A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions
Phase: NA
Conditions: Obesity
Sponsor: University of Connecticut

 
 
 
 
 
Study Protocol and Analytic Plan:  
 A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered 
Lifestyle Interventions 
NCT06393725 
June 13, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Study Protocol 
Background 
Lifestyle interventions are efficacious but costly and have poor scalability.4 Remotely-
delivered lifestyle interventions, which leverage videoconferencing software, online 
platforms, and/or mobile apps, have increased potential for reach and scale. A systematic 
review concluded that remote lifestyle interventions are effective,5 with largest effects in 
those that include human coaching. Some remote lifestyle interventions are synchronous, 
such that they are delivered via videoconferencing or phone. Other remote lifestyle 
interventions are conducted asynchronously via online platforms that allow for clinicians 
and patients to engage via text exchanges or online groups. Asynchronous interventions 
allow people to engage whenever it is convenient 24/7 which makes them conducive to ‘in 
the moment’ support, and this addresses a key barrier to lifestyle interventions which is the 
feasibility of attending numerous meetings. In this application we propose a non-inferiority 
trial comparing two remotely delivered lifestyle interventions: one that is delivered 
synchronously and one that is delivered asynchronously. Evidence for asynchronous 
interventions is needed because they may be a convenient alternative for many people, 
more scalable, and more sustainable. Further, for asynchronous telehealth to receive 
reimbursement, we need evidence for their efficacy relative to synchronous approaches.   
While some evidence shows that remote and in-person lifestyle interventions produce 
fairly similar outcomes when delivered synchronously, we know less about how 
asynchronous remote interventions compare to synchronous ones. In a non-inferiority trial 
comparing an in-person (synchronous) lifestyle intervention to an asynchronous, remote 
lifestyle intervention, we found that the in-person condition lost more weight at 6 months, 
but due to greater weight regain in that condition, the groups were not signiﬁcantly different 
in weight loss at 1 year. The asynchronous remote intervention also cost 18% less per 
pound lost. Interestingly, at the end of the trial, 64% of participants said the asynchronous 
remote intervention would be more convenient than the in-person intervention. We 
discovered another possible advantage of asynchronous remote lifestyle interventions 
which is that they may be more scalable than synchronous remote ones. In a trial of two 
asynchronous, remote lifestyle interventions—one with a group of 94 participants and one 
with a group of 40 participants,6 we observed similar weight loss and acceptability between 
conditions. However, the larger group remained intact for longer. In the year following the 
intervention, we turned the groups over to participants to lead themselves, a period we 

called the “peer-led maintenance phase.” We found that the larger group engaged for much 
longer during this phase. This suggests that larger groups may be more sustainable and 
have greater potential for long term weight loss maintenance. Our next step is to examine 
how an asynchronous remote intervention compares to a synchronous remote 
intervention, not only in short term weight loss, but also in engagement, scalability, 
sustainability, and weight loss maintenance. We are also interested in whether the 
asynchronous, remote condition, by giving people the opportunity to engage any time, will 
end up creating a higher functioning group, i.e., greater collective efficacy. Now that we’ve 
established the feasibility of large asynchronous, remote groups, we propose to randomize 
participants to large groups (n=82) in both conditions, which will allow us to compare 
synchronous to asynchronous interventions that are scaled to a level that pushes the ﬁeld 
forward.   
The proposed study is a randomized controlled non-inferiority trial. We will randomize 328 
adults who are overweight or obese in one of two conditions. Participants in the 
asynchronous condition will receive lifestyle counseling via a private group on Facebook. 
Participants in the synchronous condition will receive a lifestyle intervention via 
videoconference group meetings. Two waves of 164 participants will each be randomized 
into two groups of 82 participants. Content in both conditions is based on the Diabetes 
Prevention Program Lifestyle Intervention. Assessments will be taken at baseline, 6-, 12-, 
18-, and 24-months. Percent weight change at 6 and 12 months is the primary endpoint. 
Secondary endpoints include retention, engagement, cost, and sustainability, deﬁned as 
engagement in the year-long post-intervention period.    
We hypothesize that members in the asynchronous condition, by virtue of having more 
opportunities to engage (i.e., 24/7) will feel higher collective efficacy about their group than 
the synchronous condition where interactions are restricted to weekly or less frequent 
group meetings. Further, we hypothesize that the asynchronous condition will engage more 
in the post-intervention period because it is easier to do so than it will be in the 
synchronous condition where engagement will depend on how reliably the volunteer group 
leader arranges regular videoconference meetings and on the availability of group 
members to attend those meetings. We suspect collective efficacy may decline in the 
synchronous condition during the post-intervention period due to these participation 
barriers. Further, if few people show up to the initial group meetings in the synchronous 
condition, this may negatively impact attendance rates in subsequent meetings.   
 
 

 
 
Total participants required to answer the study question 
The total number of participants that will be enrolled into the intervention is 328. However, 
it is estimated that we will screen ~4,000 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.  
How was sample size determined? 
We powered the study to be able to detect non-inferiority for the primary outcome, percent 
weight loss at 6 and 12 months.   
Aim 1: Our sample size estimates utilize methods developed for non-inferiority trials.7 In a 
non-inferiority trial, the null hypothesis (H0) is that the new treatment is inferior to the 
standard treatment, and the alternative hypothesis (HA) is that the new treatment is not 
inferior to the standard treatment. “Not inferior to” is deﬁned by the non-inferiority margin, 
δ. Here, we set δ = 2%, based on a clinically meaningful difference in mean weight loss 
between the two conditions. Thus, adequate power for clinical non-inferiority requires a 
sample size such that there is better than 90% probability that the lower limit of the 
conﬁdence interval lies above –δ, if the true effect size is zero or above. We estimated 
SD=5.5% based on our previous trial.62  With alpha=0.05, and δ=2%, we have 90% power to 
conclude that the ASYNC condition is not inferior to the SYNC condition with 131 
participants per arm. Assuming 20% attrition, we will enroll 328 participants (164 per 
arm).   
Aim 2: Engagement, Cost. Engagement: We have 80% power to detect differences of 
≥0.79 SDs in engagement (word count) between conditions. With N=164 available per arm 
(N=328 total) and α=0.05 we have 94% power to detect differences in mean cost per 
participant of 0.35 SDs. For example, if the SD for cost is $100, then we have 94% power to 
detect differences in mean cost per participant of $35. In our previous non-inferiority trial 
comparing a synchronous in person lifestyle intervention to an asynchronous remote 
lifestyle intervention, the difference in cost per participant was $82.66. We suspect the 
difference will be less in this trial because travel costs contributed to the difference in our 
previous trial that used an in-person condition.   
Aim 3: Maintenance and Sustainability. Maintenance will be tested in a longitudinal 
design, assuming 5 time points (including pretest, 6, 12, 18, and 24 months) clustered 
within individual. From the conservative perspective of the inferiority effect size, δ=2%, SD 

=5.5%, with alpha=0.05, and ICC = 0.6, the study will have power of 97.6% to yield a 
statistically signiﬁcant result with a sample size of 328 participants. Sustainability 
(engagement during the Peer Led Maintenance Phase): We have 80% power to detect 
differences of ≥0.79 SDs in engagement (word count) between conditions.  
How are participants recruited?  
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, 
etc.).   
  
Recruitment methods we will use include strategies used in our previous remote trials. 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.11,12 To meet our goal of reaching males, we may also recruit on Reddit, 
where 74% of users are male.13 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;14 N=24015; N=32816). 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.  
  
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 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.  As per the grant, the goal of the participant sample is to recruit 50% 
female and 50% male and anticipate enrolling at least 30% minorities into the study. 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 the identity of 
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 decided after learning about the research study. Even if the participant takes the 
eligibility survey, they can choose to not provide contact information and exit out of the 
survey, but it will make them ineligible (since we will not be able to contact them to move 
forward with next steps). The contact information will be stored in a REDCap database and 
will only collect their contact information in REDCap if they decide to provide us with that 
information during the eligibility screening process.  
With all above mentioned recruitment strategies, participants will be able to follow the link 
to the REDCap survey to complete the eligibility screening. They will click on a link that will 
bring them to a landing page and the screening survey in REDCap, 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 able email us 
as our lab email will be posted on the landing page or within the recruitment 
wording/images we post online.  
Study Timeline 
The study will last for approximately 5 years from July 2023 through June of 2028 from 
startup procedures, recruitment, intervention, follow-ups, and data analysis).  
  
The timeline below is subject to change depending on various factors such as how quick 
the startup procedures are and how recruitment for each wave is moving forward.   
  

 
YR 1  
YR 2  
YR 3  
YR 4  
YR 5  
 
Q1  Q2  Q3  Q4  Q1  Q2  Q3  Q4  Q1  Q2  Q3  Q4  Q1  Q2  Q3  Q4  Q1  Q2  Q3  Q4  
Start up  
X  X  X  X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
(Wave 1)  
 
 
 
 
X  X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention  
(Wave 1)  
 
 
 
 
 
 
X  X  X  X  
 
 
 
 
 
 
 
 
 
 
6-month 
Follow-up  
(Wave 1)  
 
 
 
 
 
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
12-month 
Follow-up  
(Wave 1)  
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
 
 
 
 
 
 
18-month 
Follow-up  
(Wave 1)  
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
 
 
 
 
24-month 
Follow-up  
(Wave 1)  
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
 
 
Recruitment 
(Wave 2)  
 
 
 
 
 
 
 
X  X  X  
 
 
 
 
 
 
 
 
 
 
Intervention  
(Wave 2)  
 
 
 
 
 
 
 
 
 
 
X  X  X  X  
 
 
 
 
 
 
6-month 
Follow-up  
(Wave 2)  
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
 
 
 
 
12-month 
Follow-up  
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
 
 

(Wave 2)  
18-month 
Follow-up  
(Wave 2)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
24-month 
Follow-up  
(Wave 2)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
Data 
cleaning/  
analyses/  
manuscript 
prep  
 
 
 
X  X  X  X  X  X  X  X  X  X  X  X  X  X  X  X  X  
  
Participant Time:  
Participants will be in the study for 24-months, which will include the 12-month 
intervention, the 12-month peer-led maintenance phase, and the follow-up procedures at 
6, 12, 18, and 24 months. Prior to that, participants will complete the screening and 
baseline procedures to be enrolled. See table below for approximate time details for this 
study. Please note: Times on this chart may vary greatly depending on how much time 
participants actually engage during the 12-month maintenance period; these are our best 
estimates.  
  
Study Phase   
Approximate Time 
(min)  
Screening  
Initial Screening Survey (15 min)  
15  
Baseline  
Orientation Webinar (60 min)  
E-consent (10 min)  
105  

Scale set-up (10 min)  
Baseline survey (20 min)  
Randomized and oriented to respective condition (5 mins via email)  
Private Facebook Group  
~165 min a month in Facebook group in ﬁrst 12-months (1,980 mins)  
~60 min a month in Facebook group in second 12-months (720)   
 
Videoconference Group  
22 90-minute meetings in ﬁrst 12-months (1,980 mins)  
12 60-minute meetings in second 12-months (720 mins)  
Private Facebook 
Group  
2,700  
 
 
 
Videoconference 
Group  
2,700  
6-Month Follow-up  
    Weigh-in (~5 min)  
Online survey (~15 min)  
12-Month Follow-up  
    Weigh-in (~5 min)  
Online survey (~15 min)  
18-Month Follow-up  
    Weigh-in (~5 min)  
Online survey (~15 min)  
24-Month Follow-up  
    Weigh-in (~5 min)  
Online survey (~15 min)  
80  
Total  
2,900 minutes   
(approx. 48 hours)  

  
Methods 
Study Design: Participation starts with reading a simple information sheet and doing an 
online eligibility survey. From there, those that are eligible will be scheduled for and 
complete an orientation webinar. Participants will be asked to keep video on during the 
webinar and answer a brief question to conﬁrm webinar attendance. After that, they will be 
sent the E-consent, and if signed, they will be asked to complete another survey to collect 
baseline assessment data, and then be sent a scale. Eligible participants at this point will 
then be randomized and complete a 12-month intervention followed by a 12-month peer-
led maintenance phase, and ﬁnally complete follow-up assessments at 6-, 12- 18-, and 24-
month time points (survey and weigh-in).  
Recruitment: We will post online recruitment ads that will contain simple study 
information with a link to an online survey containing the screening questions. Ads that are 
done with Research Match will lead interested individuals to the REDCap landing page that 
will give them some more information about the study and then will bring them to the 
survey. See the recruitment section (starting on page 7) for full recruitment details.  
 Inclusion Criteria  
• 
18-70 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  
• 
Has “liked”, posted, or replied on Facebook at least twice a week over the past 
month  
• 
Has a smartphone  
• 
Able to participate in the study in English  
• 
Interested in losing weight  
• 
Lives in United States  
Age justiﬁcation: Children under 18 require different programming for weight loss and 
maintenance given their developmental needs. Weight loss for elderly adults should be 
medically supervised, something this study does not offer.  
  

Exclusion Criteria  
• 
Under the age of 18 and over the age of 70  
• 
BMI under 27 or over 45 at screening; then under 27 at the point of the ﬁrst weight on 
scale  
• 
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  
• 
Does not “like”/post/reply on Facebook at least twice a week over the past month  
• 
Not able to participate in the study in English  
• 
Not interested in losing weight  
• 
Does not live in the United States  
• 
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 (e.g., neuroleptics/antipsychotics, 
mood stabilizers, weight loss medication, or tricyclic antidepressants)  
• 
Has lost ≥5% of weight in past 6 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 due to digestive 
medical condition(s)  
• 
Unable to walk ¼ mile unaided without stopping  
• 
Unable to walk ¼ without experiencing chest pain or dizziness  

• 
Had a previous myocardial infarction/heart attack  
• 
Has a known coronary artery disease (not including hypertension)   
• 
Has chronic kidney disease   
• 
Has a heart valve abnormality   
• 
Has a heart arrhythmia   
• 
Currently smokes or vapes nicotine  
• 
Meets criteria for severe depression on the PHQ-8 (score of >19)  
• 
Participated in previous weight loss studies under the PI  
• 
If UConn employee/student, has concerns about being in a Facebook 
group/meeting with other UConn faculty, staff, and students  
• 
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 during the study period  
• 
Did not complete screening and on-board processes of study (screening survey, 
webinar, e-consent, baseline survey, scale set-up, etc.)  
• 
Prisoner 
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 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. If they are ineligible, they will be 
notiﬁed after the survey is submitted. If they are eligible  dates and times for webinars will 
be available for the participant to select 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.   
  

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 to evaluate if joining this 
study is the right choice for them. This webinar is being conducted to improve study 
retention and explain study procedures. Participants will receive a link to access the 
webinar via WebEx (under UConn’s WebEx license). Once the participants are logged into 
the webinar, staff 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. 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 One 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 a 
study scale. 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. 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 BMI has been conﬁrmed and participants are still eligible at this point, the next step is 
for the participant to be sent the online baseline survey about demographics and 
depression.   
Once all of that has been complete and the participant is still eligible, 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 let them know they are eligible to participate in 
the study and will be randomized. Once randomized, we will notify them which group they 
are in and all necessary onboarding information for that group (e.g., getting into the 
Facebook group or schedule and link for group meetings, etc.).   
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), 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 team 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. Further, we 
will also provide mental health resources to those who express mental health struggles 
during the intervention or request mental health resources.  
Intervention: Participants will be randomized into either the asynchronous or synchronous 
condition. Both programs are 12-month online weight loss interventions, with a 12-month 
peer led maintenance phase and are both based off the counselor-led Diabetes Prevention 
Program (DPP) lifestyle intervention. Breakdown of each condition and the two phases are 
below. The counselors in both conditions will be trained Lifestyle Coaches to deliver the 
National Diabetes Prevention Program. They will be trained by an organization called State 

of Wellness, which is an organization who has signed an MOU with the CDC to train the 
DPP. The counselors will either be a member of our team, or we may hire dietitians for this 
role.   
1. Asynchronous Remote Lifestyle Intervention  
In the asynchronous group, the DPP lifestyle intervention will be delivered within a 
counselor-led Facebook group with twice daily pre-programmed posts as in our previous 
studies (see 4 sample posts below).16,17,18,19 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, 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 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.  
2. Asynchronous Peer-Led Maintenance Phase  

At the end of the 12-month intervention, the counselor will query their group for two 
volunteer moderators to take over the leadership role for the next 12 months. We plan to 
give the volunteer moderators a library of 182 posts (based on the DPP protocol) that they 
can draw from to start conversations. The library will include goal setting posts, weigh-in 
posts, problem solving posts, goal accountability posts, and additional content that 
emphasizes lessons learned from the DPP. We will also arrange a 30 minute orientation call 
with each volunteer moderator to discuss the posts, give them guidance on how to 
moderate a Facebook group, send them a video produced by Facebook on how to run a 
Facebook group (including guidance on privacy), advise them to post daily and encourage 
group members to post updates about their progress and ask the group their questions, 
and ﬁnally, we will advise them on how to secure a replacement moderator if and when 
they no longer want to moderate the group. Moderators will be instructed to limit the advice 
posted to only be from the content we provide to them from the DPP. Moderators may use 
the library as they wish and post whatever they and/or the group prefer. The counselor will 
exit the group when the maintenance phase commences. Study staff will remain in the 
group but will not post or engage unless any activity occurs that could indicate a breach of 
conﬁdentiality or any other type of harm. Participants will be informed that study staff will 
continue to extract engagement data from the group during this phase.  
3. Synchronous Remote Lifestyle Intervention   
In the synchronous group, the DPP lifestyle intervention will be delivered by a counselor in 
weekly videoconference sessions via Webex. The 16 session Core of the DPP Lifestyle 
Intervention will be delivered over 6 months, typically following the pattern of weekly for 8 
weeks and then bi-weekly for 16 weeks (however, this is subject to change due to holidays, 
counselor not being able to show up due to illness, and other like issues that may occur 
during the intervention). After the 16-sesion Core of the DPP, the meetings will change to 
monthly meetings for 6 months, for a total of 22 meetings by the end of the intervention. 
These meetings will last about 90 minutes each time.  
4. Synchronous Peer-Led Maintenance Phase  
At the end of the intervention period, the counselor will query their group for two volunteer 
moderators to take over the leadership role of the group for the next 12 months. The 
leadership role would entail hosting the videoconference sessions. UConn will schedule 
and send out the invites on behalf of the volunteers for privacy reasons. We will provide the 
group leaders with additional content from the DPP to use in the groups if they choose. 
Moderators will be instructed to limit the advice talked about in meetings to only be from 
the content we provide to them from the DPP. We will also arrange a 30-minute orientation 
call with each volunteer group leader to discuss the content, give them guidance on how to 

lead a group, and advise them on how to secure a replacement group leader if and when 
they no longer want to lead the group. Group leaders may use the content we provide as 
they wish and/or run the group in whatever way they and/or the group prefers. The 
counselor will not attend the group meetings; however, a member from the study team will 
attend the group to record attendance and run the transcription software but will not 
engage unless any activity occurs that could indicate a breach of conﬁdentiality or any 
other type of harm. Participants will be informed that study staff will save the chat data and 
be using transcription software to record the group conversation during this phase so that 
this data can be used for research purposes.  
MyFitnessPal.  All participants regardless of which group they are randomized into will be 
asked to use MyFitnessPal. 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. 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.  
Weigh-Ins: Participants will receive a cellular based digital scale (such as Fitbit Aria Air 
Scale) that will be mailed to them. This will allow them to take their weight weekly and at 
assessments. Using a wiﬁ digital scale  will allow for a standard weight measure for each 
participant with a higher level of accuracy than self-reported weight.  Scales are cellular 
based, meaning that all participants have to do is step on the scale and we will receive the 
data on the back end. From a participant perspective, minimal set up is required except 
unboxing their scale, and connecting the scale to their Wi-Fi for syncing purposes to Fitbit. 
Our staff will also send a generated invitation link to request permission for the use of 
Fitabase for data collection.  Once the participant receives the link, they will need to click 
on the link which will prompt them to log in to their google account and authorize Fitabase 
to access their Fitbit data. Fitabase is a cloud-based platform that collects, manages, and 
analyzes data from Fitbit devices. This software will allow us to export data from the study 
scales without having to access participants accounts. From the perspective of the 
researchers, the weight data will be delivered immediately for accurate data collection. 
Study staff will be available through email/phone if for some reason they encounter 
difficulties with their scale. The study team will check all participants’ BMI. 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. If at 
any point the data is not being sent to us due to connectivity issues, we will ask 
participants 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 6-, 12-, 18-, and 
24-month marks after the intervention has begun. At each time point, 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 on the program. The participants will also weigh-in at each 
time point. 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 each survey at the 6-, 12-, 18-, and 24-
month mark by asking questions in the REDCap survey. During the intervention, AE’s will be 
documented when a participant reports it to the 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 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  
6-
Month
 
 
12-
Month
 
18-
Month
 
24  
Month
 
Method  

Inclusion/Exclusio
n criteria  
Initial screening 
survey*  
X  
 
 
 
 
REDCap/  
Qualtrics  
BMI  
Height  
X  
 
 
 
 
REDCap  
Weight  
X  
X  
X  
X  
X  
Fitbit/Fitabase
 
Demographics  
Marital status, 
education 
race/ethnicity, 
sexual 
orientation, 
work status, 
household 
income, 
household 
members*  
X  
 
 
 
 
REDCap  
Binge Eating 
Disorder  
SCID Eating 
Disorder 
Examination 
Questionnaire22
 
 
X**  
X**  
X**  
X**  
REDCap  
Depression  
Patient Health 
Questionnaire 
(PHQ-823)  
X  
 
 
 
 
REDCap  
Food/Drink Intake  MyFitnessPal 
Entries  
 
X  
X  
X  
X  
MyFitnessPal  
Collective Efficacy  Online 
Collective Self 
Efficacy Scale24  
 
X  
X  
X  
X  
REDCap  
Engagement  
Facebook 
Engagement / 
Webex 
transcription  
 
X  
X  
 
 
, REDCap, and 
Word Count 
(LIWC-22)  

Sustainability  
Engagement 
during peer-led 
phase, same 
method as row 
above  
 
 
 
X  
X  
REDCap, 
LIWC-22  
Counselor Time  
Done via 
Facebook and 
tracking 
through phone  
 
 
X  
 
 
REDCap  
Cost  
Tracking costs 
associated with 
intervention  
 
 
X  
 
 
REDCap / 
Accounting 
System  
Usability 
Feedback  
Contamination,
 
Satisfaction, 
burden*  
 
X  
X  
X  
X  
REDCap  
* = investigator derived  
** = as needed for AEs  
  
Psychometric information / General measure information  
Demographic data: We collect demographic data and then we report the data in our 
manuscripts so that readers can gauge the generalizability of our data. This is very 
important in clinical trial research.   
SCID Interview for BED: The SCID is an assessment of Binge Eating Disorder. We would use 
the SCID on an as needed basis for those who gain more than 5% of their weight during the 
intervention. The SCID’s severity scales demonstrated substantial internal consistency (all 
Cronbach’s alphas >.80), test-retest reliability, concurrent, and predictive validity.22  
Patient Health Questionnaire (PHQ)-8: The PHQ-8 is an 8-question measure like PHQ-9 
(with the omission of one question). 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-9.48 Together, this data shows the 
PHQ-8 is as valuable as the PHQ-9.23  

The Online Collective Efficacy Scale: The Online Collective Efficacy Scale is a 35-item 
validated scale designed to assess the degree to which members of an online group feel 
they are able to contribute to the group and the degree to which they perceive a ﬁt between 
their goals and abilities and those of other members of the group.24 This measure has 3 
subscales: social presence, engagement, and collaboration and augmentation. 
Convergence validity resulted in signiﬁcant moderate correlations between this scale and 
other related instruments.24 Further, Using McDonalds’ Omega, the study found 
satisfactory reliability for the subscales.   
Engagement: For the Asynchronous condition, we will manually extract Facebook data. Will 
collect data on number of Facebook reactions (e.g., like, care, wow, etc.), replies, posts, 
and polls per participant during the program.  For the Synchronous condition, we will use 
the transcription feature in Webex software to record and transcribe the group meetings. 
Each participant’s words spoken and typed (in the chat of the meeting) will be exported into 
a separate ﬁle and analyzed with LIWC-22 as described above.    
  
Analytic Plan 
Sex As A Biological Variable. We will strive for a sample that is balanced by sex but 
acknowledge this is very difficult to achieve in behavioral weight loss trials in that a greater 
number of women than men attempt to enroll. We will stratify randomization by sex and 
include sex as a covariate in all models. We will conduct exploratory analyses of sex 
differences in outcomes by condition.   
Aim 1: Non-Inferiority. Reporting and data analyses of this trial will follow the 
recommendation of the 2012 JAMA article “Reporting of Noninferiority and Equivalence 
Randomized Trials Extension of the CONSORT 2010 Statement”.28 We will use intention to 
treat, meaning all randomized participants will be included in the model in their originally 
randomized conditions. Preliminary analyses and evaluation of missingness. First, we will 
evaluate comparability of baseline characteristics by condition. If groups differ, these 
variables will be used as covariates in the primary analyses. Other preliminary analyses will 
include assessing patterns of missing data, dropout rates, distributional properties of 
dependent measures, and correlations among outcome measures. Attrition in weight loss 
studies may not be random.29,30 We will perform a series of sensitivity analyses to 
understand the extent of potential bias by assuming the subjects who dropped out are (i) 
missing completely at random (i.e., independent of the outcome), (ii) are responders to the 
intervention, or (iii) are non-responders to the intervention. We will have quality checks to 
make sure our missing data is minimal but if we have more than 5% data missing, we will 

use multiple imputation.31 Assessment of non-inferiority. We will model percent weight loss 
at 6 and 12 months using a general or generalized (depending on outcome distribution 
characteristics) linear regression model framework, with percent weight loss as dependent 
variable and study condition indicator as an independent variable. Test of the intervention 
condition indicator will provide a statistical test of the intervention effect and the estimated 
coefficient, along with the estimated conﬁdence interval will provide the estimate of the 
intervention effect. Our analytic approach aims to test whether the ASYNC condition is not 
appreciably worse than (i.e., not inferior to) the SYNC condition by our a priori inferiority 
margin of 2%. The effect size reveals clinical non-inferiority of ASYNC if the conﬁdence 
interval lies completely above the non-inferiority margin (2%).   
Aim 2: Engagement, Cost. Engagement. We will compare conditions on word count and 
proportion of the 4 language dimensions (analytical thinking, clout, authenticity, and 
emotional tone) using the same approach as described for the primary outcome. We will 
graphically explore distributional assumptions and adapt the analyses if necessary, ﬁtting 
the most appropriate distribution. We hypothesize that mean word count part participant 
will be higher in the ASYNC condition at 1 year and at 2 years. Exploratory analyses will 
compare conditions on the 4 language dimensions at 1 and 2 years as well. Cost. As 
previously described, the costs of delivering each condition will be tracked throughout the 
entire study. Intervention and participant costs per participant will be computed and 
average costs will be compared across conditions. As Ritzwoller32 recommends, we will 
perform sensitivity analyses to estimate the range of intervention costs after varying the 
inputs. We will estimate a range of costs based on varying assumptions. We will compare 
conditions on total program costs per participant and total program costs per pound lost. 
Assuming a normal distribution of total costs per participant, we will ﬁrst compute t-tests 
comparing the average cost per participant across treatment conditions. We will test the 
null hypothesis of no difference between groups using a two-sided test and α=0.05. If total 
cost per participant is not normally distributed, a non-parametric approach using the 
Mann-Whitney test for median comparisons will be used. If participant characteristics are 
found to differ according to treatment allocation/condition, general or generalized 
multivariable methods will be used to adjust for the potential confounding effects of these 
characteristics. Assuming a normal distribution of total costs per participant, multivariable 
general linear regression models will be used. If not normal, generalized linear models will 
be used. We hypothesize that the asynchronous condition will cost less per participant 
(and less per pound lost) than the synchronous condition.   
Aim 3: Maintenance and Sustainability. Weight loss maintenance at 18 and 24 months 
will be analyzed using the same approach described for aim 1. Sustainability (engagement 

during the peer-led maintenance phase), will be analyzed in the same way as engagement 
data in Aim 2 above.  
Weight change. We will calculate absolute and percent weight change.  
Collective Efficacy. Using the same models as for the primary outcome, we will compare 
conditions on total and subscale scores.  
Engagement. LIWC-22 will be used to determine the total words spoken in the group by 
each participant and the proportion of words that reﬂect each of the 4 dimensions of 
language (analytical thinking, clout, authenticity, emotional tone).   
Sustainability. Sustainability is deﬁned as engagement during the peer-led maintenance 
phase. Engagement will be measured in words in the same fashion as described in the 
engagement section.   
Counselor Time. Counselor time will be measured in each condition so that cost can be 
calculated. Asynchronous. Counselors will be given a study phone to use exclusively for 
counseling and will create a unique Facebook account for the study and only use it for their 
designated group. The time a user spends on Facebook each day can be found in Settings 
under ‘Your Time on Facebook.’33Counselors will enter the minutes spent each day into a 
REDCap database. Synchronous. Counselors will enter the minutes spent preparing for 
and conducting the group meetings in a REDCap database.   
Cost.  We will systematically track costs associated with delivery of both intervention 
conditions, capturing information on the costs that would be required to implement each 
intervention in practice (i.e., outside a research context).32 Intervention costs will be 
distinguished from costs associated with research and development costs (e.g., 
recruitment). We will create an accounting system that captures administrative and 
intervention for both conditions. As described in Ritzwoller,32 we will use cost capture 
templates to evaluate staff time (described above). National salary data will be used to 
calculate costs including administration (e.g., staff time to schedule intervention posts) 
and intervention delivery (e.g., counselor time) costs.  
Study Removal 
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, scale 
set-up, join the Facebook group, etc.), 2) become pregnant during the study period, 3) post 
inappropriate content in the Facebook group or be inappropriate during group meetings for 
synchronous condition (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 withdraw from 
the study and those that become pregnant will be withdrawn from the intervention but will 
be asked to complete the follow-up assessments.  
Potential risks 
Potential risks for being in this study include injury or cardiovascular events from 
exercising, accidental exposure of personal information, and discomfort with study 
procedures (e.g., feeling uncomfortable with some questions asked on a survey or 
someone says something they perceive as uncomfortable in a group meeting for those in 
that condition). 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. If someone says 
something in a group meeting (for those in that condition) they are free to leave the meeting 
and let the counselor know (if they wish) about what made the uncomfortable so the 
counselor can make sure it doesn’t happen again if that step is needed. 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.   
Potential Beneﬁts 
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, 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.  

Societal beneﬁts include providing evidence to support ways to help people achieve 
healthy lifestyle goals and improve the outcomes of their health in a way that could be less 
burdensome than other programs that are commercially available.  
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). We also encourage a slow build-up of exercise in their daily routine 
to avoid any injuries. 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 
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.  
Payment to Participants 
Participants will be paid electronically in the form of research debit cards (Clincards). 
Participants will receive $40 for the 6-month assessment, $50 at 12 months, $40 at 18 
months, and $50 at 24 months. Participants who complete both assessments (weigh in 
and survey) at all time points will receive a bonus of $50 for completing everything. The 
procedures for each assessment will need to be completed before providing 
compensation. Additionally, participants may keep the study scale provided to them.  
Data Safety Monitoring 
Because of this low-risk status, the data safety monitoring (DSM) plan for this trial 
focuses on close monitoring by the principal investigator (PI) in conjunction with a safety 
officer, along with prompt reporting of excessive adverse events and any serious 
adverse events to the NIH and to the IRB at the University of Connecticut. 
Although there are additional reports to be produced by the study coordinator as a result 
of this DSM plan, there are no substantive changes to the study protocol that might 
require review by the NIDDK. Safety reports will be sent to the study statistician, the PI, 

and the safety officer. The Project Coordinator and Data Manager will be responsible for 
assembling the data and producing these reports, as well as assuring that all parties 
obtain copies of these reports. 
The frequency of data review for this study differs according to the type of data and can 
be summarized in the following table: 
Data type 
Frequency of review 
Subject accrual (adherence to protocol 
regarding demographics, 
inclusion/exclusion) 
At the end of each recruitment wave 
(monthly at the beginning of the study) 
Adverse event rates (injuries) 
As they occur 
Compliance to treatment 
Quarterly 
Out of range laboratory data  
Yearly  
Stopping rules report regarding statistical 
power implications of drop outs and missing 
data 
Yearly 
 
Qualifications and responsibilities of the Safety Officers 
The safety officers for this trial will be Drs. Kristin Schneider and Joanna Buscemi. Dr. 
Schneider has a PhD degree, experience with lifestyle and exercise intervention trials 
including statistical analyses, and an understanding of the types and severity of injuries 
commonly experienced in lifestyle interventions. Dr. Buscemi is an expert in lifestyle 
interventions for minority populations. Safety Officers will review the reports sent by the 
study coordinator (at the frequency outlined above) and will use the checklist attached 
to this document to determine whether there is any corrective action, trigger of an ad 
hoc review, or stopping rule violation that should be communicated to the study 
investigator, the UConn IRB, and the NIDDK. In addition, the safety officer may 
comment on whether the study investigator needs to report any specific out of range 
data to the participant. 
Measurement and reporting of subject accrual, adherence to 
inclusion/exclusion criteria 
Recruitment rates and milestones, including baseline characteristics, will be reviewed 
weekly within the study team. This review will ensure that project deadlines are being 
met, that participants meet eligibility criteria, and that the gender and racial/ethnic 
diversity goals outlined in the grant proposal are being met. If recruitment falls behind 

gender and racial/ethnic diversity targets, we will discontinue recruiting individuals of 
genders and racial/ethnic groups that are already filled and focus on recruiting those we 
still need. We will also seek consultation from Dr. Buscemi on our recruitment strategy. A 
report will be provided to the safety officers each year that recruitment is active. 
 
Measurement and reporting of adverse events 
We plan to collect data on injuries and medical conditions from the treatment and 
control groups yearly. 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 the 
follow-ups. An adverse event report will be provided each year. All adverse events will 
be evaluated within 72 hours and all serious adverse events within 24 hours.  Any 
study-related serious adverse events reported to the IRB will also be reported to NIDDK 
within 2 weeks.  In the event of a serious adverse event, the safety officers and UConn 
IRB will be notified immediately. The data presented for a complete year will be blinded 
as there is no reason to expect one group to have higher rates than the other as both 
groups will receive the same intervention but via a different modality. We plan to present 
blinded adverse events data to the study statistician, the PI, and the safety officer 
throughout this trial. The adverse event form will be used by the study staff to report 
injuries or other adverse events caused by the lifestyle intervention.  There is some 
level of injury that could be expected from starting an exercise regimen. The injury rate 
observed in the general population in those who report involvement in exercise over the 
past 30 days was 3-4%. The study statistician, the principal investigator, and the safety 
officer will review adverse event rates yearly. Most exercise injuries are mild in nature 
and allow a complete return to the same activities after slowly working back up to pre-
injury levels. Participants who cannot exercise as a result of an injury may stay in the 
intervention and focus on the dietary component until they are ready to resume 
exercise.  
 
Measurement and reporting of participant compliance (engagement) to treatment 
protocol 
Once participants have started the intervention, data on participant engagement will be 
collected weekly by research staff and reviewed quarterly by the study investigator, the 
study statistician, and the safety officer. Participant engagement in the asynchronous 
intervention will be defined as any type of measurable engagement in the Facebook 
group (e.g., reactions, replies, posts, poll votes), and participant engagement in the 
synchronous intervention will be defined as attendance at videoconference meetings. If 
participants did not engage for one week, the interventionist will reach out to them via 
direct messaging (asynchronous condition) or email (synchronous condition). In the 
event of no response, research staff will phone the disengaged participant in attempt to 
re-engage them.  

Stopping rules 
In this minimal risk lifestyle intervention trial, it is more likely that drop-outs or difficulty in 
recruiting adequate numbers of participants will require stopping the trial than that 
excess adverse events will occur and require stopping the trial. However, as outlined 
elsewhere, we will monitor injury rates in all participants and the safety officer, together 
with the study investigators, will alert the IRB and the NIH if a larger than reasonably 
expected injury rate. Other issues relating to stopping rules for this trial include: 
New Information  
It is exceedingly unlikely that any new information will become available during this trial 
that would necessitate stopping the trial.   
Limits of Assumptions   
It is possible that baseline differences between the groups, excessive study dropouts 
and/or missing data by the interim measurement time point will limit the value of data 
analysis of measurements at 1 year.  Baseline differences will be evaluated after the 
first measurement time point and effects on the power to detect differences in the 
primary outcome will be evaluated and communicated to the PI, safety officer and 
NIDDK.  Given the monitoring plans outlined elsewhere in this document, it is 
exceedingly unlikely that there will be baseline differences between groups of any 
magnitude to threaten the validity of the study.   
In contrast, excessive drop-outs could occur.  In the grant proposal, we allowed for a 
20% dropout in the recruited numbers. With 20% dropout rate in both groups, the 
primary hypotheses are testable at 5% Type I error and 90% power to establish non-
inferiority. Dropout rates higher than 20% would be of concern, so we propose to 
monitor the dropout rate quarterly. Alert points are set at dropout rates of 20% (low 
alert), 30% (mid-alert), 40% (high alert) and 50% (extreme alert). With early alerts to 
problems, action would be taken to avoid higher level alerts; if a higher-level alert 
should arise, more drastic remedial action would be invoked.  The actions taken at each 
level of alert are given below: 
Mid-level alert = Conference call between study investigators to discuss approaches to 
minimize further losses to follow-up/dropouts. 
High-level alert = Conference call between investigators to determine further alterations 
of study protocol to complete the study with no further losses 
Extreme-level alert = In the unlikely event of a 50% dropout rate occurs prior to the 1-
year measurement time point, study investigators would convene on a conference call to 
discuss the usefulness of continuing the study. However, if 50% dropout rate occurred 
during the 2nd year of follow-up, it might still be of interest to continue the study; study 
investigators would convene on a conference call to discuss whether to complete the 
study.   
 

Outline of safety reports 
Below is an outline for a safety report for this trial.  Tables and figures to be included in 
this report are included in the appendix. 
I. Table of Contents  
II. Narrative/ Trial Summary  
  
A.  Summary of Main Findings (if available) 
  
B.  Discussion of Issues or Problems  
  
C.  Report Preparation Procedures  
III. Study Description  
  
A.  Project Organizational Chart, Personnel  
  
B.  Brief Statement of Purpose of Trial  
  
C.  Projected Timetable and Schedule  
 IV. Study Administration  
  
A.  Recruitment Status  
   
 
1.  Enrollment by Month  
  
  
2.  Comparison of Targeted to Actual Enrollment  
B.  Retention Status 
   
 
1.  Overall Subject Status  
   
 
2.  Individual Subject Status  
V. Study Data Reports/Tables or Figures  
  
A. Generic Information  
1. Enrollment (Table 1, Figure 1)  
2. Status (Table 2)  
3. Demographics (Table 3 and 4)  
B. Safety Assessment  
 
 
1. Treatment Duration for All Subjects (Table 5)  
2. Treatment Duration for Subjects who Discontinue Treatment 
(Table 6)  
3. Adverse Events (Table 7)  
4. Serious Adverse Events (Table 8)  
5. Deaths (Table 9) 
6. Frequency of Specific Symptoms (Table 10)  
7. Other situations that might be of safety concern 
 
 
Privacy/Conﬁdentiality 
For the initial screening survey, participants can answer the questions at their own place 
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, where, and how often they use the Facebook group or 
choose where they view and if they attend the virtual group meetings, depending which 
group they are in. We will encourage them throughout the study to attend the meetings / 
engage in 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, they can request a one-on-one if they prefer, or 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., 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/Virtual meetings and 
see each other’s names and proﬁle picture/video, 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 or attend any group meeting without sharing 
their actual name or showing their face. Any participants will be marked ineligible during 
screening/baseline if they do not wish to use Facebook/ Webex 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.   
Conﬁdential Data Storage 
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). We may use Otter.ai transcription software to 
produce transcripts in the event the Webex automatic transcriptions are not sufficient for 
data analyses. 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 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.”. 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.  
Plans for data of participants who fail screening 
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.  
Informed consent process 

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 and then they will be sent a copy of the signed consent via email.  
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? 
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.