The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)
Phase: NA
Conditions: Central Obesity, Obesity
Sponsor: East Carolina University

Title of Study: Exercise Training and Increasing Non-Exercise Physical Activity (I-CAN 
study) 
Clinical Trials ID: NCT02010060 
Document date: 10/23/2013 

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Specific Aims 
The 2008 Federal Physical Activity Guidelines recommend that adults obtain at least 150 
minutes of moderate physical activity per week to maintain and improve health. Based on 
these guidelines, sedentary individuals may adopt a structured aerobic exercise program (e.g. 
30 minutes of treadmill exercise 5 days per week) to meet these recommendations. While this 
approach is beneficial, the potential exists for aerobic training programs to be optimized by 
also addressing the low levels of physical activity outside of structured exercise training 
sessions (Non-Ex PA). Three large randomized controlled trials performed in our laboratory 
suggest that previously sedentary adults participating in aerobic exercise training still exhibit 
low levels of Non-Ex PA (e.g. 4,500 to 6,000 steps/day). In addition, our group has published 
data suggesting that obese postmenopausal women participating in aerobic exercise training 
with high levels of Non-Ex PA had greater reductions in waist circumference and body weight 
compared to those with low levels of Non-Ex PA. Our results are supported by several 
epidemiological studies demonstrating that the amount physical activity below the threshold of 
moderate to vigorous intensity has clinical benefits (lower body weight, waist circumference, 
and 2-hour fasting glucose) independent of the amount of moderate to vigorous physical 
activity performed. Therefore, a physical activity program composed of 1) aerobic training 
and 2) increasing the amount of Non-Ex PA may represent a more complete and 
clinically effective physical activity intervention compared to a program focused on 
aerobic training only. However, to date, a prospective study examining the effectiveness of 
an intervention of this nature has not been performed.  
The Intervention Composed of Aerobic Training and Non-Exercise Physical 
Activity (I-CAN) study will investigate the effects of aerobic exercise training and 
increasing Non-EX PA on waist circumference, weight, and other cardiovascular 
disease risk factors in a prospective pilot trial. We will randomize sedentary (<6,500 steps 
per day) obese adults (N= 45) with at least one additional cardiovascular risk factor to a: (1) 
structured aerobic exercise program with no intervention on Non-Ex PA (AERO group, N=15); 
(2) structured aerobic exercise program with the additional goal of increasing Non-EX PA 
(AERO-PA group, N=15), or (3) a control group (CON, N=15) for 6 months. Exercise groups 
will participate in the same aerobic training program (50 to 75% VO2 max), designed to be 
consistent with public health recommendations of 150 minutes per week of moderate physical 
activity. Non-Ex PA in the AERO group will be tracked throughout the entire 6 month 
intervention with pedometers capable of counting steps, but not displaying them to the 
participant (blind mode capable). The AERO-PA group will progressively increase Non-Ex PA 
(1,000 to 3,000 steps per day above baseline levels) throughout intervention using 
pedometers. The AERO-PA group will also participate in lifestyle counseling grounded in the 
principles of the social learning and behavioral change theories to determine/reinforce 
strategies to increase Non-Ex PA. The primary outcome measure will be change in waist 
circumference following the intervention. The study results will be used to determine the 
efficacy/feasibility of the intervention, and power a larger trial as an R01 application.  
 
Specific Aims:  
To test the hypothesis that: 
• Aerobic exercise training and increasing Non-EX PA will reduce waist circumference to 
a greater extent compared to the aerobic exercise training alone and the control group.  
• Aerobic exercise training and increasing Non-EX PA will reduce weight and fat-mass to 
a greater extent than aerobic exercise training alone and the control group. 
 
Additional Aims: We will also evaluate the effect of the intervention on fitness and insulin 
sensitivity  

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Definitions for physical activity terminology used in 
the present proposal: 
Non-Exercise Physical Activity (Non-Ex PA): Free-living 
physical activity not performed during an aerobic exercise 
training program (pedometer-determined) or below the 
threshold of moderate to vigorous physical activity 
(accelerometer-determined). 
Dose of exercise training: Amount of kilocalories 
expended during an aerobic exercise training intervention 
relative to body weight. Used to standardize training for 
caloric expenditure across participants. Expressed as 
kilocalories per kg per week (KKW). 
Figure 1. Hamilton et al. Current Cardiovascular Risk Reports 2008. Opportunities for 
sitting during the day for an individual who exercises 45 minutes 
1. Background and Significance  
The 2008 Federal Physical Activity Guidelines 1 
recommended that adults participate in at least 150 
minutes/week of moderate physical activity. 
Substantial evidence exists that physical activity 
programs consistent with these recommendation 
have profound health benefits for sedentary adults 
2-6, and a structured aerobic exercise training 
program (e.g. 30 minutes, 5 times a week) 
represents an effective strategy to meet these 
recommendations 1, 6. However, there is potential 
for aerobic exercise programs to be optimized. The results of several published studies 
indicate that the amount of physical activity performed outside training (Non-Ex PA) remains 
low (similar to pre-training levels) in previously sedentary adults participating in aerobic 
exercise training 4, 5, 7. Therefore, this low amount of Non-Ex PA may represent an 
additional intervention target to use along with aerobic exercise. Hamilton et al. 8 has 
described (in reference to sitting, Figure 1.) that ample opportunities exist for sedentary 
behavior even individuals who are presumed to be “physically active.” For example, a training 
session of 45 minutes 
represents less than 3% of 
waking hours leaving the 
remaining 95% at risk for 
potential sedentary 
behaviors.  
This relationship, along with the declining levels of occupational, 9-13 transportation-
related 10, and physical activity in the home 10 has led some researchers to question the extent 
to which a bolus of exercise training (i.e. 30-45 minutes of aerobic exercise) mitigates the risk 
associated with low levels of physical activity or prolonged periods of inactivity throughout the 
day 8, 14, 15. Thus, a physical activity program composed of aerobic training only, while 
beneficial, could be optimized by also increasing the amount of Non-Ex PA outside of training 
sessions. However, to date, no prospective studies exist combining aerobic exercise training 
and increasing Non-Ex PA. If clinically effective, this intervention could represent a more 
complete approach in treating obese sedentary adults compared to aerobic training alone, 
which may have a greater overall effect in reducing central adiposity, weight, and subsequently 
other cardiovascular disease risk factors. The core concepts of this intervention (aerobic 
exercise training and high Non-Ex PA) are transferable and feasible in clinical, public health, 
and exercise training settings. This may have important clinical implications as the majority of 
adults in the United States (58%) do not obtain the recommended amount of physical activity, 
which is especially prevalent in obese (64%) individuals 16.  
 
1.1 Non-Ex PA in Aerobic Exercise Training Studies: Adults participating in aerobic training 
still exhibit low levels of Non-Ex PA (4,500-6,000 steps/day). Our research team has monitored 
Non-Ex PA in three large randomized controlled exercise training trials 4, 5, 7 . Pedometers were 
used to quantify the amount of Non Ex-PA over the course of the entire training intervention. 
Importantly, pedometers were not worn during exercise training sessions. In the DREW 
(postmenopausal women, N=464) 5, INFLAME (adults with elevated C-reactive protein, 
N=162) 7, and HART-D (adults with type 2 diabetes, N=262)4 studies, we observed no 
significant change in pedometer determined Non Ex-PA compared to the control group (Figure 
2). This finding was consistent across studies despite differences in the duration of the 

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intervention (4 to 9 months), exercise training intensity 
(50%-85% VO2 max), and aerobic training energy 
expenditure (4 to 16 kilocalories per kg per week 
[KKW]). In the DREW trial, Non-Ex PA was not 
significantly different compared to control even at an 
exercise dose as high as 150% public health 
recommendations. Our findings are supported by other 
large randomized controlled trials such as the STRIDDE 
(duration: 8 months) 17 and the STRIDDE AT/RT 
(duration: 4 months) 18 studies, which report no 
significant change in accelerometer determined Non-Ex 
PA in overweight and obese middle aged adults.  
 
1.2 Non-EX PA independent of MVPA (moderate to 
vigorous physical activity) on CVD risk factors: Non-
Ex PA is likely performed for the most part below a 
moderate to vigorous intensity, but contributes to total 
energy expenditure. Epidemiological and retrospective 
analyses from prospective training studies suggest that 
high Non-Ex PA has clinical value in promoting lower 
weight, waist circumference and other CVD risk factors. 
 
1.3 Epidemiological evidence: Several 
epidemiological studies have demonstrated that 
physical activity below the threshold of MVPA can have 
a beneficial effect on CVD risk factors independent of 
the amount of MVPA. Specifically, Camhi et al. 19 using 
NHANES data observed that accelerometer determined 
lifestyle physical activity (760-2,019 counts/ minute) 
decreased the odds of low HDL, high triglycerides, 
elevated blood pressure, high fasting glucose, waist 
circumference, and the presence of the metabolic syndrome or type 2 diabetes independent of 
MVPA (>2,020 counts/minute). Healy et al. 20 found that higher amounts of accelerometer 
determined “light intensity physical activity” (100-1,952 counts) was associated with lower 2-
hour plasma glucose levels independent of MVPA (≥ 1,952 counts). Similarly, Healey et al. 21, 
in a different study, found that even in adults meeting physical activity recommendations, 
significant dose-response associations were observed for higher waist circumference, 2- hour 
plasma glucose and systolic blood pressure with higher television viewing time. The authors 
hypothesized that the cardiometabolic consequences of high television viewing time could be 
due to the displacement of light intensity physical activity 21.  
 
2. Preliminary studies:  
Non-Ex PA and Exercise Training: Little data exist evaluating the effect of different amounts 
of Non-Ex PA on anthropometric or CVD risk factors in adults participating in aerobic training. 
Di Blasio et al. 22 found that postmenopausal women who decreased Non-Ex PA outside of 
training did not have beneficial improvements in plasma low density lipoprotein and triglyceride 
levels compared to those that maintained or increased Non-Ex PA. Our laboratory conducted 
the Dose Response to Exercise in Women (DREW) study, which investigated the effects of 6 
months of aerobic training at levels consistent with public health recommendations, and 50% 
below or 50% above those recommendations on cardiorespiratory fitness in postmenopausal 
women. The DREW study used pedometers to quantify the amount  of Non-Ex PA outside of 
Figure 2. Non-Ex PA defined as steps/day in the 
DREW, INFLAME, and HART-D trials. Step 
counters were not worn during exercise 
sessions. KKW: kilocalories per kg per week. 
Data are expressed as (mean± SD) 

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exercise training 23. Postmenopausal women  with the highest amount of Non-Ex PA, while 
also participating in aerobic training had greater reductions in waist circumference compared to 
those in the lowest tertile of Non-Ex PA at all three doses of exercise training (4, 8 and 12 
KKW) (Figure 3). Aerobic training with high Non-Ex PA was also associated with modest 
weight loss (when all exercise groups were combined and statistical models were adjusted for 
exercise training dose) 24. Higher Non-Ex PA 
with exercise training did not provide 
additional beneficial effects for the change in 
fitness, systolic or diastolic blood pressure. 
Although, we investigated women who self-
selected to levels of Non-Ex PA outside of 
training sessions, our data does suggest that 
an intervention composed of aerobic training 
and increasing levels of Non-Ex PA may 
accelerate the improvements in waist 
circumference. This may have greater effects 
on adiposity and other CVD risk factors when 
Non-Ex PA is increased along with aerobic 
training. 
   
3. Research Design and Methods  
3.1 Innovation: 
The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity study (I-
CAN) study will evaluate for the first time a physical activity intervention composed of 
structured aerobic exercise training along with a strong emphasis on increasing the 
amount of physical activity outside of training on waist circumference, weight and other 
cardiovascular risk factors training against the standard prescription of aerobic training 
alone. To date, exercise training studies primarily focus on adherence to aerobic exercise and 
instruct participants not to alter Non-Ex PA. While studies following this model have 
established effectiveness in promoting favorable changes in CVD risk factors, the I-CAN study 
will attempt to optimize these benefits by also increasing the amount Non-Ex PA (defined as 
steps/day outside of training) through the use of pedometers along with structured aerobic 
training. The design of I-CAN is composed of several innovative features including: strict 
monitoring of Non-Ex PA throughout the entire 6 month intervention, behavioral support (both 
web-based and in-person), goals for progressively increasing Non-Ex PA with aerobic exercise 
training, and an equivalent dose of aerobic exercise training (designed to be consistent with 
public health recommendations) in the exercise groups. This could represent a practical and 
clinically effective approach for clinicians and trainers to further increase total energy 
expenditure in the treatment of obese patients. However, pilot data supporting the efficacy and 
feasibility of this intervention is necessary prior to implementation in a large randomized trial.  
 
3.2 Approach:  
The target study population of the I-CAN study will be sedentary obese men and women (BMI: 
30-40 kg/m2, age 40-65 yrs). We will randomize participants to aerobic training (AERO, N=15), 
aerobic training and increasing Non-Ex PA (AERO-PA, N=15) group or a non-exercise control 
group (CON, N=15) for 6 months (24 weeks). Participants in the AERO or AERO PA groups 
will participate in the same structured aerobic training program 3 times per week in a 
laboratory setting, and wear pedometers during the entire 6 month intervention (except during 
structured aerobic training sessions). The AERO-PA group, in addition to aerobic training, will 
increase Non-Ex PA progressively from 1,000 to 3,000 steps/day above baseline from week 6 
Figure 3. Swift et al. American Journal of Preventive Medicine. 
2012. Change in waist circumference in the DREW study 
stratified by amount of Non-Ex PA in the 4, 8 and 12KKW 

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to week 24 of the intervention. The CON group will continue their current physical activity 
habits during the intervention. The primary outcome measure of I-CAN is the change in 
waist circumference following the intervention. Secondary measures include change in 
fitness, body weight, body composition (fat and lean mass), pedometer determined steps/day 
of Non-Ex PA during the intervention, accelerometer-determined physical activity, fasting 
glucose, fasting insulin and homeostatic model of insulin resistance (HOMA-IR).  
 
3.3 Inclusion/Exclusion Criteria: The inclusion/exclusion criteria are summarized in Table 1. 
The goal of the I-CAN study is to recruit adults with moderate to high CVD risk that can safely 
perform the supervised aerobic training in our facility. In addition, all participants must have 
sufficient health to increase Non-Ex PA in their daily lives, as this will not be directly supervised 
by study staff. Therefore, we will recruit sedentary obese men and women (age: 40-65) with 
elevated waist circumference (women: ≥88 cm, men: ≥102 cm), and at least one additional 
CVD risk factor. Individuals with type 2 diabetes and known cardiovascular disease will be 
excluded due to the pilot nature of this trial, and the necessity to establish the efficacy of this 
intervention prior its utilization in a higher risk study population.    
 
Table 1. Summary of the Inclusion/Exclusion Criteria 
Inclusion Criteria for Study Participation 
Age  
40-65 years of age 
Sex 
Men and women 
Non-exercisers 
and sedentary/low 
active lifestyle 
Not currently participating in aerobic or resistance exercise ≥ 20 
minutes on ≥3 days per week for the last 6 months. Pedometer 
determined objective measurement of physical activity ≤ 6,500 step/day 
One or more of 
the following CVD 
risk factors 
Triglycerides (TG) ≥ 150 mg/dL 25, HDL-C< 50 mg/dL, Blood pressure: 
systolic ≥130 mmHG and diastolic ≥ 85 mmHg or the use of BP 
medication, Fasting glucose: 100-125 mg/dL (type 2 diabetes is 
exclusionary), LDL-C≥130 mg/dL, or currently taking cholesterol 
lowering medications 
Abdominal 
obesity/BMI 
Waist circumference ≥ 88 cm (women), ≥ 102 cm (men) 25; BMI: 30-40 
kg/m2 
Informed Consent  The capability and willingness to give written informed consent, to 
understand the exclusion criteria 
Exclusion Criteria 
Significant CVD or 
disorders 
Including but not limited to serious arrhythmias,  cardiomyopathy, 
congestive heart failure, stroke or transient ischemic attacks, peripheral 
vascular disease with intermittent claudication, acute, chronic or 
recurrent thrombophlebitis or myocardial infarction  
Diabetes  
Diagnosis or taking medication for type 1 or 2 diabetes and/or fasting 
glucose>125 mg/dL   
Resting blood 
pressure 
Systolic blood pressure >180 and diastolic blood pressure >100 26.  
Participants currently taking blood pressure medication (except for 
diuretics) can enroll in the present study  
Blood lipids 
Total cholesterol ≥ 240 mg/dL, LDL-C ≥ 160 mg/dl or TG levels ≥300 
mg/dl. Cholesterol medications are permitted. 
Other significant 
medical 
conditions 
Including but not limited to chronic or recurrent respiratory, 
gastrointestinal, neuromuscular, neurological, HIV or psychiatric 
conditions. Hospitalization for mental illness within the past 5 years or 
Musculoskeletal problems interfering with exercise. Autoimmune or 

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3.4 Primary Outcome- Waist Circumference:  We have selected waist circumference as the 
primary outcome measure of the I-CAN study for the following reasons:1) Elevated waist 
circumference is associated with CVD risk factors 27, represents one of the components of the 
metabolic syndrome 25, and has incremental value in predicting CVD, diabetes and mortality 
risk over and above BMI. 28 2) Waist circumference can be feasibly evaluated in the clinical 
setting, which has relevance to clinicians (e.g. physicians, personal trainers, nutritionists) 
working with obese adults. We considered visceral fat mass by MRI as the primary measure, 
however, the increased burden to participants, high costs, and the fact that it is not measured 
in the clinical setting lead us to the decision that it was not appropriate for this pilot trial, 
especially since we will obtain measurements of trunk fat mass through DEXA; 3) Our 
retrospective published data 24, 29 demonstrating that high Non-Ex PA with aerobic training 
resulted in greater reductions in waist circumference compared to low Non-Ex PA.  
 
Measurement of waist circumference: We will utilize standard operating procedures (SOPs) 
for assessment measures including waist circumference. Staff are tested and certified annually 
on the correct measurement technique. Participants will stand in a straight, upright position 
with the feet together with arms at thier side. Waist circumference will be measured at the 
natural waist (midway between the inferior border of the rib cage and the superior aspect of the 
iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and 
the superior aspect of the iliac crest) will be marked and the distance will be measured to 
determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape 
remains horizontal; 2) the tape touches the entire circumference of the participant; 3) 
abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the 
measurement is taken at the end of normal respiration. The measurement will be repeated an 
additional time, and the reported value will be the average of these measurements. Both 
measurements must be within 0.5 cm to be considered acceptable for data purposes. A third 
measurement is required if values are > 0.5 cm.  Waist circumference will be evaluated at 
baseline, mid-intervention, and at follow-up.  
3.5 Secondary measures: Secondary measures include: change in fitness, body weight, body 
composition, pedometer determined Non-Ex PA during the intervention, accelerometer 
determined physical activity levels, fasting glucose, fasting insulin and HOMA-IR.  
 
Anthropometric & Dual Energy X-ray Absorptiometry (DXA): Height will be measured at 
screening. Body weight will be evaluated using a calibrated scale (recorded to the nearest 1/10 
of a kg), with the participant fasted and wearing only a hospital gown. DXA will be used to 
measure body composition (fat and lean mass).  
 
Accelerometry: At each major assessment point, participants will wear the GT3X+ 
accelerometer (ActiGraph, LLC, Pensacola, Florida, USA) at their waist for seven consecutive 
days, 24-hrs/day. We have successfully used this 24-hour protocol in adults and find that it 
maximizes wear time. This accelerometer has been validated 30, 31 and is one of the most 
widely used accelerometers in research and has the capability of detecting minute-by-minute 
collagen vascular diseases. Other medical conditions which is life-
threatening or can be aggravated by exercise training  
Other exclusions 
Plan to be away from Pitt County area more than 2 weeks in the next 
3 months. Currently or plans to become pregnant. Currently or plans 
to engage in dieting or a weight loss program. No home access to 
internet. Previous bariatric or gastric banding surgery, or weight loss 
medications. Non-compliance during screening in wearing 
pedometers or failure to document physical activity levels in the 
study online database.   

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steps (steps/min, which can be totaled to obtain steps/day) and physical activity intensity using 
previously validated activity count cut points 31. More recently, it has been used to estimate 
time in sedentary behaviors as time spent at < 100 activity counts/min 32. 
 
Maximal Exercise test: Testing will be performed on a treadmill (Trackmaster 425, 
Carefusion, Newton Kansas) using a modified Balke protocol to determine maximal oxygen 
consumption (VO2 max), and the correct heart rate range for aerobic exercise training (50% to 
75% of VO2 max). Participants will walk at an initial speed of 2.0 mph with 0% grade for the 
first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 2 minutes. 
The treadmill grade will be increased by 2.5% every 2 minutes until volitional exhaustion. 
Respiratory gases (VO2, CO2) and ventilation will be measured continuously using a True Max 
2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).  
 
Pedometer: Pedometers will be used to determine sedentary status during screening (over the 
course of 7 days), and to measure Non-Ex PA during the intervention. We have selected the 
Lifecorder PLUS (New-Lifestyles, Lees Summit, Mo), which has a feature that does not allow 
the participant to see the amount of steps walked on the pedometer’s display (blind display 
mode). This feature is ideal for the determination of sedentary status during screening, and 
monitoring Non Ex-PA in the CON and AERO groups. Non-Ex PA data will be downloaded 
directly from pedometers for data purposes. We elected to use pedometers for monitoring 
Non-Ex PA because accelerometers are rarely used in clinical practice. In addition, 
pedometers allow direct feed-back (i.e. steps/day) to participants about Non-Ex PA levels.  
 
Tracking dietary changes: We will utilize the Food Frequency Questionnaire (FFQ) originally 
developed by Drs. Gladys Block and Linda Harlan, often referred to as the “Block FFQ” 33. This 
questionnaire collects information about eating habits over a 12-month period. The FFQ 
contains approximately 105 items grouped by categories and is completed for both frequency 
of consumption as well as portion size selections by the individual. The questionnaire, upon 
completion, provides estimated daily intake values for selected nutrients (kilocalories, 
macronutrients, and micronutrients) and provides information on food group servings. All 
participants will be instructed and reminded regularly not to alter dietary habits or 
engage in purposeful dieting during the intervention.  
 
Blood sample collection: Trained personnel will obtain fasting venous blood samples from 
the antecubital site with participants in a seated position.  Either 21 or 23 gauge needles will be 
used, depending on vascular access.  Standard OSHA guidelines will be followed at all times.  
At baseline and follow-up, a total of 20 mL of blood will be drawn.  Of this, 10 mL will be 
immediately sent to the Clinical Laboratory for lipid assessment, insulin and blood chemistries.  
Lipids and other biochemical measures will be made using standard analytic techniques. The 
remaining 10 mL sample will be centrifuged under refrigerated conditions, and the supernatant 
will be extracted, and divided into 1 mL portions. Vials of plasma (3-4), serum (2-3), and red 
blood cells (2-3) will be stored at -80°C for future analysis.    
 
3.6 Recruitment and Pre-Screening: Study personnel will screen interested individuals over 
the phone based on the inclusion/exclusion criteria. Eligible individuals will be invited to attend 
an orientation session, during which study personnel will provide a presentation with detailed 
information about the study (structure of the study, study-related procedures, risks, benefits, 
etc.). Individuals interested in I-CAN following this orientation session will be consented at this 
time, and scheduled for run-in visits.  
  
 Run-in visits: The run-in period will last for two weeks in order to: 1) verify sedentary status 
(pedometry) and screen for other inclusion/exclusion criteria (e.g. BMI, waist circumference, 
blood pressure); and 2) ensure participants are able to make the time commitment to come to 

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Run-in:
Information collected:
• 
Did you wear the  pedometer today (yes/No)
• 
Were there any periods of time where pedometer was not 
worn (Yes/No)
• 
If so, please provide an estimate of the approximate 
time:_____
• 
Further comments:_____
Figure  4.  Web-based questions to determine 
pedometers compliance.  
to training sessions. In our past training studies, this run-in period has helped to obtain 
excellent training adherence by allowing potential participants to thoroughly evaluate their 
ability to commit to the time demands of a study. To simulate participation in the actual I-CAN 
intervention, run-ins will be scheduled 3 sessions per week over the course of two weeks, and 
duration will be similar to that of training sessions (~1 hour). During run-ins, participants will 
wear pedometers for 7 days, and enter information about self-monitoring into the study website 
(using RED Cap, described in detail below). Participants will confirm they wore the pedometer 
at the beginning of the day, and notate the extent of non-wear time (Figure 4). Pedometers will 
be worn in “blind display mode”, so the amount of steps 
accumulated throughout the day will not be seen by the 
participant. We will ask participants to employ methods 
to remember to wear the pedometer at the beginning of 
the day (placing reminders on calendars or smart 
phones, placing pedometer on clothes to wear). On the 
last run-in session, participants will meet with a trained 
interviewer who will use a semi-structured barriers 
interview, to evaluate for any major barriers to study 
participation or completion.  
 
Pedometer compliance tracking: We will utilize RED Cap ™, a secure online research 
database to: 1) track and monitor participant compliance wearing pedometers; and 2) record 
Non-Ex PA at run-in and during the intervention. Participants will be provided a unique 
name/password to log on to the study website. The use of RED Cap ™ will allow our staff to 
monitor participant compliance throughout the trial in real-time. Our research team is 
successfully using RED Cap ™ in two on-going prospective physical activity trials.  
 
3.7 Clinical Visits (baseline, mid-intervention, and follow-up): We will obtain primary (waist 
circumference) and secondary outcome measures (DEXA, fitness, blood measures) at both 
baseline and follow-up (summarized in Figure 5). Pre-menopausal women will be asked to 
take a pregnancy test. A physician or a physician’s assistant will obtain a medical history and 
perform a brief medical exam. All clinic staff measuring outcome measures will blinded to 
participant randomization. 
At mid-intervention (week 
12), we will measure waist 
circumference, weight, FFQ, 
and accelerometry. The 
CON group will be 
scheduled for mid-
intervention and follow-up 
visits, and will be instructed 
not to alter physical activity 
habits during the 
intervention. All groups will 
be instructed not to alter 
dietary habits during the 
study. 
 
3.8 Exercise Training 
Intervention: Participants 
will participate in structured aerobic training 3 times a week at a heart rate associated with 50-
Orientation:
• 
Information session about 
study
• 
Obtain informed consent for 
screening and run-in visits 
Run-in: 
• 
6 run sessions over 2 weeks to 
test participants ability to come 
to PBRC 3 times per week 
• 
Informed consent for baseline 
evaluation
• 
Verify inclusion criteria (ie: 
baseline physical activity, waist 
circumference, blood pressure).
• 
Log compliance wearing 
pedometers using the RED CAP 
™ systemBlood draw: 
• 
Lipids, CBC, chemistry panel, 
insulin
• 
Intervention interview
Phone-screen
Orientation and Run-in
• 
Clinic Evaluation
• 
Physical/review of medical 
history
• 
Blood pressure
• 
Anthropometry 
• 
DEXA
• 
Treadmill exercise test
• 
FFQ
At baseline: Informed consent for 
randomization
Randomize to the CON, AERO, or  
AERO-PA group
Mid-intervention: FFQ, weight and 
waist circumference, accelerometry 
At follow-up: Exit interview
Clinic Evaluation
(baseline, mid-intervention and 
follow-up)
Screen for inclusion/exclusion 
criteria:
• 
Age (40-65 yrs)
• 
BMI (30-40)
• 
Diabetes (No)
• 
Heart disease (No)
• 
Stroke (No)
• 
Currently exercising (No)
• 
Height/weight
• 
Other information:
• 
Ethnic identification
• 
Contact information
• 
Medication list
Figure 5. Study Flow 

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Figure 6. Non-Ex PA in the AERO and AERO-PA group 
in a participant walking 4,500 steps/day at baseline 
75% of VO2peak.  All exercise training will occur on a treadmill (or a stationary bicycle only 
when necessary). Participants will wear heart rate monitors during exercise sessions. The 
speed and grade of the treadmill will be adjusted in order to keep participants within their heart 
rate range. Using standard ACSM equations 34,  and adjust the length of each exercise session 
to meet the daily caloric goal based on the speed, grade of the treadmill, and  participants’ 
weight 35. The caloric goal of each session will be calculated by dividing the weekly caloric 
expenditure goal by the participant’s exercise frequency (i.e. 3 times per week). Study staff 
will confirm that pedometers measuring Non-Ex PA are removed prior to beginning 
aerobic training sessions. Since individuals in both groups will participate in aerobic exercise 
training in the same room, they will be reminded frequently not to discuss group assignment 
with each other.  
 
Exercise training dose and progression: Exercise dose (expressed in KKW: kilocalories per 
kg per week) during aerobic training will be the same in both the AERO and AERO-PA groups. 
During the first month of the study, both groups will participate solely in structured aerobic 
training with no intervention on Non-Ex PA (to allow acclimation to aerobic training). 
Participants in both exercise groups (AERO, AERO-PA) will expend 8KKW in week 1, 10KKW 
in week 2 and 12 KKW in week 3. We have selected 12 KKW as the selected energy 
expenditure for aerobic training because, based on our calculations, it most closely represents 
the current recommendations of 150 minutes per week of moderate physical activity 1. We 
have utilized the 12KKW dose successfully in two completed exercise training trials 4, 5. Thus, 
the amount of exercise training should be reasonable for participants to perform. For example, 
at a speed of 3.2 MPH and 2.5% grade, the estimated session time would be approximately 50 
minutes for a participant exercising 3 days per week.  
 
3.9 Non EX-PA: Our research team has 
monitored Non-Ex PA successfully in several 
previous exercise studies4, 5, 7. For the AERO-
PA group, we will average the amount of Non-
Ex PA from week 4 to week 6 (when 
participants are at the full prescription for 
exercise training [12KKW]) to determine the 
baseline level of Non-Ex PA with exercise 
training (Figure 6).  At week 6 of intervention, 
the AERO-PA group will begin to 
incrementally increase their Non-Ex PA by an 
average of 1,000 steps/day above baseline for 
the first two weeks. Participants will continue 
to increase Non-Ex PA by at least an average 
of 500 steps/day every 2 weeks until they 
reach an average of 3,000 steps/day above 
baseline (week 14) for the remainder of the 
intervention. We have selected 3,000 steps as 
the maximum goal for Non-Ex PA based on data evaluating the increase in steps from 
pedometry-based interventions with similar study populations/design. These studies suggest 
that an increase of 2,000-4,000 steps/day is feasible 36-38. We elected to utilize a progressive 
increase in Non-Ex PA to allow participants adequate time to determine behavioral strategies 
to reach Non-Ex PA goals, and to become acclimated to the higher amounts of total physical 
activity. The investigative team will not impose any restrictions on how this increase in Non-Ex 
PA is achieved, with the exception that it is not performed specifically as additional aerobic 

10 
 
exercise training (i.e. treadmill for 30 minutes). Moderate physical activity consistent with daily 
living (i.e. leisurely walking in the evening, walking the dog etc.) will be permitted. Participants 
will be instructed to take a “recuperation day” once every week, where Non-Ex PA will be 
tracked, but not intervened on for the purposes of the study. We believe that a weekly 
recuperation day will lessen the total participant burden, and allow adequate recovery time.  
 
Lifestyle counseling to increase Non-Ex PA in AERO-PA group: The AERO-PA group will 
receive lifestyle counseling to help them obtain the required amount of Non-Ex PA. 
Participants will meet with study staff (~15 mins) once a week (from week 6-10), and every two 
weeks thereafter. Specific strategies to increases Non-Ex PA will be tailored to each 
participant (occupational strategies, home strategies, etc.). Lifestyle counseling for the AERO-
PA group will occur before or after exercise training sessions, and all sessions will be 
conducted in a private room to avoid potential contamination with the AERO group. Examples 
of strategies to increase Non-Ex PA include walking around the house during commercial 
breaks while watching television, talking on a cell phone while walking instead of sitting, 
parking car farther away from workplace. The intervention is grounded in the principles of 
social learning and behavior change theories. Counselors will utilize motivational interviewing 
and enhancement for participants whose motivation decreases during the study. Behavioral 
strategies to foster adherence to Non-Ex PA goals include stimulus control, behavioral 
contracting, problem solving training, and selective reinforcement of target behaviors. 
 
Plan for Tracking and Monitoring Non Ex-PA: Similar to run-in visits, during the intervention, 
we will utilize the study website (RED Cap ™ database) to monitor compliance. The AERO 
group will monitor Non-Ex PA in the same manner as during the run-in period throughout the 
intervention. In the AERO-PA group only, we will obtain self-reported steps data as a cognitive 
behavioral tool as well to monitor Non-Ex PA in real-time by study staff. From week 6 to the 
end of intervention, the AERO-PA group will input the amount of steps completed at the 
conclusion of the day (or within at least 72 hours of completion), whether they wore their 
pedometer as instructed, whether this day 
was a recuperation day, and any comments 
about Non-Ex PA (Figure 7). Non-Ex PA 
compliance will be defined as the amount of 
total days wearing the pedometer versus 
total amount of days in the study 
intervention. Adherence will be defined as 
total amount of steps obtained versus total 
amount of steps prescribed. Non-Ex PA 
values will also be downloaded directly 
from pedometers in order to obtain 
objective measures of steps/day in all 
participants. 
 
Control (CON) Group: As stated earlier, 
participants randomized to the CON group 
will be instructed not to change their physical activity habits during the study, but will 
participate in all assessment visits (i.e. mid-intervention, following-up testing). Non-Ex PA will 
also be measured in the CON group as participants will wear pedometers during the 6 month 
invention in “blind mode” and enter information into the RED Cap ™ database online (in the 
same manner as screening). In addition, participants will come in once a month to Pennington 
to confirm no changes in sedentary status, download pedometer data (Lifecorder Plus has a 
60 day memory), and address any issues with participant compliance.  
 Intervention (week 6-week 24)
AERO Group:
Information collected:
• 
Did you wear the  pedometer today (yes/No)
• 
Were there any periods of time where pedometer was not worn (Yes/No)
• 
If so, please provide an estimate of the approximate time:_____
• 
Further comments:_____
AERO-PA Group:
Information collected:
• 
Total amount of steps
• 
Recuperation day (Yes/No)
• 
Did you wear the  pedometer today (yes/No)
• 
Were there any periods of time where pedometer was not worn (Yes/No)
• 
If so, please provide an estimate of the approximate time:_____
• 
Further comments:____
• 
Require assistance from I-CAN staff (Yes/No)
Displayed info for participant: Number of steps left, current steps per week, 
recuperation days left
Figure 7. Web-based pedometer compliance questions in the 
AERO and AERO-PA groups 

11 
 
 
Adherence plan: We will actively monitor adherence and compliance of exercise training 
using EDIN (exercise training data base) and Non-Ex PA using RED Cap™. We will review 
these data regularly during the intervention, and I-CAN staff meetings (bi-weekly). We will also 
employ several strategies to promote adherence to the study such as certificates for excellent 
adherence, raffles for incentive items (e.g. mug, tee-shirt), and regular adherence reports to 
help motivate participants. In the case of non-adherence, every ethical research-based 
strategy will be used to prevent participant drop-out, and continued non-adherence to the 
protocol.  We have identified signs of poor adherence from previous training studies (i.e. lack 
of attendance without rescheduling, not meeting protocol goals), and have developed 
standardized responses by study staff. In the case of a non-adherence, a “case manager” will 
develop an adherence plan, and work with the participant on a one-on-one basis.  
 
3.10 Justification of study groups: Similar to pharmalogical trials, in order for the physical 
activity intervention used in I-CAN (AERO-PA group) to be incorporated in common practice, it 
must be more clinically effective compared to the current standard treatment. The current 
standard (or recommendation) for aerobic exercise is obtaining at least 150 minutes of 
moderate physical activity.  Thus, the I-CAN study will determine the extent of the additional 
clinical benefits of increasing Non-Ex PA with aerobic exercise training.  
 
3.11 Statistical Considerations: The results of the present pilot trial will be used to inform the 
design (effect size/statistical power) of a larger prospective intervention (to be developed into a 
future R01 application). Baseline participant characteristics (e.g., age sex, race, weight, BMI, 
waist circumference, % body fat, fat mass, lean mass, cholesterol, triglycerides, blood 
pressures) will be summarized by group (CON, AERO, and AERO-PA) as counts and 
percentages for categorical variables, and means and 95% confidence intervals or medians 
and IQRs for continuous variables. Adherence to protocol assessments (e.g., daily steps, 
minutes spent in very low activity, aerobic sessions/week, percent of peak VO2, MET levels) 
will be summarized similarly by week for each intervention. On study change in peak VO2, 
estimated METs, weight, waist circumference, cholesterol, triglycerides, and blood pressures 
will be summarized in an intention-to-treat analysis of (1) all participants and (2) the subset of 
participants who achieve a high level of adherence to protocol.  Linear models will provide the 
primary framework for significance testing. Statistical significance of differential longitudinal 
changes in response to interventions 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 using all 
available data. The two interventions, measurement times (e.g., baseline, mid-intervention, 
study exit), race, sex and interactions will be taken as fixed effects; participants within groups 
will be considered as having random effects. Other covariates such as age and baseline 
assessments will be included in preliminary models and retained in final analytical models if 
warranted. The model covariance structure (e.g.: unstructured, compound symmetric, auto-
regressive) across time will be investigated to enhance efficiency of statistical tests. Results for 
each outcome will be summarized as least squares means and 95% confidence intervals for 
each intervention across the assessment times (repeated measures). 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 taken, such as post-stratification and adding model covariates 
as necessary. Linear contrasts on least squares means will be used to test differential mean 
changes in each outcome from baseline to subsequent assessment times between the two 
intervention groups. Null hypotheses will be tested against two-directional alternatives at the 

12 
 
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. 
 
3.12 Limitations and Strengths: A limitation of the project is the small sample size. However, 
we feel this is appropriate due to the pilot nature of the trial. In addition, the results of I-CAN 
will be used to determine the effect size and to power a larger randomized trial (as an R01 
application) with more cardiovascular/diabetes-related outcomes. Another limitation is that we 
are not measuring total energy expenditure through doubly labeled water (DLW). Due to the 
high cost of DLW (each participant: $750, total study costs [baseline and follow-up] = $67,500), 
it is not feasible for this pilot project. However, we will incorporate DLW measurements when 
this study is developed into a larger randomized trial. The strengths of I-CAN are that it is a 
practical physical activity intervention, the core principles of which (i.e. aerobic training and 
attainment of high Non-Ex PA) are feasible in clinical, exercise training and public health 
settings. We have designed our aerobic training intervention to be consistent with public health 
recommendations. I-CAN will be the first training study to our knowledge with such a strong 
focus on the measurement of Non-Ex PA (adherence and tracking plan, pedometers [blind 
mode capable], and the use of internet databases to monitoring Non-Ex PA and support 
behavior modification) throughout the entire exercise intervention. Results of this pilot project, 
and the subsequent large randomized controlled trial could have implications for future public 
health recommendations, and other populations with co-morbid low physical activity and 
obesity (e.g. adults with cardiovascular disease or type 2 diabetes). 
 
4. Ethical aspects of the proposed research: Ethical research practices will be strictly 
adhered to during the implementation of the present study, inclusive of the safety of human 
participants and safeguarding protected health information. The aspects of this study that carry 
the greatest safety risks are the exercise training and exercise testing components. All 
members of the investigative team are required to complete Collaborative Institutional Training 
Initiative (CITI), and all staff monitoring the exercise intervention and performing the exercise 
testing will be CPR/AED certified. The PI will oversee all aspects of this trial, and will ensure 
that I-CAN is implemented in an ethical manner.  
 
 
Timeline of the I-CAN study 
Year 1 
Year 2 
Year 3 
Year 4 
 
1 
2 
3 
4 1 2 3 4 1 2 3 4 1 2 3 4 
IRB approval, MOP development, training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment and screening 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline testing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up testing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data cleaning & management 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

13 
 
 
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