SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
Phase: NA
Conditions: Overweight and Obesity
Sponsor: University of California, San Diego

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SMART 2.0: Social Mobile Approaches to Reducing 
weighT in Young Adults 
NCT03907462 
Study Protocol and Statistical Analysis Plan 
Date of Document 2/1/2019 
Submitted 02/27/2025  
 

 
 
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UCSD Human Research Protections Program 
RESEARCH PLAN  
Last Updated: February 1, 2019 
 
1. 
PROJECT TITLE 
SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults 
 
2. 
PRINCIPAL INVESTIGATOR  
Job Godino, PhD 
 
3. 
FACILITIES 
The Center for Wireless and Population Health Systems (CWPHS) and the Exercise and Physical Activity 
Resource Center (EPARC), located within the California Institute for Telecommunications and Information 
Technology (Calit2) at UCSD. 
 
4. 
DURATION OF THE STUDY 
The estimated duration of this study is February 1, 2019 – February 1, 2024.  
 
5. 
LAY LANGUAGE SUMMARY OR SYNOPSIS (no more than one paragraph) 
Weight gain and the retention of gained weight is an important issue for young adults. Throughout the transition 
from adolescence to early adulthood, young adults encounter multiple stressors and influences that can contribute 
to weight gain. In turn, weight gain leads to increased risk of cardiovascular disease, diabetes, and other health 
issues. Thus, there is a critical need to advance our understanding of how to develop and deploy multimodal, 
technology-based weight-loss interventions that have the potential for long-term effects and widespread 
dissemination among young adults. In the present study, we will test the impact of an intervention, SMART 
2.0, designed to promote weight loss through increased energy expenditure, decreased energy intake, and 
adequate sleep among young adults in a university setting. Evidence and theory-based content in SMART 2.0 
will be delivered using a consumer-level wearable and scale, text messaging, social media, and technology-
based health coaching over the course of two years. 
 
6. 
SPECIFIC AIMS 
The primary aim of the study is to determine the efficacy of SMART 2.0 with technology and personal health 
coaching or with technology alone to improve objectively measured weight in kg over 24 months (96 weeks) 
compared to a control group. 
 
Secondary aims will be to evaluate the following: 
1. Anthropometric and physiological outcomes, physical activity, diet, sleep, self-esteem, body image, 
anxiety, depression, and the frequency and composition of participants’ online communication about 
weight-related behaviors between groups at 6, 12, 18, and 24 months 
2. The dose response (i.e., quantified engagement with technological modalities) of the intervention 
3. The usability and acceptability of the intervention 
4. Potential mediators and moderators of the intervention effects (e.g., social network connectivity, 
contamination, etc.) 
5. Patterns of change in physical activity, diet, and sleep 
Given that SMART 2.0 has been greatly enhanced by what we have learned from previous research, we 
hypothesize that both interventions will significantly improve weight compared to the control group, and the 
group receiving personal health coaching will experience the greatest improvement. We further hypothesize 

 
 
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that differences in secondary outcomes will favor the SMART 2.0 intervention groups. There is a critical need 
to advance our understanding of how to develop and deploy multimodal, technology-based weight-loss 
interventions that have the potential for long-term effects and widespread dissemination among young adults. 
SMART 2.0 is designed to maximize efficacy in a scalable manner. By measuring usability and acceptability, 
this study will inform intervention dissemination to campus wellness programs should the findings warrant it. 
7. 
BACKGROUND AND SIGNIFICANCE 
Overweight and obesity are major public health concerns in the United States1,2. Recent data from the 
Centers for Disease Control and Prevention indicate that the extent of this problem is great even among young 
adults, as approximately 60.3% of those 20 to 39 years old are overweight or obese (defined as a body mass 
index (BMI) ≥25 kg/m2).3 Evidence shows that excess weight gain occurs most rapidly in young adults and is 
associated with future weight gain;4-6 cardiovascular risk factors such as hypertension, dyslipidemia, and 
diabetes;7 and psychological distress.8 Additionally, more than half of young adults in the United States are 
enrolled in tertiary education,9,10 and an estimated 40% of students are overweight or obese.11 This represents a 
period of time when students undergoing the transition from adolescence to young adulthood often adopt 
unhealthy weight-related behaviors, such as decreased physical activity (PA),12,13 poor diet quality (e.g., increased 
fast food consumption and decreased fruit and vegetable consumption),13-15 and poor sleep hygiene.13,16 
Consequently, students typically gain a significant amount of weight while in school (meta-analyses estimate it is 
between 1.31 and 1.79 kg),17-19 and there is a critical need for behavioral weight loss interventions that target this 
population.17-19 
 
One potential strategy is to deploy interventions designed to promote weight loss through healthy changes in PA, 
diet, and sleep (an important behavior that is often overlooked in the study of weight loss)20-23 via mobile and 
social technologies that are highly pervasive in the US. For example, approximately 86% of young adults own a 
smart phone and 75% of them use it to get information about their health.24,25 Furthermore, ownership of activity 
trackers and smart watches that monitor health-related outcomes has more than doubled among all adults since 
2014 (currently 49% own at least one device), and it is likely to continue increasing.26 Social media use among 
young adults is also ubiquitous, with an estimated 90% using at least one platform regularly and no differences in 
use by sex or race and ethnicity.27,28 Facebook remains the most popular platform and overall engagement is 
increasing, with approximately 70% using it daily.28 Thus, instead of relying on regular in person interactions as 
weight loss interventions have traditionally done,29-33 interventions can utilize the aforementioned technology-
based modalities to meet students in the virtual spaces they frequently inhabit.34,35 Given the highly variable 
schedules and time constraints associated with being a student, this approach may be more acceptable to college 
students than in-person approaches with limited flexibility and scalability.36 
 
A recent systematic review shows that the vast majority of technology-based behavioral weight loss studies (76 
out of 84) have been conducted exclusively among middle-aged and older adults.37 Additionally, although the use 
of several modalities would allow for greater individual tailoring and exposure to intervention content, and would 
more accurately reflect the norm of using multiple technologies in daily life, 60.4% of interventions identified 
used only one modality, 33.8% two, 5.0% three, and only one used five.37 Moreover, technology based behavioral 
interventions targeting weight loss were often lacking substantial theory- and evidence-based content,35,38 and 
very few were implemented for longer than 18 months (13.9%).37 Despite these shortcomings, on average, 
interventions achieved moderate weight loss (between -1.4 and -2.7 kg).37 Thus, there remains a very clear need 
for studies that inform and implement long-term, multimodal, technology-based weight loss interventions that 
have the potential for enhanced effect sizes and widespread dissemination among college students. 
Additionally, our multidisciplinary investigative team has extensive experience studying the efficacy of 
interventions that rely on ubiquitous technologies to meet young adults in the virtual spaces they frequently 
inhabit and use these venues to promote weight loss. The original SMART study was one of seven randomized 
controlled trials (RCT) comprising the Early Adult Reduction of weight through LifestYle intervention 

 
 
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(EARLY) trials, a consortium funded by the NHLBI (U01 HL096715; Principal Investigator (PI): Patrick; Co-
Investigators (Co-Is): Godino, Calfas, Rock, and Weibel).39-42 It was the only RCT in the consortium to 
integrate mobile and social technologies within the intervention.39 In SMART, 404 overweight or obese college 
students (aged 18 to 35 years) from three universities in San Diego, CA were randomized to receive either the 
intervention (n=202) or general information about health and wellness (control group, n=202). The 2-year 
intervention was innovative primarily because it 1) was remotely delivered via 6 technological modalities (i.e., 
mobile apps, text messaging (SMS), Facebook, emails, a website, and brief ad-hoc technology mediated 
communication with a health coach) and 2) leveraged participants’ existing as well as study engineered social 
networks to remotely deliver theory-based BCTs and evidence-based strategies for weight management 
(SWMs). The primary outcome was objectively measured weight in kg at 24 months, and differences between 
groups were evaluated using linear mixed-effects regression. Participants’ mean (standard deviation [SD]) age 
was 22.7 (3.8) years. They were 70% female and 31% Hispanic. Mean (SD) body mass index was 29.0 (2.8) 
kg/m2. At 24 months, weight was assessed in 341 (84%) participants, but all 404 were included in analyses. 
Weight, adjusted for sex, ethnicity, and college, was significantly less in the intervention group compared to the 
control group at 6 months (1.51%; -1.33 kg difference, 95% confidence interval (CI) = -2.36 to -0.30, p = 
0.011) and 12 months (1.57%; -1.33 kg difference, 95% CI =-2.30 to -0.35, p = 0.008). However, differences 
between groups at 18 months (-0.67 kg difference, 95% CI = -1.69 to 0.35, p = 0.200) and 24 months (-0.79 kg 
difference, 95% CI = -2.02 to 0.43, p = 0.204) were not significant.41 
 
Although the intervention was well-received (80.4% would recommend it to others), modalities were not fully 
integrated and engagement declined over time.41,43 To better understand why engagement may have declined, 
we interviewed 38 participants (n=20 intervention; n=18 control) throughout the final months of the study.43 
Participants in both study groups reported using non-study designed, consumer-level devices and apps to help 
them meet their weight-loss goals (e.g., Fitbit and MyFitnessPal). Additionally, although Facebook emerged as 
the primary modality through which dynamic content was delivered at the group level and over half (56%) of 
participants had at least one Facebook friend in the study,41,43 intervention participants expressed a desire for 
greater online interaction with other participants.43 This finding aligns with our preliminary quantitative 
analysis of online communication about weight-related behaviors.44 Specifically, intervention participants 
spoke more about PA and diet with their existing online social networks than did control participants. 
Furthermore, a 20% increase in social support for talking about PA and diet on Facebook (defined as likes and 
comments) was associated with a weight loss of 4.1 kg from baseline to 6 months among female participants. 
Taken together, these findings suggest that an intervention that incorporates popular consumer-level devices 
and apps, while also capitalizing on existing and study-engineered social networks, may be highly engaging to 
young adults.  
 
The ConTxt study was an RCT that assessed the efficacy of a weight loss intervention delivered almost 
exclusively via SMS (NCI R01 CA138730; PI: Patrick; Co-Is: Godino and Rock).45 The study built upon the 
success of an earlier 4-month trial of interactive SMS on weight outcomes,46,47 and 298 overweight adults (aged 
21-60 years) were allocated to one of three conditions: 1) a control condition; 2) SMS only; or 3) SMS+Health 
Coach (brief monthly phone calls). The SMS interventions offered 1-4 messages/day which were personalized 
and tailored using baseline SWMs and then reiteratively and interactively using ecological momentary 
assessment of PA and diet, goal setting and performance, and “like” or “unlike” messaging controls.48 The 
primary outcome was objectively measured weight at 12 months, and differences between groups were 
evaluated using linear mixed-effects regression. Participants were 77% female and 41% Hispanic. At 12 
months, weight was assessed in 253 (85%) participants, but all 298 were included in analyses. Compared to the 
control group, and controlling for baseline body mass index, the SMS only group lost 1.20% more weight (p = 
0.214); and the SMS+Health Coach group lost 2.99% more weight (p = 0.003). Importantly, both SMS 
interventions were well received, and the results indicate that a weight loss intervention delivered via daily 

 
 
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individualized, dynamic, and interactive SMS was most efficacious when messages were combined with brief 
monthly communication with a health coach.45 
 
Given that 1) the interventions in the SMART and ConTxt studies have evidence of short-term efficacy and can 
be merged because of their similar theory- and evidence-based content (i.e., BCTs and SWMs); and 2) there is 
evidence that the incorporation of consumer-level devices and apps along with increased social media and 
social network connectivity will enhance engagement, we believe that the proposed research is a logical, 
innovative, and important extension of our previous work. 
8. 
RESEARCH DESIGN AND METHODS 
Overview 
The SMART 2.0 study is a 24-month (96 week) parallel-group randomized control trial designed to evaluate 
the efficacy of the intervention with technology and personal health coaching or with technology alone to improve 
objectively measured weight in kg over 24 months compared to a control group. We will recruit 642 
overweight/obese young adults aged 18-35 at the University of California, San Diego (UCSD), San Diego State 
University (SDSU) and California State University, San Marcos (CSUSM) in San Diego. Participants will be 
assigned to one of three groups for a 24-month study period. The three groups include: 
 
1. SMART 2.0 with technology, social media, and personal health coaching (T1) 
2. SMART 2.0 with technology and social media alone (T2) 
3. Control group 
 
SMART 2.0 improves upon its predecessor by using a fully integrated system of modalities that includes 1) a 
popular consumer-level wearable activity tracker (Fitbit Charge 3), wireless scale (Aria Scale), and apps 
(Fitbit); 2) a highly tailored and interactive text messaging system (described in detail below) 45, 23; 3) multiple 
social media streams including Facebook, Facebook Messenger, Instagram and Twitter, and 4) enhanced social 
network mechanisms of influence. Consumer-level devices and apps will be used to self-monitor behavior, and 
their data will be passively acquired in real-time. Algorithms will be used to automatically deliver interactive 
text messages to support individually tailored goal setting, performance feedback, and goal review in a highly 
dynamic style that reflects participants’ behavioral progress towards achieving a minimum goal of 5% weight 
loss. Participants will be encouraged to share their data and behavioral progress with others via social 
networking tools built into the apps. Social network mechanisms of influence will be used both within the 
study-space, to elicit participant-to-participant and health coach-to-participant support, as well as outside the 
study-space, to invoke social support and accountability from strong ties known to be important for long-term 
behavior change.49-52 Additionally, one group will receive monthly technology-mediated, real-time personal 
health coaching that is theory- and evidence-based.53–56 
 
Subjects assigned to the SMART 2.0 with technology and personal health coaching treatment group (T1) will 
receive the following during the 24-month (96 week) intervention period: 1) Fitbit Charge 3 activity tracker and 
Aria scale, 2) daily text messages related to physical activity, diet, sleep and weight loss/maintenance, 3) access 
to SMART 2.0 social media pages and content through an online group with 6 to12 participants total, and 4) 
technology-mediated, real-time individual health coaching. Subjects will receive 1 to 2 text messages on a daily 
basis, be asked to use their Fitbit on a daily basis and self-weigh using the Aria at least once per week, be asked 
to interact with their online group via social media as frequently as possible, and speak with their health coach 
at a predetermined session schedule. 
 
Subjects assigned to the SMART 2.0 technology alone treatment group (T2) will receive the following 
activities during the 24-month (96 week) intervention period: 1) Fitbit Charge 3 activity tracker and Aria scale, 
2) daily text messages related to physical activity, diet, sleep, resilience and weight loss/maintenance, and 3) 
access to SMART 2.0 social media pages and content through an online group with 12 participants total. 

 
 
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Subjects will receive 1 to 2 text messages on a daily basis, be asked to use their Fitbit on a daily basis and self-
weigh using the Aria at least once per week, and be asked to interact with their online group via social media as 
frequently as possible. 
 
Subjects assigned to the control group will simply receive a Fitbit Charge 3 and Aria scale to use at their 
discretion. 
 
Theoretical Framework and Rationale 
 
Unlike many technology-based interventions wherein theory has only been used superficially,35 the SMART 
2.0 intervention content is mapped directly onto theory-based behavioral change techniques (BCTs). 
Specifically, the intervention is informed by Abraham and Michie’s taxonomy of 93 distinct BCTs 
clustered into 16 domains.57 Meta-analysis of 122 evaluations of interventions that targeted healthy changes 
in PA and diet revealed that the most effective BCTs were self-regulatory and included intention formation, 
goal setting, self-monitoring, feedback, and goal review.58 Therefore, content supporting these will be 
delivered via all modalities, along with content supporting BCTs that target social network mechanisms of 
influence (e.g., social support, comparison of behavior, restructuring the social environmental, etc.). All BCTs 
included in the intervention will be classified prior to delivery and the specific features of a given modality will 
determine which are best delivered via a given modality. We acknowledge that participants will vary in the 
frequency and depth of their utilization of BCTs across modalities. Our ability to measure this variation is a 
strength. Table 1 provides examples of how these will optimally be delivered.  
 
Intervention content will also be derived from the strategies for weight management (SWMs), which comprise 
35 of the most common evidence-based approaches to achieve weight loss (e.g., reduce portion sizes, avoid 
processed foods, eliminate sugar sweetened beverages, etc.). The SWMs were successfully integrated into 
previous studies showing efficacy, and our team has published two papers on the psychometric characteristics 
of the SWM questionnaire.59,60 Additional intervention content is drawn from comprehensive lifestyle 
interventions that teach stimulus control, problem solving, time management, stress management, etc.61,62 
Overall, our approach to the delivery of theory- and evidence based content in SMART 2.0 is flexible and lends 
itself well to complex and adaptive technology-based interventions that are responsive to an individual’s 
behavioral progress and ever-changing context.62-65 We do not have a single overarching theoretical framework, 
rather the intervention content reflects numerous theoretical orientations (e.g., operant conditioning,66 theories 
of social comparison,67 theories of social support,68 ecological theory,69 etc.). This represents a strength of our 
approach.62-65 
 
Table 1. Examples of how intervention content will be delivered in SMART 2.0 
Content 
Modalities 
Description of Delivery 
Intention formation and 
goal setting 
Health coaching/ 
email, SMS, social 
media/ online 
groups 
- Health coach will facilitate long- and short-term goal setting with participant 
during each session followed by an email summary of goals made.   
- Activity, dietary, and weight data collected by Fitbit and Aria scale will prompt 
tailored weekly goals disseminated via SMS. 
- Health coach will moderate online group discussion so that each group 
develops and works toward goals. In turn, the health coach will post social 
media content tailored toward each groups’ goals. 
Self-monitoring 
Fitbit, Aria scale, 
SMS, social media 
- Participant monitors physical activity, sleep, and diet with Fitbit and Fitbit app 
and weight with Aria scale. Ongoing self-monitoring is supported by prompts 
and reminders via SMS and social media.  
Feedback 
Health coaching, 
Fitbit/ Fitbit app, 
Aria scale, SMS, 
- Health coach will provide feedback on participant’s progress toward reaching 
his/her individual goals. 
- Feedback is provided in real time on devices and in Fitbit app. 

 
 
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social media/ 
online groups 
- A data driven automated SMS containing a summary of individual progress 
toward reaching tailored weekly goals is sent along with a message of 
encouragement or positive reinforcement. 
- Participant posts about progress and/or challenges on social media and in 
online group and receives feedback from their social network, other 
participants and health coach. 
Goal review 
Health coaching, 
SMS 
- During health coaching sessions, participants will discuss goals and barriers 
and facilitators for achieving them. 
- Automated SMS will be sent suggesting a new goal and providing feedback. 
Social support and 
comparison of behavior 
Health coaching, 
SMS, social media/ 
online groups 
- Health coach will provide social support during sessions and suggest ways in 
which participant can seek out support. 
- General SMS content will contain ways in which participants can leverage 
social support in order to reach activity and weight goals. 
- Participant is directly connected to other participants in structured online 
groups that will provide positive reinforcement and encouragement in response 
to participant’s posts about weight loss progress.  
Restructuring the social 
environment 
Social media/ 
online groups 
- Social media and online groups are used to encourage participants to plan 
exercise dates or go grocery shopping together 
Restructuring the 
physical environment 
Social media/ 
online groups 
- Information about where to exercise, eat well and seek mental health resources 
on campus sent via social media and online groups 
 
 
Description of the Weight Loss Intervention 
 
In the SMART 2.0 study, participants of both treatment groups (T1 and T2) will be encouraged to set a 
minimum weight loss goal of 5-10% of their baseline weight. Additionally, participants will be encouraged to 
lose 1-2 lbs/wk70 until they reach a BMI at or below 25 kg/m. Once a participant reaches a BMI  25 kg/m2 the 
goal will be to maintain their weight loss. 
 
The primary behavioral goals of the weight loss program relate to physical activity, diet, and sleep: 
1. Physical activity goals: Consistent with recent evidence-based recommendations for physical activity 
for weight loss71, participants will be prescribed stepped physical activity goals per week starting at 
their baseline exercise minutes building to 225 active min/wk, as measured by the Fitbit activity tracker. 
Consistent accumulation of 225-420 min/wk of moderate and vigorous physical activity (MVPA) is 
associated with 5-7.5kg weight loss71. To calculate baseline physical activity minutes, participants will 
be instructed to wear their Fitbit for the first week of the intervention with no physical activity goal. The  
amount of MVPA for each participant during their first week of the intervention will be calculated and 
used as their individual baseline. Weekly physical activity goals will be stepped from each participant’s 
baseline levels using a conservative progression of 20 minutes per week from the previous week’s 
minutes of MVPA. This progression will continue until a participant reaches an average of >=225 
min/wk of MVPA and 5% weight loss. Once a participant reaches both MVPA and weight loss goals, 
the physical activity goal will be to maintain at least 225 min/wk of MVPA to prevent weight regain. 
The weekly progression was chosen to maximize adherence and reduce the risk of discomfort and 
musculoskeletal injury. Physical activity accumulation will be encouraged across multiple domains 
(leisure, transportation, lifestyle, etc.) and in bouts lasting at least 10 minutes. 
2. Dietary recommendations: Consistent with the 2015-2020 Dietary Guidelines for Americans and 
evidence-based recommendations for weight loss72, participants will be prescribed to reduce energy 
intake by at least 500 kcal per day, consume a variety of nutrient-dense foods, and to limit caloric 
consumption from added sugars and saturated fats. Energy restriction of 500 kcal/d is associated with 
weight loss of approximately 0.5-0.9 kg/wk (1 pound/wk)72.Once a participant reaches a BMI  25 
kg/m2 the goal will be for their caloric consumption to match their caloric expenditure to support weight 
maintenance.   

 
 
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3. Sleep recommendations: Consistent with the NHLBI recommendations of sleep duration for adults73, 
participants will be prescribed stepped sleep duration goals per week starting at their baseline sleep 
duration building to a minimum of 7 hours of sleep per night, as measure by the Fitbit activity tracker. 
Sleep is an important behavior that is often overlooked in the study of weight loss 20-23. Additionally, 
less sleep is associated with a greater likelihood of overweight/obesity and the consumption of high-
caloric foods. To calculate baseline sleep duration, participants will be instructed to wear their Fitbit for 
the first week of the intervention to bed at least four nights each week. The average nightly sleep 
duration for the week will be calculated and used as their individual baseline. Weekly sleep duration 
goals will be stepped from each participant’s baseline levels using a progression of 20 min/wk from the 
average of the previous week’s nightly sleep duration. This progression will continue until the 
participant reaches an average of  7 hours of sleep per night where then the sleep duration goal will be 
to maintain an average of at least 7 hrs of sleep per night. 
 
Intervention Components 
 
The intervention will be delivered using our four principal intervention modalities: (1) consumer-level wearable 
and scale (Fitbit Charge 3 and Aria Scale), (2) mobile text messages, (3) online social media pages and groups, 
and (4) individual health coaching (T1 only). Modalities will incorporate the theory-based behavioral change 
techniques (BCTs) and strategies for weight management (SWMs) mentioned in Table 1. 
 
Consumer-level wearable and scale: Fitbit Charge 3 and Aria Scale 
 
Figure 1. Fitbit Charge 3 
 
A Fitbit Charge 3 (https://www.fitbit.com/charge3) and Fitbit Aria 2 scale 
(https://www.fitbit.com/aria2) will be provided to all participants in the study. The 
Fitbit Charge 3 is not considered to be a medical device or a significant risk device. 
It is made of flexible, durable elastomer material similar to that used in many sport 
watches, and it has a surgical grade stainless steel buckle. It is lightweight (1.06 
oz), 0.5 inches wide, and fits wrists that are 5.4 to 8.7 inches in diameter. It 
contains a triaxial accelerometer, an optical heart rate monitor, an altimeter, and a 
vibration motor.  
 
All participants will have the ability to monitor physical activity, sleep and diet 
with the Fitbit Charge 3 and weight with the Aria scale. Additionally, participants in both intervention groups 
(T1 and T2) will receive feedback on physical activity, sleep, diet activity, and weight collected through these 
devices via SMS messaging, as described in the following section. 
 
Data from the devices will be passively and securely streamed to the Fitbit website.  It will then be retrieved 
using software developed by Small Step Labs, LLC and Fitabase Inc (https://www.fitabase.com) and stored 
securely on their servers. All data that is subsequently downloaded from Fitabase Inc. servers for analytic 
purposes will remain de-identified and will be stored on secure, password-protected CWPHS/EPARC servers. 
There are two instances when researchers will contact Fitabase Inc. in order to delete data associated with 
participants in this study: 1) anytime that a participant chooses to withdraw from the study and 2) at the 
completion of the study (when all data analysis has been completed).  Researchers will contact Aaron Coleman, 
CEO of Small Step Labs, LLC and creator of Fitabase (aaron@fitabase.com) and he will initiate a deletion of 
the data from live servers and all data will be phased out of offline backups within 90 days. After 90 days Small 
Step Labs will have no data associated with the study on their servers. 
 

 
 
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SMS Component 
 
Participants of both treatment groups (T1 and T2) will receive a behavioral weight loss messages through 1 to 2 
tailored SMS daily. The messages will follow the same four-week format, detailed in Table 3, but will 
incorporate more advanced content and goals as the intervention progresses. This will be dependent on 
participants weight loss progress and progress in meeting weekly physical activity, dietary and sleep behavior 
goals. Tailored SMS messages will require participants to use all five core self-regulation strategies: self-
monitoring, feedback on performance, behavioral intention formation, goal setting, and goal review.  
 
Table 3. Four-week schedule of text messages to be delivered in SMART 2.0 Intervention 
 
Week # 
Sunday 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
1 
Sleep 
Feedback & 
Sleep Tip 
Exercise 
Feedback 
Monthly Diet 
Feedback & 
Diet Tip 
Weight 
Feedback & 
Weight Tip 
Diet Tip 
Mid-week 
Exercise 
Feedback & 
Exercise Tip 
Resilience 
Tip 
2 
Sleep 
Feedback & 
Sleep Tip 
Exercise 
Feedback 
Diet Tips (2) 
Weight 
Feedback & 
Weight Tip 
Diet Tip 
Mid-week 
Exercise 
Feedback & 
Exercise Tip 
Resilience 
Tip 
3 
Sleep 
Feedback & 
Sleep Tip 
Exercise 
Feedback 
Mid-month 
Diet 
Feedback & 
Diet Tip 
Weight 
Feedback & 
Weight Tip 
Diet Tip 
Mid-week 
Exercise 
Feedback & 
Exercise Tip 
Resilience 
Tip 
4 
Sleep 
Feedback & 
Sleep Tip 
Exercise 
Feedback 
Diet Tips (2) 
Weight 
Feedback & 
Weight Tip 
Diet Tip 
Mid-week 
Exercise 
Feedback & 
Exercise Tip 
Resilience 
Tip 
 
We will deliver SMS messaging using our previously developed text message system for weight loss and 
weight management. Based on data collected from a participant’s use of Fitbit and Aria Scale, we will push 
tailored text messages from our SMS library (> 3000 messages). Messages will be time-based (e.g., occur at 
convenient time for participant every day) or data-based (e.g., in response to data collected from Fitbit and 
Aria). Most messages will be directly related to the participant’s weekly weight, physical activity, caloric intake 
and sleep goals (tailored messages) and some will be general behavioral change strategies, depending on 
weekly behavioral goals. Messages based on weight, physical activity, caloric intake and sleep will be in 
response to data received from participants’ use of Fitbit and Aria. For example, after weighing themselves, a 
message will be sent praising the participant for losing 2 pounds. Additionally, after a participant reaches a 
BMI < 25 kg/m2 goals related to weight, caloric intake and physical activity will be automatically adjusted to 
reflect weight maintenance. For example, if a participant records a caloric intake that is equal to their caloric 
expenditure, their diet feedback will praise the participant and suggest continued caloric intake to maintain their 
healthy weight. 
 
A sample of a week of text messages to the user are in Table 4. Participants will receive 1-2 messages each day 
and will be able to choose the timing of messages (e.g., mornings and evenings). 
 
Table 4. Example of weekly text messages to be used in SMART 2.0 intervention 
 
Day of the Week 
Timestamp 
Message Type 
Message 
Sunday 
12pm 
Sleep Feedback 
You reached your weekly sleep goal by getting an average of 6 hrs 30 min 
a night. Keep it up and try to get in 6 hrs 50 min per night. Make sure to 

 
 
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wear your Fitbit for at least 4 nights to get a better picture of your sleep 
patterns this week. 
Sunday 
7pm 
Sleep Tip 
Sleep tip: Try reading from a book or using a blue light filter on your 
laptop/phone when studying or reading before bedtime. 
Monday 
12pm 
Exercise 
Feedback 
Good work getting in 110 active minutes last week. But, your goal was to 
complete 140 minutes. Try to set a new goal of 130 minutes for this week. 
You can do it! 
Tuesday 
12pm 
Diet Feedback 
Terrific job tracking your calories this month. On average, you are eating 
as much as you burn. To lose 1 lb, you should be in a deficit of 500 
calories per day. Continue to make progress by tracking consecutively for 
3 days this month! 
Tuesday 
7pm 
Diet Tip 
When you’re at the grocery store, make the healthiest choice by reading 
food labels and comparing calories per serving size. When in doubt, 
choose the option with less calories. 
Wednesday 
12pm 
Weigh Reminder 
Wednesday Weigh-day reminder! Time to step on the scale and see what 
progress you've made. 
Wednesday 
1pm 
Weight 
Feedback 
Great work! This week, you lost 1.5 lb(s). You got this! This week, your 
goal is to lose another 1-2 lbs. 
Wednesday 
7pm 
Weight Loss Tip 
A good way to stay away from food temptations is to be active. Next time 
you're craving something, go for a run or swim! 
Thursday 
12pm 
Diet Tip 
Eventually aim towards having only healthy items stored in your pantry 
and fridge! Do this by slowly getting rid of unhealthier items and 
replacing them with better-for-you alternatives. 
Friday 
12pm 
Exercise 
Feedback 
You're more than half way there! Good job getting to 90 active minutes so 
far. Your goal is to get 130 minutes by Monday, keep on going! 
Friday 
7pm 
Fitness Tip 
Do whatever makes exercise most enjoyable for you. Music? A podcast? 
You are much more likely to exercise consistently if you enjoy it. 
 
Saturday 
12pm 
Resilience Tip 
It’s Saturday and time to release some stress! Press two fingers in the 
center of your other palm and hold for ten seconds. 
 
 
Online Group/ Social Media 
 
After randomization, participants in T1 and T2 intervention-arms will be sorted by physical activity preference 
and placed in groups of 6 to 12 total participants through Facebook messenger. Current literature suggests that 
small, mixed-gender groups constructed based on a common characteristic (e.g. physical activity preference) 
result in improved outcomes in health interventions74,75.  
 
Each participant will “friend” the study health coach on Facebook, who will then add participants to their 
respective, private groups on Facebook Messenger. Content shared in the groups will only be accessible to the 
members of each group and the health coach. The health coach will post content and facilitate group discussion 
that follows a behavioral weight loss curriculum organized as a series of 24-week (6-month) cycles. Table 5 
summarizes the content for the first 6-month cycle. Each subsequent cycle will follow the same format but will 
incorporate more advanced content and goals, dependent on group’s progress. Health coaches will also monitor 
all group interactions, respond to inquiries from participants, and elicit interactions using the following group-
coaching methods: 
 
1. Mission statement formation: Health coaches will work with group members at start of intervention 
(week 1) to establish ground rules and roles for participants and health coach. This mission statement 
will be revisited every 6-months and revised as necessary.  
2. Informational content and resources: Health coaches will provide relevant informational content and 
resources applicable to the weekly curriculum topic as well as the group’s interests, recommendations 

 
 
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and goals. This includes, but is not limited to, local bike/running maps, healthy eating options on or near 
campus, recipes and exercise routines. 
3. Knowledge check-ins: Health coaches will frequently assess group knowledge of weekly curriculum 
topics through polls and Q&A’s. The intent is to give participants an opportunity to ask the health 
coaches questions relevant to weight loss and health behaviors.  
4. Shared experiences: To elicit group cohesion and social support, health coaches will present open-
ended questions designed to encourage participants to share their experiences with adopting and 
maintaining health behaviors and reaching personal weight loss goals. For example, a health coach may 
ask the group to share their favorite on-the-go healthy snack option. 
5. Goal-setting: Through motivational interviewing techniques55,56, health coaches will work with 
participants to create individual and group goals relating to the week’s topic area and overall weight-
loss goals. Additionally, health coaches will provide feedback on individual and group progress on 
meeting set goals. 
 
Table 5. The SMART 2.0 behavioral weight loss curriculum 
 
Week 
Weekly Topic 
Example 
1 
Intro to SMART 2.0 
Building a roadmap of the program; modalities/technology; 6-month and 
2-year goal-setting 
2 
Self-monitoring 
Tracking calories with Fitbit; Checking sleep stats and active minutes 
using the Fitbit app; Weekly weighing 
3 
Understanding diet and calories 
2015-2020 Dietary Guidelines; calories; reading food labels; visual 
calorie comparisons 
4 
Boosting active minutes 
Strategies for increasing active minutes each day; fitting in exercise with 
a busy schedule; exercise routines you can do anywhere 
5 
Getting and staying healthy on campus 
Healthy guide to each campus; meeting goals with a busy class/work 
schedule; dorm/apartment/commuting healthy living tips 
6 
Eating healthy made easy 
Easy recipes you can make anywhere; recipe videos; grocery-list guide 
7 
Take 10 to exercise 
Short breaks in sitting; environmental rearrangement; how-to get in 10-
min bouts of exercise throughout your day 
8 
Sleep and mental health 
Sleep hygiene tips; stress management tips 
9 
Portion control & smart food options 
Skills for portion control; choosing and finding low-calorie; nutrient-
dense foods 
10 
Organization & planning  
Meal and exercise planning; suggestions for healthy cooking; exercise 
routines; creating a bedtime routine 
11 
Social support 
How to get support for a healthy lifestyle; importance of mental health in 
getting healthy; fostering group support 
12 
Personal strategies for weight loss 
behaviors & problem solving 
Reviewing 3-month progress; seeing what works; identifying barriers and 
solutions 
13 
Cardiovascular exercise 
Cardio for any fitness level; gauging intensity and setting goals for 
progress; safety tips; get a buddy 
14 
Substitution & replacement 
Healthy swaps; “eat this not that”; ways to make any recipe healthy 
15 
Strength training for a healthy body 
Benefits of resistance training; sets/ reps; safety; getting a buddy; home- 
and gym-based calisthenics 
16 
Eating out, on-the-go & convenience 
food eating 
Becoming menu-wise; indemnifying healthy options on- and off-campus; 
stimulus control; becoming aware of what is in the environment 
17 
Taking charge of your thoughts 
How to replace harmful thoughts with helpful thoughts; link between 
negative affect and weight (re)gain 
18 
Managing social eating situations 
Alternatives and tips for social eating (counter conditioning) 
19 
Healthy eating on a budget 
Learning to make smart, but cost-effective food choices when eating out 
or shopping at grocery store 
20 
Getting enough sleep 
Ways to get enough sleep with time constraints; Importance of sleep for 
overall health and weight loss/management 
21 
Vigorous intensity physical activity 
Benefits of VPA; gauging intensity; safety; how to get VPA anywhere 

 
 
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22 
Have healthy food you enjoy 
Brainstorm enjoyable, healthy options; switching up your meal plan to 
stay on track 
23 
Staying active 
Tips to stay active while on break/vacation and with schedule constraints; 
ways to get back on track with exercise 
24 
Maintaining a healthy lifestyle 
Reviewing 6-month progress; seeing what works; identifying barrier and 
solutions; 6-month goal-setting; planning for next 6-month cycle 
In addition to online groups, the health coach will also post general content related to weight loss/management, 
physical activity, healthy eating, sleep and resilience to the study’s various pages on the following commonly 
used social media platforms76: Facebook, Instagram and Twitter. Participants will be required to at least “like” 
the SMART 2.0 Facebook page and will be encouraged to also “follow” the study’s Instagram and Twitter 
accounts. By “liking” and “following” these respective pages, SMART 2.0 content will appear on their 
individual social media feeds and participants will be able to “like” and “comment” on each post, communicate 
with other participants through each post, and “save” any content. 
 
Health Coaching 
 
Participants randomized into the T1 intervention arm will receive individual technology-mediated, real-time 
personal health coaching that is theory- and evidence-based. Health coaching sessions will consist of 
components of effective health coaching interventions including motivational interviewing (MI), participant 
determined behavioral goal setting, accountability for behaviors, and health education as part of an active 
learning process77-79. Additionally, the health coach will utilize behavioral change techniques (BCTs) 
appropriate for individual coaching 80,59. These BCTs include goal setting (behavior and outcome), action 
planning, problem solving, feedback on behavior, social support and instruction on how to perform a 
behavior80. All health coaches will have Master-level training in public health and at least two years’ 
experience with individual health coaching. Sessions will last 10-15 minutes and will take place over the phone 
and/or through Google/Facetime/Skype/Zoom video-calls, depending on each participant’s preference. 
Following each session, the health coach will send a session recap via e-mail that includes an outline of what 
was discussed, summary of behavioral and weight loss goals, and date/time of next session.  
 
During year one of the intervention, the health coaching curriculum will follow the CDC’s Prevent T2 Lifestyle 
Change Program (https://www.cdc.gov/diabetes/prevention/index.html). The Prevent T2 program’s goals 
include weight loss of 5-7% of participants’ baseline weight in the first six months and continued weight loss 
until participants reach their goal weight. Prevent T2 is a year-long program with curriculum outlined in Table 
6. The program emphasizes self-monitoring, self-efficacy, and problem solving and requires weigh-ins at each 
session and the self-monitoring of diet and physical activity. Health coaches will receive this feedback digitally 
through the Fitbit activity tracker and Aria scale. Health coaches will cover the curricula provided by the CDC 
during each session and will provide participants with the respective CDC handouts via e-mail prior to each 
session. The Prevent T2 session topics and curriculum has been tailored for the intervention (e.g., replacing in-
person group-based activities with related discussion topics) and for the young adult population (e.g., 
discussing causes and ways to mitigate stress applicable to participants’ lifestyles, such as during finals). Table 
6 outlines the original Prevent T2 topics, SMART 2.0 topic revision and an outline of content in each session. 
 
Table 6. The SMART 2.0 health coaching curriculum, year one 
 
Session 
Number 
Session 
Frequency 
T2 Original 
Topic 
SMART 2.0 Revision 
Content Outline 
1 
Weekly 
Introduction to 
the program 
Intro to SMART 2.0 
Participant’s motivations/reasons for joining; set 
short- and long-term weight/PA/diet/sleep goals 
2 
Track your food 
Using Fitbit to track 
calories 
Benefits of tracking; Fitbit tracking how-to; portions 
& food labels 

 
 
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3 
Track your 
activity 
Using Fitbit to track active 
minutes 
Benefits of tracking; Fitbit tracking how-to; review 
baseline activity data 
4 
Manage stress 
Stress and tracking sleep 
with Fitbit 
Sources of stress; link between stress and sleep and 
weight; stress and sleep tips 
5 
Eat well to 
prevent T2 
Eating well basics 
Dietary guidelines; tips 
6 
Get active to 
prevent T2 
Getting started getting 
active 
Benefits of PA; ways to get PA; challenges/ barriers 
7 
Burn more 
calories than you 
take in 
Balancing what you eat 
and do 
Caloric deficit and weight loss 
8 
Shop and cook to 
prevent T2 
Meal planning 101 
Planning and preparing healthy meals 
9 
Get more active 
Get more active 
Ways to increase active minutes 
 
10 
Cope with 
triggers 
Navigating triggers to eat 
unhealthily (social 
pressure) 
Overcoming triggers to eat unhealthily; reducing 
social pressures 
11 
Find time for 
fitness 
Find time for fitness 
Challenges and solutions to finding time to exercise 
12 
Keep your heart 
healthy 
Maintaining a healthy 
lifestyle 
3-month review; progress/challenges so far; develop 
solutions 
13 
Take charge of 
your thoughts 
Take charge of your 
thoughts 
Mental health; helpful versus harmful thoughts 
14 
Get support 
Social support 
How to get social support from family/friends/etc. to 
lead healthy lifestyle 
15 
Eat well away 
from home 
Eating well while eating 
out & on-campus 
Challenges and solutions to eating well away when 
dining out and on-campus 
16 
Stay motivated to 
prevent T2 
Staying motivated 
Ways to stay motivated to exercise, eat well, and 
sleep 
 
17 
Bi-weekly 
When weight 
loss stalls 
Weight loss progress/ 
plateaus 
Ways to overcome weight loss plateaus and to 
continue to lose weight 
18 
Get enough sleep 
Sleep hygiene 
Benefits of adequate sleep; challenges and solutions 
to getting at least 7 hours 
19 
Stay active to 
prevent T2 
Staying active 
Challenges and solutions to staying consistent with 
PA 
20 
Have healthy 
food you enjoy 
Eating healthy on a budget 
6-month review; ways to eat healthy on a budget 
21 
Monthly 
More about T2 
General health information 
Participant guided – work on areas where there are 
the most challenges 
22 
Take a fitness 
break 
Quick exercise ideas 
10-minute exercise ideas; ways to stay active with 
any schedule 
23 
Stay active away 
from home 
Staying on track while on 
break/ vacation 
Challenges and solutions during school breaks/ 
vacations 
24 
More about carbs 
More about 
macronutrients/ nutrient-
density 
Macronutrient information; benefits of nutrient 
dense foods 
25 
Get back on track 
Get back on track 
Staying positive after getting off-track; 5 steps to 
problem solving 
26 
Prevent T2 for 
life 
Continuing progress in 
year two of SMART 2.0 
1-year goal review; progress/challenges so far; 
action plan for year 2 
 
During year two of the intervention, participants will continue with monthly 15-20-minute sessions with the 
health coach. Sessions will be guided by participants’ unique behavioral goals, rather than predetermined topics 
as in year one. Each session will also consist of effective health coaching components77,79and BCTs80. 

 
 
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Comparison Condition 
The comparison condition will also receive a Fitbit Charge 3 and Aria Scale to use at their discretion. This will 
allow participants to access the Fitbit smartphone application which includes physical activity, dietary and sleep 
tracking.  
The study is implementing mechanisms for preventing comparison group subjects from accessing the 
intervention components of the SMART 2.0 study. For example, tailored content, goal and behavior feedback, 
and participant-to-participant and participant-to-health coach interactions will be reserved only for private, 
invitation-only online groups for participants in the two treatment groups. 
 
Standardizing Delivery of the Intervention 
The SMART 2.0 intervention is comprised of four inter- and independent components: 1) Fitbit Charge 3 and 
Aria scale, 2) mobile text messages, 3) online social media pages and groups, and 4) individual health 
coaching (T1-arm only). We will standardize the delivery of the intervention using the following four 
strategies. 
1. Intervention content will be delivered using all components throughout the intervention. 
• To reduce the possibility of bias caused by the changing dominance of an intervention delivery 
component, the SMART 2.0 will use all platforms throughout the two-year intervention. Although 
exposure to each platform is expected to differ (for example, some participants may prefer to interact 
more so via the online group than mobile text messages), we plan to “push” all platforms equally. 
• To reduce bias that may be caused by differential access to mobile technology (e.g., use of a smart 
phone vs. regular cell phone that receives text messages only), all participants will be required to own a 
smart phone, as part of the study’s inclusion criteria, to ensure accessibility to all intervention 
components. 
2. Ground all intervention content in common theory-driven principles of behavior change. 
• The SMART 2.0 intervention is grounded in theory-driven principles of behavior change. Successive 
iterations of the social and mobile content will be rigorously evaluated for adherence to the theoretical 
principles described above. New content that deviates substantially from these principles or does not 
contain at least one behavioral self-regulation strategy will not be delivered. 
3. Standardize intervention fidelity by using technology-mediated content delivery through mobile text 
messaging and online social media pages and groups and conducting regular fidelity-checks on health 
coaches’ interactions with participants via online groups and individual coaching sessions. 
• All content delivered via mobile text messaging and through online social media pages and groups will 
be standardized so that each participant in the intervention arms (T1 and T2) will receive the same 
content and feedback on Fitbit activity and Aria weight data.  
• Health coach interactions with participants through online groups will be regularly checked to 
standardize intervention fidelity. This will be done by audio-recording a random sample of 5% of all 
health coaching calls and having an independent reviewer on the study team observe to ensure that 

 
 
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health coaches uniformly utilize BCTs including goal setting, feedback on behavior, and social 
support, when responding to participants and moderating discussion. Additionally, the use of each BCT 
will be recorded to measure each participants’ dose. 
• To standardize health coaches’ interactions with participants through individual coaching sessions (T1-
arm only), we will aim to deliver the same amount of sessions for each participant and conduct regular 
and random fidelity checks. Each participant will be prescribed the same number of sessions (26 in 
year one, 12 in year two) and sessions will be scheduled at a day and time convenient for the 
participant. In the event that a session is missed, the session will be rescheduled, if possible. If 
rescheduling is not possible (e.g., no other available days/times before next allotted session), the health 
coach will send session materials to the participant via e-mail and suggest session goals based on 
participant’s weight loss progress. Each completed session and e-mail will be recorded to measure 
participants’ dose. For the two-year intervention, the fidelity checks will ensure adherence to health 
coaching components and BCTs described above. For year one of the intervention, the checks will also 
ensure adherence to the modified Prevent T2 curriculum.  
4. Intervention content will be tailored to how well participants are doing with their weight loss. 
• Baseline physical measurements, collected at the first measurement visit, and baseline behavioral 
measures, collected through Fitbit activity trackers during the first week of the intervention, and 
ongoing physical and behavioral measures collected through Fitbit activity trackers and Aria scales 
will be used to reiteratively tailor the program’s offerings. For example, if participants are making 
good progress then the intervention content delivered will acknowledge and reward this. If, on the 
other hand, if participants are finding it difficult to lose weight and adhere to healthy behaviors, 
alternative messaging with different content designed to encourage progress specific to each 
participant will be provided. 
Measurement Overview and Schedule for the RCT 
All participants will attend in-person measurement visits at baseline, 6, 12, 18 and 24 months. To maximize 
the likelihood that participants will continue with measurement visits and stay in the study, we will offer 
financial incentives for attending measurement visits and these will increase over time. All measures will be 
conducted at EPARC. Participants from SDSU and CSUSM will reimbursed $15 for travel expenses. The 
baseline measurement is expected to take approximately 3 hours and all other measurement timepoints are 
expected to take approximately 2 hours. Measures and collection time points are summarized below. 
Demographic information  
Age, sex, ethnicity, race, household income, tobacco and alcohol use, and medical history will be measured 
through self-report. 
Anthropometric and Physiological Measures 
• Body weight will be measured to the nearest 0.1 kilograms using a calibrated digital scale. Height 
(without shoes) will be measured to the nearest 0.1 cm using a stadiometer with the subject standing erect 
against a wall with heels close to the wall. Both weight and height will be measured with participants 
wearing lightweight clothes but without shoes, and two separate measurements will be averaged. Body 
mass index (BMI) will be calculated from the height and weight as kg/m2. Seca703 (Seca GmbH & Co. 

 
 
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KG., Hamberg, DE), a combined digital scale and stadiometer, will be used for body weight and height 
measurements. 
• Waist, arm, and hip circumference will be measured following standardized procedures implemented 
by trained staff. Waist circumference will be measured from the approximate midpoint between the lower 
margin of the last palpable rib and the top of the iliac crest. Hop circumference will be measured from the 
widest portion of the buttocks. Arm circumference will be measured from the approximate midpoint 
between the acromion process and the olecranon process. Waist, hip, and arm circumference will be 
measured to the nearest 0.1 cm using a stretch resistance measuring tape and two separate measurements 
of each will be averaged.  
• Blood pressure and heart rate will be measured by a trained staff with a digital monitor (Critikon 
Dinamap 8100, GE Healthcare, Chalfont, UK). Two measures of blood pressure and corresponding 
measures of heart rate will be averaged. After 5 minutes of rest in a seated position, two consecutive 
measurements will be taken at 1-minute intervals from the right arm with the forearm supported on a 
table. If measurements of systolic and diastolic pressures differ by more than 10.0 mmHg or 6.0 mmHg, 
respectively, then a third measure will be taken and the average of the two measures that differ by less 
than 10.0 mmHg or 6.0 mmHg, respectively, will be taken. Heart rate variability will be measured from 
an electrocardiogram recording taken with a Biopac MP150 system (Biopac Systems Inc., Goleta, CA). 
After 10 minutes of rest in a supine position, 5 consecutive minutes of recording will be taken and data 
will be processed using AcqKnowledge version 4.0 or later (Biopac’s proprietary software platform). 
This is an important measurement, because it is marker of autonomic nervous system function which is 
influenced by PA, diet, and sleep; alcohol, tobacco, and drug use; and anxiety,81 and it is a marker of 
cardiorespiratory fitness.82  
• Body composition and bone density will be measured with Dual-energy X-ray Absorptiometry 
(DXA). Bone density scans of the anterior-posterior (AP) spine (L1 – L4), hip, forearm, and total body 
will be conducted on all participants. Total body and regional (arms, legs, trunk, and abdomen) body 
composition (fat mass, including an estimate of visceral adipose tissue, and lean mass) will be assessed 
by DXA on a Lunar Prodigy Advance densitometer (GE/Lunar Corp, Madison, WI) or a Horizon DXA 
system (Hologic Inc., Marlborough, MA). Quality assurance (QA) tests will be performed each morning 
of use. QA will be conducted using a standard with tissue-equivalent material with 3 bone-simulating 
chambers of known bone mineral content. In vivo BMD precision in our laboratory is 1.05% for the 
spine, 0.805% for the total hip, 0.85% for total body BMD, 1.46% for fat mass and 0.55% for lean tissue 
mass. The time required for this assessment is approximately 20-25 minutes; actual scan time is <15 
minutes. Scans will initially be interpreted by state-certified DXA technicians. The minimal radiation 
dose is safe and appropriate for a pediatric population, and an experienced technician certified by the 
state of California will conduct all scans. Participants will be given a report of their results. 
Due to recent changes in DXA scan speeds recommendations, approximately 25% of total participants 
that receive scans in express mode at the baseline measurement appointment will have the proximal 
femur and AP spine scans completed two times each at the 12-month measurement timepoint. Once to 
match the previous scan speed (express) to establish longitudinal change, and once to create a new 
baseline scan in the new/proper mode (fast array). We expect that this will result in additional radiation 
exposure of 15µSv or less, or an amount similar to two days of exposure to San Diego sun.  
Behavioral Measures 
• Eating Behaviors Inventory (EBI) will be used to examine eating behaviors and is a widely used self-
report assessment of behaviors related to weight loss and weight management (e.g., self-monitoring, 
refusing offers of food, eating in response to emotions). The measure has been used in over 20 weight 

 
 
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loss interventions. Reliability and validity of the 26-item total score has been demonstrated and the 
measure has been shown to be sensitive to change in weight management interventions. 
• Physical activity and sleep will be measured objectively for 10 to 12 days consecutively after each 
measurement visit using the ActiGraph Link (ActiGraph Inc., Pensacola, FL), a previously validated, 
wrist-worn and waist-worn tri-axial accelerometer comparable to the device used in National Health and 
Nutrition Examination Survey.83-86 Participants will be asked to wear the device continuously on their 
non-dominant wrist and around their waist, except while bathing or swimming. The wear location and 
time period are in-line with the best practices for the assessment of habitual PA and result in high levels 
of acceptability and compliance among participants (>90%).87–90 After each wear period, data will 
immediately be downloaded and screened for wear time using ActiLife version 6.11.8 or newer 
(ActiGraph’s proprietary software platform). Participants who do not wear the device for a minimum of 
10 hours per day on at least 7 days, or who have irregularities in their data indicative of a device 
malfunction, will be asked to re-wear the device for another period of 10 consecutive days. PA will be 
defined as cumulative activity “counts” (ActiGraph’s proprietary metric) per day. This metric 
incorporates intensity, frequency, and duration of acceleration into a single metric and is recommended 
for assessing the total volume of PA in a 24-hour period.91 Sleep will be defined as total sleep time, sleep 
onset latency, wake after sleep onset, and number of awakenings after sleep onset per day determined by 
an algorithm developed by Cole et al.92,93 Participants will also be measured using the Fitbit devices, 
which provide data on PA (i.e., intensity, energy expenditure, steps, distance traveled, and flights of 
stairs) and sleep (equivalent to those previously mentioned) at 1-minute epochs, and heart rate at epochs 
ranging from 1 to 15 seconds. 
• Diet will be measured for 3 days (2 weekdays and 1 weekend day) after each measurement visit using the 
Automated Self-administered 24-hour Dietary Recall (ASA24), a previously validated web-based tool 
developed by the National Cancer Institute.94–96 The ASA24 prompts individuals to recall, in detail, for 
each meal and snack, the foods and beverages they have consumed during the previous 24-hour period. 
The program calculates kcal and macronutrients (e.g., fats, protein, carbohydrates), as well as 90 
micronutrients (i.e., vitamins and minerals), food groups (e.g., grains, vegetables), and other dietary 
constituents (e.g., added sugars). It also facilitates the calculation of the Healthy Eating Index, a measure 
of diet quality that can be used to assess compliance with the Dietary Guidelines for Americans.97 ASA24 
data will be collected via computer through HTML screen and directly formatted and stored in tables on 
the study’s REDcap database.  
• The Global Physical Activity Questionnaire (GPAQ) and Paffenbarger Exercise Habits 
Questionnaire will be the methods used to estimate physical activity. The GPAQ was developed by the 
World Health Organization. The Paffenbarger was developed for the Harvard Alumni Study to assess 
leisure-time physical behavior. The time reference for the GPAQ will be “in a typical week”. The time 
reference for the Paffenbarger will be “in the past week”. GPAQ and Paffenbarger data will be collected 
via survey through the study’s REDcap secure database.  
• Sedentary behaviors will be measured with the Last 7 Day Sedentary Behavior Questionnaire (SIT-Q-
7d), which was developed and validated by Dr. Godino and colleagues.98 The SIT-Q-7d assesses sitting 
or lying down in five domains (meals, transportation, occupation, non-occupational screen time, and 
other sedentary time), thus facilitating the calculation of domain-specific and total sedentary time. 
Strategies for weight management will be measured with a 35-item questionnaire that assesses the 
frequency of using evidence-based strategies to achieve decreased energy intake and increased energy 
expenditure for weight management (e.g., “Recorded or graphed my weight”).60,61 Frequency within the 
last 30 days is assessed on a 5-point response scale, ranging from “never or hardly ever” to “always or 
almost always”. 
• The Quality of Well-Being Scale (QWB-SA) will be used to assess general quality of life and for the 
subsequent cost-utility analyses. The QWB-SA is a comprehensive measure of health-related quality of 

 
 
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life that includes five sections measuring specific acute and chronic symptoms, self-care activities, 
mobility, PA, and social activity. The observed level of function and the subjective symptomatic 
complaints are then weighted by preference, or utility, on a scale obtained from independent samples of 
judges who rated the desirability of health states. The QWB-SA has been used in several multi-site NIH 
clinical trials. 
Three-minute Step Test 
The procedure for completing the 3-minute step test is as follows. All participants will be fitted with a chest-
worn heart rate monitor (Polar, Finland) that will be used for real-time monitoring by trained EPARC staff 
throughout all of testing. Participants will then be instructed to step up and down from a single step 8 inches in 
height at a rate of 24 steps per minute for 3 minutes. The cadence of stepping will be monitored by trained 
EPARC staff. Upon completion of the test, participants will be asked to sit in a chair and rest. 
Psychological Measures 
• The Rosenberg Self-Esteem Scale, a well-established 10-item questionnaire, will assess self-esteem. 
items concerning positive and negative feelings about the self (e.g., “On the whole, I am satisfied with 
myself.”).99 Agreement with an item is evaluated on a 4-point response scale, ranging from “strongly 
disagree” to “strongly agree”. 
• Body image will be assessed with the body dissatisfaction subscale of the Eating Disorder Inventory 
(EDI). This 9-item scale reflects the belief that specific parts of the body associated with increased 
‘fatness’ are too large (e.g., hips, thighs, buttocks) (e.g., “I think my stomach is too large.”).100 Items 
are evaluated on a 6-point response scale, ranging from “never” to “always”. 
• Depression will be measured with the short form of the Center for Epidemiologic Studies 
Depression Scale, which consists of 10 items designed to assess depression in the general population 
(e.g., “I felt depressed.”).101 Items are evaluated on a 4-point response scale, ranging from “rarely or 
none of the time” to “most or all of the time”. 
• Anxiety will be measured using the short-form of the state scale of the Spielberger State Trait 
Anxiety Inventory (STAI), which consists of 6 items that comprise the most highly correlated 
anxiety-present and anxiety-absent items from the full-form of the STAI (e.g., “I feel calm.”).102 Items 
are evaluated on a 4-point response scale, ranging from “not at all” to “very much”. 
• Social Support will be measured using the Social Support and Eating Habits Survey and the Social 
Support and Exercise Survey124. The surveys consist of items that assess the level of support 
individuals making changes to their eating habits and exercise are receiving from their family and 
friends.  
 
Other Measures 
 
• 
Homelessness will be assessed at each measurement visit after baseline with item A6 of the RAND 
Homelessness Survey. This item asks respondents to recall how many nights in the past week they 
spent in a non-permanent residence (e.g., shelter, car/vehicle, etc.) 
 
Social Media and Network Connectivity Measures  
We will collect participants’ Facebook, Twitter and Instagram data via the application programming interfaces 
of the respective platforms, if possible according to the rules and regulations of the platforms. We have done 
this in previous studies,41,103,104 while successfully maintaining participants’ privacy and complying with 

 
 
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requirements from the UCSD institutional review board. These data will allow us to measure the frequency 
and composition of participants’ online communication about healthy-active-living (HAL). Broadcasted posts 
(e.g., a status update or tweet) that include text will be classified with a dictionary consisting of PA (e.g., 
swimming) and diet (e.g., fruits) unigrams that was developed by Drs. Weibel and Patrick.105  
Existing and study-engineered online social network connections (e.g., friends and followers) will be tracked, 
which will allow for the generation of a number of social network statistics that describe the local structural 
features (e.g., centrality, tie strength, transitivity) that previous research suggests could be important for health 
behavior change.106  
Closest social network connections will be measured by asking participants to name up to 10 of their closest 
friends regardless of whether they are connected online and respond to 5 questions about the friendship (e.g., 
“How often do you interact with the friend in real life?”). This measure will be used to determine how real 
world tie strength may be inferred from easily quantifiable online social network interactions.107  
Engagement with Intervention Modalities  
We acknowledge that the measurement of engagement in the era of digital health is difficult, and throughout the 
proposed research, we will keep abreast of state-of-the-science methods to accomplish this.108 Among 
intervention group participants, quantitative markers of engagement will include usage of Fitbit, SMS sent and 
replied to, interactions on Facebook and Twitter related to study content (e.g., a post or tweet, like or favorite), 
website log-ins and click-throughs, emails sent and replied to, and communication with the health coach.  
Because this approach does not take into account the depth of interactions (e.g., liking a post is quantitatively 
the same as writing a post) nor the common practice of lurking (i.e., passively consuming content but not 
interacting in a visible way),43 we will also collect qualitative markers of engagement. A previously used 
questionnaire that includes eight questions (e.g., “In the past week, on average, approximately how many 
minutes per day have you spent on Facebook?”) meant to measure the intensity with which participants use a 
device or app will be adapted for use in the present study.109 Importantly, the qualitative markers of engagement 
will be measured in both the intervention and control groups. These data, combined with the data from online 
social network connections, will allow us to explore the influence that contamination (i.e., control participants 
inevitably will use weight-related devices and apps and be connected to and interact with intervention 
participants on social media) has on intervention effects.  
Usability and Acceptability  
We will conduct audio recorded exit interviews of intervention participants to gain an understanding of which 
modalities, content areas, SWMs, and BCTs were used and how the overall user experience of the intervention 
was perceived. Our approach will be similar to that used in the SMART study.43 
Table 7. List of measures and assessment timepoints 
Measures 
Assessment Time Point 
0 
6 
12 
18 
24 
Demographic information 
X 
 
 
 
 
Weight, height, waist and arm circumference, blood pressure, heart rate, heart rate 
variability, PA, sleep, diet, sedentary behavior, strategies for weight management, self-
esteem, body image, anxiety, depression, online communication about healthy-active-
living, online social network connections, closest social network connections, 
quantitative and qualitative markers of engagement, contamination 
X 
X 
X 
X 
X 
Other measures (homelessness) 
 
X 
X 
X 
X 
Body composition (DXA) 
X 
X 
X 
X 
X 
Three-minute Step Test 
X 
X 
X 
X 
X 

 
 
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Usability and acceptability 
 
 
 
 
X 
Device- and app-based measures of weight, PA, sleep, diet, heart rate will be measured 
continuously among all participants 
→ 
→ 
→ 
→ 
→ 
 
Additionally, the study team may recontact participants following the conclusion of the study to ask additional 
questions and/or inquire about participation in other research. Participants will indicate whether they agree to 
be recontacted on the study consent form. Only participants who agree to be recontacted will be contacted by 
study team and participants will be reconsented. 
 
Data Entry and Management 
 
All measures will be collected and managed using the secure, web-based tool Research Electronic Data 
Capture (REDCap) hosted at UCSD.110 REDCap provides an intuitive interface for data entry; audit trails for 
tracking data manipulation and export procedures; automated export procedures for seamless data downloads 
to common statistical packages; and procedures for importing data from external sources (e.g., all study 
anthropometric and physiological measures). 
 
Statistical Considerations 
 
Power and Sample Size 
 
In order to ensure that the RCT has adequate power to determine the efficacy of the SMART 2.0 intervention 
to improve weight in kg, we calculated the sample size based on a two-sided, two-sample t-test with 80% 
power at a significance level of 2.5% (a Bonferroni correction to account for two tests). In the SMART study, 
the standard deviation (SD) of change in weight at 6 and 12 months ranged from 3.87 kg to 5.97 kg, and we 
have assumed that the corresponding SD in SMART 2.0 will fall within this range.41 Furthermore, the smallest 
statistically significant mean difference in change in weight between the two groups occurred at 12 months 
and was approximately -1.33 kg.41 If we assume an SD of 4.92 and a modest increase in the between group 
difference (-1.60 kg), then we will need 182 subjects per group in order to detect a minimal standardized effect 
size of 0.33. Thus, we will randomize 642 participants (214 per group accounting for a 15% attrition rate). 
 
Overall Approach 
 
Analyses will be conducted using the latest version of the statistical software platform R and will be based on 
the intention-to-treat principle. All tests of significance will be two-sided and a p-value of 0.05 will be 
considered statistically significant. Summary statistics (e.g., mean, standard deviations, proportions) will be 
calculated for all variables of interest. Outliers will be assessed and variables whose distributions depart 
significantly from normality will be transformed. Appropriate non-parametric alternatives will be considered if 
parametric assumptions fail. No planned interim analyses for efficacy or futility will be conducted in this 
study. 
 
• Primary aim analysis: The primary outcome of the study is change in objectively measured weight in kg, 
and the SMART 2.0 intervention groups will be compared to the control group using a mixed model of 
repeated measures (MMRM).111 The model will include change in weight from baseline at each post-
baseline visit (i.e., 6, 12, 18, and 24 months) as the dependent variable. Fixed effects will include study 
group, visit, study group-by-visit interaction, weight at baseline, and any variables determined to be 
confounders. Visit will be treated as a categorical variable, and an unstructured variance-covariance 
structure will be used. Results will be reported as point estimates (mean differences between groups) and 

 
 
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interval estimates (95% confidence intervals). An intervention effect will be concluded if the p-value for 
the study group-by-visit interaction contrast in the model at 24 months is statistically significant. Holm's 
method will be used to adjust the two p-values for multiple comparisons.112 This approach uses all 
available data and is robust to data missing at random (MAR).111,113 However, two additional approaches 
may be employed to examine the influence of missing data on the primary outcome analysis (which takes a 
likelihood-based approach to estimation, but does not directly impute data). First, we will model the 
probability of missingness as a function of baseline covariates and previous outcomes (using logistic 
regression). The inverse of the resulting probabilities will serve as propensity scores that will be included 
in the model of the primary outcome. If data are MAR or the probability of missingness can be fully 
explained by observable data, this approach produces asymptotically unbiased estimates. Second, in order 
to allow for the possibility that the MAR assumption may not hold (an assumption that is not empirically 
testable), we will use pattern mixture models in which the distribution of the primary outcome is assumed 
to follow a mixture of two distributions: one for those who complete follow-up and another for those who 
do not. These approaches will allow us to quantify the robustness of the study findings to missing data 
assumptions. 
• Secondary aim analyses: Secondary aim 1 will be achieved by using the MMRM approach outlined 
above to compare differences between the SMART 2.0 intervention groups and the control group at 6, 12, 
18, and 24 months in anthropometric and physiological outcomes, PA, diet, sleep, body image, anxiety, 
depression, and the frequency and composition of participant’s online communication about weight-related 
behaviors (all of these measures are continuous). Secondary aim 2 will examine the dose response (i.e., 
engagement with intervention modalities) of the SMART 2.0 interventions on outcomes at 6, 12, 18, and 
24 months. Engagement variables will be included as independent variables in multiple regression models 
with the study outcomes as the dependent variable adjusting for covariates. Secondary aim 3 will examine 
the usability and acceptability of the intervention using the framework advanced by Strauss and 
Corbin.114,115 Transcribed audio recordings will be analyzed in three stages: open, axial, and selective 
coding.116 During open coding, the data will be examined line-by-line and key concepts and their 
properties will be discovered. Axial coding involves identifying the relationships among the data, which 
will then become fully integrated through selective coding. These processes will be documented via 
memos, which will provide a roadmap of the analytic process.117 Secondary aim 4 will be accomplished 
following methods outlined by MacKinnon and Kraemer. 118,119 We will examine factors that may mediate 
or moderate the effect of the SMART 2.0 interventions on study outcomes. Mediators (e.g., PA, diet, 
social support) will inform how the intervention may have worked to change the outcome, while 
moderators (e.g., sex, age, social network connectivity, contamination) will illuminate for whom and under 
what conditions the intervention may have been efficacious. Mediation will be tested via path analysis with 
regression paths from randomized group to change in the mediator and from change in the mediator to 
change in the outcome, along with a direct path from the intervention to change in the outcome. Adding 
interaction terms to the models assessing the intervention effects will test moderation. Secondary aim 5 
will examine patterns of PA, diet, and sleep as measured over 24 months by Fitbit and MyFitnessPal using 
Gaussian process regression models.120 Models will include separate long- and short-term trends for each 
of the intervention along with common terms for weekly and yearly periodic trends and indicator variables 
for holidays. We will also use the time-varying effect model to examine how changes in these behaviors 
over time influence weight.121 For all secondary analyses of interest, no adjustments for multiple 
comparisons will be made and a p-value of 0.05 will be considered statistically significant. 
 
9. 
HUMAN SUBJECTS 
Up to a total of 642 young adults will participate in the proposed research. 
 

 
 
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Inclusion criteria: a) age 18 to 35 years; b) intending to be available for a 24 month intervention; c) affiliated 
with either UCSD, SDSU or CSUSM as a student, faculty or staff; d) willing and able to use Facebook and 
follow at least one of study’s Facebook, Instagram or Twitter pages; e) willing and able to use a smartphone 
and text messaging; f) willing and able to use the Fitbit devices and app; g) willing and able to attend 
measurement visits at UCSD over the 2 year RCT; h) willing and able to engage in moderate to vigorous 
physical activity; i) overweight or obese, but not severely obese (25  BMI < 40 kg/m2).   
 
Exclusion criteria: a) any comorbidities of obesity that require a clinical referral including eating disorders, 
pseudotumor cerebri, sleep apnea or hypoventilation syndrome, orthopedic problems, and meeting American 
Diabetes Association criteria for diabetes;122 b) psychiatric or medical conditions that prohibit compliance with 
the study protocol; c) had a cardiovascular event (heart attack, stroke, episode of heart failure, or 
revascularization procedure) within the last 6 months; d) currently being treated for a malignancy (other than 
non-melanoma skin cancer); e) currently being treated and/or have an eating disorder; f) planning to have a 
weight loss surgery in the next 24 months (e.g., liposuction, lap band, gastric bypass); g) pregnant, gave birth 
within the last 6 months, currently lactating or breastfeeding within the last 3 months, or actively planning 
pregnancy within the next 24 months. This will be determined by participant self-report.; h) prescribed PA and 
dietary changes; i) prescribed medications that alter weight; j) enrolled in or planning to enroll in a weight loss 
program during the study period; k) lost more than 15 pounds within the past 3 months. 
 
We will recruit young adults, including students, faculty and staff, from three institutions in San Diego County 
enrolling approximately 86,000 students and with over 40,000 faculty and staff members. The University of 
California, San Diego (UCSD) enrolls 36,624 students: 28,587 undergraduates (mean age: 21 years), 8,037 
graduate students. Undergraduate students are 49.1% female, 37.6% Asian, 19.1% White, 17.8% Mexican-
American or Latino, 2.5% African American, with the remainder other or not stated. San Diego State 
University (SDSU) enrolls 33,870 students: 29,513 undergraduates (mean age: X years), 4,357 graduate 
students (mean age: 22 years). Among all students, 55.1% are female, 13.4% are Asian/ Pacific Islander, 34.7% 
are White, 28.9% are Hispanic/ Latino, 3.9% are African American, with the remainder as other, multiple 
ethnicities, or not stated. California State University, San Marcos (CSUSM) enrolls 13,893 students (mean 
age: 22.6 years). Among all students, 61.1% are female, 9.6% are Asian, 27.2% are White, 44.2% are Hispanic/ 
Latino, 3.0% are African American, with the remainder as other, two or more races or not stated. These 
campuses enroll a diverse group of students in terms of race, ethnicity and SES background rendering the 
results of this study generalizable to a broad range of young adults nationwide.  
 
10. 
RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
We will develop an enrollment strategy to ensure that we enroll students, faculty and staff across the broad age-
range targeted in this initiative (18-35 years). Subjects will be recruited from three college and university 
settings within San Diego County including: UCSD, SDSU and CSUSM. 
 
Participants will be recruited through the following channels: (1) digital advertisements in college e-
newsletters; (2) targeted social media advertisements; (3) posting of print and digital flyers at UCSD and 
CSUSM; (4) e-mails sent by student health services via electronic distribution lists and by departmental listserv 
managers; (5) campus-wide events via tabling.  
 
Interested individuals will be directed to complete an online screening form through the study’s secure REDcap 
database. Once the subject arrives at the screening form, he/she will have an opportunity to read and learn more 
about the study. At this point, the subject will be explained that in order to determine whether he/she meets the 
criteria for participating, he/she will be asked a few eligibility questions (see eligibility criteria described 
above). After the participant completes the form, study staff will follow up accordingly. Participants who do not 

 
 
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meet the eligibility requirements will receive an email notifying them and thanking them for their interest in the 
study. Participants who meet the eligibility requirements will receive a call from a trained research staff 
notifying them that they qualify, informing them about the study purpose, procedures, risks and benefits, 
explaining that they may be randomized to a control condition that includes a Fitbit Charge 3 and Aria Scale, 
and to confirm information provided in the online screening form. Once this is complete and the subject still 
qualified, he/she will be invited to schedule an appointment at the research office. There they will be re-
screened for inclusion and exclusion criteria, provide written informed consent, and complete the baseline 
measurement. After eligibility and consent are confirmed and baseline measurements are completed, 
participants randomized at a ratio of 1:1:1. The biostatistics team will generate the electronic randomization list 
using the latest version of the statistical software platform R (currently version 3.3.2, http://www.r-project.org) 
 
11. 
INFORMED CONSENT 
Written informed consent will be obtained in-person from each enrolled subject prior to completing the baseline 
measures.  However, there are several steps, as described in section 11, Recruitment, that the subjects will 
navigate through before the first in-person baseline visit. 
 
Potential participants who view recruitment materials and/or contact the research office will be directed to an 
online screening link describing the SMART study. The study purpose, procedures, risks and benefits will be 
described to them. If the potential participant expresses interest in participating in the study, he/she will be 
asked to complete an online screening form. Because the screening form poses no more than minimal risk of 
harm to subjects and involves no procedures for which written consent is normally required outside of the 
research context, we are seeking a waiver of signed documented consent for the online screening form. For 
those individuals who meet the online screening criteria, their inquiry will be followed up by a phone call to 
verify the data submitted via the online screening form. Since we are simply verifying information provided in 
the online screening form via phone call verbally and it involves no more than minimal risk of harm to the 
subjects and no procedures for which written consent is normally required outside the research context, we are 
requesting a waiver of written and verbal consent for the phone call. We have included a script for the oral 
consent as an attachment. We are not collecting any additional research data by phone; we are simply verifying 
the information that is provided in the online interest form. Once the potential participant has met screening 
criteria over the phone, he/she will be asked to set-up a baseline visit appointment. The SMART study staff will 
obtain written informed consent in person prior to beginning the RCT study, and it will be kept in a separate 
locked cabinet in EPARC/CWPHS. 
 
12. 
ALTERNATIVES TO STUDY PARTICIPATION 
The alternative to participation is to not participate. 
 
13. 
POTENTIAL RISKS 
Potential risks are psychological, social and physical. 
 
During the RCT subjects may experience 1) anxiety or embarrassment related to one’s personal exercise and 
nutrition practices and sharing this information with others via social media and health coaching, and when 
answering questions during the measurement questionnaires; 2) feelings of inadequacy or embarrassment if 
unable to succeed at agreed upon diet, physical activity, sleep and/or weight goals; 3) concern for privacy 
related to divulging personal information and security of providing personal information over the Internet and 
through Fitbit Charge 3 and Aria scale; 4) injury during physical activity; 5) rare occurrence of cardiovascular 
event during physical activity; 6) physical discomfort related to wearing the Fitbit device. Judging from our 
past experience and the current literature, the risks are relatively slight or low of likelihood. 
 

 
 
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During the measurement process subjects the potential risks are deemed by the research team to be no greater 
than minimal. Potential risks include: 1) anxiety when answering personal questions on medical and lifestyle 
history; 2) falling during the 3-minute step test; 3) light headedness or dizziness, nausea, dehydration, fatigue, 
delayed-onset muscle soreness and injury during the 3-minute step test; and 4) the effective dose of radiation to 
an individual received during the five to six scans that each participant will receive.  The total amount of 
radiation projected for these scans of thespine, hip, and total body scan combined is approximately 0.285 to 
0.305 mSv. This amount is less than a participant would receive from one year of natural exposure in the San 
Diego area, which is approximately 1.6 mSv. Additionally, approximately 25% of the total population that 
received the DXA express scan speed at the baseline measurement appointment will be exposed to an 
additional radiation exposure of 15µSv or less at the 12-month measurement appointment. This is because these 
participants will need a scan of the proximal femur and AP spine two times each; once to match the previous 
scan speed (express) to establish longitudinal change, and once to create a new baseline scan in the new/proper 
mode (fast array).  
 
Additionally, participants will be responsible for contacting the team in the event that their device(s) are lost 
stolen, or damaged. The research team will handle the issue on a case-by-case basis and may determine that the 
participant is financially responsible.  
 
The risks involved in this study are no more than minimal and are reasonable in relation to the potential 
knowledge that may result from this study. 
 
14. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
The Human Research Protections Program of UCSD approved all methods utilized. Participants will be given 
copies of the Experimental Subjects Bill of Rights. The study is supervised by Dr. Job Godino, experienced in 
conducting clinical and population health research.  
 
Risks of embarrassment and/or anxiety will be minimized by fully informing participants of the topics to be 
addressed and specific involvement required of them, e.g. participation in online groups, before they agree to 
participate. Subjects will be informed that they can discontinue their participation at any time, with no impact to 
the incentives previously received. Research staff will be trained to provide a very positive and supportive 
context for the intervention and assessments. Subjects will be told that all responses are confidential. Risks to 
privacy will be minimized by fully informing participants that all measurements and individual test results will 
be de-identified and treated confidentially.  Written informed consent will be kept in locked files cabinets 
separate from participant data which will be kept on the study’s secure REDcap database. This way individuals 
are not easily connected to the study results.  All data from the Fitbit Charge 3 and Aria Scale will be 
continuously, passively, and securely streamed to the Fitbit website. It will then be retrieved using software 
developed by Fitabase Inc. (https://www.fitabase.com) and stored securely on their servers.  All data that is 
subsequently downloaded from Fitabase Inc. servers for analytic purposes will remain de-identified and will be 
stored on secure, password-protected CWPHS/EPARC servers. There are two instances when researchers will 
contact Fitabase Inc in order to delete data associated with participants in this study: 1) anytime that a 
participant chooses to withdraw from the study and 2) at the completion of the study (when all data analysis has 
been completed).  Researchers will contact Aaron Coleman, CEO of Small Step Labs, LLC and creator of 
Fitabase (aaron@fitabase.com) and he will initiate a deletion of the data from live servers and all data will be 
phased out of offline backups within 90 days. After 90 days Small Step Labs will have no data associated with 
the study on their servers. 
 
Numerous privacy issues regarding the use of social networking platforms will be addressed with safeguards at 
multiple levels throughout the system. We will use Secure Socket Layer (SSL) protocol for communications 
with the Facebook, Instagram and Twitter servers. Engagement data collected from study’s posts on social 

 
 
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media platforms will be collected using Sendible (https://www.sendible.com/), a social media management 
tool. Sendible collects social media reports which aggregates participants’ engagement via “likes”, “comments” 
and “shares”. In turn, engagement of individual participants will not be collected reducing concerns for privacy.  
 
The study’s Facebook, Instagram and Twitter pages will protect user data and honor privacy choices. 
Participants will be issued guidelines as to appropriate information to publish and reveal on the social media 
pages and within their online groups. To ensure that all participants are aware of Facebook, Instagram and 
Twitter privacy policies and how they can control and/or change their privacy settings, each participant will be 
provided with a handout prior to the start of their participation in the study on how to set their privacy 
preferences. The SMART Health Coach will be a “friend” of all participants on Facebook in order to invite 
them to online groups on Facebook messenger. The Health Coach will monitor the Facebook, Instagram and 
Twitter study pages and each Facebook Messenger group and alert participants to any observed privacy risks.  
Risks of anxiety, embarrassment, or feelings of inadequacy during the measurement process will be minimized 
by fully informing participants of the study procedures and explaining that they may refuse to participate or 
stop participation at any time if they are unable to complete a laboratory test. Participants will also be informed 
that the Fitbit Charge 3 is not considered to be a medical device or a significant risk device. Physical discomfort 
from wearing the devices will be minimized by providing instructions on how best to wear the Fitbit Charge 3 
and study staff will be present to make any necessary adjustments.  
Chances for falling during the 3-minute step test will be reduced through adequate warm-up and instruction. 
Participants will be asked to arrive to each testing session well-hydrated and in athletic attire. The chances of 
serious fatigue or injury will be further reduced by monitoring the participant at all times during tests, providing 
sufficient recovery time following testing. 
To minimize exposure to radiation with the DXA scan, scans will only be conducted by highly skilled 
technologists certified by the state of California. These credentials help ensure correct subject positioning, 
selection of scan mode, and scan acquisition. This in turn minimizes the need for repeated scans and thus added 
radiation exposure. 
Risks of injury of rare occurrence of a cardiovascular event due to physical activity will be minimized by 
ensuring participants selected for the study meet certain criteria and have no known serious physical or mental 
health problems. Injury during physical activity is reduced because lessons and instruction on how to reduce the 
risk of injury will be provided. Risk will be further reduced by having participants indicate medical problems 
that would contraindicate physical activity. Screening will occur prior to entry into the study, as ability to 
perform moderate physical activity is an inclusion criterion.  
The research team will reduce the risk of lost, stolen, or damaged devices by providing participants with special 
care instructions prior to receiving the devices.  
 
15. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND MANAGEMENT 
Risks to privacy will be minimized by fully informing participants that all measurements and individual test 
results will be de-identified and treated confidentially. Written consent forms will be kept in separate locked 
files cabinets separate from participant data on the study’ secure REDcap database so that individuals are not 
easily connected to the study results. Audio recordings of health coaching sessions will be kept for the duration 
of the study and IRB approval and will be destroyed after all analysis is complete. Audio files will then be 
removed from the password protected server. All data from the Fitbit Charge HR will be continuously, 

 
 
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passively, and securely streamed to the Fitbit website.  It will then be retrieved using software developed by 
Fitabase Inc (https://www.fitabase.com) and stored securely on their servers. All data that is subsequently 
downloaded from Fitabase Inc. servers for analytic purposes will remain de-identified and will be stored on 
secure, password-protected EPARC servers.  There are two instances when researchers will contact Fitabase 
Inc in order to delete data associated with participants in this study: 1) anytime that a participant chooses to 
withdraw from the study and 2) at the completion of the study (when all data analysis has been completed).  
Researchers will contact Aaron Coleman, CEO of Small Step Labs, LLC and founder of Fitabase Inc 
(aaron@fitabase.com) and he will initiate a deletion of the data from live servers and all data will be phased out 
of offline backups within 90 days.  After 90 days Fitabase Inc. will have no data associated with the study on 
their servers. 
Breach of confidentiality is highly unlikely because all personally identifying information will be kept separate 
from data collected. No personally identifying information will be coded on the device-captured data or scoring 
sheets. Subject identification numbers are assigned to each participant and only the PIs and limited research 
staff have access to the file that links subject name with subject number.  All data are stored in locked file 
cabinets in locked offices or password-protected computers located behind secure and maintained firewalls. 
Data and records are collected specifically for this research project by trained research associates who have 
completed on-line training in CITI human subject research, research data management and confidentiality, and 
training to criterion on project protocol.  Research data will not be shared with Fitbit.   
 
16. POTENTIAL BENEFITS 
The risks to participants are both unlikely and minor. By conducting this study, we will obtain accurate 
information related to the efficaciousness of a theory-based intervention that utilizes multiple technological 
modalities to promote weight loss in young adults. Participants will receive feedback on their physical activity, 
diet, and sleep, however they may or may not benefit from their participation in the study. Long term benefits 
to society include helping bring about healthier lifestyles to prevent weight gain and reduce premature 
morbidity and mortality due to cardiovascular disease, cancer, and other health problems. 
 
17. RISK/BENEFIT RATIO 
The risks involved, including exposure to radiation from the 5 total DXA scans, are minimal and reasonable in 
relation to the importance of the knowledge that may be expected to result from the study. As addressed above 
in Background and Significance, efficacious technology-based behavioral interventions aimed at improving 
weight in young adults are critical for improving the health status of our country. Given the magnitude of the 
public health burden associated with overweight and obesity, it is important to evaluate whether real-time 
communication at critical point-of-decision moments will translate into decreased weight and improved health 
behaviors. There is very little research on how multiple modalities can be used to improve health behavior, yet 
these technologies are highly popular with young people. This study will advance health behavior research by 
examining the utility of devices and apps, smart phones, and social media and social networking to promote 
healthy weight-related behaviors. Moreover, because this research will be anchored in health behavior theory, it 
will permit us to examine cognitive, social, and ecological constructs and their role in mediating or moderating 
intervention effects. 
 
18. EXPENSE TO PARTICIPANT 
There will be no costs to the participants. 
 
19. COMPENSATION FOR PARTICIPATION 
To maximize the likelihood that participants will continue with measurement visits and stay in the study, we 
will offer incentives for attending measurement visits as follows:  Fitbit Charge 3 and Aria Scale (valued at 

 
 
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$300 total) at baseline, $20 at 6 months, $25 at 12 months, $25 at 18 months and $30 at 24 months. Subjects 
affiliated with SDSU and CSUSM will receive an additional $15 for each measurement visit to compensate for 
additional travel costs. 
20. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES 
1. Job Godino, Ph.D., Principal Investigator: will lead the main efforts of this project including 
development, coordination, implementation, and monitoring of program activities. He will also lead 
the analyses, preparation of manuscripts, and dissemination of results. Dr. Godino holds a Masters and 
PhD in Epidemiology, is an Assistant Professor and Research Associate at the Center for Wireless and 
Population Health Systems (CWPHS) and Department of Family Medicine and Public Health at 
UCSD, and is the Director of Research and Applied Technology at the Exercise and Physical Activity 
Resource Center (EPARC) and the California Institute of Telecommunications and Information 
Technology’s Qualcomm Institute (Calit2) at UCSD. He has obtained in-depth research training and 
experience in the primary and secondary prevention of obesity, diabetes, and cardiovascular disease. 
He has worked on 19 research studies (funded by the NIH, RWJF, and MRC of the UK) in different 
capacities, 11 of which have been randomized controlled trials. The majority of his current research 
focuses on the development and evaluation of interventions that utilize mobile and wearable 
technology to promote healthy changes in physical activity, sedentary behavior, diet, and sleep for the 
prevention of chronic disease. 
2. Eric Heckler, Ph.D., Co-Investigator: holds a Masters in Clinical Psychology and a PhD in Clinical 
Health Psychology. He is an Associate Professor and Director in the Department of Family Medicine 
and Public Health and CWPHS at UCSD, respectively. His research focuses on the development of 
personalized digital health interventions for behavior change. Additionally, he has expertise in and 
will provide input on the overall direction of the project as it relates to the use of control systems 
engineering methods for behavioral interventions, just-in-time adaptive interventions, human-centered 
design methods and processes for advancing health behavior change, and mobile health (mHealth) 
interventions. 
3. Kevin Patrick, MD, MS, Co-Investigator: holds a MD and a Masters in Community Medicine. Dr. 
Patrick will serve as the study physician and will be on the study steering committee. He will also 
contribute to the intervention development and implementation, interpretation of findings, and will 
assist in the preparation of manuscripts and dissemination of results. He has extensive experience in 
formative research, survey methodology, measurement technologies, behavioral interventions and 
informational technology. His work focuses on the use of text messaging, smartphone apps, mobile 
video, the mobile web and social media to measure health states and promote health behavior change.  
4. Cheryl Rock, Ph.D., Co-Investigator: hold a Masters of Medical Science and a PhD in Nutritional 
Sciences. She will contribute to this project as a nutritional scientist with extensive knowledge and 
experience in conducting diet and weight loss intervention studies, biomarker measures, and clinical 
nutrition research. Dr. Rock has previously developed, led, and conducted several dietary and weight 
loss interventions and clinical trials focused on the role of nutritional and dietary factors in the 
development and progression of disease. Currently, she directs the Diet and Physical Activity Shared 
Resource at the UC San Diego Moores Cancer Center and is a co-investigator on other studies that are 
focused on diet, obesity, weight loss intervention, and behavioral and metabolic risk factors and 
disease management. 
5. Nadir Weibel, Ph.D., Co-Investigator: holds a Masters and PhD in Computer Science and is a 
research faculty member in the department of Computer Science and Engineering at UCSD. 
Additionally, he is one of the faculty and an active member of the UCSD DesignLab, the UCSD’s 
CWPHS, the Center for Microbiome Innovation, and the UCSD Interface and interdisciplinary 
program in multiscale biology. He is also appointed as Research Health Science Specialist at the VA 
San Diego. His research focuses on capturing, storing, managing and visualizing multimodal data 
from behavioral activity in real-world settings. He is skilled in a broad variety of computer science 

 
 
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techniques from information management to human-computer interaction, software engineering, and 
data visualization. He has a total 80+ publications, including 60+ published peer-reviewed articles 
both in renowned journals and in the most important venues in Human-Computer Interaction and 
Pervasive Healthcare during his 7 years at UCSD. Dr. Weibel will contribute to the intervention 
development and implementation and the assessment of usability and acceptability of the intervention. 
6. Sonia Jain, Ph.D., Co-Investigator: holds a Masters and PhD in Statistics and is a Professor in the 
Division of Biostatistics and Bioinformatics in the Department of Family Medicine and Public Health 
at UCSD. Dr. Jain will contribute to the interpretation of findings and will assist in the preparation of 
manuscripts and dissemination of results. 
7. Shadia J. Assi, MPH, Study Manager: holds a Masters in Public Health and has 4 years’ experience 
working in academic health research. She will serve as the study manager for the project and will 
assist the PI in managing recruitment, development, coordination, implementation and monitoring 
program activities. Her previous research and training include health promotion, behavioral science, 
and individual and group-based behavioral change interventions. 
8. Natalie Golaszewski, Ph.D., Postdoctoral Scholar: holds a Masters in Health Education and PhD in 
Health Behavior and Health Promotion. Dr. Golaszewski has a wide array of research experiences 
from managing and conducting large-scale, multi-year randomized control trails, lab-based validation 
studies, and qualitative studies. Currently, her research focuses on the social influences of physical 
activity, diet, and weight loss. She will contribute to the theoretical development of the project as well 
as understanding the meaning of online social behaviors in the small, online groups and whether these 
have an impact on physical activity and diet behaviors. 
9. David Wing, MS, Measurement Coordinator: holds a Masters in Exercise Physiology, and has 
been involved in multiple studies of physical activity and function. Additionally, Mr. Wing is a 
member of CWPHS and serves as the Laboratory Director for EPARC. In this capacity he has 
developed extensive expertise in the objective measurement of physical activity, fitness, function, 
sleep, and overall health utilizing a variety of accelerometers, heart rate monitors, and other biological 
sensors individually and in concert. Under the direction of Dr. Godino, Mr. Wing will oversee all 
anthropometric and physiological measurements in the study. He will help train, supervise, and 
schedule Research Assistants. 
1. Victoria Costello, MPH, Health Coach: will work under the Direction of Dr. Godino and in 
conjunction with Ms. Assi. The Health Coach will have a masters-level education, experience in 
motivational interviewing relevant to weight loss interventions, and a history of using health-related 
devices, apps, and multiple social media streams. The Health Coach will be responsible for the 
anonymous delivery of intervention content via multiple social media streams, email, and personally 
in one-on-one, real-time technology mediated health coaching sessions with relevant participants. 
2. Research Assistants (TBN): will assist with recruitment, screening, measurement and data 
collection. In addition, they will assist the Study Manager and Health Coach in managing online social 
media pages. 
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22. FUNDING SUPPORT FOR THIS STUDY 
This project is funded by NIH under project # R01HL136769: “SOCIAL MOBILE APPROACHES TO 
REDUCE WEIGHT (SMART) 2.0” 
23. BIOLOGICAL MATERIALS TRANSFER AGREEMENT 
NA 
 
24. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER 
NA 
 
25. IMPACT ON STAFF 
NA 
 
26. CONFLICT OF INTEREST 
There are no known conflicts of interest. 
 
27. SUPPLEMENTAL INSTRUCTIONS FOR CANCER-RELATED STUDIES 
NA 
 
28. OTHER APPROVALS/REGULATED MATERIALS 
NA 
 
29. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY ASSESSMENT 
NA