A Randomized Controlled Trial of Incentives Versus Environmental Strategies for Weight Loss
Phase: NA
Conditions: Obesity
Sponsor: University of Pennsylvania

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A Randomized Controlled Trial of Incentives vs 
Environmental Strategies for Weight Loss 
 
Study Protocol  
v July 26, 2018 
Penn IRB#: 821428 
NCT02878343 
1. 
Abstract ................................................................................................................................................................. 4 
2. 
Background ........................................................................................................................................................... 4 
    2.1. Impact of Obesity on Health, Benefits of Weight Loss 
2.2.  Changes in benefit design and the use of incentives for employees 
2.3. Use of Financial Incentives to Change Health Behavior in General 
2.4. Effects of Financial Incentive Interventions for Obese Patients 
2.5. Impact of Environmental Changes on Food intake and Physical activity 
2.6. Cost of Obestiy and Cost-effectiveness of Behavioral Interventions 
3. 
Data Management/Way to Health Platform ........................................................................................................ 7 
4. 
Overall Objectives/ Specific Aims ......................................................................................................................... 8 
Primary Aims 
1. Lottery vs. Control Group 
2. Environmental Strategy vs. Control Group 
3. Combined Incentive and Environmental Strategy vs. Control Group 
4. Combined Incentive and Environmental Strategy and Weight loss over 18 months 
Secondary Aims 
5. Assess costs by arm 
5. 
Primary Outcome Variable .................................................................................................................................... 9 
          5.1. Change in weight from BL to 18M 

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5.2 Specific Aims 1-3 
 
5.3 Specific Aim 4 
6. 
Secondary Outcome Variable(s) ........................................................................................................................... 9 
6.1 Specific Aim 5 
7. 
Study Instruments ................................................................................................................................................. 9 
 
7.1 Surveys and Assessments 
 
7.2 Demographic Measures 
 
7.3 Physical Activity 
 
7.4 Dietary Behavior 
 
7.5 Stages of Change Model 
 
7.7 Biometric Assessment Data Part A 
 
7.8 Biometrics Assessment Data Part B 
 
7.9 Medical History 
 
7.10 Health Related Quality of life 
7.11 Healthy Utility Index (HUI) 
 
7.12 Insurance Claims 
 
7.13 Withings Scale 
8. 
Study Design ....................................................................................................................................................... 11 
8.1. 
Research Design and Methods 
8.2. 
Measurement of cost effectiveness 
8.3. 
Key Inclusion Criteria 
8.4. 
Key Exclusion Criteria 
     9.            Subject Recruitment ................................................................................................................................. 13 
9.1. 
Target Population 
9.2. 
Accrual 
9.3          Subject Recruitment 
9.4 
Subject Compensation 
10. Study Procedures ................................................................................................................................................ 15 
 
Consent Process  

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10.1 Overview 
Procedures 
10.2 Baseline pre-treatment assessment for patients 
10.3 Randomization 
10.4 Environmental Change Strategies 
10.5 Outcome Assessments 
10.6 Design of the Incentives 
     10.7 Study Duration   
      10.8 Dissemination 
11. Analysis Plan ....................................................................................................................................................... 21 
11.1 Statistical Considerations 
11.2 Power and Sample Sizze Consideration 
11.3 Measurement of Effect 
12. Human Research Protection ............................................................................................................................... 24 
12.1 Subject Confidentiality 
12.2 Subject Privacy 
12. 3 Protection of Human Participants  
12.4 Cost Effectiveness Analysis 
12.5 Source of Materials 
12.6 Potential Risks Involved in the Proposed Study 
12.7 Risks Involved in the Cost-Effectiveness Analysis  
12.8 Adequacy of Protection from Risks Recruitment and Informed Consent 
12.9 Protection against risk 
12.10 Electronic Data Security 
12.11 Potential Study Benefits 
12.12 Resources necessary for Human Research Protection 
13. Data Protection ................................................................................................................................................... 29 
13.1 Data and Safety Monitoring Plan 

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13.2 Data and Safety Monitoring Board 
13.3 Potential Study Benefits 
13.4 Alternatives to Participation 
13.5 Risk/Benefit Assessment 
 
 
1. 
Abstract 
Identifying effective strategies for treating obesity is both a clinical challenge and a public health 
priority. Between 1960 and 2010, obesity prevalence (body mass index [BMI] 30 kg/m2) in US adults 
increased from 11% to 35.5% in men and from 16% to 35.8% in women, and about 70% of US adults are 
considered either overweight or obese. This situation has troubling implications, as obesity in young 
adulthood and middle age translates into higher rates of cardiovascular risk factors, disability, 
hospitalization, Medicare expenditures, and mortality risk later in life. While a variety of approaches are 
successful in achieving initial weight loss techniques for combining initial weight loss and successful 
maintenance of weight loss have been elusive. Research shows that most people who successfully lose 
weight will regain 1/3 to 2/3 of that weight after one year. Rigorous testing of promising, innovative 
approaches to weight loss and maintenance is an important public health priority. While both behavioral 
economic and environmental strategies have shown promise, we propose to test a novel blend of these 
approaches in this initiative. We will also test these interventions in populations with a high rate of 
African Americans and low to moderate income individuals who are obese, addressing important 
concerns about the health disparities due to high rates of obesity. The proposed study will evaluate the 
comparative effectiveness of behavioral economic financial incentives and environmental strategies, 
separately and together, in achieving initial weight loss and maintenance of weight loss, in obese 
employee populations. Our study contributes to the CDCs efforts to combat obesity but in particular to 
CDCs winnable battles (physical activity and obesity); the NCCDPHP strategic priorities around well- 
being, health equity, and evaluation and dissemination of environmental and systems-wide solutions to 
address public health problems; and the NCCDPHP domain around healthier worksite initiatives, CDC 
efforts to improve nutrition and physical activity to prevent obesity, and reduction of cardiovascular 
disease risk. We propose a 4-arm randomized controlled trial (RCT) in which 344 employees of the City 
of Philadelphia, IBC, and SEPTA with initial Body Mass Index of 30 or greater and at least 1 other 
cardiovascular risk factor (high blood pressure, hypercholesterolemia, diabetes, smoking) will be 
randomized to receive one of the following: 1) Daily lottery type incentives tied to achievement of 
weight loss goals (incentive arm); 2) individually tailored environmental strategies around food intake 
and physical activity (environmental arm); 3) a combination of incentives and environmental strategies 
(combined arm); or 4) standard employee wellness benefits and weigh-ins every 6 months (control arm). 
Phase I of the study (first 6 months) will focus on weight loss; Phase II (months 7-18) will focus on 
continued weight loss or maintenance for those who choose to maintain weight loss as opposed to 

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continuing to try to lose weight; Phase III (months 19-24) will provide a period of post-intervention 
follow-up to measure sustainability of effects. 
2. 
Background 
2.1 Impact of Obesity on Health, Benefits of Weight Loss.  Obesity is the second leading cause of 
preventable death in the United States, associated with high blood pressure (BP), type 2 diabetes, 
coronary heart disease, and osteoarthritis. Weight loss of just 5-10 kg can improve risk factors (e.g., BP, 
glycemia, and serum lipid levels) and reduce the incidence of diabetes. In older adults, weight loss 
interventions have shown clear improvements in BP, arthritis, and functional status. However, 
maintenance of weight loss is needed to achieve long term health benefits, and successful strategies for 
long-term maintenance are lacking. Weight regain after a period of intentional weight loss is widely 
observed with all interventions due to loss of motivation, lack of sustained rewards for weight loss 
behavior, difficulty adhering to diet, and need for ego-depleting exertion of willpower. Since weight loss 
programs  offered  as  part  of  standard  employer-sponsored  benefits  are  generally  unsuccessful  in 
achieving  weight  loss  maintenance,  supplemental  motivation  from  incentives  or  environmental 
feedback may help people keep weight off.  
2.2 Changes in benefit design and the use of incentives for employees. There have been significant shifts 
in recent years in the use of incentives to increase healthy behaviors among employees of American 
companies. HIPAA's 2006 regulations permitted employer health plans to offer financial incentives for 
achieving health- contingent standards such as body mass index as long as this was part of a wellness 
program. Programs were required to meet a number of conditions, including that they have a 
"reasonable chance" of improving health and not be "overly burdensome.  The  Affordable  Care  Act  
(ACA)  increased  the  incentive  ceiling  to  30%  of coverage costs and gave regulators the authority to 
further increase the ceiling to 50% if "appropriate." In recently issued final rules, regulators lifted the 
ceiling to 50% as long as any incentives beyond the 30% threshold targeted tobacco use.99 In 2013, 
approximately 85% of large employers in the US are using  incentives  for healthy  behavior,  making  the 
use of such  approaches  increasingly  a widely used standard for efforts to reduce obesity. However, the 
approaches being utilized generally have not been well tested and rarely utilize insights from behavioral 
economics that utilize the decision errors that are common in people to design more effective programs. 
These strategies also fail to incorporate environmental change strategies which are increasingly 
recognized as important to obesity reduction and maintenance of healthy weight, and few such 
strategies have been rigorously evaluated in the context of weight management  programs.   
2.3 Use of Financial Incentives to Change Health Behaviors in General. Individuals put disproportionate 
value on present relative to future costs and benefits, known as present-biased preferences. While this 
bias typically works against healthy behavior, the same factors can be used to promote healthy behavior 
by providing tangible but small immediate rewards for beneficial behaviors. Evidence from hard-to-
change behaviors such as tobacco and other substance use, indicate that incentives can be beneficial, 
but patients require regular monitoring, and frequent feedback is an important component to success. A 
review of 11 randomized trials of financial incentives found that financial incentives promoted 
adherence better than any tested alternative, leading to better blood pressure control, appointment 

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attendance, and higher immunization rates. Other reviews have found various incentives (including 
lotteries) effective in changing behavior. However, few studies have examined longer-term effects of 
incentives on health behaviors after cessation of incentives, or the relative effectiveness of incentives vs. 
other obesity reduction strategies. Lottery-type incentives are particularly appealing for improving 
adherence to a weight loss regimen. Although small payouts (e.g., $10 to quit smoking) may not be 
effective, lottery incentives have shown promise in altering health behaviors even when awards have 
relatively low expected values (e.g., $50). Lotteries typically include several features that make them so 
appealing, despite a very low rate of return. They typically offer a combination of a relatively large 
chance of a small payout and a very small chance of a larger payout. The frequent small payoffs increase 
the attractiveness of lotteries by giving lottery players intermittent positive reinforcement. Moreover, 
the feedback is often very rapid; most games have daily draws and more than 40% of state revenues 
now come from instant scratch-off tickets. The small chance of a large payoff is especially attractive 
because people tend to overweigh small probabilities in making decisions. Structuring financial 
incentives as a lottery has several benefits over a set pay-off amount. Lotteries may be less costly to 
provide than comparable cash incentives because of the effectiveness of intermittent reinforcement. 
Beyond their monetary payoffs, lotteries provide entertainment value, enhancing their reinforcing 
properties as a motivator.  Lotteries may be particularly effective in lower-income populations (in whom 
lotteries are more popular), who have higher rates of non-adherence than other populations.   
2.4 Effects of Financial Incentive Interventions for Obese Patients.  Incentives are effective in weight loss 
interventions. Jeffery et al showed that participants without any weight management training lost 
weight when they deposited valuables with a therapist with return of their valuables contingent on 
progress towards pre-specified goals, and that incentives for weight loss are more effective than 
incentives for attending weight loss training. Finkelstein et al. found that over a 3- month period, 
participants offered $14 per percentage point of weight loss lost 4.7 pounds whereas participants 
offered $7 lost 3.0 pounds and control participants lost 2.0 pounds. In work done by our group using 
daily lotteries (published in JAMA), we found that about 50% of participants offered an incentive 
reached a weight loss goal of 1 pound per week over 16 weeks (average weight loss 13.1 pounds)  
compared  to  about  10%  of  control  group  participants  (average  weight  loss  4.0  pounds). Dropout 
rates were about 7%, remarkably low for a weight loss intervention. Further work extended successful 
weight loss to 8 months and showed the effectiveness of competition between groups in augmenting 
motivation, though the individual arm was less effective without frequent feedback. These studies 
illustrate that incentives ideally provide frequent feedback, and that daily lottery incentives using a 
technology platform can be highly effective at sustaining engagement and achievement of weight loss 
goals.  
2.5 Impact of Environmental Changes on Food intake and Physical activity. It has long been recognized 
that social and physical environmental factors influence food intake and physical activity.  Worksite  
interventions  to  improve  food  environments  have  shown  modest  success. Most worksite nutrition 
and weight intervention studies have not included clearly defined environmental strategies, though 
combination interventions have achieved significant, albeit modest, success. The use of environmental 
interventions to increase physical activity is recommended, though the evidence base of intervention 

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research is limited. Cross-sectional research indicates that having multiple environmental  supports  
(stairways,  facilities,  equipment)  at  worksites  is  associated  with  meeting physical   activity   
interventions.   In   addition   to   environmental   changes   to   worksite   structures, environmental re-
engineering is a promising strategy and is being studied in several trials with a home environment focus. 
A recent study of environmental changes for weight gain prevention in worksites found no impact on 
body mass from environmental changes alone, perhaps due to limited strength of the interventions, 
deployment of single strategies in isolation, inadequate implementation, and because such studies 
included normal weight, overweight, and obese employees. 
2.6 Cost of Obesity and Cost-effectiveness of Behavioral Interventions. Recent studies concluded that 
annual US expenditures attributable  to  overweight  and  obesity  are  between  $90  and  $100  billion.  
Among nationally representative cohorts, the average annual incremental cost of obesity is about 
$1,308. Higher BMIs in young adulthood and middle age are associated with substantially higher 
Medicare expenditures in old age. Higher BMI also translates into significantly higher health care 
charges within 18 months, 1 suggesting that health plans may find it cost effective to invest in behavior 
modification to lower health expenditures. Several economic assessments of behavioral interventions 
for weight loss have been published.  The  Diabetes  Prevention  Program,  reported  that,  compared  to  
placebo,  the intensive lifestyle intervention had cost per QALY ratios ranging between $32,000 and 
$52,000, depending  upon  whether  direct  medical  costs  alone  or  direct  and  indirect  costs  were  
counted. Finkelstein et al. reported that the 1-year incremental cost per 1% reduction in 10-year CHD 
risk associated with an enhanced behavioral intervention was $637.135. The substantial health and 
economic consequences of obesity highlight the importance of testing new approaches to maintenance 
of weight loss and the potential cost effectiveness of successful interventions. 
3. Data Management and the Way to Health Platform  
The Way to Health online platform will serve as the core mechanism for recruiting and enrolling 
subjects, transmitting general and intervention-specific messages, collecting individual weight 
measurements and online survey data, and providing regular feedback to subjects on their progress in 
the study. This platform has supported a series of other NIH-funded studies that harness new 
technologies to encourage healthy behaviors and treatment adherence. The University of Pennsylvania 
Biomedical Informatics  Consortium  (BMIC)  will  be  the  hub  for  the  hardware  and  database 
infrastructure that will support the project and where the web portal is based. The data collected for 
this study will be stored in mySQL databases on a dedicated BMIC-run server. All data will be stored in 
both a non-editable database and in a separate modifiable database, allowing researchers to correct 
mistakes while preserving the raw data for auditing purposes.  Every SQL  transaction,  including 
accessing  and  changing  data,  will  be logged  for  auditing  purposes.  Data will be entered into the 
database through several different mechanisms. Participants will enter their own personal information 
and respond to surveys through a PHP-based web interface. Researchers will have a separate interface 
that will allow them to manually enter data if needed. The dataset will be blinded of all personally 
identifiable information when exported for analysis. The web application will automatically remove all 
identifiers when a researcher requests an analytic dataset. The only people with access to identifiable 
participant information will be pre-specified research staff responsible for contacting participants for 

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follow-up. Personal information and research data will be stored in separate SQL tables and will be 
linked by a computer-generated ID number. Furthermore, the web platform will be set up with pre-
specified ranges of eligible values for most questions to minimize participants’ data entry errors. 
Specifically designated administrators will have the ability to make corrections. Each modification, 
however, will be logged along with justification for the change. The original data will be preserved in a 
separate non-modifiable database.  The UPENN Biomedical Informatics Consortium (BMIC) will be the 
hub for the hardware and database infrastructure that will support the project and where the Way to 
Health web portal is based. The BMIC 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 BMIC 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 BMIC 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. BMIC requires all 
users of data or applications on BMIC servers to complete a BMIC-hosted cybersecurity awareness 
course annually, which stresses federal data security policies under data use agreements with the 
university.  Curriculum includes 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 Health Insurance 
Portability and Accountability Act certification in accordance with University of Pennsylvania regulations. 
All data for this project will be stored on the secure/firewalled servers of the BMIC Data Center,  in  data  
files that  will  be  protected  by  multiple  password  layers.  These data servers are maintained in a 
guarded facility behind several locked doors, with very limited physical access rights. They are also 
cyber-protected by extensive firewalls and multiple layers of communication encryption. Electronic 
access rights are carefully controlled by University of Pennsylvania system managers. We will use highly 
secure methods of data encryption for all transactions involving participants’ financial information using 
a level of security comparable to what is used in commercial financial transactions. We believe this 
multi-layer system of data security, identical to the system protecting the University of Pennsylvania 
Health Systems medical records, greatly minimizes the risk of loss of privacy. 
4. Overall Objectives/Specific Aims 
Primary  
1. 
Assess the effectiveness of a daily lottery-based financial incentive, relative to the control 
group, on cumulative weight loss over an 18-month period. H1: Mean weight loss from 
baseline to 18 months among participants randomized to the lottery incentive will be at least 
5 kg greater than among control group participants.  

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2. 
Assess the effectiveness of environmental strategies, relative to the control group, on 
cumulative weight loss over an 18-month period. H2: Mean weight loss from baseline to 18 
months among participants randomized to the environmental strategies group will be at 
least 5 kg greater than among control group participants.   
3. 
Assess the effectiveness of the combined incentives and environmental strategies arm, 
relative to the control group, on cumulative weight loss over an 18-month period. H3: Mean 
weight loss from baseline to 18 months among participants randomized to the combined 
arm will be at least 8 kg greater than among control group participants.  
4. 
Assess the comparative effectiveness of a combination of lottery-based financial   incentives 
and environmental strategies on cumulative weight loss over an 18-month period. H4: Mean 
weight loss among participants randomized to the combined arm will be at least 3 kg 
greater than among participants in either of the individual arms.   
 
Secondary 
 
5. 
Assess costs of each of the intervention arms from both the employer and social perspective 
and compare cost differences between each arm relative to effectiveness measured by 
incremental weight loss achieved.   H5: From an employer's perspective, each individual 
intervention will have favorable cost-effectiveness ratios relative to control; the combined 
arm will have a favorable cost-effectiveness ratio relative to individual arms.  
5. Primary Outcome Variable 
5.1 Change in weight from baseline to 18 months.  
5.2 Specific Aims 1-3  
Compare effectiveness of financial incentive, environmental strategy, and combined arm to control 
during Phases I and II.  For expected weight change between months 0-18 of -8 kg, -5 kg and 0 kg in the 
combined, intervention and control groups, respectively (a net difference between single intervention 
and control groups of 5 kg and between combined intervention and control groups of 8 kg) and 
assuming a standard deviation (SD) of weight loss of 5 kg, 65 participants per group provide greater than 
90% power to detect a difference with each intervention arm and control. With this sample size, there 
will also be approximately 87% power to detect a difference between the combined intervention arm 
and each of the single intervention arms. These calculations assume a 20% missing rate at the end of 
Phase II and hypothesis testing done using the Holm p-value correction for multiple comparisons (more 
details provided below).  
5.3 Specific Aim 4 
Compare effectiveness of financial incentives and environmental strategies and combined arm during 
Phases I and II. 
6. Secondary Outcome Variable(s) 

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Specific Aim 5  
6.1 Compare the cost differences between each arm relative to the effectiveness measured by 
incremental weight loss achieved. 
7. Study Instruments 
7.1 Surveys/Assessments will be administered during various time points throughout the study via the 
online Way to Health (WTH) study platform  
7.2 Medical history variables will be obtained as part of eligibility screening on the WTH study website.  
 
7.3 Demographic measures will be collected at baseline (race, income, household size, education).     
7.4 Physical Activity:  The Global Physical Activity Questionnaire (GPAQ) measures adherence to national 
recommendations for moderate (30 minutes moderate physical activity 5 days per week) and vigorous 
(20 minutes continuous vigorous activity on 3 days per week) physical activity recommendations. This 
will be collected at 0, 6, 12, 18, and 24 months.  
7.5 Dietary Behavior: The Food Intake 3 Factor Eating Questionnaire will be collected at months 0, 6, 12, 
and 18, and 24.  
7.6 Stages of Change Model [Transtheoretical Model (TTM)], a commonly used measure of behavioral 
change which envisions the process of behavior change as stages through which an individual may 
progress, regress, or cycle as needed. This correlates with many types of health behaviors within 
different populations. This will be measured   at 0, 6, 12, 18, and 24 months.    
7.7 As an ongoing measure of health-related quality of life we will use the SF-8 form (shortened version 
of SF-36, to assess quality of life in different domains in the general population) to reduce data 
collection and respondent burden. The SF-8 form will be administered at 0, 6, 12, 18, and 24 months.  
7.8 We will use the EuroQol survey at 0, 6, 12, 18, and 24 months. The EuroQol survey is an assessment 
for overall quality of life.  
7.9 Biometric assessment data, medical benefit claims information, and wellness program activities 
data: 
Biometric assessment data will be obtained as part of their routine biometric assessments by the 
participant's employers (or 3rd party wellness vendors who provide wellness services for employees of 
IBC, the City of Philadelphia, and SEPTA), all of whom share the same insurance carrier, Independence 
Blue Cross. {height; weight; blood pressure; cholesterol; glucose; HbA1c (if applicable to participant). 
The opportunity to have these data collected for free are available to employees  at  SEPTA,  IBC,  and  
the  City  of  Philadelphia  as  part  of  annual  wellness biometric screening. Approximately 30% of all 

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employees participate in biometric screening. We will use this as a secondary measure for exploratory 
analyses.  
Medical benefit claims information will be collected from the participants’ insurer, Independence Blue 
Cross, which is relevant to our research.  
Information on the participants’ use of wellness program activities provided by the employers will be 
collected (the City of Philadelphia, IBC, SEPTA).  
• 
The use of wellness program activities and biometric screening results will only be collected 
from the time participants enroll in the study until their completion date of the study. The 
medical benefit claims information will be collected starting from one year prior to participants’ 
enrollment in the study, until their completion date of the study.  
• 
The three categories of data listed above (biometric assessment data, medical benefit claims 
data, and wellness program activities) will be included in the informed consent form. In 
addition, all necessary Data Use Agreements, including the method of transfer to the University 
of Pennsylvania, will be executed and communicated to the IRB prior to the transfer of all data.  
7.10 Withings Scale: Digital scales will be distributed to subjects in this study to measure and 
electronically deliver subjects'  weight  measurements  throughout  the study  using  a secure wireless 
connection. 
8. Study Design 
8.1 Research Design and Methods 
Study participants will be obese employees recruited from three employers: SEPTA, IBC, and the City of 
Philadelphia. We will structure the first 6 months of the study (Phase I) as a weight loss phase in which 
participants will be encouraged as a weight loss goal to lose 0.5 pound per week [Note: weight loss 
targets for sample size calculations use kg to fit in with the literature but we will use pounds for the 
incentive targets, as that is what Americans are most familiar with]. Phase II (months 7-18) will consist of 
a period of weight loss maintenance in which participants will be able to choose a weight loss goal each 
month of either 0 or 0.5,  pounds of weight loss per week. Phase III (months 19-24) will be a period of 
post-intervention follow-up concluding with an in-person weigh-in at month 24.  
Participants will be randomized to either a control group (information provision and the standard 
wellness program at each employer along with measurement of weight at 0, 6, 12, 18, and 24 months), a 
lottery-based financial incentive, or a series of environmental strategies and counseling regarding  food  
intake  and  physical  activity,  or  a  combination  of  the  financial  incentive  and environmental 
strategies. Participants in the incentive arm will be eligible for daily winnings based on the weights that 
are transmitted using wireless scales which we will provide so that they receive daily feedback on their 
winnings to keep weight loss goals salient. However, we will only provide the full payments based on 
validation of weight measurement at 6 months intervals, taking advantage of the motivating power of 
loss aversion by highlighting to participants that they only receive their daily winnings if they continue to 

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maintain weight loss (or lose further weight) (an approach we have used with great success in previous 
studies).  
All participants will receive $50 after validation of weight measurements at months 0, 6, 12, and 24, and 
$75 at the 18-month time point, regardless of what their weight is, an approach we have used in many 
studies to minimize the risk of differential rates of lost to follow-up in the intervention and control arms. 
The study is powered to test the effectiveness of each intervention arm relative to control as well as the 
relative effectiveness of the intervention arms. A cost-effectiveness analysis will be conducted to 
examine potential  for  wider  dissemination  and  implementation.  Measures and time points are 
shown in Table 1 (attached with the protocol application). We will leverage existing annual biometric 
assessments done by each of our employer partners at baseline, 12 months, and 24 months for 
information on glucose, cholesterol, and blood pressure. Dependent measures for primary aims: We will 
use change in weight as the primary outcome measure. This will match our primary outcome with the 
tracking that participants are doing on their own at home using wireless scales.  
Measures of mechanisms for degree of weight change: Approaches to assessing measures related to 
daily weight tracking, dietary behavior, physical activity, and psychosocial constructs are as follows: 
Ongoing tracking of participation: For all participants we will use the Way to Health system to track 
participation  in  their  respective  arm:  (1)  daily  weigh-ins  and  receipt  of  incentives  (incentive  and 
combined arm); (2) daily weigh-ins and use of environmental strategies at home or at work 
(environmental, incentive, combined arm); (3) study follow-up visits attended regardless of arm. The 
Way to Health system will track this using a substantial degree of automation. In the Environmental and 
Combined arms, use of recommended strategies will be tracked by logs as described above. If necessary, 
a stepped approach to greater promotion of the strategies will be used to ensure adequate uptake or 
dose of the environmental  strategies 
8.2 Measurement of cost-effectiveness   
We will conduct a within-trial analysis that directly compares incremental costs and maintenance of 
weight loss using data measured in the trial. The principal analyses will compare over 18 months the 
incremental cost effectiveness ratios estimated from the incremental costs and effects between each of 
the individual arms and the control group as well as the combined intervention versus each individual 
arm. The analysis will be from the employer perspective, as the employer faces the decision as to 
whether to implement this program. Secondary analyses will evaluate the same incremental cost- 
effectiveness ratios but: 1) use data following 6 months of post-intervention follow-up (24 month visit); 
2) use data at 12 months, a common follow-up interval in employee health programs; and 3) use the 
limited social perspective (because participant costs are crucial to understanding the full economic 
impact of interventions). Measurement  of  cost:  For  the  employer  perspective,  measured  costs  will  
include:  1)  incentive payments; 2) administrative costs of providing the interventions; and 3) medical 
expenditures. For the limited  social  perspective,  measured  costs  will  include  1)  the  costs  included  
in  the  employer's perspective, 2) exercise costs, and 3) costs of nonstudy counseling services. This 
social perspective is limited in that we include incentive payments (which are transfers and typically 
omitted from the social perspective) and federal fee schedules to cost out medical services (as a proxy 

13 
 
for social opportunity cost). Service use already documented in the study: Many of the services that will 
be costed out are already  being  measured  in  the  clinical  case  report  forms  detailing  participant  
adherence  to  daily feedback, lottery winnings, attendance and participation, dietary behavior, and 
physical activity.  Project personnel diaries: Project personnel will complete time-diaries quarterly 
detailing their time spent on administrative tasks in the past week including time administering all 
participant related aspects of the intervention and usual care (excluding time related to general project 
administration). These tasks will be itemized by type of activity. They will also record the number of 
participant contacts by type of activity. Using personnel wages, these dairies will be used to estimate 
unit costs of administrative contacts. Elements of cost: 1) Incentive payments. Incentive payments to 
participants will be computed directly from the amount of incentive paid in the trial. The costs will 
include the daily lottery payments and the direct payments. 2) Administrative costs of program: The 
administrative costs of the incentive and environmental strategies interventions will include those for 
maintaining account balances, mailing payments and conducting follow-up visits, and other costs such as 
the scales used to weigh the participants. We will include project personnel costs by measuring the 
average time required for project personnel to conduct specific intervention-associated administrative 
tasks as opposed to general project/ evaluation administration using personnel wages to convert this 
administrative time to costs. 
 
8.3 Key Inclusion Criteria 
Eligibility Criteria:  Men and women > 18yrs. of age who are full-time or part-time employees at SEPTA, 
IBC, or the City of Philadelphia; who have a BMI of 30 to 55 kg/m2. (the upper limit of BMI will minimize 
the influence of outliers on the main result of weight loss). Participants must also have at least one 
other cardiovascular risk factor (high blood pressure, hypercholesterolemia, diabetes, smoking), which 
will be obtained by self-report. Participants must receive their health benefits from Independence Blue 
Cross; one of our partners in the study. 
8.4 Key Exclusion Criteria 
Exclusion criteria will be limited to factors that may confound results or that make participation in a 
weight loss program unfeasible, unsafe, or require more intensive monitoring, as detailed in our prior 
work.  These exclusions include: unstable heart disease, uncontrolled hypertension, kidney disease, and 
other  serious  chronic  illness  (e.g.,  transplant  recipient,  terminal  illness);  substance  abuse;  bulimia 
nervosa or related behaviors; or diabetes medication other than metformin; pregnancy or breast 
feeding; contraindications to counseling about diet, physical activity, or weight reduction; unstable 
mental illness. Participants with diabetes on medications besides metformin are excluded because these 
medications may require adjustment during weight loss to prevent hypoglycemia and dehydration. 
Individuals unable to read consent forms or fill out surveys in English will be excluded. 
9. Subject Recruitment 
9.1 Target Population 

14 
 
For this study we are collaborating  with 3 important  community  partners  in Philadelphia:  SEPTA 
(which  runs  public  transit  in  Philadelphia);  IBC,  the  region’s  largest  insurer;  and  the  City  of 
Philadelphia,  the  largest  employer  in  Philadelphia.  Each of these entities has  a  large  number  of 
employees (9,200 SEPTA; 4,500 IBC; and 5,300 City of Philadelphia) with a high degree of obesity 
(estimated 55% SEPTA, 36% IBC, 42% City); and a high proportion of African Americans (56.6% SEPTA, 
38.4% IBC, 50% City). Eligible participants will be men and women above age 18 who are full-time or 
part-time employees at SEPTA, IBC, or the City of Philadelphia who have a BMI of >30 to < 55 kg/m2. 
Participants  must  also  have  at  least  one  other  cardiovascular  risk  factor  (high  blood pressure, 
hypercholesterolemia, diabetes, smoking), which will be obtained by self report. 
 
9.2 Accrual 
There are an estimated 4,800 employees from the Southeastern Pennsylvania Transportation Authority 
(SEPTA), Independence Blue Cross (IBC), and the City of Philadelphia who have BMI greater than 30 and 
1 or more cardiovascular risk factor, of whom approximately 48% are black. We plan to enroll 344 
participants over 6 months making our recruitment targets easily attainable given the size of the 
recruitment pool. 
9.3 Subject Recruitment 
With assistance from IBC, SEPTA, and the City Department of Public health, we will advertise this as a 
research study of different ways to help people lose and keep off weight. The initial outreach to 
employees will be facilitated by IBC, SEPTA, and the City of Philadelphia, utilizing their existing 
communication channels (e.g. letter mailings, email, text, intranet, flyers, posters, digital display in the 
workplace). All recruitment materials will be submitted to the IRB before any study activities occur. 
Interested participants will be asked to go to the Way to Health (WTH) website for prescreening and 
eligibility ascertainment. The screening intake form will be completed using the WTH website 
supplemented by phone support as needed. In order to verify BMI eligibility for the study, a verified in-
person weight measurement will be required during the screening process.   
Recruitment at Independence Blue Cross site (IBC): 
After initial outreach by IBC’s communication channels, individuals will be asked go to the 
Way to Health (WTH) website for prescreening and eligibility ascertainment.  In collaboration with IBC, 
the research study team will have a table set up at the IBC site during their annual biometric screening 
event. For IBC employees who previously completed online pre-screening and consent, the research staff 
will obtain individuals’ weight measurement from their biometric screening. For 
IBC employees who did not complete the online p re-screening and consent prior 
to the biometric screening event, verbal consent will be obtained (similar to phone 
screening) to record their weight measurement from the biometric screening in order to 
determine BMI eligibility for the study.  

15 
 
For IBC employees who are interested in the study but did not attend the biometric screening event, in-
person weight measurements will be obtained on site by the Fitness Director at IBC’s MediFit Fitness 
Center. For these IBC employees, informed consent will have been obtained (online) in advance of the 
in-person weight measurements. Specific language is outlined in the consent form reflecting this 
method of in-person weight measurements for IBC employees. Individuals weight data will be 
transferred to the research team via SecureShare; a web-based application used by the University of 
Pennsylvania for secure file exchange 
 
 
Recruitment at SEPTA site:  
After initial outreach by SEPTA’s communication channels, individuals will be asked go to 
the Way to Health (WTH) website for prescreening and eligibility ascertainment. In-person weight 
measurements will then be obtained at the SEPTA medical department by the research study staff, and 
also by the SEPTA nurse. The SEPTA nurse is also the main point-of-contact working with the research 
team for this study. The SEPTA nurse will obtain in-person weight measurements only on an as needed 
basis in the event research staff is not available to be on-site.  
In-person weight measurements at the City of Philadelphia (CoP) site:  
After initial outreach by the City of Philadelphia’s communication channels, individuals 
will be asked go to the Way to Health (WTH) website for prescreening and eligibility ascertainment. In-
person weight measurements will then be obtained at the CoP site by the research study staff.  
 
9.4 Subject Compensation 
To enhance retention, we will provide participants a total of $250 for completing follow-up visits. 
Participants will receive $50 for completing weights at the screening baseline visit and at follow-up visits 
at 6, 12, 18, and 24 months regardless of weight. This strategy has minimized differential drop out in our 
previous studies.  (For the lottery incentive payments, please refer to the 'Design of the Incentives' 
header in the Procedures section of this application) 
 
10. 
Study Procedures 
Consent Process 
10.1 Overview 
Upon the initial outreach, individuals who are interested in learning more about the study will be 
directed to the Way to Health web portal.  Upon reaching the portal, participants will complete a 

16 
 
screening intake form to determine their eligibility. If participants are interested in participating, the 
Way to Health portal will take them through an automated online written informed consent session. The 
consent session 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. Each section will have a button allowing the 
user to contact a researcher via email if she has questions about the consent form. Successive screens 
will explain the voluntary nature of the study, the risks and benefits of participation, alternatives to 
participation, and that participants can cease to participate in 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 then be 
randomized to one of the four arms by the web application. The participant will be led through an 
automated description of the details specific to that arm. After receiving such information, participants 
will be asked to confirm that they understand and wish to continue. Participants will be able to contact 
the research staff if they have any questions about their assigned condition before they proceed to the 
next step. 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 subjects individual Way to Health web portal 
dashboards throughout the study. 
Procedures 
 
10.2 Baseline pre-treatment assessment for patients 
Individuals who meet study entry criteria and have provided consent online will complete an intake 
survey measuring their health history, dietary intake, exercise habits, and previous weight loss efforts, 
and selected psychosocial variables shown to predict weight loss participation and success. 
 
10.3 Randomization 
Randomization: Study participants at study inception are randomized through the Way to Health 
Platform using a random number generator and permuted block randomization with variable block sizes 
to force balance among treatment group assignments; variable block sizes will preclude prediction of 
treatment assignments by study staff. Randomization will be in a 1:1 ratio for each intervention 
compared to control and will be stratified by: (1) the employer site; (2) sex, and (3) degree of obesity at 
baseline (BMI 30-37.9 and 38-55 kg/m2), as baseline BMI may moderate treatment effects. Following 
randomization, the study coordinator will provide instructions about the control, incentive, or 
environmental arms. 
10.4 Environmental Change Strategies 
The environmental change strategy arm will involve a menu of promising or evidence-based 
environmental change strategies to promote healthy eating and physical activity, delivered through 
print, website-based and mobile communication channels to employees assigned to the Environmental 
and Combined arms of the trial. The strategies have been identified through systematic literature 

17 
 
reviews, through Dr. Glanz' previous intervention studies, and from discussions with collaborators 
working on novel environmental change strategies.  The planned environmental change strategies  are  
based  on  our  preliminary assessment and discussions with the participating worksite informants 
during the development of this proposal and are circumscribed by the context of these urban worksites 
and the structure of their employees work activities. The interventions are targeted at individual 
employees rather than work groups, due to the inclusion criteria (i.e., obese employees with at least one 
other CVD risk factor), feasibility considerations (individual rather than group randomization, total 
resources available), and the potential for translation, scalability and dissemination. As in many urban 
worksites, there are no in- house cafeterias but employees have access to lunchrooms for limited food 
and beverage preparation and storage (refrigerators, microwave ovens, vending machines) and are 
located near numerous food sources  (restaurants,  quick-serve  or  fast-food  restaurants,  lunch  trucks,  
snack  bars).  Also,  these worksites do not have fitness facilities on-site but have ample access to 
stairways, neighborhood gyms, and  walking  routes  and  parks  within  a  5-10  minute  walk  of  their  
worksites.   
Healthy eating environmental change strategies will be designed to guide participants in identifying 
environmental influences on excess food intake and making environmental modifications easier for 
them to implement in their worksites, in the area around worksites, and in their homes. At the worksite, 
the strategies will emphasize identifying healthy vending options, healthy snack access, social 
environment change, and establishing healthy catering policies for work-based events. In the 
neighborhood near the worksite, strategies will include tools to help workers find healthy choices easily 
at restaurants and periodic promotions (arranged with vendors) to encourage trying new healthful 
prepared foods. Home environment changes will be guided by the Home Food and Activity Environment 
Audit tool, originally developed for research conducted by Dr. Glanz and colleagues at the Emory 
Prevention Research Center and recently adapted for an urban, low-income community intervention. 
Physical activity environment change strategies will also include strategies for worksites, near worksites, 
and in homes. At the worksites, strategies will include individually-delivered prompts to use stairs, 
standing desks, and walking breaks. In the area near worksites, strategies will include guidance on safe, 
convenient walking routes, link to benefits for incentives toward gym memberships, and safe bicycling 
paths. The Home Food and Activity Environment Audit will address physical activity environments in 
homes. Environmental strategies will be communicated to participants in the Environmental and 
Combined study arms twice weekly during the first 6 months, and weekly during months 7-18.  
They will be varied to maintain interest and offer a variety of approaches that participants can use. The 
Way to Health platform will be programmed to send links to web and mobile intervention information, 
and to prompt participants who wish to have hard copy/paper copies of intervention materials.  One 
week after a strategy tool is distributed, a simple log will be provided for participants to indicate their 
liking for, and use of, the various strategies. All participants in each of the three intervention arms will 
also receive a free wireless scale (value $110) as this will be used to both obtain weights and provide 
participants with feedback. We are not providing these scales to participants in the usual care arm 
because that would not be consistent with usual care. Usual care: Employees of IBC, SEPTA, and City of 
Philadelphia are all offered the same wellness program that consists of: (1) yearly biometric screenings 

18 
 
for which members receive incentives to participate; (2) reimbursements for fitness and weight 
management program participation (up to $150 per year for documentation of 120 workouts and up to 
$150 for documentation of participation in Weight Watchers); (3) Eat Right for Life educational program 
which includes onsite seminar and workshop materials; (4) six visits with a registered dietician as part of 
health benefit; (5) free use of WebMD tools - members biometric data is uploaded or self-reported and 
tools are available to the member to set goals and track progress.  
Psychological research has identified social support as a factor that can help support weight loss.  In an 
effort to strengthen the social support environment for participants in the environmental strategies and 
the combined incentives and environmental strategies arms, we will create a “secret” Facebook group 
where participants in these arms will be encouraged to provide support and seek support from one 
another.  We will encourage wall posts of text, healthy recipes, pictures related to nutrition, physical 
activity and the environment.  The research study team will periodically post helpful links or tips that 
participants can use to improve their nutrition and physical activity environment.  
Language added to the original informed consent document informs participants that we will ask 
participants assigned to some arms (who wish to join a voluntary Facebook group) to provide us with 
their Facebook e-mail address.  Participants will be asked to provide us with their Facebook e-mail 
address by completing a single question survey on their personal account page on the Way to Health 
platform.  Preceding the survey will be a Facebook addendum to the consent explaining more in depth 
details of participation in the Facebook group.  Participants will be informed here that they can view and 
print a version of the Facebook addendum from their personal Healthy Weigh account page at any time. 
This form will also direct participants to view the “study instructions” section of their dashboard content 
for more specific information on how to locate one’s Facebook e-mail address, how to create a 
Facebook account, and how to accept our Facebook invitation.   If participants do not have a Facebook 
profile, or choose not to provide us with this information, they may still participate in the study. This will 
be notated  in the Way to Health dashboard content  and on the Facebook addendum.  We will invite 
participants in the environmental strategies arms to join the group called “Healthy Weigh,” via the 
Facebook e-mail address that they provide through the single question survey.  Participant identity will 
only be revealed to other enrolled subjects in the environmental strategies arms if a participant decides 
to join the Facebook group. If a participant declines, they will remain anonymous.    
The privacy type for the group will be “Secret.” This means that only research staff will have control over 
who joins the group.  Only current or former group members, people who were in the group but left, 
can see the group’s name.  No one outside of the study will be able to locate, view or join the group 
without an invitation from the study team.  Only current members can see who else is in the group.  
Only current and former members can see group activity.  Only current members can post in the group.  
Only current and former members will be able to find the group in a search.   Only current members can 
see stories about the group on Facebook (in the News Feed and search).   
The research study team will closely monitor Facebook group activity in order to ensure that all activity 
occurring with the group is appropriate and related to the study.  If an inappropriate post is made the 
research study team will promptly remove the post, and will contact the participant who made the post 

19 
 
to review the purpose of the group and to review with the participant which types of posts are  
appropriate for the purposes of the research study.  Inappropriate posts are any posts that do not relate 
to weight loss, social support, nutrition, physical activity, or the environment.   
We intend to analyze the Facebook activity of participants within the Facebook group in order to 
determine: how many and which participants opt to join the group; how many posts, likes, and 
comments each participant makes during the study period; and whether the amount or nature of 
Facebook group activity corresponds with weight loss success.  We also plan to look qualitatively at the 
nature of the posts, likes and comments of participants.   No data analysis will be conducted until the 
end of the intervention.  Data will be transcribed directly from Facebook into an excel sheet for tracking 
and organization of participant activity.  This task will be completed by the research study personnel. 
The excel sheet will be stored in a password protected file on the secure/firewall servers of the PMACS 
Data Center, in data files that will be protected by multiple password layers. These data servers are 
maintained in a guarded facility behind several locked doors, with very limited physical access rights.  An 
additional amendment will be forthcoming, which will explain the detailed data analysis process.    
 
10.5 Outcome assessments  
Weight for all participants will be ascertained in-person upon enrollment into the study and then at the 
visits at the end of Phase I (6 months), at 12 and 18 months (end of Phase II), and at 24 months (end of 
Phase III). The primary outcome will be change in the in-person weight from baseline to 18 months. We 
will utilize other measures collected at months 6, 12, 18 and 24 as part of routine biometric assessments 
by the participants’ employers, all of whom share the same insurance carrier, Independence Blue Cross 
(IBC). The allowable visit windows for these weight milestones are: -2/+4 weeks for the 6 month visit,     
-2/+6 weeks for the 12 and 18 month visits, and -2/+8 weeks for the 24 month visit. 
 
10.6 Design of the Incentives  
The incentive programs incorporate key aspects of optimal design, including objective and reliable 
confirmation of behavior change at specified intervals (weight measurement), reinforcement of the 
target behavior (weight maintenance) with non-drug reinforcers (incentives), large payments to 
reinforce the target behavior, and intermittent reinforcement. All incentive participants will receive 
daily feedback for 18 months; they will be given an electronic scale (accurate to ±0.2 lbs) and given a 
weight loss goal for the first 6 months of 0.5 lb a week. At the beginning of Phase II and each month 
from months 7-18 they will be asked to set a goal of either maintaining weight loss or losing further 
weight (e.g. choice will be either 0, 0.5 pounds per week, with a default of 0 pounds if nothing is 
chosen). Inviting people to set more ambitious goals than maintenance is based on evidence that people 
often voluntarily commit to more ambitious goals than would be economically rational and this 
commitment can help them achieve those goals.  

20 
 
Each month we will provided each study participant with a graph on the web portal that shows a line 
beginning at their current weight and dropping to their target weight over the remaining months of 
Phase I (see Figure 4 in grant proposal, which presents a sample weight loss line for a participant who 
begins Phase I at 250 lbs and sets a one pound per week weight loss goal over 6 months ideal weight 
loss trajectory and fresh start trajectory described below.). Participants will self-monitor weights daily. 
Each morning before eating or drinking and after urinating, participants will weigh themselves and their 
weights will automatically be transmitted by the Withings Scales to the Way to Health system.  
Participants will then receive automated feedback from  the  system  (they  may  choose  text or email)   
on their progress relative to their goals and their potential earnings, helping to make the payments feel 
immediate. They will be told that they will receive the full amount if they meet the 6 month target for 
their weight (the sum of the monthly weight loss goals) but half the money if they do not. Daily 
monitoring provides participants with a frequent reminder of their goals, chosen because people tend to 
adopt a narrow frame of reference to diets, rededicating themselves each day. Daily weigh-ins should 
reduce binge eating by making participants constantly accountable for their weight. Monthly graphical 
feedback provides encouragement and a symbolic reward for slow and steady progress. Participants in 
the lottery arm will be eligible for a daily lottery prize with an expected value of $3.00/day if, prior to 
resolution of the lottery, they reported a weight at or below their goal on the ideal weight loss trajectory 
in Figure 4. The lottery provides both infrequent large payoffs (a 1 in 100 chance at a $100 reward) and 
frequent small payoffs (a 1 in 5 chance at a $10 reward) since subjects are motivated by both the future 
(fixation on large potential winnings) and the past (how often did I win?). Subjects will be assigned a 2-
digit number with two distinct digits upon entry into the study, e.g. 27. A two digit random number will 
be generated for each day. If the last digit includes either a 2 or 7 (a 1 in 5 chance), and the subject 
reported a weight at or below target weight, s/he wins $10. If the two digits are 27 (a 1 in 100 chance) 
the subject wins an additional $100. When a subject reports a weight above target, we will still generate 
a 2- digit daily number and tell the subject if s/he would have won the lottery that day if s/he had 
reported a weight at or below target. We believe that a desire to avoid the regret associated with not 
winning combined with learning that one would have won, had one been adherent, will motivate 
participants to a greater degree than only on the value of the rewards. A key aspect of the weight loss 
trajectory is that it can be reset monthly, a critical feature in the likely event that a participant falls short 
of attaining a monthly weight loss goal. To avoid discouraging such subjects, who would otherwise 
suddenly have to lose a lot of weight to get back on track and might decide to drop out of the study, 
each participant will be given the opportunity for a fresh start. The overall goals set at beginning of 
Phase I will stay the same, but the slope of the trajectory will adjust (i.e., steepen) such that the 
participant need not binge diet following a month of poor weight loss performance (see Fresh start 
trajectory in Figure 3, for a subject who lost 1 lb. instead of 4 lbs. in first month). Keeping the overall 
weight loss goal constant makes the procedure fair for participants who maintain the ideal trajectory, 
while adjusting the slope of the weight loss line allows for recovery from slip-ups, an approach we have 
used to attain minimal lost to follow-up rates of less than 10% in previous weight loss studies. To give 
participants frequent feedback, we will pay out 50% of winnings to date at the end of each month. To 
minimize falsification of weights and to utilize the amplification of motivation provided by loss aversion, 
the other half will be held in a virtual account and paid to participants at the end of each 6-month 

21 
 
period only if they have met or exceeded their monthly goal. The monthly goal will include a two-pound 
margin to account for the added weight of clothing worn by participants at each 6 month in-person 
weigh-in.  Between months 19-24 (Phase III), participants will not receive incentives tied to weight 
maintenance to evaluate sustainability of effects achieved in Phases I and II. 
10.7 Study Duration 
The duration of participation for each individual participant is expected to be is 2 years (24 months). We 
plan to recruit and enroll participants starting in April 2015, until June 2015 (over a three month time 
period). We expect the total duration of the study to last 5 years (60 months) for the completion of all 
three phases of the study. 
10.8 Dissemination 
Findings from this research will be disseminated through incorporation into the wellness/benefits design 
for employees of City of Philadelphia, SEPTA, and IBC. Broader dissemination will include use in benefit 
design approaches used for IBC throughout the region and more widely through collaborating 
organizations  nationally,  other  employers,  and  health  delivery  organizations  once  findings  are 
published. 
11. 
Analysis Plan 
11.1 Statistical Considerations 
Descriptive analyses 
We will produce data summaries regularly using frequencies for categorical variables and means, 
medians, and ranges for continuous variables. We will assess data quality and examine distributional 
assumptions with graphical methods.  To evaluate balance among groups achieved by randomization, 
we will compare baseline values of all variables across the 4 arms using appropriate tests.  
General procedures 
 All primary analyses will be on an intent-to-treat basis including each participant in the group to which 
s/he was randomized, regardless of adherence to the assigned strategy. Given the high rates of missing 
data typical of weight loss studies, handling of missing data is an important issue. Primary analyses will 
use multiple imputation for the missing in-person weight outcome at 18 months, using the 
randomization strata (sex, employer, initial BMI), study arm and other baseline variables as predictors in 
the imputation model. Baseline variables will include age, race, income, education, marital status, 
household size, physical activities, eating behavior index, stages of change, SF-36 General Health, and 
baseline weight. Sensitivity analyses will be performed with imputation models that also use post-
baseline data, , and recent weight loss trend before drop out, as well as an analysis that assumes that 
any participants for whom follow-up weight loss data are unavailable have had their weight return to 
baseline (weight at beginning of Pre Phase). Within each arm, this last assumption is likely to be 
conservative but this may not be the case in inter-arm comparisons, depending on the dropout rates in 

22 
 
the different arms and true follow-up weights of the dropouts. Thus, a key secondary analysis will 
consider the effect of differential dropout among the treatment arms. For this analysis, methods that 
address potential patterns of MNAR may be considered in the missing data imputation, such as pattern 
mixture models as appropriate. Finally, we will also consider a per-protocol type analysis, which 
examines the difference in the intervention arms in the complete case data. 
Efficacy Analyses 
 All hypotheses will be tested using two-sided, 0.05-level tests unless otherwise specified (notably the 
Holm testing approach will be used for the five primary hypotheses in Specific Aims 1-4). The primary 
analyses will be an unadjusted intent-to-treat analyses, using a t-test for differences in weight change 
from baseline to 18 months, as measured by the in-person weight, between each intervention group 
and the control group, and the combined compared to each single intervention, applying the Holm p-
value correction for multiple comparisons testing. If weight change appears to be non-normally 
distributed in the blinded data, we will find an appropriate. Missing data will be handled as described 
above.  
Weight change between baseline and 18 months, with 95% confidence intervals (CIs), will be estimated 
for comparison with adjusted analyses.  We will estimate regression models adjusted for the 
stratification variables (sex, employer,  initial  BMI) and other participant characteristics factors including 
age, race, income, and education. We will evaluate the evidence of confounding for other baseline 
variables (baseline weight, marital status, household size, physical activities- i.e total minutes of 
MVPA+walking/week, eating behavior index, stages of change, SF-36 General Health)  using change in 
estimate criterion (10%). We will fit exploratory models of the repeated weight measurements that 
incorporate time as a polynomial function or using visit-specific indicator variables to determine the 
most parsimonious model that adequately describes the observed patterns, as necessary. Models will be 
built separately for the in-person and at home weight data. Models using the at-home weight data 
would be considered only as potential exploratory analyses comparing the 3 intervention arms, since at-
home weights are not available for the control arm. We will investigate random-effects models that 
allow for baseline individual variability as well as variability in the changes in weights over time; an 
example is the following: E(weightij) = 0 +1Timej + 2Groupi+ 3Xi + b0i + b1i Timej, where i indicates 
subject, j indicates assessment times, the parameters are fixed effects linking time, a treatment group 
vector, and a vector of other demographic or clinical covariates Xi to the outcomes, and b0i and b1i are 
random intercept and slope effects. Tests for significance of random effects will use likelihood ratio tests 
for nested models; we will compare models with different random effects structures using the 
maximized log-likelihoods and the Akaike Information Criterion (AIC). We will apply standard diagnostic 
techniques to assess model adequacy. We will use treatment by time interactions to assess whether the 
rate of change in weight differs by intervention arm. We hypothesize that incentives may be more 
effective among lower income individuals and will evaluate this using interaction terms of income with 
treatment group. We will explore differential effects by race and education and baseline levels of 
intrinsic motivation and stages of change. We will also consider other potential mediators, such as the 
home food and activity environment. To assess the sensitivity of treatment effect estimates to missing 

23 
 
data, we mayfit hierarchical or mixed effects models with and without accounting for informative 
missing data. 
For Specific Aim 5, we will consider appropriate methods for cost effective analysis such as the models 
proposed below. We will assess the costs of each of the intervention arms from both the employer and 
social perspective and compare the cost differences between each arm relative to the effectiveness 
measured by incremental weight loss achieved. The principal incremental cost-effectiveness ratios 
between intervention and control arms will be from the employer’s perspective and we will compare 
costs during the intervention from baseline to 18 months per unit change in weight. Secondary analyses 
may also 1) evaluate this same ratio but use either 6 months post- intervention data (24 month visit) or 
12 months of intervention data (12 month visit) and 2) evaluate these 2 ratios using a limited social 
perspective. Cost models will use a generalized linear model with a log link and gamma family. Missing 
data strategies will parallel those described above. We will assess sampling uncertainty for the 
comparison of costs and effects by calculating parametric 95% CIs for the cost per kg lost and 
acceptability curves. Standard errors and correlation of the difference in cost and effect will be derived 
using a bootstrap procedure. 
11.2 Power and Sample Size Considerations  
We have designed the study with adequate power to detect differences in weight loss over an 18-month 
period. Our intervention should achieve its maximal impact in maintaining initial weight loss at the end 
of Phase II (month 18), when the incentive payments cease. To maintain the experiment-wide Type I 
error  and  guard  against  false  conclusions  of  effectiveness,  we  will use the Holm multiple 
comparisons adjustment for test the 5 primary comparisons in Specific Aims 1-4 . If the interventions are 
as effective as hypothesized, the proposed sample size maintains greater than 90% power to show 
significance for each of the three intervention arms compared to control and greater than 80% power to 
show significance for the combined intervention group compared to each of the two interventions 
alone.  
It is important to note that while we originally planned to recruit 328 participants, a small subset was 
unable to successfully set up their Withings scales post randomization due to Wi-Fi connectivity issues. 
Therefore, we increased our target sample size by the number of people who were unable to connect 
their Withings scales to the Way To Health platform (16 additional subjects), bringing our recruitment 
total to 344 participants. The final statistical analysis is adjusted for the stratification factors to account 
for any imbalances that may have occurred. We have previously communicated this information to the 
IRB and the members of the Data Safety and Monitoring Board (DSMB), who approved this approach. 
The following information outlines our original power calculations and sample size considerations.  
We plan to recruit approximately one third of the  participants required for the start of Phase I from 
each of our participating employers (IBC, SEPTA, and City of Philadelphia). Given the large number of 
potentially eligible employees, we can, if needed, easily increase the proportion of participants from any 
of these employers to meet recruitment targets. Participants will be randomized to our 3 intervention 
groups and the control group using a 1:1 ratio for the intervention arms. We built in a margin of 20% of 

24 
 
our original target sample size of 328 for potential attrition before the 18-month assessment, resulting 
in an expected 260 participants (65 per arm) who are available for analysis at the end of Phase II. This 
sample size will provide us with greater than 90% power to detect a difference in weight change 
between baseline and the 18-month weigh-in of 5 kg between each single intervention group and the 
control group (primary outcomes for Specific Aims 1-3) and 87% power to detect a 3 kg difference 
between the combined group and either the incentive or environmental strategies groups (Specific Aim 
4). Namely, we will have greater than 85% power for the 5 primary comparisons of interest for an 
expected weight change between months 0-18 of -8 kg, -5 kg and 0 kg in the combined, intervention and 
control groups, respectively (a net difference between single intervention and control groups of 5 kg, 
combined intervention and control groups of 8 kg, and 3kg between the single interventions and 
combined group) and assuming a standard deviation (S.D.) of weight loss of 5 kg. We will also have 
greater than 80% power to detect a difference of 4.6 kg in weight change between single intervention 
and control groups and 7.3 kg between the combined and control groups (primary outcomes for Specific 
Aims 1-3), while maintaining approximately 80% power for a 2.7 kg difference between the combined 
and each single intervention (Specific Aim 4). For our secondary outcomes (Specific Aim 5), we wish to 
compare the cost differences between each arm relative to the effectiveness measured by incremental 
weight loss achieved.  We  will  calculate  a point  estimate  of  cost  per  kg  of  weight  loss  based  on 
estimated  inter-arm  differences  in  weight  loss  and  the  incremental  cost  of  the  interventions,  as 
described in C.3.d.ii.c. For weight loss at 18 months, given an expected incremental cost of $810 
(incentives) and incremental weight loss of 5 kg, 328 participants provide 80% power to detect a cost 
per kg lost of $430 and greater than 90% power to detect a cost per kg lost of $575. This study is 
primarily a test of the efficacy of these interventions. Due to resource constraints and because we do 
not yet know about intervention effectiveness, we did not power this study based on cost effectiveness 
analyses. Estimated detectable costs per kg are a function of wide confidence intervals due to sample 
size. 
11.3 Measurement of effect:  
The goal of this analysis will be to assess relative weight loss in the intervention arms relative to control.  
For  the  principal  cost-effectiveness  analysis,  measurement  of incremental weight  loss  will  be  based  
on  differences  in  weight  between  baseline  and  the  18  month  visit;  in secondary analyses it will be 
based on weight differences between baseline and 24 months and baseline and 12 months.  
12. Human Research Protection 
12.1 Subject Confidentiality 
Each participant will be assigned a unique, numeric identifier which will be used on all collected study 
information.  The  source  document  in  which  the  unique  identifier  is  associated  with  personal 
information will be stored in a password protected computer file to which only study personnel have 
access. All data will be stored on the Way to Health web-based platform database. Threats to 
confidentiality will be minimized by careful data collection and the private and secure web-based 
platform. At the conclusion of the study, all identifying information will be destroyed and all data will be 

25 
 
archived in a password protected folder. The web application for this study will use account-based 
authentication and permission systems to protect confidentiality. An investigator or statistician who logs 
in will be able to access only de-identified data. Only research staff will be responsible for contacting 
participants for study related activities (responding to questions about the study) will be able to view 
participant names and contact information. All of these personnel will have completed research and 
confidentiality (CITI) training. The system will automatically generate logs of all data queries, and these 
will be reviewed weekly by research staff to ensure that no unauthorized persons have gained access to 
identifiable information.   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 
Health Insurance Portability and Accountability Act certification in accordance with University of 
Pennsylvania regulations. All data for this project will be stored on the secure/firewalled servers of the 
PMACS Data Center, in data files that will be protected by multiple password layers. These data servers 
are maintained in a guarded facility behind several locked doors, with very limited physical access rights. 
They are also cyber-protected by extensive firewalls and multiple layers of communication encryption. 
Electronic access rights are carefully controlled by University of Pennsylvania system managers.  We  will  
use  highly  secure  methods  of  data  encryption  for  all transactions involving participants financial 
information using a level of security comparable to what is used in commercial financial transactions. 
We believe this multi-layer system of data security, identical to the system protecting the University of 
Pennsylvania Health Systems medical records, greatly minimizes the risk of loss of privacy. All study-
related emails will be sent to non-work based email addresses. Research material will be obtained from 
participant surveys, and the wireless scales. All participants will provide informed consent  for access to 
these materials.  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 individuals' 
information will be used for the survey data, in that individual identifiers will be used only for linkage 
purposes or to contact individuals. The study identification number, and not other identifying 
information, will be used on all data collection and contained in these databases. All study staff will be 
reminded to appreciate the confidential nature of the data collected and contained  in  these  databases.  
The UPenn Biomedical Informatics Consortium (BMIC) will be the hub for the hardware and database 
infrastructure that will support the project and where the Way to Health web portal is based. The BMIC 
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. 
12.2 Subject Privacy 
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas confidentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy   guidelines   developed   by   relevant   professions,   professional   associations   and   scholarly 
disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 

26 
 
With assistance from IBC, SEPTA, and the City of Philadelphia, we will advertise this as a research study 
of different ways to help people lose and keep off weight. The initial recruitment outreach will be 
facilitated by IBC, SEPTA, and the City of Philadelphia, utilizing existing communication channels (as 
described in the recruitment section).  Interested participants will be asked to go to the Way to Health 
(WTH) website for prescreening and eligibility ascertainment. Screening intake will be done using the 
WTH website supplemented by phone support as needed, with the final step being confirmation of 
weight by validated employee biometric assessment data (within 4 weeks), or through participants 
physicians  (documentation  provided  from  the  patient's  outreach  to  their  physician).    During  the 
screening intake on the WTH website, we will collect subjects names, addresses, email addresses, phone 
numbers, height and weight, medical history, sociodemographic data, social security numbers, and 
employees' biometric assessment data. All of these data will be stored in an encrypted database that 
conforms to applicable data security standards. Access to all such data will be limited to specifically 
designated  research  staff  that  will  be  responsible  for  contacting  participants  for  follow-ups  and 
responding to questions and concerns from participants. All communications between participants and 
the  study  website  will  be  encrypted  with  SSL/HTTPs  technology.  Social  security  numbers,  bank 
account numbers and routing numbers for all persons to whom rewards are sent will be transmitted in 
encrypted format to Accounts Payable, who will store the data for W-9 forms. After the social security 
numbers are no longer needed they will be deleted from our system. 
12.3 Protection of Human Participants:  
Human subjects involvement and characteristics. For the proposed study, 344 subjects with a BMI of 30 
to 55 kg/m2 and over the age of 18 who are full- time employees of SEPTA, IBC and the City of 
Philadelphia will be eligible for study. Eligibility will be determined from the study inclusion/exclusion 
criteria (Refer to inclusion/exclusion section of the protocol application). Exclusion criteria were limited 
to factors that may confound results or that make participation in a weight loss program infeasible, 
unsafe, or require more intensive monitoring. These exclusions include unstable heart disease, 
uncontrolled hypertension, kidney disease, and other serious chronic illness (e.g., transplant recipient, 
terminal illness). Patients with diabetes mellitus on hypoglycemic medication other than metformin will 
be excluded because medication adjustments and monitoring that they would require is beyond the 
scope of this trial. Patients on diabetes or high dose diuretic medication are excluded because these 
medications may require adjustment during weight loss to prevent hypoglycemia and dehydration. 
Women who are pregnant or breastfeeding are excluded because their energy requirements are 
obviously different from other individuals. Substance abuse and unstable mental illness were chosen 
because adherence to the intervention may be disproportionately difficult in these individuals compared 
with other individuals. We will exclude temps or part-time employees because lost to follow-up rates 
over 24 months may be high. Persons with a history of bulimia nervosa-related behaviors are excluded 
because they may employ these behaviors to reach their weight goals. We will also exclude potential 
subjects who cannot or will not give consent. No subjects will be excluded on the basis of sex or race. 
There will be approximately equal representation of African-Americans and Caucasians and 30%-40% 
men based on our recruitment experience in previous weight loss clinical trials and the demographics of 
the employer populations.  

27 
 
12.4 Cost-Effectiveness Analysis.  
Participants will be asked to provide informed consent when enrolled in the research project after full 
explanation of the research project. For the cost- effectiveness analyses, we will not be using claims data 
so HIPAA authorization related to access to their medical charts will not be required. We will request 
access to all biometric data collected as part of employer wellness programs that study participants are 
part of. All participants will be over the age of 18. Women and minorities will be included.  
12.5 Sources of materials.  
All research material obtained from study participants will be gathered prospectively  and  will  include  
weight,  and  subjects  responses  to  questionnaires.  We will obtain biometric information through the 
participants employer as this information is already collected as part of the employee wellness program. 
In addition, research material that is obtained will be used for research purposes only.  
12.6 Potential Risks Involved in the Proposed Study.  
There are minimal risks associated with providing lottery-based financial incentives and making 
environmental manipulations to encourage initial and maintenance of weight loss. The main risk is loss 
of confidentiality, which will be protected as described below. There are no potential risks associated 
with any other measures or data to be collected. During the consent process, we will inform subjects of 
the risks associated with loss of confidentiality.  
12.7 Risks Involved in the Cost-Effectiveness Analysis.  
As stated above, the main risk is loss of confidentiality. The immediate benefits of this study for 
participants are minimal; however, as mentioned, so are the risks. Overall the risk to benefit ratio is 
highly favorable given the long term potential of this study to significantly contribute to our knowledge 
of financial incentive and environmental strategies to combat obesity and their impact on health and 
health-related behaviors.  
12.8 Adequacy of Protection from Risks Recruitment and informed consent.  
With assistance from IBC, SEPTA, and the City Department of Public Health we will advertise this study 
as a research study of different ways to help people lose and keep off weight. Potential participants will 
be told that some participants will also receive financial incentives, but this feature will not be 
advertised, lest subjects enlist primarily for that reason. Interested participants will be asked to go to the 
Way to Health (WTH) website or to contact study personnel by phone for prescreening and eligibility 
ascertainment. Intake will be done using the WTH website supplemented by phone support as needed.   
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 

28 
 
cost of their care. They will be told that they may not benefit directly from the study and that all 
information will be kept strictly confidential, except as required by law.  
12.9 Protection against risk.  
In the event of an adverse effect necessitating  medical  or  professional  intervention,  referral  to  the  
study  participants  primary  care provider  or an appropriate  specialist  will occur.  In emergency  
situations  when  a study  participant contacts  one of the research  personnel  first, the particular  
research  staff member  will either make contact with emergency personnel or advise the study 
participant to do so immediately and follow up with the emergency personnel to ensure communication 
of the study interventions and their associated risks. Participants will be queried for potentially relevant 
health status changes at each data collection visit throughout follow-up. Additionally, an independent 
DSMB will review the clinical data routinely with safety as its primary objective. No results will be 
reported in a personally identifiable manner.  
12.10 Electronic Data Security.  
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 where the Way to Health web portal is based. 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  
PMAC  servers  to  complete  a  PMACS-hosted  cybersecurity  awareness  course annually, which 
stresses federal data security policies under data use agreements with the university. Curriculum 
includes 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 Health Insurance Portability and 
Accountability Act certification in accordance with University of Pennsylvania regulations. All data for 
this project will be stored on the secure/firewalled servers of the PMACS Data Center, in data files that 
will be protected by multiple password layers. These data servers are maintained in a guarded facility 
behind several locked doors, with very limited physical access rights. They are also cyber-protected by 
extensive firewalls and multiple layers of communication encryption. Electronic access rights are 

29 
 
carefully controlled  by  University  of  Pennsylvania  system  managers.  We will use  highly  secure 
methods of data encryption for all transactions involving participants financial information using a level 
of security comparable to what is used in commercial financial transactions. We believe this multi-layer 
system  of  data  security,  identical  to  the  system  protecting  the  University  of  Pennsylvania  Health 
Systems medical records, greatly minimizes the risk of loss of privacy. 
12.11 Potential Study Benefits 
Potential Benefits of the Proposed Research to the Participants and Others Participants in this study will 
benefit directly by receiving free health monitoring  as well as weight  management,  nutrition,  and 
physical  activity  education.  The  benefits  of  weight  loss  are  many;  weight  loss  can  result  in 
improvements in hypertension, hyperglycemia, dyslipidemia, arthritis, sleep apnea, and many other 
obesity-associated conditions. More importantly, while the subjects themselves might not derive 
benefit, knowledge gained from the study will assist in the treatment of others who are overweight or 
who attempt weight loss by one of the methods studied. 
12.12 Resources necessary for Human Research Protection  
The  proposed  research  project  will  be  conducted  by  a  team  based  within  an  environment  at  the 
University of Pennsylvania (UPENN) that provides substantial research experience, infrastructure 
support, and expertise in areas important to this project. In particular, the Center for Health Incentives 
and Behavioral Economics (LDI CHIBE) is one of 2 NIH-funded Centers in Behavioral Economics and 
Health in the United States and has developed an NIH-funded infrastructure (the Way to Health) for 
conducting behavioral interventions using a combination of wireless technologies and automated 
feedback including participant payment of incentives and the Center for Health Behavior Research 
(CHBR) has extensive community based research experience including work on environmental change 
strategies.  The team includes investigators experienced in obesity interventions, clinical trials, health 
economics research, behavioral economics, and cost-effectiveness analyses. Dr. Kevin Volpp (Multiple 
PI) is an expert in behavioral economics and health and directs the Center for Health Incentives and 
Behavioral Economics (CHIBE) and the NIA-funded Penn CMU Roybal P30 Center on Behavioral 
Economics and Health.  He  is  a  Professor  of  Medicine  at  the  Perelman  School  of  Medicine  and 
Professor of Health Care Management at the Wharton School as well as an elected member of the 
Institute of Medicine of the National Academy of Sciences. Dr. Karen Glanz (Multiple PI) is an expert in 
the field of obesity research, nutrition, and physical activity behavior and interventions and is the 
George A. Weiss University Professor of Epidemiology and Nursing at the University of Pennsylvania and 
also an elected member of the Institute of Medicine; Dr. Pamela Shaw, a biostatistician experienced in 
the design and analysis of weight loss intervention studies and an Associate Professor of Biostatistics at 
UPENN, will lead the statistical analyses; Dr. Will Yancy (consultant) is an expert in the design and 
conduct of clinical trials of weight loss interventions and Associate Professor of Medicine at Duke 
University School of Medicine. Dr. George Loewenstein (Consultant) is the Herbert A. Simon Professor of 
Economics and Psychology at Carnegie Mellon University and a founder of the fields of behavioral 
economics and neuroeconomics who has led or co- led both incentive and environmental interventions 
to reduce obesity. We have successfully completed 4 weight  loss  RCTs  using  financial  incentive  

30 
 
interventions  as  well  as  worksite  and  community intervention studies using environmental 
strategies. We plan to enroll employees from the Southeastern Pennsylvania Transportation Authority 
(SEPTA), Independence Blue Cross (IBC), and the City of Philadelphia. There are an estimated 4,800 
employees from these entities who have BMI greater than 30 and 1 or more cardiovascular risk factor, 
of whom approximately 48% are black.174 We plan to enroll 344 participants over 6 months making our 
recruitment targets easily attainable given the size of the recruitment pool. We have extensive 
experience working with outside entities (Weight Watchers, CVS Caremark, Humana, Horizon Blue Cross 
Blue Shield, Aramark are a few examples) and have enrolled thousands of participants in behavioral 
economic interventions around the United States and always  achieved  our  enrollment  targets.  All 
senior/key personnel  and  research  staff  who  will  be involved in the design and conduct of the trial 
have completed the mandated human subjects research certificate program.  In addition, all staff  
working  on this study  are required  to carefully  read  the protocol and will be trained on all related 
study procedures and information. The multiple PIs will be responsible for ensuring that project faculty 
and staff have the equipment and training required to protect privacy and confidentiality and will 
monitor and document that these individuals are properly certified. If new senior/key personnel and 
staff become involved in the research, documentation that they have received the required education 
will be included in the annual progress reports. 
13. Data Protection 
13.1 Data and Safety Monitoring 
Individual-level data for participants will be kept confidential and will only be stored on highly secure 
servers. Only authorized project personnel will have access to the data and the data will be stored on 
servers only and not stand-alone PCs or laptops. All data will be reported at units of aggregation which 
make it impossible the identification of individual subjects. However, because we are contacting 
individuals after their initial enrollment, there is an obvious need to have data with identifiers and 
contact information from the master enrollment files. Study personnel who work with these data will 
have undergone all of the required human subjects training. They will work with the data in password 
protected files.  The data and safety monitoring plan will have three parts. 1) PMACS will develop and 
implement  methods  of  verifying  entered  data  and  of  quality  control.  2)  the  PIs  will  be  directly 
responsible for identifying and reporting all serious adverse events, protocol deviations/violations and 
unanticipated events to the IRBs and funding agency promptly, as appropriate. The PIs will also report all 
adverse events, accrual rates, retention rates, and all other logistical issues to the DSMB (described 
below) at least biannually (and more frequently if there are serious adverse events). 3) there will be a 
data safety monitoring board (DSMB) responsible for monitoring the trial. Specifically, the multiple 
principal investigators (PIs) and the IRB will be responsible for ensuring risks to human subjects are 
minimized, risks are reasonable, subject selection is equitable, the research team has access to 
adequate resources to conduct the study, the informed consent process meets regulatory and ethical 
requirements, adequate provision is made to protect human subjects by monitoring the data collected 
and there are adequate provisions to protect subject privacy per HIPAA regulations and confidentiality 
of data. All senior/key personnel and research staff who will be involved in the design and conduct of 
the study must receive education in human research subject protection from a training program that is 

31 
 
approved by a properly constituted independent Ethics Committee or Institutional Review Board. The 
multiple PIs will be responsible for ensuring that project faculty and staff have the equipment and 
training required to protect privacy and confidentiality and will monitor and document that these 
individuals are properly   certified.  If  new senior/key personnel  and  staff  become involved in the   
research, documentation that they have received the required education will be included in the annual 
progress reports.   
13.2 Data and Safety Monitoring Board 
The DSMB will be composed of 3 experts, with expertise in clinical trials, obesity research, and 
biostatistics, along with multiple PIs Drs. Glanz and Volpp as non-voting members. We consider the 
proposed trial to be relatively low risk. Therefore, we plan to arrange for a monitoring committee that is 
assigned to review the study and staff training protocols, monitor the trial for safety and adverse events, 
and conduct a semi- annual meeting. These members will not be involved directly with the trial and will 
perform several duties. First, they will review and approve the research protocol and plans for data and 
safety monitoring prior to initiation of the study. Second, they will evaluate the progress of the trial. This 
will include assessment of data quality, participant recruitment, accrual and retention, participant risk 
versus benefit, performance of trial sites, and study outcomes. This assessment will be performed at 
meetings every 6 months during the clinical trial and more frequently if needed. Third, they will make 
recommendations to ensure that all of the issues above are appropriately addressed. The multiple PIs of 
the project will be responsible for responding to all recommendations of the DSMB and submitting 
DSMB reports to the respective IRBs. We will identify members for the DSMB when the project is 
funded. 
13.3 Potential Study Benefits 
Potential Benefits of the Proposed Research to the Participants and Others Participants in this study will 
benefit directly by receiving free health  monitoring  as well as weight  management,  nutrition,  and 
physical  activity  education.  The  benefits  of  weight  loss  are  many;  weight  loss  can  result  in 
improvements in hypertension, hyperglycemia, dyslipidemia, arthritis, sleep apnea, and many other 
obesity-associated conditions. More importantly, while the subjects themselves might not derive 
benefit, knowledge gained from the study will assist in the treatment of others who are overweight or 
who attempt weight loss by one of the methods studied. 
13.4 Alternatives to Participation 
Participants may always consult with their primary care physician regarding ways to lose weight. 
13.5 Risk/Benefit Assessment 
Anticipated risks of this study should be minimal and the risk/benefit ratio is extremely favorable. 
Participants who are obese are at greatly increased risk of many medical problems including diabetes, 
hypertension, cardiovascular disease, musculoskeletal disorders, and certain cancers. Losing weight 
would significantly lower these risks. To minimize the chance for serious and unexpected  adverse 

32 
 
events, study participants will be screened through exclusion criteria for any health conditions that may 
be exacerbated by participating in a weight loss study. Our incentives try to motivate a gradual rate of 
weight loss that should pose little health risk in participants with BMIs of at least 30 on enrollment. 
Weight loss will be monitored electronically and participants who are losing more than 5 pounds in a 
week, 8 pounds in two weeks or 12 pounds in four consecutive weeks will be asked to slow down the 
pace of their weight loss, and will be reminded that they do not receive any additional incentive for 
losing more than an average expected pounds per month.