Multi-component Workplace Energy Balance Intervention
Phase: NA
Conditions: Abdominal Obesity
Sponsor: Pennington Biomedical Research Center

6400 Perkins Road, Baton Rouge, Louisiana 70808-4124 • Phone: (225) 763-2693 • irb@pbrc.edu
IRB Certificate
 of Approval
FWA # 00006218
  
Date of Approval:  November 11, 2019
Study Expiration Date:  November 10, 2020
Submission Type:  Continuing Review
Review Frequency:  12 months
Number of Subjects Approved:  40
Review Type: Expedited
Approval Status: Approved
Principal Investigator:  Corby Martin, Ph.D.
IRB # 2015-024-PBRC WorkACTIVE-P
Title:  WorkACTIVE-P: Multi-Component workplace energy balance intervention
Sponsor:  CDC National Institute for Occupational Safety and Health
Expedited Approval Category:  8c. Continuing review of research previously approved 
by the convened IRB where the remaining research activities are limited to data 
analysis.
Approval Includes:  Study and Investigator(s) for an additional continuing review 
period.  This approval expires on the date noted above.
Clinicaltrials.gov responsibility: Principal Investigator
Clinicaltrials.gov records are required to be updated regularly.   The Study Status 
section must be verified at this time; please update the Record Verification Date, 
Recruitment Status and Study Completion Date as applicable.  Also be sure to include 
any modifications that have been submitted since the last update.
Investigators and study staff must comply with the Human Research Protection 
Program policies and procedures that apply to IRB members and staff, which can be 
found at www.pbrc.edu/HRPP
Signed Monday, November 11, 2019 3:36:17 PM ET by Rhode, Paula Ph.D.
NCT02561611

IRB#: 
2015-024-PBRC
WorkACTIVE-P Protocol v. 12
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WorkACTIVE-P: 
Multi-component workplace energy balance intervention
Protocol
Corby K. Martin, PhD, Principal Investigator
Daniel S. Hsia, MD, Medical Investigator
Catrine Tudor-Locke, PhD, Co-Investigator
William Johnson, Co-Investigator
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Table of Contents
I.
Summary
3
II.
Background and Significance
3
III.
Overview of Research Design
7
IV.
Study Population
7
V.
Recruitment
8
VI.
Measurements and Procedures
9
VII.
Interventions
11
VIII.
Participant Safety and Confidentiality
13
IX.
Data Management
15
X.
References
18
Appendix 1
21
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I.
Summary
The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative multi-component 
intervention focused on increasing energy expenditure and re-balancing the disrupted energy balance equation of 
sedentary workplaces with an ultimate target of reducing workers’ abdominal obesity. The energy expenditure 
intervention includes replacing workplace sedentary time with access to a dedicated pedal desk and increasing 
steps/day with wearable monitors. Both components are incorporated into an electronically-delivered behavior 
monitoring and support infrastructure, thus enabling continuous management. We will utilize pedal desks 
manufactured and owned by Pennington Biomedical Research Center to conduct this study at Blue Cross Blue 
Shield of Louisiana, Louisiana State University, Louisiana Office of Technology, Louisiana Healthcare 
Connections, and Pennington Biomedical Research Center offices in Baton Rouge, LA. 41 individuals will be 
recruited and randomized to either a control arm or combined Walk More Pedal Desk (WMPD) intervention. 
Primary (MRI-determined visceral adipose tissue) and secondary (changes in body weight, total adipose tissue, 
subcutaneous adipose tissue, blood pressure, blood lipids, fasting glucose and insulin, HbA1-c, free-living 
accelerometer-determined walking, time spent in sedentary behavior, exercise, and dietary intake) outcomes will 
be assessed at baseline and month 3. 
II.
Background and Significance
Low Energy Expenditure/Sedentary Behavior/Weight Gain: Energy balance is a tentative equilibrium between 
energy intake and energy expenditure.13 Sedentary behaviors, pervasive in contemporary office-based 
workplaces,14 result in lowered energy expenditure, thus disrupting energy balance and contributing to weight 
gain and attendant chronic diseases (e.g., cardiovascular disease and Type 2 diabetes).3 Hu and colleagues15 
estimated that the risk in obesity and Type 2 diabetes increases 5-7% for each 2-hour increase in occupational 
sitting time. As further evidence of the deleterious effects of low energy expenditure occupations on obesity, there 
has been a trend toward Service Industry occupations that are largely composed of desk-based sedentary behavior 
over the past 50 years in the U.S., and with it an associated population-level weight gain.16 The direct17 and indirect 
(non-medical)18 costs of obesity are high. For workers, the overall estimated impact of obesity on lifetime 
earnings of U.S. men and women born between 1982 and 1993 was close to $1 trillion.9 The increasing obesity 
rate was found to be the most important contributor to employers’ increased health care spending between 2005 
and 2010 (based on data from over 340,000 tracked employees).19 Further, compared to normal weight 
employees, overweight and obese workers are estimated to cost employers $201 and $644 more per employee per 
year, respectively.20 
Within office-based Service Industry workplaces, the predominant ergonomic theory has promulgated office 
furniture and environmental design deliberately intended to reduce even token workload demands, resulting in 
occupational energy expenditures that are near basal requirements.7 These transitions have also logically shifted the 
need to obtain adequate amounts of energy expenditure to maintain body weight to a decreasing amount of 
personal time. Traditional workplace wellness approaches to providing access to fitness facilities and otherwise 
promoting increased participation in structured exercise outside of work hours have produced modest effects, 
largely due to “lack of time.”
Abdominal Obesity: Workers employed in low energy expenditure occupations (e.g., typists) are 63% more likely 
to be abdominally obese (>102 cm in men and >88 cm in women) compared to workers in high energy 
expenditure occupations (e.g., construction trades).6 Abdominal obesity is considered a driving force behind the 
metabolic syndrome.21 A meta-analysis of exercise therapy for abdominal obesity22 concluded that aerobic 
exercise is central to intervention, but that even light intensity aerobic exercise, that is below current public health 
recommendations, may be sufficient for beneficial modification of abdominal obesity. Case in point, John et al.10 
reported an average 5.5 cm waist circumference reduction in 12 sedentary office workers provided dedicated 
access to treadmill desks (walking at self-selected speeds and durations) for 9 months. Dr. Tudor-Locke, Co-
Investigator of WorkACTIVE-P has also been an investigator on pedometer-based interventions that have 
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elicited significant improvements in waist circumference.1,2 This trial is therefore focused on evaluating changes 
in the primary outcome of abdominal obesity in sedentary, overweight/obese Service Industry workers exposed to 
a multi-component energy expenditure intervention that combines dedicated pedal desk use with a step-counting 
intervention.
Workstation Alternatives: Incipient reports support the feasibility of elevating net energy expenditure by replacing 
occupational sedentary behavior with low-intensity non-exercise physical activity via “workstation alternatives” 
to the traditional seated computer-and-desk-based combinations. For example, Edelson and Danoff 23 introduced 
the feasibility of performing computer-based work while walking on a treadmill in 1989, and Levine and Miller 
popularized the concept with a publication in 2007 demonstrating its ability to elevate energy expenditure over 
the seated condition.8 Dr. Tudor-Locke recently published a systematic review5 reporting the comparative 
potential for workstation alternatives (including stability balls, sit-to-stand desks, treadmill desks, and pedal 
desks) to elevate occupational energy expenditure. Active workstations (i.e., specifically treadmill desks and 
pedal desks) offer the greatest promise (approximately 2-4 kcal/min compared to 1.2 kcal/min in the traditional 
seated working condition), but only to the extent that workers find them acceptable, tolerable, and congruent with 
their primary working tasks and therefore frequently use them for extended periods of time. Dr. Tudor-Locke has 
recently completed a randomized controlled trial implementing treadmill desks in a real world workplace and 
have documented a number of challenges to widespread adoption and thus scalability of treadmill desks (recently 
published11). In response to these challenges, we have developed a much more affordable, convenient, integrated 
and tolerable pedal desk: a semi-recumbent (upright) portable pedal station with a maneuverable and adaptable 
desktop. Workers are able to complete their tasks comfortably in a more traditional seated position. The cost and 
size of the device makes it feasible for workers to have their own dedicated pedal desk rather than sharing access 
(as we have learned, a scheduling and management impediment) to larger and more expensive treadmill 
workstations.11 Alternative pedal device designs (notably those that slide under conventional desks) have not yet 
facilitated extended use in workers,7 in part because workers “bang their knees” against the desk. Dr. Tudor-
Locke’s pilot data collection in 10 workers to date indicate that pedal desk use can more than double the energy 
expenditure of seated computer based work.
Increasing Steps/day with Wearable Step Counters: Steps/day is an increasingly utilized metric for objectively 
capturing and representing total daily walking.24,25 Researchers recently reported 5-year changes in body mass 
index (BMI), waist-to-hip-ratio, and insulin sensitivity related to 1,000 step incremental changes in step-defined 
physical activity.26 Meta-analyses indicate that step-counting interventions can expect to realize incremental 
increases in walking behavior on the order of 2,000-2,500 steps/day. The Co-Investigator of this R21 is a world 
leader in such interventions.25,27,28 She developed a self-selected goal approach that elicited up to an extra 4,000 
steps/day in individuals with Type 2 diabetes,2 and was subsequently adapted and delivered as a workplace 
intervention that elicited a 3,500 steps/day change.1 As reported in a recent meta-analysis,29 at least four other 
controlled workplace studies have incorporated wearable step-counters into multi-component interventions. The 
inclusion of a pedal desk is novel. No one has previously estimated the relative contributions of independent 
intervention components to changes in abdominal obesity. 
A Combined Approach: Pedaling actions are largely ignored by waist-worn step counters.30 Therefore, layering a 
step-counting intervention on top of a pedal desk intervention permits a clear evaluation of their separate and 
combined dose-response effects. Daily electronic tracking of pedal desk use (duration, rpm, estimated distance 
and energy expenditure) and steps/day via automatic internet-based software enables continuous tracking of both 
behaviors for tailored feedback, behavioral shaping, and evaluation purposes. WorkACTIVE-P will clearly 
inform the feasibility of combining these distinct yet compatible components of a workplace multi-component 
energy expenditure intervention.
Remote Food Photography Method (RFPM) and SmartIntake: Use of the Remote Food Photography Method© 
(RFPM) 1,2 and SmartIntakeSM smartphone app offers a number of advantages over other methods to estimate food 
intake. Self-report methods, such as pen-and-paper and dietary recall, rely on the ability of the participant to 
accurately recall the types and portion sizes of foods consumed, and the accuracy of these methods have been 
questioned 3,4 5,6. Importantly, ~50% of the error in self-report methods is due to participants inability to 
accurately estimate portion size, a limitation that is avoided when using the RFPM and SmartIntakeSM app. 
Additionally, self-report methods result in larger underestimates of food intake for overweight and obese 
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individuals 5, people tend to selectively underreport dietary fat intake 7, and people tend to under eat during the 
monitoring period 7,8, which results in data that is not representative of habitual food intake. All of these 
limitations are overcome with the RFPM 1, which demonstrates the significance of using this approach in the 
proposed project. 
Research to Practice (r2p):  Controlled but simulated environments and artificial constraints are typically 
implemented in research design to circumvent every conceivable threat to validity. For example, the rate of 
energy expenditure of active workstations at researcher-set speeds has been previously measured under laboratory 
conditions using portable metabolic devices.8,31 However, it is more logical that patterns of use enacted under real 
world conditions will naturally vary more with user preferences, access, and day-to-day work schedules.7 Rather 
than controlling access and use by tight scheduling and enforcement, we agree with others32,33 that believe that 
supporting and tracking user-initiated use is a more realistic and effective approach to documenting, evaluating, 
and ultimately enabling optimal yet flexible use under real world conditions. We have previously established an 
excellent collaborative relationship with a large office-based Service Industry while we were engaged in 
evaluating their adoption of treadmill desks.11 They are supportive of working with us together again on this 
endeavor (see Appendix 1 for letter of support). 
Expected Outputs and Outcomes: WorkACTIVE-P will provide clear feasibility and preliminary effectiveness 
evidence for a combination of practical technology-supported products and programs for Service Industry 
employers and workers interested in addressing health risk exposures (and related health care costs) associated 
with occupational sedentary behavior.
Innovation: 
The innovation of WorkACTIVE-P is based on the following tenets:
1)
Occupational requirements for extended sedentary behaviors in contemporary workplaces have 
disrupted the energy balance equation and present a real risk for weight gain, abdominal obesity, and 
corollary conditions.
2)
The health care costs of low energy expenditure occupations are not trivial and are borne by the 
individual workers, employers, and society.
3)
Abdominal obesity is a driving force of the metabolic syndrome but appears amenable to aerobic 
exercise and even light intensity physical activity interventions.
4)
Traditional workplace wellness programs focused on exercise and fitness have reported modest 
adherence and limit the opportunity to re-balance the occupational energy expenditure deficit to time 
outside of work.
5)
Workplace deliveries of interventions that use wearable step counters to increase lifestyle physical 
activity have demonstrated some short term success.
6)
Further elevating energy expenditure by replacing sedentary working behaviors with tolerable low 
intensity non-exercise physical activity via scalable active workstations (e.g., pedal desks) is a 
promising strategy.
7)
Uniquely, we have fashioned an affordable, convenient, integrated and user-friendly pedal desk: a 
semi-recumbent (upright) portable pedaling station with an attached, maneuverable, adaptable 
desktop capable of supporting a large computer monitor. This is an improvement over “under desk” 
designs.
8)
No study has documented the separate and potentially synergistic effects of a behaviorally supported, 
multi-component workplace energy expenditure intervention that layers step counting on top of pedal 
desk use.
9)
Moving the study of workstation alternatives out of the laboratory and into real workplaces is 
necessary to assess scalability and track real patterns of use, ultimately informing their true potential 
to elevate workplace energy expenditure. 
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a.
Specific Aims:
     The objective of WorkACTIVE-P is to conduct a preliminary outcome evaluation of an innovative multi-
component intervention focused on raising energy expenditure and re-balancing the disrupted energy balance 
equation of sedentary workplaces with an ultimate target of reducing workers’ abdominal obesity. The energy 
expenditure intervention includes replacing workplace sedentary time with access to a dedicated pedal desk and 
increasing steps/day with wearable monitors. Both components are incorporated into an electronically-delivered 
behavior monitoring and support infrastructure, thus enabling continuous management. This pilot study is a 
necessary step towards our long term goal to conduct an RO1 investigation to exactly quantify the separate and 
combined dose-response effects of this multi-component intervention on promoting healthy weight management, 
and in particular, abdominal obesity in the sedentary workplace. 
Recent evidence suggests that contemporary sedentary behaviors may contribute to the obesity epidemic and 
trigger the development of cardiovascular disease and Type 2 diabetes.3 Because occupational sitting is the single 
largest contributor (52%) to total weekday sitting time,4 employment in a sedentary occupation may represent a 
risk factor for weight gain, especially among those who are physically inactive during leisure-time.3,5 Workers 
employed in such low energy expenditure occupations (e.g., typists) are 63% more likely to be abdominally obese 
(>102 cm in men and >88 cm in women) compared to workers in high energy expenditure occupations (e.g., 
construction trades).6
 In response to these challenges, researchers have begun to consider7 how modern occupational practices and 
environments could be enriched to facilitate, rather than discourage, increased energy expenditure by replacing 
sedentary behaviors with opportunities for non-exercise physical activity without competing with time committed 
to work tasks. For example, in 2007 Levine and Miller described a “walk-and-work desk,” a treadmill and desk 
combination.8 Since that time, Thompson et al.9 reported a positive treadmill desk feasibility study with nurses, 
clinical assistants, and secretaries and John et al.10 published the pre-post impact of a 9-month treadmill desk 
intervention in 12 sedentary office workers. Between baseline and 9 months, median steps/day increased from 
4352 to 7080 and average waist circumference decreased 5.5 cm. Despite these initial positive reports, Dr. Tudor-
Locke’s pilot randomized controlled study of treadmill desks in a local workplace (recently published11) suggest 
that there are many behavioral and logistical challenges, including financial (treadmills desks are $4000-6000) 
challenges, that make widespread adoption formidable. In direct response to these identified challenges, we have 
fashioned a much more affordable (approximately $800), convenient, integrated and user-friendly pedal desk: a 
semi-recumbent (upright) pedal station with an attached, maneuverable and adaptable desktop capable of 
supporting a large computer monitor. Workers are able to complete their tasks comfortably in a more traditional 
seated position. The cost and size of the device makes it feasible for workers to have their own dedicated pedal 
desk rather than sharing access to larger and more expensive treadmill workstations. We believe that the 
combination of using a pedal desk while also increasing steps/day will provide workers with flexible and 
compatible strategies for effectively combating the low energy expenditure of a sedentary working lifestyle. 
b. Primary Aims and Hypotheses: 
Primary Aim: The primary outcome is the change in abdominal obesity operationalized as MRI-determined 
visceral adipose tissue (VAT). Over the course of a 2-year period and working collaboratively with a real 
workplace, WorkACTIVE-P will randomly assign 41 low active (< 7,500 steps/day), overweight/obese 
sedentary full-time workers (reporting “mostly sitting” during the work day), 18-64 years of age, with abdominal 
obesity defined by waist circumference and at least one additional component of the metabolic syndrome 
(dyslipidemia, elevated blood pressure, and/or impaired fasting glucose12), to a 3-month-long controlled trial.  The 
trial will include baseline and 3 month assessments and two intervention arms: 1) a combined electronic behavior 
support program of “walk more and pedal desk” (WMPD, n=20), which, in addition to provision of a dedicated 
pedal desk in individual worker’s office space, participants are supported to increase daily walking by at least 
3000 steps/day; and 2) a no-intervention control condition (CON, n=20). This design allows us to test the 
hypothesis that: this innovative multi-component workplace energy expenditure intervention will elicit 
measureable improvements in abdominal obesity superior to the control condition. Relative contributions of the 
two intervention components (walk more and pedal desk) will be determined by regression analyses predicting 
VAT changes. 
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Additional Aims: Secondary outcomes include changes in body weight, total adipose tissue, subcutaneous adipose 
tissue, blood pressure, blood lipids, fasting glucose and insulin, [HbA1c], free-living accelerometer-determined 
walking (steps/day and cadence), time spent in sedentary behavior, exercise (time spent at moderate-to-vigorous 
physical activity), and dietary intake. We will electronically track daily steps data for WMPD participants and 
also duration of use and cadence (revolutions per minute, or RPM) of dedicated pedal desks. After completion of 
this pilot study, a subsequent R01 will be proposed to perform a full-scale RCT to quantify the separate and 
combined effects of the intervention components on change in the study endpoints.
III.
Overview of Research Design
The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative multi-component 
intervention focused on increasing energy expenditure and re-balancing the disrupted energy balance equation of 
sedentary workplaces with an ultimate target of reducing workers’ abdominal obesity. The primary outcome is 
MRI-determined visceral adipose tissue (VAT), which is an indicator of abdominal obesity. Secondary outcomes 
include changes in body weight, total adipose tissue, subcutaneous adipose tissue, blood pressure, blood lipids, 
fasting glucose and insulin, HbA1-c, free-living accelerometer-determined walking, time spent in sedentary 
behavior, exercise, and dietary intake. 
Table 1 describes the timeline of activities during the 2 year trial period for WorkACTIVE-P.
IV.
Study Population 
The target study group will be up to 41 sedentary men and women aged 18 to 64 years.  Because potential 
participants will be overweight and obese individuals, the study sample will be at risk for negative health 
conditions associated with excess adiposity, including cardiovascular disease (CVD). Consequently, the same will 
be representative of individuals who have a sedentary job and are likely to be prescribed exercise regimens. 
Table 1. Timeline
Activity
Year 1
Year 2
1
2
3
4
1
2
3
4
MOP development, procedures training
Recruitment & screening
Writing design & methods paper
Baseline testing & randomization
3-month testing
Data cleaning & management
Data analysis & interpretation
Paper writing & submission
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Rationale for inclusion/exclusion criteria: Since this is a real world implementation the gender breakdown will 
reflect the makeup and preferences of the targeted office-based workplace. Ages 18-64 were chosen since these 
are the ages that increase our likelihood of targeting metabolic syndrome. This will reduce the costs of screen fails 
in this pilot study. We anticipate that we will expand the age range to include younger people with metabolic 
syndrome in a future R01 study. 
Table 2. Criteria for Study Participation 
Inclusion Criteria
Gender
Both men and women. 
Age
18-64 years. 
BMI
BMI > 25 kg/m2 
Waist 
circumference 
alone OR two or 
more of the 
remaining four   
risk factors 
defining 
metabolic 
syndrome12

Waist circumference ≥102 cm (men) or ≥88 cm (women)
OR

Triglycerides ≥ 150 mg/dL or currently prescribed and taking anti-hyperlipidemic 
medications

HDL cholesterol < 40 mg/dL (men) or < 50 mg/dL (women) or currently prescribed and 
taking anti-hyperlipidemic medications

Resting systolic blood pressure ≥ 130 mm Hg or diastolic ≥ 85 mm Hg or currently 
prescribed and taking anti-hypertensive medications

Fasting glucose ≥ 100 mg/dL34
Sedentary worker
Affirmative response to “I mostly sit during the day at work and do not walk about very much”
Objectively 
determined low 
active
Averaging < 7,500 steps/day at Run-In as confirmed by step counter
Other

Willing to accept randomization into either Walk More Pedal Desk (WMPD) group or 
Usual Working Condition (UWC) group and follow the intervention procedures 
associated with that group. 

Plan to remain employed full-time at the workplace participating in the study for the 
duration of the study (4 months)

Willing to wear activity monitor devices during the study

Willing and able to have a partially closed MRI 
Exclusion Criteria 
Weight
Weigh more than 275lbs
Resting blood 
pressure
Systolic blood pressure > 179 mmHg and/or diastolic blood pressure > 99 mmHg
Diabetes
Self-reported Type 1 or Type 2 diabetes, or use of diabetes-related medications 
Significant CVD 
or disorders
Including but not limited to serious arrhythmias, cardiomyopathy, congestive heart failure, stroke 
or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, 
uncontrolled angina. Any cardiovascular event in the past 6 months will be exclusionary. 
Other significant 
medical 
conditions
Including but not limited to implants that may interfere with MRI, chronic respiratory, 
gastrointestinal, neuromuscular, or psychiatric conditions, malignancies in the past 5 years, with 
the exception of skin cancer therapeutically controlled, endocrine (including diabetes), any other 
medical conditions or disease (including arthritis) that is life threatening or that can interfere with 
or be aggravated by exercise. 
Poor compliance 
to activity 
monitors
Failing to wear the step counter or accelerometer for at least 4 days or failing to return the device 
to clinic.
Females Only
Pregnant, has been pregnant in the past 6 months, is currently nursing, or planning to become 
pregnant over the next 4 months.
Other 

Currently enrolled or planning to enroll in a diet/nutrition, exercise, or smoking cessation 
program. 

Plan to be out of town for longer than 2 total weeks over the next 4 months

Currently taking any weight loss medications
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V.
Recruitment
Since we are primarily targeting workers from a local, large corporation (Blue Cross Blue Shield, Baton Rouge, 
LA) that Pennington Biomedical has previously worked with to conduct a randomized controlled trial of a treadmill 
desk intervention, we will be using specially tailored recruitment strategies based on this earlier direct experience.  
During the study startup phase, members of our research team will attend face-to-face meetings with key members of 
the company’s staff including facilities directors, human resources representatives, information technologists, 
department supervisors, and wellness coordinators. If required, we will also attend a supervisors’ meeting to present 
information about the planned study, including who will be eligible, time and space requirements, and other 
expectations. Email and telephone communication will also prepare the company for the study recruitment and 
implementation. We will also recruit from Pennington Biomedical Research Center, Louisiana State University, LA 
Office of Technology, LA Healthcare Connections, Entergy, and LA Community and Technical College System in 
order to supplement enrollment. All companies will follow similar recruitment strategies and processes if deemed 
appropriate by the site. 
A company-generated email providing a link to an online screening survey (maintained by Pennington 
Biomedical) will be sent out to full-time company employees using their company intranet. The online screening 
survey will include a series of eligibility questions for the initial screening process (identified in Table 2). As 
previously requested by one of the collaborating companies, a list of identified individuals deemed eligible from the 
online survey will be subsequently reviewed by workplace supervisors to confirm individuals’ permission to 
participate in the study if the site chooses to include this in their recruitment process.  Once a full list of approved staff 
members is generated from the supervisors within the company, recruiters will contact participants to complete a 
phone screen.  A similar “real world” recruiting process was followed for a previous randomized controlled trial of 
treadmill desk adoption in the same workplace.11 A verbatim list of reasons for excluding participants will be obtained 
to inform future implementation in terms of characterizing workers and workplaces/jobs that would be suitable targets 
for such an intervention.
VI.
Measurements and Procedures
Table 3. Schedule of Procedures
Measure
Orientation
(at Workplace)
Run-in
(at Workplace)
Screening
(in Clinic)
Baseline
(in Clinic)
Intervention
(at Workplace)
3-month Follow-up
(in Clinic)
Informed consent
X
Demographics 
Questionnaire
X
Physical Activity 
Questionnaire
X
X
MRI
X
X
Height
X
X
Anthropometrics 
(BP, weight, HR)
X
X
X
Waist 
circumference
X
X
X
Urine Pregnancy 
Test
X
X
Blood draw 
(measures)
X
X
Adverse Events
X
X
Step counter 
distribution
X
Step counter 
return
X
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Accelerometer 
distribution
X
Accelerometer 
return
X
X
FitBit
*WMPD only
Pedal Desk 
Installation
*WMPD only
Dietary intake+ 
X
X
Randomization
X
*WMPD: Walk More Pedal Desk Intervention
+Participants will use Remote Food Photography Method for dietary intake for 1 week (7 days) to assess dietary intake patterns.
Orientation:
Interested participants who are deemed eligible on the online screening survey, received supervisor approval to 
participate, and complete the phone screen will attend a 1-hr orientation visit conveniently located at their 
worksite where they will receive detailed information on the purposes, goals, procedures, participant flow, 
timeline, and randomization. Interested participants will be offered an informed consent form to continue. 
Participants will sign two copies of the informed consent and will be able to keep one copy. All questions and 
concerns will be clarified prior to participants signing the form or conducting any procedures. Participants will be 
scheduled for their run-in visit and provided a step counter (pedometer or Fitbit Zip) which requires 1 week (7 
days) of self-monitored step counter-determined physical activity. 
Run-In:
A Run-In visit will occur approximately one week after Orientation and will be held at their workplace. At the 
Run-In visit, initial inclusion/exclusion criteria will be assessed (e.g., BMI, waist circumference, blood pressure). 
Participants will return the step counter to determine their ability to self-monitor behavior and further confirm 
baseline eligibility (< 7,500 steps/day) from the step-counters retrieved at their workplace. Participants will 
complete questionnaires related to physical activity, medical history, and demographic information.  Those who 
continue to remain eligible will be scheduled for an in-clinic screening visit (SV1) held at the Pennington 
Biomedical Research Center. Participants may be asked to repeat measures based on the PI’s discretion.
Screening Visit 1:
At Screening Visit 1, which will occur as early as two working days after the Run-In visit, participants will have a 
blood draw to measure fasting levels of glucose, insulin, HOMA-IR, HbA1c and blood lipids.  Anthropometrics 
will be taken during SV1 including height, weight, BMI, blood pressure, heart rate, and waist circumference. 
Food intake data will be captured with the Remote Food Photography Method (RFPM) using participants’ 
personal (or one of our loaned) smartphones to collect energy and nutrient intake data. Participants will be 
distributed an Actigraph Accelerometer (GT3X+) and will be instructed to wear the device for one week (7 days). 
After lab results are available, study staff will confirm if the participant is eligible to continue based on the 
inclusion criteria.  
If more than 16 days lapse between SV and Baseline scheduled date, participants may be asked to repeat measures 
to re-assess eligibility. 
Baseline Visit:
Eligible participants after SV1 will return to Pennington Biomedical Research Center approximately one week but 
up to 16 days after SV1 for a Baseline Visit. Participants will return the accelerometer to further evaluate each 
participant’s ability to comply with the wearing requirement of objectively monitored devices (i.e., at least 4 days 
with at least 10 hours of wear time recorded), allowing us to exclude participants with poor adherence to study 
requirements. Accelerometer data (physical activity and sedentary behavior) obtained during this screening 
process will serve as participants’ baseline accelerometry data. An MRI will be completed to collect visceral fat, 
subcutaneous fat, and muscle compartments. Female participants will have a urine pregnancy test before the MRI.  
Randomization will occur at the conclusion of the Baseline Visit. Using a computerized pseudo-random number 
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generator, the study statistician will determine the randomization order in advance. The participants will be 
enrolled as directed by the next assignment letter contained in a randomized sequence of sealed and numbered 
envelopes. The project manager or interventionist (i.e., unblinded staff member) will reveal the randomization 
assignment to the participant. The participant will be provided with a behavioral expectations document informing 
them of the expectations of their randomized group. Study assessment staff will remain blinded to a participant’s 
study arm allocation. 
Month 3 Follow Up:
Randomized participants will return to Pennington Biomedical Research Center for a Follow-Up Visit 
approximately 3 months after intervention starts. Participants will return an accelerometer that was provided to 
them 1 week prior at their work place. Participants will complete questionnaires related to physical activity. All 
measures collected at the Screening and Baseline Visits will be repeated (blood work, body measurements, MRI, 
and RFPM. Female participants will have a urine pregnancy test prior to the MRI.
a.
Description of Tests and Procedures:

Accelerometry (Physical Activity): Participants will be instructed to wear the GT3X+ accelerometer 
(ActiGraph, LLC, Pensacola, Florida, USA) at their waist for seven consecutive days, approximately 24 
hrs/day. We have successfully used this 24-hour protocol in diverse populations including children, 
adults, and older adults and find it maximizes wear time. This accelerometer has been validated35,36 and is 
one of the most widely used accelerometers in research and has the capability of detecting minute-by-
minute physical activity intensity and sedentary behavior using previously validated activity count cut 
points.36,37  Participants enrolled in the WMPD Intervention Group will be fitted with a FitBit® activity 
monitor to wear at their waist during the intervention.  Participants will be asked to wear the FitBit® for 
all 12 weeks of the intervention, removing it only for activities involving water, such as baths or 
swimming, and while sleeping.

Blood Draws: Participants will be asked to fast at least 12 hours prior to blood draw. In addition, 
participants will be asked to refrain from consuming alcohol or participating in an exercise training 
session at least 24 hours prior to blood withdrawal. Fasting levels of glucose, insulin, HOMA-IR, HbA1c, 
and blood lipids will be analyzed. Approximately 12 mL of blood will be collected at SV1 and Month 3 
visits, which is a total of 24 mL during the course of the study. 

Blood pressure: Blood pressure will be measured at rest. Two measures will be taken with a heart rate in 
between. The average will be recorded per standard Pennington Biomedical’s procedures. 

Dietary Intake: Food intake data will be captured with the Remote Food Photography Method (RFPM) 
using participants’ personal (or one of our loaned) smartphones. The RFPM and SmartIntake© app 
(previously developed and validated by study Principal Investigator, Dr. Corby Martin and colleagues38,39) 
will be used to collect energy and nutrient intake data at baseline and month 3. Participants will use the 
procedure to photograph and track their dietary intake for 7 consecutive days, with the first 1-2 days being 
a run-in period to acclimate participants to the procedure, resulting in approximately 4-5 complete days of 
data per participant. Three days of recorded food intake has been shown in several studies to provide an 
accurate estimate of average food intake;40-42 hence, we are collecting ample data to obtain a 
representative sample of habitual food intake.

Height and weight: Height and weight will be measured to the nearest 0.1 kg using a standard stadiometer 
and balance beam scale, according to Pennington Biomedical’s SOP. 

MRI-determined visceral adipose tissue (VAT; indicator of abdominal obesity): Magnetic resonance 
imaging (MRI) will be performed using a 3.0 T scanner (General Electric, Discovery 750w System, 
Milwaukee, WI).   Subjects will in a supine position on the scanner table with the arms above the head. 
Subcutaneous fat, visceral fat, and muscle compartments will be traced on each slice by a trained analyst 
using Analyze™ software (AnalyzeDirect, Overland Park, KS) and a standardized tracing protocol.  

Step-counter: Participants will be instructed to wear the NL-1000 pedometer or a similar model at their 
waist for seven consecutive days. Fitbit Zip© devices may be worn in place of the pedometer during the 
Run-In period as needed. 

Waist circumference: Waist circumference will be taken according to Pennington Biomedical’s SOP and 
measured to the nearest 0.1 cm. 
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VII.
Interventions
Participants will be randomized into 1 of 2 intervention arms: Usual Working Condition Control group (UWC) or 
a combined intervention of Walk More and Pedal Desk (WMPD). 
a.
Usual Working Condition Group (UWC): The no-intervention control condition will be asked to maintain 
their usual work and lifestyle throughout the study. Participants may be contacted by Pennington Biomedical 
staff during the intervention.
b.
Combined Intervention (Walk More and Pedal desk; WMPD): Participants in the WMPD condition will 
engage in both step-counting (Walk More, WM) and pedal desk (PD) intervention components. The content 
of both intervention components will be covered during scheduled phone contacts (or in-person meetings, as 
needed). The step-counting component of the WMPD intervention will be modeled off the success of The 
First Step Program (FSP), originally developed by Dr. Tudor-Locke.  Briefly, the FSP is a facilitated behavior 
modification program built on the framework of Social Cognitive Theory (SCT),43,44 emphasizing the 
components of self-efficacy and social support.45 Participants will be given internet-enabled step-counting 
devices (Fitbits). Participants will be taught how to manage their own stepping behavior by regularly 
checking the on-board visual display and also by monitoring the accompanying internet reporting software to 
track their own average steps/day each week. Dr. Tudor-Locke has successfully piloted this technology to also 
provide interventionists with an opportunity to view participants’ data as they accrue. We have implemented 
this same interventionist-supported behavior change and monitoring approach on numerous occasions.2,46-49 
Using these same techniques to collect pilot data for WorkACTIVE-P, we successfully motivated 98 
participants averaging 4973 steps/day during at baseline up to an average of 9692 steps/day (max 13971) 
during a three month pedometer-based intervention, an average increase of almost 5,000 steps/day. We are 
thus confident that participants assigned to WMPD condition in WorkACTIVE-P will be easily able to 
increase their daily ambulatory activity at least 3,000 steps,50,51 and much likely more as confirmed by our 
pilot data.
Co-investigator, Dr. Tudor-Locke has developed an integrated pedal desk: a semi-recumbent (upright) 
pedal station with an attached, maneuverable and adaptable desktop capable of supporting a large computer 
monitor. She has also fabricated additional units and enabled them with hardware sensors and accompanying 
software capable of displaying and tracking daily use. Pilot testing with 41 workers demonstrated their 
acceptability; participants estimated they could use the pedal desk a median 4 hours/day. The user is able to 
view a pop-up box on the computer monitor with a real-time display of rpm, accumulated revolutions (“rev 
counting”), and energy expenditure estimates based on the measured rpm. Pilot testing affirmed the validity of 
this rev counting sensor. They are also able to readily view graphical presentations of their daily, weekly, and 
monthly accrued data. All data are also transferred via internet to an interventionist’s level, permitting 
programmatic oversight and tracking of use parameters. Pilot testing has affirmed the functioning of this 
tracking software. This is a powerful tool that is used both for measurement but also for identifying 
behavioral issues as they emerge, and intervening early if needed. Pilot testing has also affirmed that 
participants can actually use the pedal desk for multiple hours in a day comfortably.
SCT will be used to guide WMPD participants to monitor their own pedal desk use data and review the 
previous week’s pedal desk use during their weekly meetings with the study interventionist, discuss preferred 
strategies for success, and set personally-relevant and incremental time-based goals. For example, participants 
may set a goal of using their pedal desk for 2 accrued hours/day initially but over time work their goals up to 
4 or more hours/day, depending in part on their work schedules that may regularly require their attendance at 
events/meetings outside of their office and away from their desk. Participants will also be taught how to track 
and manage their own behavior using the real time visual display, monitoring their display graphics, and 
recognizing and addressing relapse (defined as not achieving their time-based pedal desk use goal on any 
single week).
Study interventionists will discuss goal achievements and progress with WMPD participants throughout 
the study intervention.  This will be done by periodic (weekly or biweekly) phone contacts or in-person 
meetings as a group or one-on-one. In-person meetings will be scheduled conveniently at the participants’ 
workplace. WMPD participants will be trained to view and report on their own electronically averaged 
steps/day and pedal desk data each week, including recognizing when they fulfill their goals. Our experience 
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indicates that such detailed and accurate self-monitoring requires considerable training and a number of 
learning trials; therefore, participants will receive extensive training during the first 4 weeks of the 
intervention. Objective data will be used to identify participants who require more resources to adhere to their 
condition-specific goals. For the WMPD pedal desk component, interventionists will rely on our proprietary 
pedal desk tracking software to maintain accurate time-based use records and track adherence. These methods 
follow the “toolbox” approach used during the Diabetes Prevention Program, 52 Look Ahead, 53 and CALERIE 
Phase II trials. The toolbox approach provides guidelines to deliver specific intervention strategies for certain 
problems that participants encounter, and the approach requires that the strategies’ effectiveness be evaluated 
regularly (every two weeks). More intense strategies are used if less intense strategies fail to result in 
improved adherence. 
c.
Adherence: The importance of completing the expected intervention will be reinforced at every opportunity. 
A concern is that some participants may fail to complete their time on the pedal desk as well as complete the 
extra 3,000 steps per day. Prior to randomization, participants will have completed an extensive screening 
process, including the run-in, which we have found promotes adherence and excludes potential participants 
who cannot commit to the study. Participants will also be given a study expectations page for their 
intervention. If a participant misses a day on the pedal desk, his/her interventionist will contact them  to check 
in, encourage attendance, and help problem-solve if a barrier to participation is present. These staff will be 
trained by Dr. Martin, a licensed Clinical Psychologist, in behavioral strategies to promote adherence, and Dr. 
Martin will be available for consultation regarding challenging participants. The exercise laboratory will be 
open 5 days per week for 12.5 hours/day to accommodate a variety of schedules.
We recognize that it is unrealistic to expect 100% adherence to the intervention protocol. Participants may 
miss work due to illness or family obligations or have vacations planned. Therefore, we are defining 
acceptable compliance to the study protocol as completing 75% or more of the total amount of sessions 
prescribed. This will be defined as attended sessions per week on the pedal desk divided by expected sessions 
per week. In addition, steps per day will be used to calculate total adherence by dividing completed steps per 
day by expected steps per day. An average of the two compliance and adherence numbers will be used for the 
participant’s total adherence. 
d. Dropouts: We define dropout as failing to return for the 3-month examination. We believe the run-in and 
screening visit will exclude many at high risk of dropout. Personalization and problem solving approaches to 
ensure adherence to exercise also will be helpful in preventing dropout. 
e.
Participant incentives:  We will provide $200 per individual as a compensation stipend for participation in 
the study regardless of group assignment. Enrolled participants (control or WMPD group) will receive $100 
for completing baseline and another $100 for completing follow-up clinic visits held at the Pennington 
Biomedical clinic for a total of $200.
VIII.
Participant Safety and Confidentiality
Below describes the risk to subjects for procedures included in WorkACTIVE-P.
a.
Risks to Subjects:

Accelerometry: There is no known risk associated with measuring activity with accelerometers, .  
Accelerometers fit comfortably on your arm and can easily be adjusted should they become 
uncomfortable.  In rare cases, the device may irritate your skin.  If this should happen, the device can 
easily be repositioned to be more comfortable.

Blood Draws: There is the possibility of pain and bruising at the vein on your arm where the needle is 
inserted. Aseptic (sterile) technique and trained personnel minimize these risks. 

Blood Pressure Testing: Participants may experience temporary discomfort during blood pressure 
recordings due to the pressure of the cuff on their arm.

Height measurement: There is no risk to participants who record their height. 
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
Waist circumference: There is no anticipated risk to participants who record their waist circumference. 
Measurements will be taken in a secluded area to protect the participants’ privacy. 

Body weight: There is no risk to participants who record their body weight. Measurements will be taken 
in a secluded area to protect the participant’s privacy.

WMPD intervention: The potential risks and discomforts associated with participating in this study are 
very minimal. You can self-select the pace at which you would like to pedal while working. However, 
there remains the risk of muscle soreness associated with an increase in activity level and minimal anxiety 
associated with trialing a novel task. You may also find the seat mildly uncomfortable. Every effort is 
made to minimize these risks by having study staff closely observe your tracked behavior and by 
soliciting your comments and concerns throughout the intervention.

Questionnaires: There are no anticipated risks from completing self-report questionnaires. It is estimated 
that the questionnaires will take from 15 to 30 minutes to complete. The questions contained in some of 
the questionnaires may make people feel uncomfortable since they ask about topics such as how they feel 
about their body size. Responses to the questions will be coded to protect confidentiality, and participants 
may choose to not answer questions.

 Magnetic resonance imaging (MRI): There are no significant risks associated with MR spectroscopy and 
imaging. There is a small chance of claustrophobia or muscular discomfort from lying partially in the 
magnet for up to 30 minutes. During the imaging measurement, the subject may hear loud banging that 
may be somewhat unpleasant. Earplugs and/or headphones, however, are provided to mute this banging. 
Although the long-term risk of exposure to a magnetic field is not known, the possibility of any long-term 
risk is extremely low in view of the information accumulated from this type of testing over the past 10 
years. 
b.
Data Safety Monitoring Plan
WorkACTIVE-P is a study with a minimal level of risk to study participants and does not warrant the 
establishment of an independent Data and Safety Monitoring Board. This plan describes the safety monitoring 
procedures for the proposed study, including a description of how often and to whom serious and unexpected 
adverse events will be reported. The plan will help ensure the safety of all participants. The PI will 
communicate via electronic submission to the IRB all unanticipated problems as defined by the IRB and all 
serious adverse events (SAEs) to the program officer within 24 hours. All less serious adverse events will be 
reported to the program officer within 3 days of occurrence. 
The study investigators will monitor conduct of WorkACTIVE-P. Study staff will report adverse events 
or other problems directly to the PI as they occur. The PI will schedule monthly meetings with study staff to 
review data on adverse events, and recruitment or adherence to regimen problems. Any significant health 
problems coming to our attention during the study will be referred to the participant’s usual source of medical 
care, with his/her permission. We will cooperate fully with his/her physician by providing relevant medical 
records. The following criteria, if detected during any part of the study regimen, will lead to referral to the 
participant’s usual source of medical care:
o 1. Clinical symptoms or signs of CVD to include chest pain suggestive of angina pectoris, unusual 
dyspnea on exertion, severe ankle edema, symptoms suggestive of transient ischemic attacks or 
intermittent claudication.
o 2. Musculoskeletal injuries or problems causing severe pain during exercise or interference with daily 
activities.
c.
Adverse Events
Adverse events that occur in WorkACTIVE-P will be classified as a Serious Adverse Event (SAE) or an 
Adverse Event (AE). Serious adverse events in WorkACTIVE-P are defined to include:

Death

A life-threatening event

Severe illness including worsening of a pre-existing condition, injury or accidents
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
An inpatient hospitalization, surgical procedure, or a treatment to prevent an SAE

A permanent disability or incapacity

A clinically significant abnormal laboratory or diagnostic test result

Any other event that, in opinion of the principal investigator or study physician, might have resulted in a 
serious adverse event if medical intervention had not been initiated
Serious adverse events will be reported to the study PI, Project Manager, and MSO throughout the trial. 
Serious adverse events will be collected from randomization until the final closeout visit. SAE Data will be 
analyzed quarterly, but serious or life-threatening adverse events require immediate reporting and follow-up. In 
the event an adverse event occurs on campus and results in a serious or life threatening situation, the investigator 
or other project staff present will begin emergency measures, as appropriate, and call 911.

For minor physical injury, the individual will be encouraged to see a health care practitioner of his or her 
choice.

If the study participant experiences psychological or emotional distress, the project staff will cease 
research activities and attempt to calm and reassure the participant. The participant will be directed to an 
appropriate health care practitioner for further assessment and treatment as needed.

The investigator and/or project staff will record detailed narrative notes describing the adverse event they 
witnessed or that was reported by participant. The MSO will complete the form Notification of a Serious 
Adverse Event.
Serious adverse Event reporting will follow the requirements of the IRB of the Pennington Biomedical 
Research Center. Serious adverse events that are unanticipated problems will be reported within 48 hours. 
d.
Stopping Rules
There is minimal risk for participating in this trial. The most likely scenario that would indicate a cessation of 
the study would be failure to recruit participants or implement the intervention as planned. Nevertheless, in 
addition to monitoring recruitment and compliance to the intervention, we also will monitor the rates of injury in 
our participants. The safety officers, in conjunction with the study investigators, will alert the IRB and NIH if a 
larger than reasonably expected injury rate occurs in the treatment groups. Other issues that are related to the 
stopping rules include:

New information – It is unlikely that new information will become available during this study that would 
result in discontinuing the trial.

Limits of assumption – It is possible that the value of data analysis will be limited by differences between 
the intervention groups at baseline or because of study dropouts or missing data. Baseline differences will 
be analyzed annually and effects on the power to detect differences in the outcome measures will be 
evaluated and discussed with the PI, safety officer, and the NIH Project Officer. Although an excessive 
number of dropouts could occur, this has not been our past experience. In our DREW study, the dropout 
rate was only 8%. If the dropout rate for the proposed study exceeds 15%, the safety officer will initiate a 
meeting with the PI to discuss strategies to increase retention. If the dropout rate exceeds 25%, the safety 
officer will meet with the study investigators to determine whether or not the study should continue.

Limit of rules – We acknowledge that circumstances, other than what are listed, may justify stopping the 
study.
e.
Confidentiality
All attempts will be made to maintain a subject’s privacy.  Safeguards such as password protected computer 
and networks have been put in place in order to limit access to subject data.  Subjects will be given ample time to 
read over the consent, ask questions, and agree to participate in the research study.  Subjects may decline 
answering questions they are not comfortable with.  Each procedure will be explained to the subject before it is 
performed.  We will always ensure the privacy of the subjects.  When weighing, it will be done in a private 
setting. 
 
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IX.
Data Management and Quality Control
a.
Sample size and statistical power: 
This is a study of an innovative multi-component intervention delivered in a real workplace. The primary 
outcome is change in VAT. The sample sizes herein were set based on data collected in our Pounds Lost51 study 
that showed baseline VAT to be approximately 5.43 kg and indicated that a 21% reduction in VAT (equivalent to 
1.15 kg,  SD=1.20kg) can be achieved with a suitable intervention. The nominal level of significance alpha = 0.05 
will be used to compare mean VAT change (e.g., reduction) in WMPD vs CON, A minimum of 18 subjects per 
intervention who all complete protocol through end of study would conservatively provide at least 80% power for 
detecting significance where the underlying true differential intervention change in VAT is at least 1.15 kg. We 
have planned for 20 participants per group (total n = 41) in this study to allow for 10% attrition. As designed, this 
study will clearly inform the feasibility of combining these components of a workplace multi-component energy 
expenditure intervention.
b.
Data Management:
The data management will be conducted by the Pennington Biomedical Research Computing Group.  
There will be limited access to all data including locked cabinets for paper files and password protected 
computers for electronic data. The PBRC has a fully integrated, campus-wide, automated, data management 
system. All data are entered into a Central Database using existing methodology that has been fully validated and 
undergoes continuous quality assurance by the PBRC Research Computing Core and NORC. Most data are 
automatically uploaded from the instruments that measure the endpoint. All self-report inventories will be 
scanned and scored automatically using the Psychological Assessment Laboratory’s optical scanning system, 
which automatically uploads the data into the Central Database. Exercise testing data will be downloaded from 
the Parvo Medics’ TrueOne® 2400 cart directly following each test and reviewed for integrity. All data are 
backed-up daily and the Research Computing Core at the PBRC oversees all data management.
c.
REDCap Database:
REDCap, a web-based application used to build and manage surveys and databases, will be used for 
questionnaire collection in this study. REDCap (Research Electronic Data Capture) is a secure, web-based 
application that is flexible enough to be used for a variety of types of research. REDCap provides an intuitive user 
interface that streamlines project development and improves data entry through real-time validation rules (with 
automated data type and range checks). REDCap also provides easy data manipulation (with audit trails for 
reporting, monitoring and querying patient records) and an automated export mechanism to common statistical 
packages (SPSS, SAS, Stata, R/S-Plus). 
 
In addition to traditional data capture functionality, REDCap’s survey capabilities are a powerful tool for 
building and managing online surveys. The research team can create and design surveys in a web browser and 
engage potential respondents using a variety of notification methods. All data collection projects rely on a 
thorough, study-specific data dictionary, defined by all members of the research team in an iterative, self-
documenting process. This iterative development and testing process results in a well-planned and individualized 
data collection strategy. Pennington Biomedical has a license agreement with Vanderbilt and the database and 
software are installed on our local servers and hosted by Pennington Biomedical, not by Vanderbilt.  The 
Vanderbilt University Office of Research will not be used as a central location for data processing and 
management.  That is all done by Computing Services and RCG staff at PBRC. More information about the 
consortium is available at http://www.project-redcap.org/. 
d.
Data Analysis: 
Baseline participant characteristics (e.g., age sex, race, weight, BMI, fasting glucose insulin, and HOMA-
IR) will be summarized by intervention group as counts and percentages for categorical variables, and means and 
95% confidence intervals for continuous variables. Adherence to protocol assessments (e.g., daily steps, minutes 
accrued on the pedal desk, rpm on the pedal desk) will be summarized similarly by week for each intervention. 
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On study change in MRI-determined VAT, weight, waist circumference, fasting glucose and insulin, HOMA-IR 
will be summarized by intervention group as means and 95% confidence intervals in an intention-to-treat analysis 
of (1) all participants and (2) the subset of participants who achieve the highest tertile of adherence to the 
intervention. Linear models will provide the primary framework for significance testing. In the analysis of VAT 
(the primary outcome), statistical significance of differential longitudinal changes in response to intervention 
(WMPD vs CON) will be assessed employing repeated measures mixed effects models with maximum likelihood 
estimation and Kenward-Rogers adjustment to the degrees of freedom in an intention-to-treat analysis of (1) and 
(2) for each outcome measure using all available data. Study arm (WMPD. or CON), age, race, sex and 
interactions will be taken as having fixed effects; participants within groups will be considered as having random 
effects. Covariates such as age, sex, race and baseline assessment of VAT will be included in preliminary models 
and retained in final analytic models if warranted. The model residual covariance structure (e.g., unstructured, 
compound symmetric, auto-regressive) across time will be investigated to enhance efficiency of statistical tests. 
Secondary outcomes, such as on-study changes in weight, waist circumference, fasting glucose, inssulin, and 
HOMA_IR will be analyzed using statistical models analogously to the approach described for the primary 
outcome.] Results for each outcome will be summarized as least squares means and 95% confidence intervals for 
each intervention across the assessment times. Model residuals will be tested to see if they have distributions that 
are approximately Gaussian and data transformations will be performed if needed. Group differences in baseline 
characteristics will be tested and corrective steps, such as post-stratification and adding model covariates will be 
employed as necessary Null hypotheses will be tested against two-directional alternatives at the nominal 0.05 
significance level using Bonferroni adjusted p-values when appropriate. All statistical analyses will be performed 
using statistical software in SAS version 9.3. 
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X.
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Appendix 1: Letter of Support 
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