are minimal. If injury during exercise was to occur, it would likely 
be minimal because we screen out those at risk for injury or pain. Even then, injury can still 
happen, therefore we suggest activities where injury is unlikely and/or would be minor (e.g., 
playing tennis may result in feeling minor pain/discomfort which should subside in a few days; 
and soreness may decrease over time as the body adjusts to the increase in movement). Any 
discomfort during the study can be mitigated because participants can stop participating or skip 
any questions they don’t want to answer at any point. Accidental exposure of personal 
information is unlikely as steps are taken to prevent it (e.g., password protected UConn 
computers, only using secure websites or servers like the R drive and REDCap, only having 
approved personnel that are trained via CITI handle data). All these risks are outweighed by the 
possible benefits to participants (weight loss and enhancements in mental, physical, social, and 
emotional health) because it could improve their health and quality of life. 
 
Costs to Participants: 
Will there be any costs to the participants? 
 ☒ No   ☐ Yes -> Describe:  
 
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. 

Page 1 of 14 
 
 
 
Payment/Course Credit to Participants: 
Will there be any payment or course credit to the participants? 
 ☐ No 
 ☐ Yes ->  ☐ Payment ☐ Course Credit 
 
• What is the amount of payment/course credit?  Please describe below.    
• Describe the scheduling of payment/course credit, i.e., how the amount will be 
prorated across the duration of the study:  
 
Participants will be paid in the form of online Amazon gift cards. Participants will receive 
compensation at two points in the study. The participants will receive $50 for completing the 
first follow-up assessment (the week after the intervention ends) which includes a weigh-in and 
a survey. Further, participants will receive $25 at the second follow-up assessment (one month 
after the intervention ends) which includes a weigh-in. Payment will be in the form of an online 
gift card paid after the follow-up procedures are completed at each time point. 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 
(Complete this section for research that is greater than minimal risk, i.e., 
anticipating full board review)  
☐ N/A (research is minimal risk to the participants) 
 
Describe your data safety monitoring plan:   
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 8-week intervention will be sent to the two safety officers once follow-
ups have been completed. Recruitment is monitored daily during the recruitment phase by the 
research coordinators and research assistants. All surveys are monitored once submitted to 
REDCap within 48 business hours by the research coordinators and research assistants. The 

Page 1 of 14 
 
 
Facebook group is monitored daily by the coaches. Weigh-in submissions are monitored weekly 
by the research coordinators and research assistants. App usage is monitored weekly by the 
research assistants, research coordinators, and the data managers. All data is continuously 
reviewed by the data managers. 
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 PI/statistician and 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 safety 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 
safety 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 safety 
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 safety 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 

Page 1 of 14 
 
 
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 
report will be provided in the safety report. 
4. 
Data evaluated for problems  
Data reports will be reviewed by the data manager, statistician, and PI.  
5. 
Actions taken during certain occurrences 
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 of serious events that the IRB recommends we 
report. 
Are there any plans to do an interim analysis?   ☒ No ☐ Yes  
 
If yes, describe the interim analysis plan:  
 
Have stopping rules been established for the study?    ☒ No ☐ Yes  
 
If yes, describe the stopping rules:  
       
Are there defined criteria for when study interventions should be discontinued? 
☒ No  ☐ Yes 
 
If yes, describe the criteria:  
 
Are there exams or procedures that the subject will be asked to have done or 
follow to safely withdraw from the study?  ☒ No  ☐ Yes 

Page 1 of 14 
 
 
If yes, describe the procedures for safe withdrawal of subjects (NOTE: 
Withdrawal procedures should also be described in the consent):  
 
 
Privacy/Confidentiality: 
Explain how the privacy interests of participants will be maintained during the 
study (note that privacy pertains to the individual not to the data):  
 
For the initial screening survey, participants can answer the questions at their own pace and in 
an environment of their choice since it is done via a link online. If they do not want to finish, 
they can exit out of the survey whenever they would like. We also provide a simple information 
sheet prior to the survey so they can decide if they even want to move forward with doing the 
screening survey. 
 
During the webinar process, UConn staff will go over all the details of the study and what it 
means to be a participant to give them a thorough description of what they can expect and 
what the study is so they can decide if this study is a good fit for them. During the webinar, they 
turn their video and audio off and choose where they view the webinar. 
 
Most contact is done online so participants can control where they are and how they answer on 
their own time. They will have ample time to decide if they want to participate or not and ask 
UConn staff any questions they may have. Consent will also be done online so they can control 
where they are when reading the form as well as the amount of time they have to read through 
the form before deciding.  
 
Participants will be informed in the consent form that they are able to withdraw from the study 
at any time for any reason without any consequences. They can skip questions during baseline 
and follow-up assessments if it makes them uncomfortable as well. 
 
The participant can control when and where they use MyFitnessPal and Facebook group. We 
will encourage them throughout the study to use the app and the Facebook group as directed, 
but we only do so when it seems like they may be falling behind and if they do not reply to our 
contacts, we do not bother them about it again. 
 
Most communications are done on an individual basis to respect their privacy. For the webinar, 
we have alternate methods to help respect their privacy (e.g., turn off video/audio during 
webinar).  
 
All communications and data collections are done only for necessary research purposes. 
Participants can specify preferred and non-preferred communication methods (e.g., calls, texts, 
emails) that staff will honor and only use non-preferred communication if needed (e.g., 

Page 1 of 14 
 
 
participant prefers phone calls, but staff needs to send a survey link, we would then email 
them).  
 
Participants will likely interact with each other in the Facebook group and see each other’s 
names and profile picture, but we make sure during the webinar and in the consent that they 
are aware of that so all enrolled participants will be comfortable with sharing with others they 
may or may not know. Participants are free to change their Facebook name or profile picture if 
they wish. Any participants will be marked ineligible during screening/baseline if they do not 
wish to use Facebook for the study and any that become uncomfortable with it are free to 
withdraw at that point. 
 
All data from participants is collected on an individual basis. Surveys are provided to them 
through secure links via REDCap that is unique to each participant.  
 
Describe how confidentiality of the data (including audio/video recordings) will be 
maintained (where stored, how stored, security of storage, coding of data/how 
coded, how long the data will be kept in identifiable or de-identified format, 
obtaining a certificate of confidentiality, etc.):   
 
The data will be maintained on UConn servers (R Drive, REDCap, and OneDrive) where security 
will be maintained through access controls. Files will be managed by the project 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, 
OneDrive, and R drive if the data manager or coordinator has given them access. The only staff 
who will have access to data are those approved on the IRB personnel and completed necessary 
CITI training. All participants will be assigned an ID number, which will link them to their study 
data. The ID number will be 2-4 numerical characters representing the number of participants 
in the study (e.g., the first person who fills out an eligibility screener would be ID 1). PII fields 
will be stored in a REDCap form. Any data with PII in the R Drive will be minimal and only what 
is necessary for data management and analysis. It will be marked as such. Data will be 
completely de-identified once we have our master dataset saved in our R drive (which will be 
fully de-identified). At this time, the link between ID number and PII will be destroyed. 
 
List any exceptions to confidentiality (e.g., mandated reporting) and identify any 
external agencies (study sponsor, FDA, collaborating institution IRB etc.) that will 
have access to the data. ☐ N/A   
 
UConn IRB and their representatives as well as the study sponsor (NIH) will have access to the 
research data if requested. 
 
Also, it is possible that participants in this study may know each other. 
 

Page 1 of 14 
 
 
If participants fail screening, describe the plans for storage or destruction of their 
identifiable data: ☐ N/A    
 
The data collected from the screening will be stored in a form in REDCap under their 
study ID and will be kept until the end of the study. We will de-identify everything once 
we have the master dataset finalized. 
 
Complete and submit the Data Security Assessment Form 
(required for all studies): 
The form is available here (https://ovpr.uconn.edu/services/rics/irb/irb-
forms-templates/).   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 tip 
sheet here: 
http://content.research.uconn.edu/pdf/storrs/rcs/irb/TipsDataSecurityAsse
ssmentForm.docx.   
 
Informed Consent Process 
The PI is responsible  for ensuring that participants are fully informed about the 
study prior to their agreement to participate.    
 
Consent/permission Setting:  
☐ N/A - Waiver of consent is being requested below.  
Describe the consent/permission process that is respectful of the participant’s 
privacy, including: 
 
 
When will consent be obtained:  
 
Participants will first read through a simplified information sheet prior to doing the eligibility 
screener. This will contain information about the study in general, next steps, and what data we 
will collect from them at this point. After reading through it, they will mark if they are or are not 
interested in participating in the study. If yes, they will go through the screening survey. From 
there, participants will then do an online webinar to learn more about the study and decide if 
this is a right for them, and then after that they will be sent the e-consent via a REDCap link 
where they will read through the consent from and consent online (via signature) and then they 
will be sent a copy of the signed consent via email. 
 

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Who, on the study team, will obtain consent:  
 
The research assistants/coordinators will obtain consent by sending a link via email to the e-
consent form for participants to read and sign (if they choose).  
 
Where will consent be obtained:  
 
REDCap. 
 
How much time participants will have to decide to be in the study:  
 
Participants will be given ample time. At both the eligibility screener phase and informed 
consent phase, they will be given as much time as they would like. They will have our contact 
information if they want to reach out to ask any questions. They will have up until recruitment 
closes to make that decision. 
 
Will an assessment be made of the participant’s capacity to consent, i.e., they 
appreciate the information being presented (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): ☐ N/A   
 
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. 
 
Consenting participants with limited decision capacity, language 
barriers etc.:   
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 have IRB 
approval in order to include this individual and obtain permission from the 
participant’s legally authorized representative. ☐ N/A   
 
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 webinar 
process prior to consent 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 PI who will determine whether to 
exclude the participants on this basis. 
 

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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, and 
the child’s consent to continue in the study will need to be obtained when they 
reach 18 years old.  ☒ N/A  
 
 
Documentation of Consent:   
☐ N/A - Waiver of the documentation of consent is being requested below.  
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 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 in addition to a consent 
form. An information sheet is given before the eligibility survey just to make sure they 
are interested and understand what data we collect from them at that point and then 
the official consent is given after they complete the webinar. 
 
Waiver or Alteration of Consent:   
The IRB may waive or alter the elements of consent in some minimal risk 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 without signing a form), please answer the following questions using 
specific information from the study: 
 
 
 
Note: An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for 
the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed 
consent of the prospective subject or the subject’s legally authorized representative, if either of the following 
conditions are met: 
(1) The investigator will obtain information through oral or written communication with the prospective 
subject or legally authorized representative, or 
(2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing 
records or stored identifiable biospecimens.  
 

Page 1 of 14 
 
 
Why is the study considered to be minimal risk?   
N/A 
 
Why will the waiver not affect the individual’s rights and welfare?   
N/A 
 
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:  
N/A 
 
Explain why the research could not be practicably carried out without using 
identifiable private information and/or identifiable biospecimens (if identifiable 
information or biospecimens are not being obtained, state N/A):  
N/A 
 
If appropriate (e.g., research that uses deception/incomplete disclosure), how will 
additional pertinent information be provided to the participants (state N/A if this 
doesn’t apply to the waiver request)?    
N/A 
 
Explain if the waiver/alteration as noted above is applicable to the entire study or 
to a portion of the study:  
N/A 
 
Waiver of documented (signed) consent (i.e. , no signature, participants give 
consent only after reading an information sheet or through oral discussion).   
*Choose the (one) appropriate criterion below, and justify:  
 
(i) The only record linking the subject and the research would be the informed 
consent form and the principal risk would be potential harm resulting from a 
breach of confidentiality. Each subject (or legally authorized representative) will 
be asked whether the subject wants documentation linking the subject with the 
research, and the subject’s wishes will govern; (not applicable to FDA-regulated 
studies) 
Explain: 
N/A 
 

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(ii) That the research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written consent is normally required outside of 
the research context (e.g., short telephone or web-based survey, etc.) 
Explain: 
N/A 
 
(iii) If the subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm, that the 
research presents no more than minimal risk of harm to subjects and provided 
there is an appropriate alternative mechanism for documenting that informed 
consent was obtained. (Not applicable to FDA-regulated studies, or DOJ-funded 
studies) 
Explain: 
N/A 
 
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