Social Incentives To Encourage Physical Activity and Understand Predictors
Phase: NA
Conditions: Obesity
Sponsor: University of Pennsylvania

Social Incentives and Gamification to Increase Physical 
Activity Among Overweight and Obese Adults:  
The STEP UP Randomized Clinical Trial 
 
Study Protocol 
 
August 11, 2017 
 
NCT03311230 
 
 
 

Outline 
1. Abstract 
2. Overall objectives 
3. Aims 
 
3.1 Primary outcome 
 
3.2 Secondary outcomes 
 
3.3 Exploratory outcomes 
4. Background 
5. Study design 
 
5.1 Design 
 
5.2 Study duration 
 
5.3 Target population 
 
5.4 Accrual 
 
5.5 Key inclusion criteria 
 
5.6 Key exclusion criteria 
6. Subject recruitment 
7. Subject compensation 
8. Study procedures 
 
8.1 Consent 
 
8.2 Procedures 
9. Analysis plan 
10. Investigators 
11. Human research protection 
 
11.1 Data confidentiality 
 
11.2 Subject confidentiality 

 
11.3 Subject privacy 
 
11.4 Data disclosure 
 
11.5 Data safety and monitoring 
 
11.6 Risk/benefit  
 
 
11.6.1 Potential study risks 
 
 
11.6.2 Potential study benefits 
 
 
11.6.3 Risk/benefit assessment 
 
 

1. Abstract 
Regular physical activity is associated with reduced risk of cardiovascular disease, diabetes, 
hypertension, and obesity. Despite these benefits, more than half of adults in the United States do 
not achieve enough physical activity to obtain these benefits. Moreover, nearly 70% of 
Americans are overweight or obese and could benefit from greater physical activity. Many 
stakeholders are increasingly interested in using digital health approaches to increase physical 
activity including using wearable devices to monitor activity and using engagement strategies 
such as gamification to change behaviors. However, the evidence on these approaches is limited. 
Social incentives, the influences that impact individuals to adjust their behaviors based on social 
ties or connections, are ubiquitous and could be leveraged within gamification interventions to 
provide a scalable, low cost approach to increase engagement. Gamification, or the use of game 
design in non-game situations, is commonly used in the real world, but in most cases has not 
appropriately leveraged principles from theories of health behavior. By incorporating insights 
from behavioral economics, these approaches could be designed to anticipate predictable barriers 
to behavior change. In this study, we will test the effectiveness of three social incentive-based 
gamification interventions to increase physical activity using a 24-week intervention period with 
a 12-week follow-up.  
2. Overall objectives 
The objective of this study is to use a randomized, controlled trial to test the effectiveness of 
three interventions using social incentives and gamification to increase physical activity among 
overweight and obese adults.     
3. Aims 
 
3.1 Primary outcome 
The primary outcome is change in daily steps from baseline to the intervention period (weeks 5 
to 24 which excludes the 4-week ramp-up phase). 
 
3.2 Secondary outcomes 
Secondary outcomes include the proportion of participant-days that step goals are achieved 
during the intervention and follow-up periods, and change in daily steps from baseline to the 
follow-up period. 
3.3 Exploratory outcomes 
We will explore how participant characteristics and behaviors are associated with strong or poor 
physical activity performance.  
 

4. Background 
Regular physical activity is associated with reduced risk for cardiovascular disease, diabetes, 
hypertension, and obesity. Less than half of adults in the United States, however, achieve enough 
physical activity to obtain these benefits. Digital health approaches that use engagement 
strategies such as gamification are commonly found within workplace wellness programs and 
mobile applications, but the evidence on their effectiveness is limited. Our prior work has 
demonstrated that insights from behavioral economics can be used to design interventions to 
address predictable barriers to behavior change.  
Social incentives or those influences that impact individuals to adjust their behaviors based on 
social ties and connections have been demonstrated in retrospective studies to influence behavior 
but have not been well examined prospectively. Insights from behavioral economics can be used 
to design gamification interventions to enhance social incentives such as the support, 
competition, or collaboration but the optimal design to increase physical activity is unknown. 
 
5. Study design 
 
5.1 Design 
This is a four-arm randomized, controlled trial with a 24-week intervention period and 12-week 
follow-up period.  The study will be conducted using Way to Health, a research information 
technology platform at the University of Pennsylvania used previously for physical activity 
behavioral interventions.   
Recruitment will occur by email invitation to employees in the United States at Deloitte, a large 
consulting company. Interested participants will be instructed to visit the study website to create 
an account, review and provide informed consent, and complete a baseline eligibility survey. 
Eligible participants will also be asked to complete a custom sociodemographic survey; the 
DOSPERT survey to evaluate risk preferences; the Big Five Inventory survey to evaluate 
personality characteristics; and the Grit Scale to assess perseverance at the time of enrollment. At 
0 and 6 months, participants will be asked to complete an EQ-5D-5L survey for economic 
evaluation of health status, the Self Efficacy for Exercise Behaviors survey, the Eating Habits 
Questionnaire, the Pittsburgh Sleep Quality Index, the PHQ-9 questionnaire to assess mental 
health state, the MOS Social Support survey, and a qualitative survey to provide feedback on 
their experience in the study. Once surveys are completed in enrollment, a wearable activity 
tracking device will be mailed to the participant and they will be told to wear the device during 
day and night to get accustomed to it during a 2-week run-in period. Data collected from this 
time will be used to estimate a baseline step count by using data from the second week (days 8 to 
14), ignoring values less than 1000 steps (since evidence suggests these value are unlikely to 
represent actual activity). Participants without at least 4 days of data will be called to inquire if 

there are any issues with using the device and the period will be extended until at least 4 days of 
data are available to estimate a baseline step count. 
Participants that have been confirmed by the study team to have an appropriate baseline step 
count will be asked to select a step goal increase as follows: 
--Goal Setting-- 
Each participant will be asked to choose a step goal increase that is either 33%, 40%, or 50% 
higher than baseline (each step goal will be rounded up to the nearest hundred). A participant 
may also select to choose another goal as long as it is at least 1500 steps greater than his or her 
baseline. 
--Randomization— 
Participants are considered ready to be randomized once they have completed all surveys, 
established a baseline step count, and selected a step goal increase. 
Participants will be stratified on baseline step count (less than 5000 steps, 5001 to 7500 steps, or 
more than 7500 steps). Participants will then be randomly assigned within their strata in blocks 
of four groups, with each group having 3 participants. The first participant in the group will be 
randomly assigned to the arm and the next 2 participants will be assigned to fill that group. Then 
the next participant will be randomly assigned to an arm within that block and the following two 
participants will be assigned to fill that group, and so on until the block within the strata is filled 
of 4 groups, each with three participants per group.  
Participants in all arms will be asked to complete a series of follow-up surveys the end of the 24-
week intervention period and again at the end of the 12-week follow up period. The interventions 
within each arm are as follows: 
--Arm 1: Control— 
Participants in this arm will receive no other interventions during the 24-week intervention 
period or the 12-week follow-up period. 
--Arm 2-4: social incentive-based gamification interventions-- 
Participants randomized to the one of the three intervention arms will have a 4-week ramp up 
towards their step goal (the “ramp-up period).  The net difference between baseline and their 
goal will be divided by 4 and the participant will be asked to achieve the 25% increase each 
week for the 4-week ramp-up and then maintain the step goal for the remaining study period.  
For example, a participant with a baseline of 6000 steps and goal of 8000 steps will be asked to 
achieve goals of 6500, 7000, 7500, and 8000 for each of the first four weeks of the study.  The 
participant will be asked to maintain their goal (e.g. 8000 steps per day) during the 20-week 
“maintenance period” and the 12-week “follow-up period”   

Participants in arms 2-4 will be entered into an intervention approach that has points and levels 
designed to incorporate insights from behavioral economics.  First, participants will be asked to 
sign a pre-commitment pledge to strive to achieve their step goal during the 36-week study.  Pre-
commitment has been demonstrated to motivate behavior change. Second, at the beginning of 
each week the participant receives 70 points (10 for each day that week).  If the participant does 
not achieve their step goal, they lose 10 points from their balance.  This leverages loss aversion, 
which has been demonstrated to motivate behavior change more effectively with losses than 
gains. Third, at the end of each week if the participant has at least 40 points, he or she will move 
up a level (levels from lowest to highest: blue, bronze, silver, gold, platinum).  If not, participants 
will drop a level.  All participants begin at the silver level.  Each week, participants get a fresh 
set of 70 points on Monday.  
At 8 and 16 weeks, participants struggling to meet their goals (defined as in the blue or bronze 
levels of the game) will be contacted to inquire about their progress in the study. They will be 
reset to the silver level and given the opportunity to readjust their goals among the initial options.  
Weekly feedback will differ among the three arms to induce the different social incentives 
(support, competition, and collaboration) as follows: 
--Arm 2: Supportive social incentive intervention— 
Participants in this arm will be asked to identify a family member or friend to be their support 
sponsor. This sponsor will be encouraged to support the participant in their progress during the 
study.  A weekly report will be sent by email to the sponsor with the participant’s performance 
(e.g., step goal, average step count for that week, points and level).   
--Arm 3: Competitive social incentive intervention— 
Participants in this arm will be in a group of three total participants.  At the end of each week the 
participants will receive an email with a leaderboard that ranks them on their cumulative points 
in the study thus far and also displays their level. In the event there is a tie in total cumulative 
points, the participants will be secondarily ranked on level. This feedback may help to induce 
participants to compete for the top spot among the group.   
--Arm 4: Collaborative social incentive intervention— 
Participants in this arm will be in a group of three total participants as a team.  Each day one of 
the members of the group will be randomly selected to represent their team for that day.  If the 
participant selected met his or her step goal on the previous day, the team keeps their points.  If 
he or she didn’t meet their goal, then the team loses 10 points.  In this design, each person is 
accountable to the others on the team and this may induce a collaborative effort to meet their 
daily goals.  The entire team moves up a level only if the team has at least 40 points by the end 
of the week.   

 
5.2 Study duration 
This study is anticipated to take up to 2 years to complete and includes a 24-week intervention 
period and 12-week follow-up period 
 
5.3 Target population 
Adults age 18 years or older with a self-reported body mass index of 25 or greater, that are 
employees of Deloitte. 
 
5.4 Accrual 
This study has been powered for two phases of hypothesis testing. In the first phase, we will 
compare each of the three intervention arms to control. We estimate that a sample of 600 
participants allocated in a 1:1:1:1 distribution, will ensure at least 80% power to detect an 800 
step difference between each intervention arm and control, with a standard deviation of 2000 
steps.  This calculation assumes a 10% dropout rate and a conservative Bonferroni adjustment of 
the type I error rate with a 2-sided alpha of 0.017. In the second phase, we will compare 
successful intervention arms to each other. We expect that the magnitude of difference between 
intervention arms will be less than that of successful intervention arms compared to control. For 
this second phase of analyses will use a conservative Bonferroni adjustment of the type I error 
rate with a 2-sided alpha of 0.017 to adjust for up to 3 comparisons. Because only intervention 
arms which demonstrated a significant difference with the control are compared with each other 
in the second phase, the overall familywise error rate of this two-phase procedure is controlled at 
0.05. 
5.5 Key inclusion criteria 
1) Age 18 years or older; 2) ability to read and provide informed consent to participate in the 
study; 3) Self-reported body mass index (BMI) of 25 or greater. 4) Smartphone or tablet 
compatible with application for the wearable activity tracking device.  
 
5.6 Key exclusion criteria 
1) Conditions that would make participation infeasible such as inability to provide informed 
consent, illiteracy or inability to speak, read, and write English; 2) conditions that would make 
participation unsafe such as pregnancy or being told by a physician not to exercise; 3) already 
enrolled in another study targeting physical activity; 4) any other medical conditions or reasons 
he or she is unable to participate in a physical activity study for 36 weeks. 
6. Subject recruitment 
Recruitment will occur by email invitation to employees in the United States at Deloitte, a large 
consulting company. 

7. Subject compensation 
All participants will receive $25 to enroll in the study (defined as being randomized and starting 
the intervention), $50 for completing the 24-week intervention and surveys, and $50 for 
completing the entire 36-week study. 
8. Study procedures 
 
8.1 Consent 
Upon recruitment, individuals who are interested in learning more about the study will be 
directed to the Way to Health web portal. Upon reaching the portal, potential participants will be 
asked to create an account and will then be informed of the details of the study, including its 
objectives, duration, requirements, and financial payments.  If participants are still interested in 
participating, the Way to Health portal will take them through an automated online informed 
consent. The consent document will be divided into sections and potential participants will have 
to click a button to advance through each section. This is to help ensure that participants read the 
consent form thoroughly by breaking down the form into manageable blocks of text. Successive 
screens will explain the voluntary nature of the study, the risks and benefits of participation, 
alternatives to participation, and that participants can withdraw from the study at any time. On 
the final consent screen, potential participants who click a clearly delineated button stating that 
they agree to participate in the study will be considered to have consented to enroll. Participants 
will be provided with details regarding how to contact the research team via email or phone at 
any time if they subsequently wish to withdraw from the study. This contact information will 
remain easily accessible via the participants’ individual Way to Health web portal dashboards 
throughout the study.   
 
 
8.2 Procedures 
After providing informed consent, participants will complete an online questionnaire to 
determine their eligibility and complete the study surveys. Eligible participants will be mailed a 
wearable activity tracking device to wear a two week run-in period to collect a baseline step 
count.   
Participants will select step goals and then be randomly assigned as described in the Study 
Design section. 
We will obtain additional information about characteristics and behaviors of participants from 
the KBM Group, a data analytics firm. Participants will provide consent for the study team to 
send KBM Group their name and address using secure data transfer methods. 
9. Analysis plan 

All analyses will be performed using intention-to-treat. Data can be missing for any day if the 
participant did not use the activity tracking device or did not upload data. For the main analysis, 
we will use multiple imputation for step values that are either missing or for values less than 
1000 steps because evidence suggests these are not accurate measures of actual activity. We will 
perform five sets of imputations and results will be combined using Rubin’s standard rules. We 
will perform sensitivity analyses to assess the robustness of the findings using only collected data 
with and without step values less than 1000 steps.  
The primary analysis will fit mixed effects regression models to evaluate changes in physical 
activity outcomes measures adjusting for each participant’s baseline step, time at the observation 
level using calendar month fixed effects,  participant random effects, and adjusting for repeated 
observations of participant step counts. We will compare changes from baseline to the 
intervention period (excluding weeks 1 to 4 during the ramp-up phase) and from baseline to the 
follow-up period. Secondary analyses will fit mixed effects regression models adjusted for other 
variables of interest such as participant characteristics. Exploratory analyses will fit mixed 
effects regression models to evaluate associations of participant characteristics or behaviors with 
strong or poor performance in the outcome measures. We will also conduct an exploratory 
qualitative evaluation of the survey free text responses.     
This study has been powered for two phases of hypothesis testing. In the first phase, we will 
compare each of the three intervention arms to control. We estimate that a sample of 600 
participants allocated in a 1:1:1:1 distribution, will ensure at least 80% power to detect an 800 
step difference between each intervention arm and control, with a standard deviation of 2000 
steps.  This calculation assumes a 10% dropout rate and a conservative Bonferroni adjustment of 
the type I error rate with a 2-sided alpha of 0.017. In the second phase, we will compare 
successful intervention arms to each other. We expect that the magnitude of difference between 
intervention arms will be less than that of successful intervention arms compared to control. For 
this second phase of analyses will use a conservative Bonferroni adjustment of the type I error 
rate with a 2-sided alpha of 0.017 to adjust for up to 3 comparisons. Because only intervention 
arms which demonstrated a significant difference with the control are compared with each other 
in the second phase, the overall familywise error rate of this two-phase procedure is controlled at 
0.05. 
10. Investigators 
Mitesh Patel, MD, MBA, MS is the Principal Investigator (PI) and is an Assistant Professor of 
Medicine and Health Care Management at the Perelman School of Medicine and The Wharton 
School at the University of Pennsylvania. He is the Director of the Penn Medicine Nudge Unit 
and has led more than 15 randomized clinical trials including many physical activity behavioral 
interventions that use the Way to Health research information technology platform. He has 
experience and training in behavioral economics, clinical trial design and analysis, health 

services research, and statistical analysis. He currently spends 80% of his effort on research and 
20% on clinical and teaching activities. 
11. Human research protection 
 
11.1 Data confidentiality 
Paper-based records will be kept in a secure location and only be accessible to personnel 
involved in the study. Computer-based files will only be made available to personnel involved in 
the study through the use of access privileges and passwords. Wherever feasible, identifiers will 
be removed from study-related information. Precautions are in place to ensure the data are secure 
by using passwords and encryption, because the research involves web-based surveys. 
 
11.2 Subject confidentiality 
Research material will be obtained from participant surveys and wearable devices.  All 
participants will provide informed consent for access to these materials. The data to be collected 
include data on participant characteristics and behaviors, step counts, and sleep patterns.  
Research material that is obtained will be used for research purposes only. The same procedure 
used for the analysis of automated data sources to ensure protection of patient information will 
be used for the survey data, in that patient identifiers will be used only for linkage purposes or to 
contact patients. The study identification number, and not other identifying information, will be 
used on all data collection instruments. All study staff will be reminded to appreciate the 
confidential nature of the data collected and contained in these databases. The Penn Medicine 
Academic Computing Services (PMACS) will be the hub for the hardware and database 
infrastructure that will support the project and is where the Way to Health web portal is based. 
The PMACS is a joint effort of the University of Pennsylvania's Abramson Cancer Center, the 
Cardiovascular Institute, the Department of Pathology, and the Leonard Davis Institute. The 
PMACS provides a secure computing environment for a large volume of highly sensitive data, 
including clinical, genetic, socioeconomic, and financial information. Among the IT projects 
currently managed by PMACS are: (1) the capture and organization of complex, longitudinal 
clinical data via web and clinical applications portals from cancer patients enrolled in clinical 
trials; (2) the integration of genetic array databases and clinical data obtained from patients with 
cardiovascular disease; (3) computational biology and cytometry database management and 
analyses; (4) economic and health policy research using Medicare claims from over 40 million 
Medicare beneficiaries. PMACS requires all users of data or applications on PMACS servers to 
complete a PMACS-hosted cybersecurity awareness course annually, which stresses federal data 
security policies under data use agreements with the university. The curriculum includes Health 
Insurance Portability and Accountability Act (HIPAA) training and covers secure data transfer, 
passwords, computer security habits and knowledge of what constitutes misuse or inappropriate 
use of the server. We will implement multiple, redundant protective measures to guarantee the 
privacy and security of the participant data. All investigators and research staff with direct access 

to the identifiable data will be required to undergo annual responsible conduct of research, 
cybersecurity, and HIPAA certification in accordance with University of Pennsylvania 
regulations.  
Data will be stored, managed, and analyzed on a secure, encrypted server behind the University 
of Pennsylvania Health System (UPHS) firewall. This server was created for projects conducted 
by the Penn Medicine Nudge Unit related to physician and patient behavior at UPHS. All study 
personnel that will use this data are listed on the IRB application and have completed training in 
HIPAA standards and the CITI human subjects research. Data access will be password protected. 
Whenever possible, data will be deidentified for analysis. 
 
11.3 Subject privacy 
Interested participants will be directed to the Way to Health portal where they will be asked to 
enter data related to eligibility and their demographic characteristics. Enrollment will include a 
description of the voluntary nature of participation, the study procedures, risks and potential 
benefits in detail. The enrollment procedure will provide the opportunity for potential 
participants to ask questions and review the consent form information with family and friends 
prior to making a decision to participate. Participants will be told that they do not have to answer 
any questions if they do not wish and can drop out of the study at any time, without affecting 
their medical care or the cost of their care. They will be told that they may or may not benefit 
directly from the study and that all information will be kept strictly confidential, except as 
required by law. Subjects will have access to a copy of the consent document. All efforts will be 
made by study staff to ensure subject privacy. 
 
11.4 Data disclosure 
The following entities, besides the members of the research team, may receive protected health 
information (PHI) for this research study: Wells Fargo, the company which processes study-
related payments. Patient addresses and account balances will be stored on their secure 
computers. Nokia, the company that designs and manufactures the wearable devices  used in the 
study to track participant physical activity. Twilio, Inc., the company which processes some 
study-related messages. Twilio will store patients' phone numbers on their secure computers. 
Qualtrics, Inc., the company which processes most study-related surveys. Qualtrics will house 
de-identified answers to these surveys on their secure servers. The Office of Human Research 
Protections at the University of Pennsylvania -Federal and state agencies (for example, the 
Department of Health and Human Services, the National Institutes of Health, and/or the Office 
for Human Research Protections), or other domestic or foreign government bodies if required by 
law and/or necessary for oversight purposes. 
 
11.5 Data safety and monitoring 

The Principal Investigator will be responsible for monitoring the study. All participants will be 
given anticipatory guidance on when to seek medical attention.  In addition, participants will be 
asked to report to the study team any injuries or medical care that they feel resulted from 
participation in the study.  They can either call the study team or send an email.  The research 
coordinator will call the participant to collect information regarding the issue and then the PI will 
review and determine whether it is ok to proceed, further investigation is needed, or the 
participant should stop the study. For this study there will be no stopping rules or endpoints and 
thus no planned interim analyses. 
 
11.6 Risk/benefit 
 
11.6.1 Potential study risks 
To minimize the chance for serious and unexpected adverse events, study participants will be 
screened through exclusion criteria for any health conditions that may be exacerbated by 
participating in a physical activity study. The program will use a gradual increase in physical 
activity during the first month that should pose little health risk to participants.  Participants are 
given guidance on when to seek medical attention and a reporting protocol is in place to capture 
any changes in symptoms with physical activity. Another potential risk of this study is a breach 
of participant confidentiality. We will minimize this risk by using secure data methods as 
described previously. Due to the financial incentives in this study, we will be collecting social 
security numbers so that we can complete W-9 forms for participants. Social security numbers 
only will be used to generate W-9 forms and will be deleted once they are no longer needed. We 
will also collect home addresses to mail incentive payments. This will be done through a 
University of Pennsylvania approved partnership with Wells Fargo. Accidental disclosure of 
social security numbers could lead to identity theft. We will use commercial-grade encryption to 
protect social security information in transit. Names and addresses will be stored in encrypted 
databases. These data will be viewable only by the respective participants, the study 
coordinator(s) and the project manager(s). All other members of the research team will be able to 
view only participant ID numbers. Even the study arms will be identified by code letters until 
both the statistician and PI agree that analysis is complete. 
 
 
11.6.2 Potential study benefits 
Through participation in this study, each participant will have the potential to increase physical 
activity which could improve their health and reduce their risk for future disease. If this approach 
is effective, it could have tremendous benefits for society if adopted on a wide scale to help 
individuals. It is expected that other people will gain knowledge from this study and that 
participation could help understand how to effectively motivate individuals to change behavior. 
Participants may also receive no benefit from their participation in the study. 
 
 
 

11.6.3 Risk/benefit assessment 
Anticipated risks of this study should be minimal and the risk/benefit ratio is very favorable. To 
minimize the chance for serious and unexpected adverse events, study participants will be 
screened through exclusion criteria for any health conditions that may be exacerbated by 
participating in this study.  We have previously outlined the procedures that will be used to 
prevent a breach of participant data.