Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss: A Randomized Trial Using a Factorial Design
Phase: NA
Conditions: Overweight, Obesity
Sponsor: Drexel University

Study Protocol cover page 
 
Official study name: Sharing Digital Self-Monitoring Data with Others to Enhance Long-Term 
Weight Loss: A Randomized Trial Using a Factorial Design 
R01DK129300 
Most recent protocol IRB approval: December 5, 2022 
Approval letter included in this document. 

Approval of Modifications 
 
Date: December 5, 2022 
Protocol Number: 
2103008421A017 
Principal Investigator: 
Meghan Butryn, PhD 
Review Type: 
Expedited 
Review Date:  
December 5, 2022 
Approved On: 
December 5, 2022 
Committee: 
IRB 3 
Sponsor: 
National Institute of Health 
Project Title: 
Sharing Digital Self-Monitoring Data with Others to Enhance 
Long-Term Weight Loss: A Randomized Trial using a Factorial 
Design 
 
On December 5, 2022, the IRB approved the following modifications: 
 
- 3 month assessment - clarifying language in protocol and index consent form about the 3 
month assessment point.  
- addition of radio language for recruitment 
- Fengqing Zhang - co-investigator personnel, FCOI and HRP-201 
 
If you modified the consent form, you can access your IRB-approved, stamped consent 
document or consent script through Coeus. Open the Attachments tab to find the approval letter 
or approval packet. The stamped documents are labeled as such. Copies of the IRB approved 
stamped consent document or consent script must be used in obtaining consent. 
 
Please contact the IRB at (267) 359-2471  or HRPP@drexel.edu if you have any questions. 
 
Office of Research & 
Innovation 
Human Research Protection 
Program 
Drexel University  
Bellet Building 
1505 Race Street, 7th Floor  
Philadelphia, PA 19102 
Institutional Review Board 
Phone: (267) 359-2471  
Fax: (215) 762-6258 
E-mail: HRPP@drexel.edu  
 
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1) Abstract of the study 
Adults attempting weight loss through lifestyle modification (LM) typically find 
maintenance of behavior change difficult. Outcomes might be improved if 
participants are provided with sustained sources of accountability and support and 
ongoing opportunities to reflect with others on goal progress. This study proposes 
that sharing digital data with other parties has the potential to improve long-term 
weight loss. The proposed study will enroll adults (“index participants”) (N = 
320) with overweight/obesity in a 24-month LM program and instruct them to use 
digital tools for self-monitoring of weight, physical activity, and eating on a daily 
basis. Groups will meet remotely each week in months 1-3 to initiate weight loss. 
In months 4-24, intervention contact will be remote and will include the 
following: quarterly group meetings held via videoconference; brief phone calls 
with the coach held twice per quarter; and monthly text messages with the coach, 
with a small group of fellow group participants, and with a friend or family 
member outside of the program. Text message content will vary according to 
treatment condition, i.e. three types of data sharing partnerships: Coach Share, 
Group Share, and Friend/Family Share. Outcomes will be measured at months 0, 
3, 6, 12, and 24. Primary aims include determining if Coach Share, Group Share, 
and Friend/ Family Share each improve long-term weight loss, PA, and calorie 
intake, and examining if effects are additive when participants are assigned to 
engage in more than one type of data sharing partnership. The secondary aim is to 
explore mediators and moderators of intervention effects. The tertiary aim is to 
determine how the quality of relationship with coach, group members, and 
friends/family member over time may differentially moderate treatment effects 
and predict data sharing efficacy. As digital technology makes data sharing 
increasingly feasible, it is critical to determine how to optimize these partnerships 
to improve long-term outcomes in LM. 
2) Protocol Title 
Sharing Digital Self-Monitoring Data with Others to Enhance Long-Term Weight 
Loss: A Randomized Trial using a Factorial Design 
3) Sponsor / Funding 
National Institutes of Health 
4) IRB Review History 
This is an original IRB submission for this project. 
5) Investigator 
Meghan Butryn, Principal Investigator 
Drexel University 
 
Evan Forman, Co-Investigator 
Drexel University 

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Danielle Arigo, Co-Investigator 
Rowan University 
 
Fengqing Zoe Zhang, Co-Investigator 
Drexel University 
 
Bonnie Spring, Co-Investigator 
Northwestern University 
 
Brandy-Jo Milliron, Co-Investigator 
Drexel University 
 
6) Objectives 
This study is designed to test new approaches to supporting long-term behavior change. 
Specifically, this study will test whether using coaches, program peers, or family/friends 
as sources of support and accountability can improve long-term weight loss. 
Aim 1: Test the hypotheses that Coach Share, Group Share, and Friend/Family Share will 
each improve long-term weight loss (primary outcome) and PA and calorie intake 
(secondary outcomes) (i.e., outcomes will be compared for participants who are 
randomized to engage in that type of data sharing partnership, versus those who are not). 
Exploratory analyses also will determine if effects are partially or fully additive, 
antagonistic, or synergistic when participants are assigned to more than one type of data 
sharing partnership. 
Aim 2: Test the following mediators of intervention effects: perceived supportive 
accountability, motivation, self-regulation, self-monitoring engagement, coaching 
quality, social comparison, and social support. 
Aim 3: Determine how quality of the relationship with the coach, group members, and 
friend/family member over time may differentially moderate treatment effects and predict 
data sharing efficacy. 
7) Background 
In the proposed study, adults with overweight/obesity (i.e., “index participants”) will 
enroll in a 24-month LM program and use digital self-monitoring tools on a daily basis 
(wireless body weight scale, wearable PA sensor, and app to record dietary intake). In 
months 1-3, groups will meet remotely every week through videoconferencing to initiate 
weight loss. Contact in months 4-24 will continue remotely, with group meetings 
continuing to be held via videoconferencing (once per quarter) and brief, individual 
phone calls with the coach (twice per quarter). Participants also will exchange monthly 
text messages with the coach; monthly text messages with a small group of fellow 
participants; and monthly text messages with a friend or family member outside of the 
program who will be trained to provide support. A factorial design will be used to 
efficiently test the independent effects of three types of data sharing partnerships: 

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1) Coach Share: The behavioral coach will view digital self-monitoring data 
throughout the program and will directly address data observations during 
intervention contacts. 
2) Group Share: Participants in a given LM group will view each other’s self- 
monitoring data in their small-group text messages. 
3) Friend/Family Share: A friend or family member will view the participant’s data 
via automated text message. 
Coaches, group members, and friends/family in Share conditions will be trained to 
respond to shared data in ways that support motivation and self-regulation, without 
judgment or a critical tone. With the 2 x 2 x 2 factorial design, index participants will be 
randomly assigned such that half receive Coach Share and half do not; half receive Group 
Share and half do not; and half receive Friend/Family Share and half do not. Amount of 
intervention contact between the participant and each party is comparable in all 
conditions, isolating the effects of data sharing. Outcomes will be measured at months 0, 
3, 6, 12, and 24. 
 
8) Setting of the Human Research 
Group treatment for all months will be held over Zoom videoconferencing software. 
All study visits will be held remotely and copies of physical data will be held at 
Drexel’s University City Campus. 
 
9) Resources Available to Conduct the Human Research 
Center for Weight, Eating and Lifestyle Science (WELL Center) 
Drexel University’s WELL Center is actively engaged in vibrant research initiatives to 
advance the science and practice of weight control. The WELL Center currently houses 
26 faculty, staff, and trainees and has a portfolio of $15M in research funding. Adequate 
space in the WELL Center will be devoted to this project. Project staff will have offices 
available for conducting project management tasks, conducting phone screening of 
participants, conducting assessments, and storing data and project supplies. The WELL 
Center is primarily a research center, but there is also an arm with a clinic that serves the 
community. There is no involvement of the clinic in this study. 
 
Dr. Butryn and Dr. Forman, principal and co-investigator on the project respectively, are 
experts in the area of the development of treatments for health-related behavior change. 
Their lab has several NIH-funded research grants related to eating behavior and lifestyle 
modification, many of which Dr. Zhang (co-investigator) similarly has the primary 
responsibility of data analyses. Dr. Milliron (co-investigator) is an expert in the areas of 
community nutrition science and cancer prevention. Dr. Arigo (co-investigator) 
specializes in understanding social influences on health and health behavior (e.g., social 
comparison, social support) and harnessing social influences to improve outcomes in 
health behavior interventions (e.g., for weight loss and physical activity promotion). Dr. 
Spring (co-investigator) has more than 30 years of experience leading interdisciplinary 
science teams funded by NIH, VA, and foundation grants to develop and evaluate 
technology-supported interventions that promote healthy change in multiple chronic 

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disease risk behaviors, particularly poor quality diet, physical inactivity, obesity, and 
smoking. 
 
Collective research expertise from the team and past success recruiting for studies ensure 
that this study will likewise be successful in its recruitment goals. As described in 
Recruitment Methods below, 320 index participants will be recruited in five cohorts (n = 
64 per cohort) through digital media, radio stations, and public transportation, and 
publicizing the program in primary care practices and community centers. These methods 
have yielded large samples in previous NIH-funded clinical trials conducted at the WELL 
Center by this research team. Also, to enhance retention, study staff will send newsletters 
and birthday/holiday cards to participants. All study staff are well-qualified and well- 
trained in conducting weight and eating-related research, as well as general best practices 
for research with human subjects. All persons assisting with research will be trained and 
monitored by the Principal Investigator. 
 
Department of Psychology 
The Department of Psychology is actively engaged in research initiatives to advance 
the science and practice of psychology. The faculty is highly collaborative, frequently 
cooperating on research projects, co-mentoring doctoral students, and providing 
consultation to one another as needed. The department currently houses several 
prominent research laboratories that focus on research similar to the proposed study. 
 
Computing Facilities 
At present, all relevant personnel at Drexel have desktop computers equipped with 
broadband Internet connections and all necessary word processing and statistical 
software. The system is protected by firewalls and password protection to ensure 
security for sensitive data. 
 
10) Prior Approvals 
Does not apply 
 
11) Study Design 
a) Recruitment Methods 
Recruitment will be conducted in five waves using methods that have yielded a high rate 
of recruitment in recent NIH-funded obesity trials conducted by this research team. Broad 
study details (including the study purpose and time commitment) and contact information 
will be provided via digital media, WELL Center mailing list, radio stations, and public 
transportation, and publicizing the program in primary care practices and community 
centers via flyers. 
The WELL Center Screening and Registry Study is a screening and enrollment tool 
that collects information of interested participants to determine preliminary eligibility for 
WELL Center research studies and matches participants with the study that best fits their 
needs. There are 4 phases within the WELL Center Screening and Registry Study tool, 
consisting of (1) General Interest Survey, (2) WELL Center Informed Screening 

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Consent, (3) Universal Eligibility Screener, and (4) Weight Loss Phone Screen. 
Prior to their scheduled phone screen, participants will be sent the Fitlink Screening 
Informed Consent Form. The Fitlink Screening Informed Consent is required for 
Participation in the Project FitLink screening process. At the beginning of the phone 
screen, the assessor will review the Fitlink Screening Informed Consent Form with the 
participant. The participant will then be prompted to ask any questions they have. If the 
participant chooses not to sign the Fitlink Screening Informed Consent Form, the phone 
screen will not continue. Fitlink Phone Screen acts as a preliminary eligibility check 
specific to Fitlink study, including participants’ interest, friends/family nomination, and 
availability for meetings. 
Participants who are interested and preliminarily appear eligible for this study will be 
invited to sign up for an information session (specific to this study), at which prospective 
participants learn more detailed information about the study and the enrollment process 
(including risks, benefits, and alternatives to participation) and have the opportunity to 
ask additional questions. Finally, participants who remain interested are scheduled for a 
remote study visit, when research staff will complete assessment of other aspects of 
eligibility that were not well suited for the phone screen (e.g., measurement of weight, 
psychiatric conditions). Participants that completed all materials at the time of the study 
visit will be sent a copy of the study consent to review. After the clinic visit, index 
participants will be randomized to treatment condition, stratifying by biological sex and 
baseline BMI category. During Session 0, participants will review the study consent form 
with a member of the research team present, able to answer any questions the participant 
may have. After eligibility is determined and all enrollment requirements are complete, 
the participant will digitally sign the consent form. 
 
During enrollment, all index participants will nominate one friend or family member to 
provide support for their LM efforts. After a friend/family member has been selected, the 
friend/family member will be sent an email from study staff. The email will give a 
description of the study and provide the friend/family member a link to complete an 
online consent form and complete self-report measures. The friend/family member will 
be given the opportunity to sign up for a visit with study staff if they have additional 
questions. After providing consent, the friend or family member will be asked to 
participate in one webinar at the start of the program and three booster zoom meetings (at 
Months 6, 12, and 18) to learn how to provide support for the participant’s LM efforts. 
 
b) Inclusion and Exclusion Criteria 
Overweight/obese index participants (N = 320) will be recruited and screened by 
website to assess initial eligibility. 
Inclusion criteria for index participants: 
● Individuals must be of overweight or obese BMI (27-50 kg/m2) 
● Individuals must be adults (aged 18-70) 
● Able to engage in physical activity (defined as walking two city blocks without 
stopping) 

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● Access and willingness to use a smartphone and internet 
● Has one adult friend or family member who indicates willingness to serve in a 
support role 
● Satisfactory completion of all enrollment procedures 
● English fluency 
Exclusion criteria for index participants: 
● Medical or psychiatric condition (e.g., cancer, type I diabetes, psychosis, full- 
threshold eating disorder) that may pose a risk to the participant during 
intervention or cause a change in weight, or limit ability to comply with the 
program or participate appropriately in group-based treatment 
● Currently pregnant or breastfeeding, or planning to become pregnant in the next 
24 months 
● Use of insulin or a medication that can cause significant change in weight 
● History of bariatric surgery 
● Weight loss of > 5% in the previous 3 months 
● Weight loss of > 10% within the past 3 years 
 
No adults unable to consent, children, pregnant women, or prisoners will be enrolled as 
index participants. 
Data for those who fail screenings and do not meet inclusion criteria will be destroyed 
or, with consent from the participant, participants may be screened for another study 
or added to the WELL Center database to be contacted for future studies. 
Friends and family members (N = 320) have the following eligibility criteria: Age 18 
or older; access and willingness to use a smartphone and internet; willingness to serve 
in a support role. No adults unable to consent, children, or prisoners will be enrolled 
in the friend/family member role. 
 
c) Local Number of Subjects 
We expect to enroll 320 index participants in total (64 per wave). To reach this, 
we expect to screen 2844 participants over the phone (568 per wave), conduct 525 
study visits (105 per wave), and consent 400 participants (80 per wave). Based on 
previous obesity trials run in the WELL Center, these projections will yield 320 
index participants in total enrolled in the study. 
In addition to the 320 index participants, we expect to enroll 320 friends/family 
members of the index participants. 
Thus, the total sample size will be 640 participants. 
d) Study-Wide Number of Subjects 
This is not a multicenter study. Recruitment will be restricted to participants enrolling 
at Drexel. Please see the recruitment methods specified above for more information 
on participant recruitment. 
 

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e) Study Timelines 

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Recruitment and enrollment of all participants is expected to take twenty-seven 
months from the start date, and each participant will be enrolled in the study for 
duration of twenty-four months. Index participants will complete assessments at 0 
months (baseline), 3 months, 6 months, 12 months (mid-treatment), and 24 
months (post-treatment). Friend/family members will not be required to attend 
any assessments. Primary and secondary analyses will be completed within five 
years of the start date. 
f) Study Endpoints 
The study is expected to begin in June 2021 and complete data collection by 
September 2025. Data analyses and write-up will be completed by the summer of 
2026. 
g) Procedures Involved in the Human Research 
Study Design 
In the proposed study, 320 index participants will be recruited via digital media, radio 
stations, and public transportation, and publicizing the program in primary care practices 
and community centers. These index participants will each select one friend/family 
member to serve in a support role (N = 320). 
 
Screening and Enrollment Tools 
 
The screening process for this study will utilize the following tools to screen participants 
for preliminary eligibility: 
 
• WELL Screening and Registry Study (#2112008968) 
• Project FitLink Screening Consent Form 
• Project FitLink Phone Screen 
 
After attending an information session, participants must complete a total of five self- 
report surveys before their clinic visit appointment. This information will be used to 
make determinations about a participant’s study eligibility and will not be used for data 
analyses. 
 
● WALI-A: Weight And Lifestyle Inventory-Abbreviated 
● Beck Depression Inventory-II 
● PARQ: Physical Activity Readiness Questionnaire 
● Technology Use Survey 
● 
Pre-Clinic Visit Food Records 
 
If participants are unable to attend the scheduled clinic visit, they may reschedule one 
time before they are deemed ineligible. 
 
Participants must do the following to continue in the enrollment process after the Clinic 
Visit: 

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● Sign up for Session 0 
● Complete Pre-Session 0 instructions 
● Attend Session 0 
● Successfully set up all study devices and sign the Informed Consent Form 
● Complete all baseline assessment requirements 
● Attend Session 1 
 
 
Intervention: Index Participants 
Uniform Components 
All index participants will receive a 24-month lifestyle modification (LM) intervention. 
They will receive 20 sessions of group-based behavioral treatment for weight loss. 
Groups will meet weekly in months 1-3 over the Zoom videoconferencing platform. In 
months 4-24, one group meeting held over Zoom will take place every 3 months, and two 
brief (15-minute) individual coach phone calls will occur twice per quarter (14 calls in 
total over 21 months). During phone calls, coaches will check in about progress towards 
goals, review core behavioral skills that are most relevant, and collaboratively set goals 
for the next month. All index participants also will regularly exchange program text 
messages with the LM coach; with fellow LM participants; and with a designated 
friend/family member. All index participants will be instructed to use digital self- 
monitoring devices daily (PA sensor, food record app, smart scale) throughout the 
program. 
Treatment Conditions 
The content of the text messages (in particular, whether or not the message includes the 
participant's digital device data) delivered during months 4-24 will vary according to 
treatment condition. These three treatment conditions will be provided to 50% of 
participants, with an equal number of participants randomized to have each of the below 
three treatment conditions ON or OFF. For example, 160 index participants will have 
their self-monitoring digital data accessible to their friend/family member, and 160 
participants will not have this feature as part of their intervention. Random assignment 
will be conducted using minimization procedures, which results in better condition 
balance than simple randomization. Baseline covariates used for randomization will 
include biological sex and BMI. 
1. Coach Share: If an index participant is randomized to have Coach Share ON, the 
coach will have continuous access to objective, real-time, detailed device data, and 
address data directly in all individual interactions with index participants (groups, 
individual weigh-ins, phone calls, texts), conveying that they are closely monitoring 
progress. Among index participants who are randomized to have Coach Share OFF, 
the coach will have no access to their device data. Index participants will be explicitly 
told their coach does not have data access. During groups and phone calls, the 
participant will self-report progress, and goal setting will be based on that self-report. 
Text messages from the coach will be personalized in the OFF condition, as they are 
when coach data sharing is ON, though these messages will not be informed by 

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device data. Instead, text messages will provide a reminder of key goals and strategies 
discussed in the previous phone call and provide encouragement for participant 
efforts in that area. 
2. Group Share: If Group Share is ON, participants in a given LM group will view and 
respond to aspects of each other's self-monitoring device data in their small-group 
text messages. The project 'bot' will begin each text exchange by highlighting one 
participant's data. Over the course of 3 or 4 days, one participant's data will be 
highlighted each day, in order to maximize engagement. Among index participants 
randomized to have Group Share OFF, supportive accountability will not be the target 
of participant interactions and no data will be shared with LM program peers. Instead, 
prompts for the once monthly small group text exchanges will encourage index 
participants to provide social support (primarily of the informational type) to each 
other. Index participants will be explicitly told that they should not include 
information on goal progress such as weight change or minutes of PA. Similar to 
Group Share ON, prompts to continue the conversation will continue for several days 
in a row. 
3. Friend/Family Share: Index participants who are randomized to have Friend/Family 
Share ON will give their friend or family member access to their self-monitoring data. 
Text messages sent by the program bot, which includes the index participant and 
friend/family member, will use a similar format as described in Group Share ON. The 
friend or family member will be trained to respond to data in ways that enhance the 
participant’s motivation and self-regulation. If an index participant is randomized to 
Friend/Family Share OFF, the text messages from the bot will prompt the participant 
and friend/family member to communicate about the LM program; those messages 
will be standardized, except for names, and will not be tailored to index participant 
progress. Index participants will be instructed to refrain from sharing any device data 
with friends or family members. 
Assessments: Index Participants 
Research assistants who are blind to study condition will administer assessments 
remotely at months 0, 3, 6, 12, and 24. These staff members will have no involvement 
with the intervention. Index participants will be instructed not to disclose information 
about their treatment condition to assessment staff. Assessment staff will receive training 
in adherence to the data collection protocol, and their skills will be periodically 
reassessed for quality control. As compensation for time, index participants will be paid 
for assessment visits 6, 12, and 24. To enhance retention, study staff will send newsletters 
and birthday/holiday cards to index participants. Self-report data will be electronically 
captured and managed through REDCap, a secure web-based research database 
application. 
 
 
Primary and secondary outcomes 
Weight will be measured using a wireless scale, which is accurate to 0.2 kg. In order to 
maximize accuracy, we will (1) provide instructions (e.g., place scale on flat, hard 
surface; weigh upon waking, without clothes, after using the bathroom), (2) require 

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participants to confirm that they are following instructions at each assessment point, (3) 
use an average of 4 consecutive daily weights for each timepoint, (4) remove errant 
weights (e.g., 3%+0.1%*daysbtwnweights ).(Height also will be measured at baseline using a 
tape measure or yard stick to calculate BMI.) Minutes per week of moderate-to-vigorous 
PA will be measured by using FitBit, a consumer-grade wrist-worn activity tracker 
utilized in several other studies. The wearable FitBit has superior compliance and close- 
to-equivalent accuracy as a research-grade accelerometer. The Fitbit is sufficiently well- 
validated for steps and minutes of PA to support its role in this study and has demonstrated 
high inter-device reliability (crucial for obtaining accurate within-person change in PA).  
Seven days of calorie intake as derived from a digital food log will be used as a 
secondary outcome. 
Participants will already be tracking their consumption using the app as part of standard 
treatment. . 
 
Mediators 
Perceived supportive accountability for weight control will be measured with the 
Supportive Accountability Measure. Self-regulation will be measured with the 
Helpfulness of Program Components measure. Self-monitoring will be objectively 
measured as the number of days in which digital devices were used to measure weight, 
record eating (with a minimum threshold of 5 foods/beverages recorded), or PA 
(minimum threshold of 500 steps). Coaching quality will be assessed by rating 15% of 
each coach’s group sessions, text messages, and phone calls with a rubric adapted from 
the ASPIRE-VA checklist. The tendency for participants to engage in social comparison 
with fellow LM group members will be measured with the Iowa-Netherlands Comparison 
Orientation Measure, with items modified to be focused on the LM group, and with the 
FitLink Social Comparison Measure. Perceived social support will be assessed with the 
Social Support for Healthy Behaviors measure. Index participants will report the 
frequency with which friends and family members engaged in behaviors that support or 
undermine healthy eating and physical activity in the past month. Quality of group and 
friend/family interactions will be assessed with the Quality of Interactions measure. 
Weight stigma will be assessed using the Weight Self-stigma Measure. A demographic 
questionnaire will also be administered to participants at the baseline assessment. The 
Power of Food Scale will be used to assess individual reactions to food in their 
environment. The food environment will be assessed with Grocery Shopping and Home 
Food Environment Items. Food Addiction will be assessed using the Modified Yale Food 
Addiction Scale 2.0 (mYFAS 2.0). Utilization of stimulus control strategies will be 
assessed with the Measure of Stimulus Control. Satisfaction with the FitLink program 
will be assessed with the Treatment Acceptability Questionnaire. 
Moderators 
Relationship quality will be measured with items adapted from the client version of the 
Working Alliance Inventory-Bond Subscale. Ratings will be completed separately for the 
relationship with the coach, the LM group, and the designated friend/family support 

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person, with adaptation in wording as needed, yielding scores for each party. Most 
mediators and the moderator are only measurable once treatment has begun (e.g., 
coaching quality, social comparison with the LM group, and quality of the relationship 
with the group cannot be rated at pretreatment). Therefore, the “baseline” administration 
of such variables will occur at month 3 of treatment, with analyses controlling for weight 
loss achieved from months 0-3 as appropriate. 
Qualitative data 
Semi-structured interviews (n = 30) will be conducted at post-treatment to gather 
qualitative information about index participant experiences. 30 of the 320 index 
participants will be randomly selected with representation across conditions, age, sex, and 
race/ethnicity; additional interviews will be conducted if saturation is not reached. 
Interviews will last 45-60 minutes and will be digitally recorded and transcribed 
verbatim. 
Optional Ecological Momentary Assessment- Wave 1 Only  
 
Wave 1 participants only will have the opportunity to take part in a five-day 
ecological momentary assessment (EMA) to learn more about participants’ 
thoughts and feelings about self-monitoring their weight, their weight loss 
trajectory in the program so far, and whether these responses differ by treatment 
condition (i.e., based on which sources of support they have been sharing their self-
monitoring data with). Participants will be paid an additional $75 for completing 
this optional assessment and will lose $3 for every survey they do not complete.  
 
Wave 1 participants will be verbally informed about the opportunity to complete 
the optional additional assessment by their coaches. All Wave 1 participants will be 
emailed a revised informed consent through RedCap that includes the information 
on this additional assessment. All participants will digitally read and submit and 
revised informed consent. After, they will indicate whether or not they would like 
to opt-in to the study. Those who do not want to participate will exit the RedCap 
survey. Those who do want to participate will be asked to complete a 5-minute 
survey that asks about their overall satisfaction with weight loss so far, their lowest 
weight during the program, and their current weight loss goals (maintain, lose a 
little more, lose a lot). 
 
EMA assessment will last five days. Participants will complete three assessments 
per day: 1) immediately upon waking, 2) immediately after self-weighing (or if 
they do not self-weigh, at 10:00 am), and 3) at the end of the day (9:00 pm). The 
morning survey will ask participants to respond to report their state self-
compassion (3 items), state distress tolerance (1 item), affect (5 items), motivation 
for weight control (1 item), body-related shame (1 item), and guilt about weight 
control behaviors (1 item). The post-weighing survey will ask participants to 
respond to the same questions as the morning survey, as well as a qualitative 
question (1 item). Participants will be asked to type a couple sentences in response 
to the question “Please explain your immediate thoughts and feelings about your 
weigh-in today.” Participants who did not weigh in will instead be asked to “Please 

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explain your thoughts and feelings about your weight loss progress right now.” On 
the final day of the surveys, the post-weighing survey will include an additional 
open-ended question (1 item) asking participants who skipped any weigh-ins 
during the period to explain why they chose not to weigh those days. At the end of-
day survey, participants will be asked to report their expectations for their weight 
control trajectory based on their behavior that day (1 item), their expectations for 
whether the following day’s weigh-in would show weight gain, maintenance, or 
loss (1 item), and how they expect to feel about the next day’s weigh-in (1 item). 
They will also report their perceived calorie intake at the end of the day (1 item). 
Finally, participants will also be asked to respond an open-ended item: “Please 
explain your thoughts and feelings about your weight loss progress right now.” (1 
item).  
 
Training and Supervision 
Coaches will have a minimum of masters-level training in psychology or a related field 
and will have experience conducting LM. We anticipate that many of the coaches will be 
existing members of the research staff who provide intervention for other research studies 
within the WELL Center. If needed, we will hire additional coaches for this study by 
advertising the position. Coaches are not participants. Coaches will be balanced across 
conditions. Initial training, as well as quarterly retraining to prevent drift, will include 
role plays of session content. Weekly supervision will be conducted. Using a structured 
rubric, 15% of each coach’s group sessions, phone calls, and text messages will be rated 
for fidelity to the treatment protocol. The rubric will take into account treatment integrity 
(delivering treatment as intended) and differentiation (the intended separation of study 
arms). Any coach deviations from the protocol (i.e., fidelity rated at <90%) will be tagged 
during review and addressed in supervision and retraining sessions. 
 
Intervention and Assessment: Friends/Family Members 
 
Friends/family members are asked to attend a webinar (held in Month 1 of the program, 
over Zoom), where they will learn how to provide support for the index participant’s 
lifestyle modification. Following the workshop, they will receive monthly text messages 
for a period of 2 years (24 message exchanges in total) that will prompt them to provide 
support to the index participant. Depending on which condition the index participant is 
assigned to, the messages may include information about the index participant’s food 
intake, exercise, and weight data. Friends/family member also will be asked to participate 
in three booster zoom meetings(one at month 6, one at month 12, and one at month 18) to 
receive additional guidance and tips about how to provide support. 
 
Friends/family members are not asked to complete any assessment tasks or measures. 
 
a) Data and Specimen Banking 
Does not apply. 

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b) Data Management 
Data Collection, Storage, and Quality Control 
This study will use methods that have been effective in previous studies in this lab to 
ensure data security and quality control. Dr. Butryn will administer a data collection and 
storage training to all project staff, who must demonstrate competence in all tasks (e.g., 
phone screening, informed consent, etc.) before commencing their responsibilities. Staff 
will be assigned to review assessment data for accuracy and completion, and to pursue 
missing data by re-contacting participants. Specialized validity tools (e.g., customized 
spreadsheets and data entry software) will be used to maximize data accuracy. Double- 
entry will be utilized where appropriate. To maximize efficiency, data will be 
electronically captured and managed through REDCap, a secure application that has been 
successfully used by this team on several projects. For the optional ecological 
momentary assessment for Wave 1 participants, data will be collected and managed 
through Ethica, a secure experience sampling platform. Study messages will be sent 
through a secure, web-based portal to an app on your phone. Index Participants and 
friends/family members will be assigned a username and password to receive these 
messages. Their first name, user name, phone number, and email address will be stored 
on the web-based portal. Information from the participant’s scale, Fitbit, and food record 
will be collected through the Fitbit API, and also stored on the study web-based portal. 
The study portal will be accessed only by authorized study staff. The development team 
for the web portal has been approved by Drexel’s Information Security Office. The 
development team has agreed to abide by Drexel’s Application Development Standards 
under the Security of Information and Networked Systems policy, encrypt at rest and in 
motion, and abide by privacy by design, security by design, and responsible computing 
principles. As part of participation, participants will be provided with informational 
handouts that correspond to the skills taught in that week’s session. Participants will 
access these handouts in Google Classroom There will be no personal, identifying, or 
health information shared in any of these documents. Other features of Google 
Classroom, such as discussion boards, will not be used; participants will simply be using 
Google Classroom as a user-friendly place to locate these handouts. All paper-based data 
will be stored in a locked filing cabinet, and all electronic data will be password 
protected and stored on secure computer servers. On-site and off-site backup storage will 
be utilized to protect against loss. All data and informed consent forms will be stored for 
three years following completion of the study, in accordance with Drexel policy. After 
this time, the data will be destroyed. 
 
Statistical Analysis 
Descriptive statistics and exploratory graphing will be generated for all variables. Data 
summaries will be produced for the full sample and by condition. Continuous variables 
will be transformed if necessary. Baseline characteristics will be compared for each ON 
versus OFF contrast, as well as for each of the 8 study arms, using ANOVAs for 
continuous variables and a chi-square tests for categorical variables. Key baseline 
variables that differ by condition will be considered for use as covariates in the analyses 
described below. Likelihood-based estimation methods and multiple imputation models 

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will be used to handle missing data. 
Aim 1 

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This study will evaluate the hypotheses that long-term weight loss (primary outcome) and 
PA and calorie intake (secondary outcomes) will be superior in Coach Share ON vs. 
OFF; in Group Share ON vs. OFF; and in Friend/Family Share ON vs. OFF. We will 
model the pattern of change in weight over time using multilevel models. The first level 
will model individual weight loss over time with baseline as time 0. At the second level, 
the individual intercept and slope will be entered as outcomes with each of the three types 
of data sharing examined separately as a predictor. The cross-level interaction between 
time and type of data sharing (e.g., Coach Share ON vs. OFF) will be used to determine 
the effect of the partnership factor on the pattern of change in weight. Restricted 
maximum likelihood will be used to estimate model parameters and to test the 
significance of random effects. Both linear and higher-order time effects will be 
examined. Similar multilevel models will separately examine the effect of each of the 
three partnerships on PA and calorie intake. As an exploratory aim, we also will test the 
interaction effects of the three data sharing partnerships by adding higher-order 
interaction terms to the aforementioned multilevel models. 
Aim 2 
Analyses will determine if change in potential mediators from baseline to 12 months 
predict weight loss at 24 months. Analyses will determine whether temporally precedent 
changes in hypothesized mediators explain the effect of condition on weight loss, with 
the expectation that the Share ON participants will maintain a high level of the proposed 
mediator from baseline to 12 months, while decreases in that variable will be observed in 
Share OFF. Coach Share, Group Share, and Friend/Family Share will each be examined 
separately, with possible mediators including perceived supportive accountability, 
motivation, self-regulation, and self-monitoring. In addition, coaching quality will be 
examined as a mediator for Coach Share ON vs. OFF, social comparison will be 
examined as a mediator for Group Share ON vs. OFF, and perceived social support will 
be examined as a mediator for Friend/Family Share ON vs. OFF. We will use the 
mediation model outlined by Preacher and Hayes to estimate the indirect effect of each 
hypothesized mediator individually. The bias-corrected bootstrap test will be applied to 
test the significance of the indirect effect, which allows for the most robust and accurate 
interpretation of the mediating effects. Should these mediation analyses prove promising, 
we will explore how the entire pattern of changes in the mediators from baseline to later 
time periods influences the corresponding pattern of weight loss over time using parallel 
process growth models. 
Aim 3 
To test if intervention effects depend on quality of the relationship with the coach, group 
members, or friend/family member, relationship quality will be examined as a potential 
moderator by adding it to the multilevel model described in Aim 1 and determining 
whether the effect of condition on change in weight depends on this variable. 
Relationship quality will be examined at baseline, and also will be examined separately at 
6 and 12 months (controlling for weight loss up to that point). Statistically significant 
interactions will be interpreted by plotting simple regression lines for high and low values 
of this variable. To analyze qualitative data, transcribed interviews will be coded for 
thematic analysis. Coding steps will include the development of preliminary themes, 

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additional codes based on themes that arise, non-substantive codes, and detailed codes for 
analysis of specific topics. We will create a coding dictionary based on analysis of the 
first five transcripts, and every fifth subsequent transcript will be double-coded in order 
to assess interrater reliability. If there is <90% agreement in coding, we will re-assess 
domains to identify areas in which different labeling may have been used for similar 
ideas. 
Power analyses suggest that a sample size of 238 is required for 80% power with the 
significant level of 0.05 and four assessment points, assuming the ratio of the variability 
of level-1 coefficient to the variability of level-1 residual is at least one. The study is 
adequately powered with the proposed sample size of 320 with up to 25% attrition. 
 
c) Withdrawal of Subjects 
Participants will be withdrawn from the research without their consent if there is a 
change in the subject’s medical condition, if all or part of the study is discontinued for 
any reason by the sponsor, investigator, university authorities, or government 
agencies, new information is available to the investigator, or there are harmful 
unforeseen reactions experienced by the participant or other participants in the study. 
Participants will be notified about any new information that may affect their health, 
welfare, or choice to stay in the research. 
If the friend/family member identified by the index participant does not consent to 
participate in the study, the index participant will be asked to identify another 
friend/family member. If they cannot find another friend/family member who would 
be willing to consent to the study (which is an inclusion criteria), then the index 
participant will be deemed ineligible and provided with relevant weight loss referrals. 
Index participants and friends/family members may withdraw from the study at any 
time, and it will not be held against them. If an index participant or friend/family 
member stops being involved in the research, already collected data may not be 
removed from the study database. Any fee the index participant or friend/family 
member may be paid will be determined by the amount of time they spend in the trial 
and, if they do not complete the study, the reason for leaving the study early. 
If termination is necessary, the project coordinator will contact the index participant 
or friend/family member immediately to discuss the grounds for their termination. 
2) Risks to Subjects 
Potential risks to participants are considered minimal. Participants will be informed of 
all potential risks when providing consent and assent before study participation. 
However, key personnel will address any discomfort or concerns expressed by the 
participant in regard to any aspect of the study if they do occur. If participants 
indicate any substantial distress, then risk assessment will occur and appropriate 
referrals for treatment will be provided as necessary. 
One risk of the program is that as index participants lose weight, they may need to take 
less of any medications they are on, or they may develop gallstones. Index participants 
taking any medication will be instructed to carefully coordinate the oversight of these 

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medications with their primary care physicians to make any necessary adjustments of 
dosage necessary if weight loss occurs. Gallstones can result if weight is lost too quickly, 
but our study is designed to help individuals lose weight at only approximately 1-2 
pounds per week. When using exercise equipment, however briefly, there is always a risk 
for injury if adequate precautions are not taken. In addition, PA may be uncomfortable to 
those index participants who are inactive or overweight, or may cause exacerbation of 
certain medical conditions. However, this is unlikely given the moderate recommendation 
(walking). An Adverse Event Questionnaire will be administered to all participants at 6, 
12, and 24 months. This questionnaire will collect information about any medical events 
that have occurred during the course of the program. If an adverse event is reported and 
more information is necessary, an interview will be conducted with the participant to 
collect the additional information. This information will then be reported to NIH. 
Psychological risks include reduced self-esteem in persons who fail to lose weight or 
regain weight, a sense of shame if not meeting program goals, or fellow program 
members or friends/family making critical remarks about an individual’s weight or LM 
habits. However, several precautions will be taken to guard against psychological risks to 
participants. A methodical process of treatment development will be carried out to ensure 
that participant needs are met in a sensitive, caring, and culturally competent way. All 
clinicians will have had prior training and experience delivering LM programs. In 
addition, clinicians will receive specialized training in the delivery of the intervention 
programs, in particular how to monitor, respond to, and prevent participant feelings of 
shame or embarrassment. Dr. Butryn will take responsibility for ensuring that adequate 
training and supervision are provided, with assistance from the study co-investigators. 
There also is a risk that group members or the designated friend/family member could 
share information about that index participant outside of the program. For both index 
participants and friends/family members, there is the risk that having the friend/family 
member serve in a support role could introduce a strain in the relationship. In all 
conditions in which any form of data sharing occurs, the coach will regularly discuss with 
participants any concerns they have about data sharing, so that problem can be addressed 
(e.g., if a data sharing friend/family member is making critical remarks, the index 
participant can be coached how to address this with that party, or that party can be 
replaced with a different friend/family member for data sharing). Coaches will be given 
training in how to assess any possible iatrogenic effects of data sharing that are disclosed 
by index participants (e.g., relationship strain with the data sharing partner), and coaches 
will log all such reports in a REDCap field to allow for trial monitoring and reporting. 
Several steps will be taken to protect index participant confidentiality in the context of 
group-based treatment. At the first group meeting the importance of confidentiality will 
be discussed and concrete guidelines will be provided regarding permissible versus 
inappropriate disclosure of information about group-based treatment to others, including 
via social media (e.g., when discussing this LM program with other parties, the focus 
should be limited to one’s one experience, not what is shared by others in group; names 
and identifying details of other index participants should never be disclosed to others; 
etc.). To maximize adherence to these guidelines, they will be presented in a way that 
elicits feedback from the group (so that group members have a sense of ownership 

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regarding these norms) and index participants will be encouraged to publicly commit in 
group to upholding these standards of confidentiality. Index participants will be notified 
that failure to respect the confidentiality of other group members is grounds for dismissal 
from the program. Similar training about confidentiality will be conducted with 
designated friends/family members who participate in the program to support an index 
participant’s LM efforts. 
 
3) Potential Benefits to Subjects 
Participants may or may not benefit directly from this study. It is possible that the 
intervention may promote healthy behaviors, such as increasing physical activity and 
reducing caloric consumption, which may benefit index participants psychologically and 
medically. Also, the prescribed behavioral changes for index participants are known to 
promote improved quality of life and positive health outcomes. Participants in LM 
programs typically report that mood and quality of life also improve during the course of 
the program. 
 
4) Privacy and Confidentiality 
This study will not use nor disclose Protected Health Information (PHI). 
As per policy of the IRB, all participant data, including the fact of their participation, 
will be treated as confidential and will be safeguarded according to the practices 
described above. All study staff will be trained regarding the importance of 
confidentiality, and all possible efforts to protect participant privacy will be observed. 
Participant materials will be labeled with a study identification number rather than 
personally-identifiable information (e.g., name). All data will be stored in password- 
protected files on secure servers that are only accessible to identified study staff. 
After being stripped of identifiable information, written materials from participants 
will be stored in locked filing cabinets. Drexel University Institutional Review Board 
and HIPAA guidelines will be observed. 
Privacy and confidentiality will be explained to participants during the consent process, and 
questions about privacy will be answered as needed throughout the study. Participants 
will be reminded that they can decline to answer person questions as appropriate (e.g., 
during assessments). They also will be provided with contact information for the 
principal investigator and community mental health resources, to be used in the event of 
unforeseen distress. 
Dr. Butryn will administer a data collection and storage training to all project staff, 
who must demonstrate competence in all tasks (e.g., phone screening, informed 
consent, etc.) before commencing their responsibilities. Staff will be assigned to 
review assessment data for accuracy and completion, and to pursue missing data by 
re-contacting participants. Specialized validity tools (e.g., customized spreadsheets 
and data entry software) will be used to maximize data accuracy. Double-entry will 
be utilized where appropriate. To maximize efficiency, data will be electronically 
managed through REDCap, a secure application that has been successfully used by 
this team on several projects. All paper-based data will be stored in a locked filing 

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cabinet, and all electronic data will be password protected and stored on secure 
computer servers. On-site and off-site backup storage will be utilized to protect 
against loss. 
All data given to the statistician, as well as given to the DSMP-identified security 
officer, will be masked and, therefore, will contain no identifying information, except 
as required when reporting adverse events. No identifying information will be 
contained within study databases. All research data will be kept separate from 
identifiers and linked with a participant number. Only Dr. Butryn and her research 
coordinator will have access to the file linking names and participant numbers, and 
this file will be stored in their locked offices. 
5) Economic Burden to Subjects 
This research includes free assistance with developing healthy eating and physical 
activity and use of a commonly used digital self-monitoring device and wireless 
scale. Index participants will be financially compensated for their time spent in 
assessments. 
 
Index participants and friend/family members are required to have access to a 
smartphone and data plan for using the study app. Financial assistance will be 
provided as needed for this technology or for text message costs. 
 
6) Subject Compensation 
Index participants can earn up to $140 for participating in this study, contingent upon the 
completion of all assessment assignments. 
 
Index participants will be paid $40 for completing the 6-month assessment, $50 for 
completing the 12-month assessment (mid-treatment), and $50 for completing the 24- 
month (post-treatment) assessment. Compensation is contingent upon participants 
completing assigned study tasks.  
 
Wave 1 participants who volunteer to complete the optional ecological momentary 
assessment study will receive an additional $75, making their total compensation $215.  
 
The selected friend/family member involved in the study intervention will be 
compensated $50 upon completion of their webinar attendance. 
 
Payment will be provided for index participants and friend/family members as an e-gift 
card from Amazon or through direct ACH payments to the participant’s bank 
account. ACH is a very common, secure and fast electronic payment method used by 
all major banks. The use of ACH as a payment option allows for remote payment and 
helps us protect the privacy and safety of the participants and the research staff. To 
use this form of payment, we will provide JPMorgan Chase Bank the participant’s 
study ID, name, and email or phone number. Chase will then send the participant an 
invitation to receive payment either as an email or a text message. Once the 
participant accepts the invitation, the funds will be deposited to their bank 

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account. Drexel University and the research team do not have any access to the 
participant’s account information and are not directly involved in the disbursement of 
the funds. 

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If participants cannot or do not want to receive a direct, electronic payment nor an e-gift 
card, they will have the option of receiving a check from Drexel University. This option 
takes several weeks to process, requires the participant to complete a federal W9 form 
and requires disclosing their name and social security number to Drexel’s Accounts 
Payable department. They will also need to disclose their name and address to JPMorgan 
Chase Bank, who would be the distributor of the check. 
 
7) Consent Process 
The consent process will follow the IRB recommended “Investigator Guidance: Informed 
Consent (HRP-802)” document. Index participants will be told that the purpose of the 
study is to test new approaches to supporting long-term behavior change, specifically, 
that this study will test whether using coaches, program peers, or family/friends as 
sources of support and accountability can improve long-term weight loss. They will 
be told participation is voluntary and they can withdraw from the study at any time. 
Participants will be sent a copy of the screening consent before the phone screen. 
They will be prompted to ask any questions and will be assessed for comprehension. 
After reviewing the form and clarifying any confusion, signatures will be collected. If 
the participant chooses not to sign the screening consent, the phone screen will not 
continue. 
At the end of the clinic visit, each index participant will be given a copy of the full study 
consent form. Participants will then review the consent form ahead of their Session 0. 
At Session 0, a staff member will review the consent in detail and the index 
participant will digitally sign and return it if. 
Full eligibility will not be determined until following the study visit. Index participants 
will be explicitly informed that their eligibility is still not final at the conclusion of 
the study visit. There may be some occasions on which it is more subjective whether 
a prospective participant meets the inclusion or exclusion criteria (e.g., psychiatric 
condition) and so eligibility cannot be confirmed immediately during the study visit. 
Throughout the enrollment process, we will hold consensus meetings where these 
types of enrollment decisions and questions will be reviewed by staff and 
investigators. We cannot inform index participants of their final eligibility until after 
these meetings are held and criteria are discussed. Index participants will be contacted 
after the visit to confirm whether they are enrolled. We do expect that a small number 
of index participants will be deemed ineligible after the consensus meeting. We will 
make a phone call to these participants and provide relevant weight loss referrals. 
 
Wave 1 participants who are invited to participate in the optional ecological momentary 
assessment will be sent an electronic version of the informed consent form to 
digitally sign and return. Changes to the original informed consent will be clearly 
highlighted.  
Dr. Butryn will provide several hours of training to familiarize study staff with the 
process of properly obtaining informed consent. Before signatures are collected, 
participants will be asked the following questions to assess their understanding of the 
risks and benefits of participation: 

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- 
What are we going to ask you to do as part of this study? 
- 
What time commitment will the study require? 
- 
What are the main risks and benefits of participating? 

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Friend/family members who have been selected by index participants will be sent an 
email from the research team with study details and a link to provide consent digitally 
and to complete self-report measures. The friend/family member will be given the 
opportunity to sign up for a study visit with study staff if they have additional 
questions. This session will give adequate time for friends/family members to 
understand the study and ask any questions. 
 
8) Process to Document Consent in Writing 
We will be following “INVESTIGATOR GUIDANCE: Informed Consent (HRP- 
802).” Fitlink Informed Screening Consent Form will be sent out to index 
participants prior to scheduled phone screen with Fitlink screeners. If participants 
do not complete the Informed Screening Consent Form before scheduled phone 
screen, screeners will guide participants to read the consent form. They will then 
be asked to sign the screening consent via a REDCap survey and encouraged to 
contact the PI at any time if they have any questions or concerns. 
 
The Index Participant Informed Consent Form will be provided to participants 
after the clinic visit is complete. The participant will review it ahead of their 
Session 0. At Session 0 participants will have time to ask any questions that they 
may have. They will then sign the form via an online REDCap survey and submit. 
Participants will be encouraged to contact the PI at any time if they have any 
questions or concerns. 
 
Friends/family members will be provided with a digital consent form before they 
begin any self-report measures. After friends/family read the consent, they will be 
asked if they have any questions regarding the research and a member of the 
research team will be available to read through the consent and answer questions. 
They will then be asked to sign the consent and encouraged to contact the PI at 
any time if they have any questions or concerns. 
 
9) Vulnerable Populations 
Does not apply. 
 
10) Multi-Site Human Research 
Does not apply. 
 
11) Sharing of Results or Incidental Findings with Subjects 
Findings will be disseminated to the research and practice communities through 
presentations at professional conferences and publication of results in peer-reviewed 
journals. We will register our clinical trial at ClinicalTrials.gov before subject 
recruitment and ensure that summary results data are submitted there in a timely 
fashion (e.g., participant flow, baseline characteristics, outcome measures, statistical 
analyses, data on adverse events). Our informed consent documents will include 
specific statements related to posting information and results at ClinicalTrials.gov. 

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Consent forms will also explain that all data will be de-identified prior to the 
registration of results in order to protect participant privacy and confidentiality. 
Drexel University has an internal policy in place to ensure that clinical trial 
registration and results reporting occur in compliance with NIH policy requirements. 
We will assume full responsibility for following the appropriate requirements and 
timelines. 
 
12) Research Conducted in a Foreign Country 
Does not apply 
13) Community-Based Participatory Research 
Does not apply 

Research Subject Consent Form 
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APPROVED  
Human Research Protection 
Protocol: 2103008421A017 
Approval Date: 12/052022 
 
 
Title: Sharing Digital Self-Monitoring Data with Others to Enhance Long Term Weight Loss: A 
Randomized Trial using a Factorial Design 
 
Protocol Number.: 2103008421 
 
Sponsor: National Institutes of Health 
 
Investigator: Dr. Meghan Butryn, PhD 3141 
Chestnut St. Stratton 
Hall 119 Philadelphia, 
PA, 19104 
mlb34@drexel.edu 
 
Daytime Phone Number: (570)391-4641 
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Research Subject Consent Form 
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APPROVED  
Human Research Protection 
Protocol: 2103008421A017 
Approval Date: 12/052022 
 
 
Consent to Take Part in a Research Study 
You are being invited to take part in a research study. A person who takes part in a research 
study is called a research subject, or research participant. 
 
Concise Summary of Key Information: 
● This research is being done to test new approaches to supporting long-term behavior 
change. Specifically, this study will test whether using coaches, program peers, or 
family/friends as sources of support and accountability can improve long-term weight 
loss. 
● Your consent and participation in this study is completely voluntary. 
● Participants will be enrolled in the study for a total of 2 years (24 months), with 
assessments at baseline (0 months), 3 months, 6 months, mid-treatment (12 months), and 
post treatment (24 months). 
● Every day for the full two years, you will use a smart scale to weigh yourself, wear a 
physical activity tracker, and track your meals on a food record smartphone application. 
● For the first 3 months of your participation in the study, you will attend weekly remote 
group-based behavioral weight loss sessions. 
● For months 4-24, you will: 
o Attend a group-based behavioral weight loss session online via Zoom 
videoconferencing software once every 3 months, and 
o Participate in a brief, individual phone call with a coach once a month. 
● Every month, you will exchange text messages concerning your progress in the program 
with a coach, with fellow group members, and with a friend/family member. 
● Depending on your random condition assignment your coach, fellow group members, 
and/or your friend/family member may have real-time access to the data gathered by 
your smart scale, physical activity tracker, and food record app to inform their text 
messages. 
 
● Study messages will be sent through a secure, web-based portal to an app on your phone. 
You will be assigned a username and password to receive these messages. Information 
from your scale, Fitbit, and food record will be collected through the Fitbit API, and also 
stored on the study web-based portal. The study portal will be accessed only by 
authorized study staff. 
● We cannot promise any benefits to you or others from your taking part in this research. 
However, possible benefits include weight loss as the behavioral weight loss treatment 
employed in this study has much scientific support. 
● Participation in the study may involve unforeseen risks. If unforeseen risks are seen, they 
will be reported to the Drexel Office of Human Protection Office. If any events occur 
that might be related to the treatment, you should bring them to the attention of your 
personal physician. 
● If you do not wish to take part in this research, we can provide you with a list of referrals 
for other weight loss programs in the area or you can talk to your doctor. 
● You will only be responsible for any smartphone data use incurred from using the 
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Research Subject Consent Form 
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program app. 
You can receive a total compensation of $140 for completion of all assessments. 
Contingent upon completing all assignments, you will receive $40 for 6- months, $50 
mid-treatment (12 months), and $50 for post-treatment (24 months). Payment will be in 
the form of e-gift cards (Target or Amazon), direct ACH payments, or by check. 
 
What should I know about this research? 
 
● Someone will explain this research to you. 
● This form sums up that explanation. 
● Taking part in this research is voluntary. Whether you take part is up to you. 
● You can choose not to take part. There will be no penalty or loss of benefits to which 
you are otherwise entitled. 
● You can agree to take part and later change your mind. There will be no penalty or loss 
of benefits to which you are otherwise entitled. 
● If you don’t understand, ask questions. 
● Ask all the questions you want before you decide. 
 
Why is this research being done? 
The purpose of this research is to test new approaches to supporting long-term behavior change. 
Specifically, this study will test whether using coaches, program peers, or family/friends as 
sources of support and accountability can improve long-term weight loss. 
 
320 participants and 320 friends and/or family members of the participants will take part in this 
research. 
 
 
How long will I be in this research? 
We expect that your taking part in this research will last 2 years (24 months). 
 
What happens to me if I agree to take part in this research? 
 
If you choose to participate in this research study, you will be given a smart scale, physical 
activity tracker, and access to a food recording smartphone app. You will use these digital data 
trackers to weigh yourself, track your physical activity, and record all of your meals and snacks 
daily for the duration of the study (24 months). Due to study requirements, you may only be 
eligible if you own a smartphone. 
For the first three months, you will attend and participate in weekly, remote group-based 
behavioral weight loss treatment sessions (90 minutes) through the Zoom videoconferencing 
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platform. Each group will be led by a Masters-level coach, who will teach you skills related 
to losing weight and maintaining that weight loss in the long term. For the rest of the study, 
groups will continue to be held online via Zoom videoconferencing, and will take place once 
every three months. You also will participate in brief (15 minutes), individual phone calls 
with your coach once per month. During these phone calls, your coach will check in about 
your progress towards your goals, review core behavioral skills that are most relevant to you, 
and collaboratively set goals with you for the next month. Lastly, you will exchange text 
messages monthly with your coach; with 3-4 fellow members of your group; and with a 
designated friend/family member. 
 
You will be randomly placed in 1 of 8 conditions. Your study condition determines which 
components of the intervention you will receive. There are 3 components, and they differ by the 
party with whom your weight, physical activity, and food record data will be shared with: your 
coach, a small group of your fellow group members, and your friend/family member. Neither 
you nor the study investigator will choose which components you receive or your study 
condition. 
Every participant will take part in 20 group sessions, 14 coach calls, and monthly text exchanges 
with a coach, with a small group of fellow group members, and with a friend/family member. 
Depending on your study condition, your coach, small group of fellow group members, and/or 
your friend/family member will have access to the data collected by your scale, physical activity 
tracker, and food record app (i.e. your weight, minutes of physical activity, and caloric intake). 
They will use this information to inform the text exchanges you have monthly. If they do not 
have access to your digital data, you will still engage in the text exchanges with each of them. 
Study messages will be sent through a secure, web-based portal to an app on your phone. You 
will be assigned a username and password to receive these messages. Your first name, user 
name, phone number, and email address will be stored on the web-based portal. Information 
from your scale, Fitbit, and food record will be collected through the Fitbit API, and also stored 
on the study web-based portal. The study portal will be accessed only by authorized study staff. 
The development team for the web portal has been approved by Drexel’s Information Security 
Office. The development team has agreed to abide by Drexel’s Application Development 
Standards under the Security of Information and Networked Systems policy, encrypt at rest and 
in motion, and abide by privacy by design, security by design, and responsible computing 
principles. As part of participation, participants will be provided with informational handouts that 
correspond to the skills taught in that week’s session. Participants will access these handouts in 
Google Classroom. There will be no personal, identifying, or health information shared in any of 
these documents. Other features of Google Classroom such as discussion boards will not be used; 
participants will simply be using Google Classroom as a user-friendly place to locate these 
handouts. 
Assessments will be completed at the beginning of treatment (0 months), 3 months after 
treatment begins, 6 months after treatment begins, at the mid-point of treatment (12 months), and 
at the end of treatment (24 months). At this time, you will be asked to complete a set of surveys 
and to track weight, physical activity, and food intake for 7 days. 
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The exception is month 3 assessment, where you will only be asked to complete a limited battery 
of self-report measures and 7 days of self-weighing. During your final assessment, you may be 
randomly chosen to participate in a 45-60 minute semi- structured interview to provide feedback 
about the study. 
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to: 
● 
Attend all required study visits and assessments. 
● 
Every day, you will: 
○ 
Weigh yourself using the smart scale you were given, 
○ 
Wear the physical activity tracker 
○ 
Record your food intake using the designated program smartphone application. 
● 
Attend and participate in all group behavioral weight loss sessions 
● 
Participate in all phone calls with your coach. 
● 
Read and participate in all text message exchanges between you and your coach, you 
and your small group of fellow group members, and you and your friend/family 
member. 
● 
Contact the investigator if any complications arise 
 
Could being in this research hurt me? 
Participation in this research study includes minimal risk. During this study, you will be 
undergoing behavioral weight loss treatment with prescriptions of gradual exercise increase 
and decreased caloric intake with the goal of losing approximately 1-2 pounds per week. If 
you lose a large amount of weight too quickly, you are at risk of developing gallstones. You 
also may injure yourself when engaging in physical activity. Both of these risks are unlikely 
given the prescribed physical activity of brisk walking. If you are taking any medication, 
you should carefully coordinate the oversight of these medications with your primary care 
physicians to make any necessary adjustments of dosage necessary if weight loss occurs. 
There may also be psychological risks to you such as feelings of shame or embarrassment 
related to eating habits and/or weight, which may be amplified if you are randomly assigned 
to share your digital data with a coach, small group of group members, and/or a friend/family 
member. However, your coach will be trained to deliver the program in a way that feels 
positive to you and will be able to address your concerns if they arise. Lastly, there is always 
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a risk for loss of privacy and confidentiality, though the research team will take many 
precautions to protect against this. 
Participation in the study may involve unforeseen risks. If unforeseen risks are seen, they will be 
reported to the Drexel Office of Regulatory Research Compliance. In addition to these risks, 
taking part in this research may harm you in unknown ways. 
 
Will it cost me money to take part in this research? 
This research includes free assistance with developing healthy eating and physical 
activity and use of a commonly used physical activity tracker and Fitbit Aria Air smart 
scale. You will be financially compensated for your time spent in assessments. 
 
You will only be responsible for any smartphone data use incurred from using the program 
app. Financial assistance will be provided as needed for this technology or for text message 
costs. 
 
Will being in this research benefit me? 
We cannot promise any direct benefits to you or others from your taking part in this research. 
However, it is possible that the intervention may promote healthy behaviors, such as increasing 
physical activity and reducing caloric consumption, which may benefit you psychologically and 
medically. Also, the prescribed behavioral changes are known to promote improved quality of 
life and positive health outcomes. Participants in LM programs such as this one typically report 
that mood and quality of life also improve during the course of the program. 
 
What other choices do I have besides taking part in this research? 
Instead of being in this research, your choices may include: 
● Other programs in the area, for which we can provide you with a list of referrals. 
● Talking to your doctor about other weight loss options that may be a better fit for you. 
 
 
What happens to the information collected for this research? 
Your private information will be shared with individuals and organizations that conduct or 
watch over this research, including: 
 
● The research sponsor: National Institutes of Health (NIH) 
● People who work with the research sponsor(s) 
● Government agencies, such as the Food and Drug Administration or the Department of 
Health and Human Services 
● The Institutional Review Board (IRB) that reviewed this research 
● Drexel University and its affiliates 
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We may publish the results of this research. However, we will keep your name and other 
identifying information confidential. 
 
We protect your information from disclosure to others to the extent required by law. We cannot 
promise complete secrecy. 
Data collected in this research might be de-identified and used for future research or distributed 
to another investigator for future research without your consent. 
 
A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
What is a Certificate of Confidentiality? 
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. 
A Certificate of Confidentiality helps protect your identifiable information and biological 
samples. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by The National Institutes of Health which is funding this project or for 
information that must be disclosed in order to meet the requirements of the federal Food and 
Drug Administration (FDA). You should understand that a Certificate of Confidentiality does 
not prevent you from voluntarily releasing information about yourself or your involvement in 
this research. If you want your research information released to an insurer, medical care 
provider, or any other person not connected with the research, you must provide consent to 
allow the researchers to release it. 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law, such as child abuse and neglect, or harm to self or others. 
 
Who can answer my questions about this research? 
If you have questions, concerns, or complaints, or think this research has hurt you or made you 
sick, talk to the research team at the phone number listed above on the first page. 
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This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of 
people who perform independent review of research studies. You may talk to them at (267) 
3592471 or HRPP@drexel.edu if: 
 
● You have questions, concerns, or complaints that are not being answered by the research 
team. 
● You are not getting answers from the research team. 
● You cannot reach the research team. 
● You want to talk to someone else about the research. 
● You have questions about your rights as a research subject. 
 
Can I be removed from this research without my approval? 
The person in charge of this research can remove you from this research without your approval. 
Possible reasons for removal include: 
● If there is a change in your medical condition. 
● If the study is discontinued for any reason by the sponsor, investigator, university 
authorities, or government agencies. 
● If new information is available to the investigator. 
● If there are harmful unforeseen reactions experienced by you or other participants in the 
study. 
We will tell you about any new information that may affect your health, welfare, or choice to 
stay in this research. 
 
What happens if I agree to be in this research, but I change my mind later? 
You can agree to take part in the research now and stop at any time. 
Participation in this study is voluntary, and you can refuse to be in the study or stop at any time. 
Any fee you may be paid will be determined by the amount of participation you completed and, 
if you do not complete the study, the reason for leaving the study early. 
If you stop being in the research, already collected data may not be removed from the study 
database. 
 
Will I be paid for taking part in this research? 
For taking part in this research, you may be paid up to a total of $140 in the form of e-gift cards 
(Target or Amazon, your choice) or direct ACH payments to your bank account. ACH is a very 
common, secure and fast electronic payment method used by all major banks. The use of ACH 
as a payment option allows for remote payment and helps us protect the privacy and safety of 
the participants and the research staff. To use this form of payment, we will provide JPMorgan 
Chase Bank your study ID, name, and email or phone number. Chase will then send you an 
invitation to receive payment either as an email or a text message. Once you accept the 
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invitation the funds will be deposited to your bank account. Drexel University and the research 
team do not have any access to your account information, and they are not directly involved in 
the disbursement of the funds. 
 
The payment is contingent upon completion of all assessment materials and procedures at each 
time point, such as surveys and dietary recalls, and is broken down as follows: 
● $40 for completing the 6-months assessment 
● $50 for completing the mid-treatment (12 months) assessment 
● $50 for completing the post-treatment (24 months) assessment 
 
If you cannot, or do not want to, receive a direct, electronic payment, you have the option of 
receiving a check from Drexel University. This option takes several weeks to process, requires 
you to complete a federal W9 form and requires you to disclose your social security number to 
Drexel’s Accounts Payable department. You will also be required to disclose your name and 
address to JPMorgan Chase Bank, who would be the distributor of the check. 
Federal tax law requires to you to report this payment as income to the Internal Revenue Service 
if you are compensated more than $599.00 (in total) this year for participating in research. You 
may be asked to tell us your social security number or other identifying information (e.g., full 
name). If payments for this study are more than $599.00, we will report them to the Internal 
Revenue Service and send you a Form 1099-MISC. This information will not be associated with 
the information or data you provide for this research. It will be stored separately from your data, 
it will not be linked in any way, and your identifying information will be destroyed within 1 
year of study completion. 
What else should I know about this research? 
If in your initial assessment, we determine that you do not meet the eligibility for this particular 
study, you have the option to elect to be screened for other studies at Drexel University’s WELL 
Center as well as to remain in the WELL Center database for future studies. Please initial below 
if you are interested in one or both of these options: 
 
I elect to be screened for other studies at Drexel University WELL Center if I am not 
eligible for this study. 
 
 
 
I would like to be added to the WELL Center database to be contacted for future studies 
that I might be eligible for. 
 
Signature Block 
 
Your signature documents your consent to take part in this research. 
 
 
Printed Name and Signature of adult subject capable of consent 
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Printed name and Signature of person obtaining consent 
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