The MOVES Trial: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Phase: NA
Conditions: Endometrial Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center

LINEBERGER COMPREHENSIVE CANCER CENTER 
 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
 
 
PROTOCOL AMENDMENT #3 
 
LCCC 1614:  The MOVES Trial: MOtiVating Endometrial Cancer Survivors with 
Activity Monitors and Tailored Feedback  
 
AMENDMENT INCORPORATES (check all that apply): 
_x_ Editorial, administrative changes 
___ Scientific changes (IRB approval) 
___ Therapy changes (IRB approval) 
___ Eligibility Changes (IRB approval) 
 
AMENDMENT RATIONALE AND SUMMARY: 
 
This amendment increases the accrual from 36 to 39 participants to account for 
participants who did not complete the study and ensure enough evaluable data is 
collected to meet the aims of the study.  
 
1. We updated Section 1.1 to justify accrual from 36 to 39 patients.  
2. Section 4.0 graphics was updated to show new accrual goal.  
3. Section 5.0 was also updated to justify new accrual goal 
4. We are changing the PI from Leslie H. Clark MD to Victoria Bae-Jump MD 
 
 

LINEBERGER COMPREHENSIVE CANCER CENTER 
 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
 
PROTOCOL AMENDMENT #2 
 
LCCC 1614:  The MOVES Trial: MOtiVating Endometrial Cancer Survivors with 
Activity Monitors and Tailored Feedback  
 
AMENDMENT INCORPORATES (check all that apply): 
_x_ Editorial, administrative changes 
___ Scientific changes (IRB approval) 
___ Therapy changes (IRB approval) 
___ Eligibility Changes (IRB approval) 
 
AMENDMENT RATIONALE AND SUMMARY: 
 
This amendment adjusts timing of consent and enrollment visits to minimize the time 
lapse in between these two occurrences (~3 months). After careful review, waiting about 
three months between consent and enrollment can askew data and cause patient 
behavioral changes.  
 
1. Edited exclusion criteria in section 3.2.2 to exclude patients with no computers or 
Bluetooth capabilities as those are required for the study.  
2. Edited schema in section 4.1 and changed “Day on enrollment” to “Baseline 
Visit”  
3. Edited section 4.2 to include:  
a. The possibility of contacting physician-identified patient’s via telephone 
to assess interest and obtain verbal consent.  
b. In-person interactions will now allow coordinator to approach possible 
subjects to introduce the study prior to consent 
c. A third phone call to remind patient of fasting prior to the post-
intervention visit 
d. Clarification that all subjects will now receive reminder emails to sync 
Fitbit and log into UNC CHART 
4. Edited section 4.3 to reflect re-adjustment of timing of consent & enrollment 
visits so these can occur on the same day.  
5. Removed mentions of GPAQ show cards and Appendix 2 and 3 in the protocol 
(section 4.3 and section 5.1) 
 
 
 
 
 
 

LINEBERGER COMPREHENSIVE CANCER CENTER 
 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
 
PROTOCOL AMENDMENT #1 
 
LCCC 1614:  The MOVES Trial: MOtiVating Endometrial Cancer Survivors with 
Activity Monitors and Tailored Feedback  
 
AMENDMENT INCORPORATES (check all that apply): 
_x_ Editorial, administrative changes 
___ Scientific changes (IRB approval) 
___ Therapy changes (IRB approval) 
_x__ Eligibility Changes (IRB approval) 
 
AMENDMENT RATIONALE AND SUMMARY: 
 
This amendment adjusts timing of consent and enrollment visits to ensure study 
coordinators can approach subjects at standard of care visits and call subjects prior to day 
of eligibility and enrollment to the study. This amendment also alters eligibility criteria to 
exclude those with documented medical conditions, which would limit a subject’s 
physical activity. The six-minute walk test is excluded, as it is not practical to conduct in 
the gynecology oncology clinic.  
 
1. Edited exploratory objective 2.2.1 for clarity  
2. Deleted previous inclusion criteria 3.1.5 describing the 6-minute walk test.  
3. Added inclusion criteria 3.1.5 requesting approval from treating physician to 
engage in physical activity 
4. Added inclusion criteria 3.1.6 and 3.1.7 to include patients having smart phones 
with Bluetooth capabilities and access to email  
5. Edited exclusion criteria 3.2.4 and 3.2.5  
6. Added exclusion criteria 3.2.6 
7. Edited schema in section 4.1 
8. Edited timeline of events in section 4.1 
9. Edited section 4.2 Duration of Study to reflect adjusted timing of consent.  
10. Added email reminders in section 4.2 
11. Edited 4.3 Study Details to reflect new timing of consent  
12. Edited 4.4.4 to include language about UNC CHART  
13. Edited section 5.1 time and events table to reflect new timing of consent  
14. Deleted erroneous randomization details in 7.1 Study Design 
15. Edited sections 8.3 and 8.4.2 to reflect new Lineberger Comprehensive Cancer 
Center policies  
16. Removed appendices 2-6 on section 10.0  
 
 
 

LINEBERGER COMPREHENSIVE CANCER CENTER 
 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
LCCC  1614:  The MOVES Trial: MOtiVating Endometrial Cancer Survivors with 
Activity Monitors and Tailored Feedback  
 
Principal Investigator(s): 
Victoria Bae-Jump, MD, PhD 
Division of Gynecologic Oncology 
University of North Carolina at Chapel Hill 
919-843-4899 (phone) 
919-843-5387 (fax) 
Email: victoria_baejump@med.unc.edu 
 
 
Co-Investigators: 
Derek Hales, PhD, Carmina Valle PhD, Leslie H. Clark MD, Wanda Nicholson MD, Paola 
Gehrig MD, Wendy Brewster MD PhD, Daniel Clarke-Pearson MD, Emma Rossi MD, 
John Soper MD, Linda Van Le, MD, Stephanie Sullivan MD, Arthur Tran MD, Stuart 
Pierce MD, Lindsay West MD, Allison Staley MD, Katherine Tucker MD 
 
Biostatistician  
Naim Rashid 
Lineberger Comprehensive Cancer Center 
 
Sponsor:  Lineberger Comprehensive Cancer Center 
 
Funding Source: Lineberger Comprehensive Cancer Center 
 
Version Date:  September 13, 2019 

LINEBERGER COMPREHENSIVE CANCER CENTER 
 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
LCCC  1614:  The MOVES Trial: MOtiVating Endometrial Cancer Survivors with 
Activity Monitors and Tailored Feedback  
 
Principal Investigator 
Victoria Bae-Jump, MD, PhD 
Division of Gynecologic Oncology 
University of North Carolina at Chapel Hill 
919-843-4899 (phone) 
919-843-5387 (fax) 
Email: victoria_baejump@med.unc.edu 
 
Signature Page 
 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable U.S. federal regulations 
and ICH guidelines. 
 
Principal Investigator (PI) Name: Victoria Bae-Jump 
 
PI Signature: ___________________ 
 
Date:____________________ 
 
 
 
Version Date:_______________________ 
 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
i 
TABLE OF CONTENTS 
1.0 
BACKGROUND AND RATIONALE ..................................................................3 
1.1 
Study Synopsis ......................................................................................................3 
1.2 
Background ...........................................................................................................3 
1.3 
Purpose and Rationale ...........................................................................................3 
2.0 
STUDY OBJECTIVES/AIMS AND ENDPOINTS/OUTCOMES .....................4 
2.1 
Primary Objective .................................................................................................4 
2.2 
Secondary Objectives ............................................................................................4 
3.0 
PATIENT ELIGIBILITY ......................................................................................4 
3.1 
Inclusion Criteria ...................................................................................................4 
3.2 
Exclusion Criteria ..................................................................................................5 
4.0 
STUDY PLAN .........................................................................................................5 
4.1 
Schema ..................................................................................................................6 
4.2 
Duration of Study ..................................................................................................6 
4.3 
Study Details .........................................................................................................7 
4.4 
Expected Risks ......................................................................................................8 
4.5 
Removal of Patients from Protocol .......................................................................8 
5.0 
TIME AND EVENTS TABLE ...............................................................................8 
5.1 
Time and Events Table ..........................................................................................9 
6.0 
UNANTICIPATED PROBLEMS .........................................................................9 
6.1 
Definition ..............................................................................................................9 
6.2 
Reporting .............................................................................................................10 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
ii 
7.0 
STATISTICAL CONSIDERATIONS ................................................................10 
7.1 
Study Design .......................................................................................................10 
7.2 
Sample Size and Accrual.....................................................................................10 
7.3 
Data Analyses Plans ............................................................................................10 
7.4 
Data Management ...............................................................................................11 
8.0 
STUDY MANAGEMENT ....................................................................................11 
8.1 
Institutional Review Board (IRB) Approval and Consent ..................................11 
8.2 
Required Documentation.....................................................................................12 
8.3 
Registration Procedures.......................................................................................12 
8.4 
Adherence to the Protocol ...................................................................................12 
8.5 
Amendments to the Protocol ...............................................................................13 
8.6 
Record Retention .................................................................................................13 
8.7 
Obligations of Investigators ................................................................................13 
9.0 
REFERENCES ......................................................................................................14 
10.0 APPENDICES .......................................................................................................16 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
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1.0 
BACKGROUND AND RATIONALE 
1.1 
Study Synopsis 
Overweight and obese endometrial cancer (EC) survivors at UNC-CH will be approached for tailored 
feedback fitness intervention. We aim to enroll 36 evaluable women (18 in each arm) to evaluate if receipt 
of weekly tailored feedback messages can improve physical activity in EC survivors. We anticipate 
enrolling 39 participants to be able to evaluate 36. We hypothesize women receiving the feedback message 
intervention will increase step counts from baseline more than 2,000 steps compared to women in the non-
intervention arm. 
1.2 
Background 
In 2016, approximately 60,050 new cases of EC will be diagnosed with 10,470 women dying from EC 
(1). EC incidence in the United States has been increasing largely due to a combination of an aging 
population and increasing adolescent and adult obesity. In our recent multi-institutional analysis of 1400 
EC patients treated over 5 years, 66% of our EC patients were obese, and 85% were overweight/obese (2). 
Obesity, diabetes, and insulin resistance contribute to the development of EC through hormonal alterations 
resulting in an estrogen dominant state, as well as through hyperinsulinemia and elevated serum glucose 
levels causing increased cellular proliferation and tumor growth (3-5). In addition to driving cancer 
development, obesity is associated with an increased risk of death in EC patients (6-9). Morbidly obese 
women with EC have a 6.25-fold increased risk of death from EC as compared to their non-obese 
counterparts (7). Fortunately, many ECs are diagnosed at an early stage and able to be fully treated via 
hysterectomy +/- radiation. As a result, three years following their diagnosis, EC patients are more likely 
to die from cardiovascular causes due to significant medical co-morbidities than from EC (10).  
  
EC Survivor Knowledge and Readiness. Given the strong relationship between EC and obesity, we 
recently conducted a survey study of EC survivors to assess their knowledge of the relationship between 
EC and obesity (11). We found that only 46% of responders knew of the link between obesity and EC. 
There is evidence to suggest that the time of cancer diagnosis represents a “teachable moment” where 
patients are more motivated to make behavioral change (12, 13). Indeed, we found that majority (70%) of 
women desired to live a healthier lifestyle after their EC diagnosis (11). Despite this reported desire, only 
52% of patients attempted weight loss and only 48% of patients attempted to increase physical activity. 
Survivors who did not attempt weight loss cited a lack of time, money or knowledge of how to lose weight. 
Survivors were most likely to attempt behavioral change 3 to 6 months following their diagnosis.  
 
Physical Activity and Weight Loss. Weight loss is attained through a combination of physical activity 
and diet. Specifically, an individual must increase one’s metabolic expenditure and reduce caloric intake 
in order to maintain weight loss. Modest sustained weight loss of approximately 10 kg has been shown to 
result in improved health outcomes (14). While both diet and physical activity are critical to sustained 
weight loss, physical activity appears to be particularly important to improving cardiovascular health. In 
fact, increasing levels of physical activity and fitness have been shown to have health benefits, even in the 
absence of weight loss in obese patients (15, 16). Further, increasing physical activity by 2000 steps per 
day (or a 20 minute walk at moderate pace) is associated with a 10% reduction in long-term cardiovascular 
events (defined as cardiovascular mortality, stroke, or myocardial infarction) (17). Thus, in EC survivors 
with significant risk of cardiovascular mortality, we will focus on increasing physical activity as the 
primary intervention of our study. 
 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 4 
 
Activity Trackers and Physical Activity. It has been well reported that step-based physical activity 
programs can effectively and safely increase physical activity in sedentary individuals (18-20). Activity 
trackers represent the ideal accelerometer as they can track steps, calories, heart rate, and other parameters 
overtime that can be used by researchers or providers to monitor activity through web-based interfaces. 
Further, activity trackers have the added advantage of allowing women to perform self-monitoring of their 
behavior change, which has been shown to be more effective in similar populations (21-23).  
 
CHART and Tailored Feedback. The Carolina Health Assessment and Resource Tool or CHART has 
been successfully utilized in a variety of settings to facilitate behavior change. CHART has available 
modules for wearable activity trackers, physical activity and weight. The modules provide users with 
individual assessment and tailored feedback to promote behavior change. Further, the CHART wearables 
module has been applied effectively to provide weekly tailored feedback in both AA men (iMOVEIt) and 
childcare providers (CARE2bFit). Both studies showed improved self-monitoring compliance and modest 
changes in physical activity. Men using wearables had about 600 more steps per day, while women in the 
CARE2bfit program increased their MVPA by 60% (12 to 20 minutes per day) through the middle three 
weeks of the study, but decreased back to week 1 levels as the program concluded. This tool has not been 
previously evaluated in EC patients, who appear highly motivated following their cancer diagnosis. Thus, 
we propose a physical activity intervention in the EC survivor population, using weekly tailored feedback 
to increase steps per day using a wearable activity tracker.  
 
1.3 
Purpose and Rationale 
Given that overweight and obese women diagnosed with EC are more likely to die from cardiovascular 
causes of death than from EC, weight loss and physical activity in the EC survivor population is critical. 
We have previously shown that EC survivors are motivated to make behavioral change following their 
cancer diagnosis, but have a low success rate of increasing physical activity and losing weight without 
intervention. Tailored feedback interventions have been shown to be helpful in motivating behavioral 
change in other populations. Thus, we propose a tailored feedback and activity tracker intervention to 
increase physical activity in EC survivors.  
2.0 
STUDY OBJECTIVES AND ENDPOINTS  
2.1 
Primary Objective: To assess if a tailored feedback fitness intervention can increase physical activity 
in EC survivors from baseline to 12 weeks post-baseline.  
2.2 
Exploratory Objective(s):  
2.2.1 To determine the acceptability of the fitness intervention in EC survivors through completion 
survey.  
2.2.2 To assess if a tailored feedback message fitness intervention can (1) decrease BMI, (2) reduce 
waist to hip (W/H) ratios, (3) improve quality of life (QOL) and (4) improve serum metabolic 
markers (insulin, glucose, and low-density lipoprotein (LDL) levels) in EC survivors.  
3.0 
PATIENT ELIGIBILITY 
3.1 
Inclusion Criteria 
To participate in this study, all subjects will:  

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 5 
 
3.1.1 Be over the age of 18 years  
3.1.2 Have a confirmed diagnosis of endometrial cancer and have completed therapy (surgery, 
chemotherapy or radiation) within the past 6 months  
3.1.3 Have no current evidence of endometrial cancer 
3.1.4 Have a BMI 25 kg/m2 or greater 
3.1.5 Have approval from their treating physician to engage in moderate-intensity physical activity. 
3.1.6 Have a smart phone with Bluetooth capabilities turned on 
3.1.7 Have access to email 
 
3.2 
Exclusion Criteria 
Individuals will be excluded from this study if they: 
3.2.1 Are currently undergoing treatment for their cancer 
3.2.2 Are unable to read a sample message aloud 
3.2.3 Do not have a computer or smart phone with Bluetooth capabilities  
3.2.4 Are pregnant 
3.2.5 Have a history of angina or palpitations with exertion 
3.2.6 Have a history of uncontrolled pulmonary disease (COPD or asthma) 
 
3.2.6 Have one or more significant medical conditions that in the physician’s judgment preclude 
participation in the walking intervention.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 6 
 
4.0 
STUDY PLAN 
5.0 
Schema 
 
This is a randomized controlled pilot study of 39 total participants to ensure 36 evaluable datasets (n=18 
per arm) of overweight or obese patients with endometrial cancer. The primary purpose of this study is 
to evaluate the change from baseline of daily steps in women randomized to the tailored feedback 
message fitness intervention. We anticipate a patient’s active participation will last approximately12 
weeks.  
 
5.1 
Duration of Study 
Patients enrolled in this study will participate for approximately 12 weeks. The participants will be 
consented at the end of their cancer treatment. The participant will remain on study until their next clinic 
visit (~3 months).   
 
There will be up to three in-person interactions with the patients in this study: during a clinic visit where 
the study is introduced, on the day of the baseline visit, and at the time of their 3-month follow up or 
post-intervention visit.  Patients will be approached by the study coordinator for participation in this 
study during routine clinic visits.   If a provider identifies eligible patients in advance of their scheduled 
visit and notifies the study coordinator, the study coordinator will contact the patient via telephone prior 
to their clinic visit to introduce the study and assess interest. If the patient is interested, the study 
coordinator will obtain a telephone consent.  At the next scheduled visit, the study coordinator will 
obtain the patient’s signed consent and provide a physical hardcopy of their signed consent form to the 
patient prior to initiating any study activities.  

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 7 
 
 
There will also be three phone calls from the study team: prior to the baseline visit to remind the patient 
to fast for blood collection, at the end of week 1 to ensure successful use of the fitness tracker, and prior 
to the post-intervention visit to remind the patient to fast again. For all subjects, study staff plans to send 
out email reminders so they can sync their Fitbits in time and log into UNC CHART to ensure data 
quality.  
5.2 
Study Details 
Women with endometrial cancer, at the end of cancer treatment, will be recruited from the Gynecologic 
Oncology clinic at UNC-CH (see inclusion/exclusion criteria above). The standard care of a woman 
diagnosed with endometrial cancer is to undergo treatment with hysterectomy followed by possible 
adjuvant radiation or chemotherapy in high risk or advanced stage cancer. Following completion of 
therapy, a patient is seen by her oncologist every 3 months in the first 2 years following treatment for 
cancer surveillance. We aim to identify women within 6 months of treatment completion, generally at the 
initial surveillance visit. Women meeting enrollment criteria will be approached for consent. Enrolled 
women will receive a Fitbit fitness tracker and be instructed in how to use UNC CHART. Study staff will 
spend time with each participant to help them access CHART, learn to see messages, and set-up and use 
of the fitness tracker. All participants will keep the fitness tracker after completion of the study as token 
of appreciation for their participation.  
 
At the baseline visit, patient’s baseline height and weight will be obtained. Blood pressure and baseline 
heart rate will also be documented. Baseline BMI will be calculated. In addition to BMI, the W/H ratio 
will be evaluated. The W/H ratio is defined as the waist circumference in centimeters divided by the hip 
circumference in centimeters. W/H may be a better predictor of cardiovascular morbidity than BMI as it 
takes into account abdominal adiposity (25). The proper technique for measurement of the waist and hip 
circumference is to have the subject stand with both feet together and arms at the side without bulky 
clothing. Measurements should be taken at the end of expiration and be repeated twice using stretch-
resistant measuring tape. Both measurements should be within 1cm of each other and the average value 
used. The waist measurement is taken midway between the last palpable rib and the top of the iliac crest. 
The hip measurement is taken at the widest portion of the buttock with the tape parallel to the floor (26). 
W/H ratio at baseline will be calculated.  
 
After the above measurements and vitals are taken, patients will complete an enrollment survey including 
the GPAQ survey to measure baseline activity and baseline FACT-G assessment (27, 28). Pre-intervention 
FACT-G total score and sub-scale scores (physical well-being, social well-being, emotional well-being 
and functional well-being) will be compared to post-intervention scores. Finally, baseline fasting glucose, 
insulin and LDL will be obtained at the time of study baseline activities. Blood and urine will be collected 
and stored for potential future metabolomic profiling.  Patients will then be randomized to either receive 
or not receive tailored feedback messages through UNC CHART. Participants randomized to the message 
arm will begin receiving encouragement and reminder UNC CHART messages to increase physical 
activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will 
receive 1 message per week during the 3-month study period.  
 
For the first week after initiating the study, each patient’s baseline step count will be obtained from the 
fitness tracker. The mean step count over these 7 days will represent the patient’s baseline step count. 
After the baseline week is completed, the study team will contact patients to ensure successful use of 
technology.  
 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 8 
 
At the time of next follow up visit, the patient will undergo repeat weight, height, waist circumference, 
and hip circumference assessment. Heart rate and blood pressure will also be recorded at the follow up 
visit.  The patient will complete a post-intervention acceptability survey and complete a post-intervention 
FACT-G assessment. Post-intervention fasting glucose, insulin, and LDL will be performed. Urine and 
blood will also be banked via the Tissue Procurement Facility (TPF) at the Lineberger Comprehensive 
Cancer Center (LCCC) for future metabolomic profiling. 
5.3 
Expected Risks 
5.3.1 Physical Harm: The risk of physical injury related to increasing physical activity in sedentary 
individuals is low. Similar trials have been conducted in high-risk coronary artery disease 
patients without adverse events. Patients with untreated cardiac symptoms (angina, palpitations) 
or poorly controlled pulmonary comorbidities (such as COPD or asthma) will be excluded. There 
is a potential for musculoskeletal or joint injury with increased physical activity. However, there 
are no reported injuries in multiple large randomized trials (29-31).  
 
5.3.2 Blood Drawing: Patients will need to undergo blood draws at baseline and post-intervention. 
Risks to blood draws are minimal and include pain and discomfort, infection and 
hematoma/bruising. Thus, women have little increased risk secondary to blood collection. Blood 
work will be obtained by trained staff trained hospital staff at the time of clinic visits.  
 
5.3.3 Urine Collection: Patients will need to undergo urine collection at baseline and post-
intervention. Risks to urine collection are minimal and include a small risk of infection. Thus, 
women have little increased risk secondary to urine collection. 
 
5.3.4 Breach of Confidentiality: The major risk to participants included in this study is data security 
and confidentiality. Data will be stored in a secure, password-protected server accessible solely 
to trained study staff. The Study Coordinator will be trained and certified in research ethics and 
HIPAA tenets. All data and specimens will be given a unique research ID that will be blinded to 
investigators with the exception of the Study Coordinator, who will function as an honest broker. 
UNC CHART does not contain any identifying information, subjects are identified through study 
ID. Subjects must log on to UNC CHART to receive message, UNC CHART will not have email 
or smart phone contact information.  
5.4 
Removal of Patients from Protocol  
Patients will be removed from the protocol if musculoskeletal injury is incurred. Patient will also be 
removed from the protocol at patient request. The patients will receive a phone call following week 1 to 
assess for adverse events, but will not be contacted in weeks 2-12 to minimize bias from the Hawthorne 
effect of repetitive phone calls while on trial.  Patients will be instructed to contact study personnel if 
any concern for injury or adverse event related to trial enrollment and be removed from study. 
 
6.0 
TIME AND EVENTS TABLE 
 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 9 
 
6.1 
Time and Events Table 
 
 
 
 
 
Baseline 
visit 
Week 1 
Week 
2-12 
Follow up visit (Week 13) 
Inclusion/Exclusion 
Criteria  
X 
 
 
 
Informed Consent 
X 
 
 
 
Education on 
fitness tracker and 
CHART 
X 
 
 
 
Blood draw for 
fasting glucose, 
insulin, LDL 
X 
 
 
X 
Blood and urine for 
banking 
X 
 
 
X 
Fitness tracker 
daily step count 
monitoring 
 
X 
(Baseline) 
X 
X 
Weekly  messages 
 
 
X1 
 
AE Assessment 
 
X (Phone 
call) 
 
X (in person) 
FACT-G2 
X 
 
 
X 
Baseline survey 
including GPAQ3 
X 
 
 
 
Measurements: 
Weight, Height, 
Waist/Hip Ratio 
X 
 
 
X 
Completion survey 
 
 
 
X1 
1Only patients in the tailored feedback message arm will receive weekly messages in weeks 2-12 and 
complete the completion survey. 
2Functional Assessment of Cancer Therapy, version 4 scale will be used to evaluate quality of life. 
 
3Global Physical Activity Questionnaire, version 2 will be used to assess baseline physical activity.         
 
7.0 
UNANTICIPATED PROBLEMS 
7.1 
Definition 
As defined by UNC’s IRB, unanticipated problems involving risks to study subjects or others (UPIRSO) 
refers to any incident, experience, or outcome that: 
• 
Is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that 
are described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and (b) the characteristics of the subject population being studied; 
• 
Is related or possibly related to a subject’s participation in the research; and  
• 
Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) related to the research than was previously known or 
recognized. 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
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7.2 
Reporting 
Any UPIRSO that occurs during the conduct of this study and that meets all three criteria listed in 6.1 
must be reported to the UNC IRB using the IRB’s web-based reporting system.   
 
8.0 
STATISTICAL CONSIDERATIONS 
8.1 
Study Design 
This is a randomized, single-center, tailored feedback message intervention trial. The project will use 
fitness trackers to measure increase in physical activity from baseline in women randomized to receive 
weekly motivational feedback messages.  A control group will receive a fitness tracker but no feedback 
message reinforcement. The primary objective of the study is to detect a 2,000 mean daily step increase 
from baseline in patients undergoing the feedback message intervention. Therefore, patients will be 
randomized, 1:1 using a 6-block scheme.  
 
Exploratory objectives include gathering data on the acceptability of the intervention, as well as desired 
frequency, timing, and content of messages for use in a larger trial.  Additionally, outcomes that will be 
the goal of a larger trial will be explored.  These endpoints include: BMI, waist/hip ratio, QOL as measured 
by FACT-G, and serum metabolic markers (fasting insulin, glucose, and LDL). 
8.2 
Sample Size and Accrual 
Prior studies and systematic reviews have shown participant standard deviations in daily steps of 
approximately 1300-1800 steps/day (20, 30, 32). Furthermore, previous studies measuring the impact of 
similar interventions on patient fitness levels have observed a patient step count change score standard 
deviation of approximately 1700 steps/day (29), where change score is defined as the change in step count 
from baseline to a particular week post-baseline. To determine whether there is a significant increase in 
physical activity among patients receiving the feedback messaging intervention versus those that do not 
receive the intervention, we will compare participant change scores between the each arm in our study.  
Assuming a participant change score standard deviation of 1800 steps/day, we estimate that 15 women 
will provide 80% power to detect a 2000-step difference in change score between arms (30), utilizing a 
two-sided Wilcoxon Two-Sample test with an alpha of 0.05. Within each arm, we will have sufficient 
power with n = 15 subjects to determine whether change scores within an arm are significantly different 
from zero, and we estimate that we will have >95% power to detect a change score of at least 2000 
steps/day using a two-sided Wilcoxon Signed Rank test, assuming an alpha of 0.05 and a patient change 
score standard deviation of 1800 steps/day. We will also perform similar tests utilizing change scores 
computed at 4 weeks and 8 weeks post-baseline to determine whether these effects appear earlier on during 
the intervention period. We will also directly examine linear trends in daily step count with respect to time 
in days, as well as the overall three month average change in step count from baseline, via linear mixed 
models.  Prior similar fitness intervention noted a 5% attrition rate in a large trial over 6 months time (29). 
To make a conservative estimate we will allow for 20% attrition and thus aim to enroll 39 total  patients 
to obtain 36 evaluable datasets (18 patients in each arm).  All power calculations were computing using 
G*Power software version 3.1.9.2 (33). 
8.3 
Data Analysis Plans 
Our primary objective will be measured by comparing patients baseline step counts (defined as the mean 
step count recorded by the fitness tracker for each participant in the first 7 days following enrollment) to 
week 12 (final week of study participation) step counts. The week 12 step counts will also be the mean 
step count recorded by the fitness tracker over 7 days in a participant’s final week on the study. The 

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mean change in steps in the intervention group will be compared to the no-intervention group using a 
Wilcoxon Two-sample test.   
 
For our exploratory objectives: 
Acceptability of the intervention will be measured, as previously reported, using the results of a post-
intervention Likert scale survey (29). At study conclusion, patients randomized to the feedback messaging 
arm will complete a post-intervention survey regarding the acceptability of the invention. Question #1 of 
the post-intervention survey will ask patients about the acceptability of the intervention using a 5-point 
Likert scale. The completion survey will also include information about desired frequency of messages, 
desired content of messages, and timing of messages. The information obtained in this portion of the study 
will allow improvements to be made in our intervention prior to implementation of a larger randomized 
trial. The acceptability of the intervention will be defined as the proportion of patients answering favorably 
(very helpful or somewhat helpful) to question #1 on the completion survey. We aim to have 80% 
acceptability. Previous surveys of adults have shown 81% to find mobile health interventions acceptable 
(34). We will report the proportion of subjects reporting favorable responses to question #1 on the 
completion survey and the corresponding 95% CI. 
 
Finally, we will look for decrease in BMI, improved W/H ratio, improved QOL, and improved serum 
metabolic markers. These data will be preliminarily evaluated in this pilot study, but will represent the 
primary endpoints of interest in the randomized trial to be conducted following completion of this pilot. 
Basic descriptive and comparative statistics will be performed to evaluate BMI, QOL, W/H ratio and 
insulin/glucose/LDL levels as exploratory endpoints at each time point, in addition to the change in each 
exploratory endpoint between time points. All computed descriptive statistics would be stratified by study 
arm. 
 
8.4 
Data Management/Audit 
Data will be collected and stored in an Excel spreadsheet and stored on the departmental J drive in a 
password-protected document for security.  
 
As an investigator initiated study, this trial will also be audited by the Lineberger Cancer Center audit 
committee every six or twelve months, depending on the participation of affiliate sites. 
9.0 
STUDY MANAGEMENT 
9.1 
Institutional Review Board (IRB) Approval and Consent 
It is expected that the IRB will have the proper representation and function in accordance with federally 
mandated regulations.  The IRB should approve the consent form and protocol. 
 
In obtaining and documenting informed consent, the investigator should comply with the applicable 
regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) and to ethical principles 
that have their origin in the Declaration of Helsinki. 
 
 
 
Before enrollment onto this study, the patient will be given a full explanation of the study and will be 
given the opportunity to review the consent form. Each consent form must include all the relevant elements 
currently required by the FDA Regulations and local or state regulations. Once this essential information 
has been provided to the patient and the investigator is assured that the patient understands the implications 
of participating in the study, the patient will be asked to give consent to participate in the study by signing 
an IRB-approved consent form. 

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Prior to a patient’s participation in the trial, the written informed consent form should be signed and 
personally dated by the patient and by the person who conducted the informed consent discussion. 
9.2 
Required Documentation 
Before the study can be initiated at any site, the following documentation must be provided to the Office 
of Clinical & Translational Research (OCTR) at the University of North Carolina. 
• A copy of the official IRB approval letter for the protocol  
• A copy of the IRB-approved consent form 
9.3 
Registration Procedures 
All subjects must be registered with the Lineberger Comprehensive Cancer Center, and entered into the 
web based clinical research platform, Oncore®. 
9.4 
Adherence to the Protocol 
Except for an emergency situation in which proper care for the protection, safety, and well-being of the 
study patient requires alternative treatment, the study shall be conducted exactly as described in the 
approved protocol.   
9.4.1 Emergency Modifications 
UNC investigators may implement a deviation from, or a change of, the protocol to eliminate an 
immediate hazard(s) to trial subjects without prior UNC IRB approval.  
 
For any such emergency modification implemented, a UNC IRB modification form must be completed 
by UNC Research Personnel within five (5) business days of making the change.   
9.4.2 Single Patient/Subject Exceptions 
Eligibility single subject exceptions are not permitted for Lineberger Comprehensive Cancer Center 
Investigator Initiated Trials under any circumstances. Other types of single subject exceptions may be 
allowed if proper regulatory review has been completed in accordance with Lineberger Comprehensive 
Cancer Center’s Single Subject Exceptions Policy. 
9.4.3 Other Protocol Deviations/Violations 
According to UNC’s IRB, a protocol deviation is any unplanned variance from an IRB approved 
protocol that:  
• Is generally noted or recognized after it occurs 
• Has no substantive effect on the risks to research participants 
• Has no substantive effect on the scientific integrity of the research plan or the value of the 
data collected  
• Did not result from willful or knowing misconduct on the part of the investigator(s).  
 
An unplanned protocol variance is considered a violation if the variance meets any of the following 
criteria:  
• Has harmed or increased the risk of harm to one or more research participants. 
• Has damaged the scientific integrity of the data collected for the study. 
• Results from willful or knowing misconduct on the part of the investigator(s). 
• Demonstrates serious or continuing noncompliance with federal regulations, State laws, or 
University policies. 

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If a deviation or violation occurs please follow the guidelines below: 
 
Protocol Deviations: UNC personnel will record the deviation in OnCore®  (or other appropriate 
database set up for the study), and report to any sponsor or data and safety monitoring committee in 
accordance with their policies.  Deviations should be summarized and reported to the IRB at the time of 
continuing review. 
 
Protocol Violations: Violations should be reported by UNC personnel within one (1) week of the 
investigator becoming aware of the event using the same IRB online mechanism used to report UPIRSO.   
 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO: 
Any events that meet the criteria for “Unanticipated Problems” as defined by UNC’s IRB (see section 
6.1) must be reported by the Study Coordinator using the IRB’s web-based reporting system.   
9.5 
Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be originated and documented by 
the Principal Investigator at UNC.  It should also be noted that when an amendment to the protocol 
substantially alters the study design or the potential risk to the patient, a revised consent form might be 
required.   
 
The written amendment, and if required the amended consent form, must be sent to UNC’s IRB for 
approval prior to implementation.   
9.6 
Record Retention 
Study documentation includes all Case Report Forms, data correction forms or queries, source 
documents, Sponsor-Investigator correspondence, monitoring logs/letters, and regulatory documents 
(e.g., protocol and amendments, IRB correspondence and approval, signed patient consent forms). 
 
Source documents include all recordings of observations or notations of clinical activities and all reports 
and records necessary for the evaluation and reconstruction of the clinical research study. 
 
Government agency regulations and directives require that all study documentation pertaining to the 
conduct of a clinical trial must be retained by the study investigator.  In the case of a study with a drug 
seeking regulatory approval and marketing, these documents shall be retained for at least two years after 
the last approval of marketing application in an International Conference on Harmonization (ICH) 
region.  In all other cases, study documents should be kept on file until three years after the completion 
and final study report of this investigational study. 
9.7 
Obligations of Investigators 
The Principal Investigator is responsible for the conduct of the clinical trial at the site in accordance with 
Title 21 of the Code of Federal Regulations and/or the Declaration of Helsinki.  The Principal 
Investigator is responsible for personally overseeing the treatment of all study patients.  The Principal 
Investigator must assure that all study site personnel, including sub-investigators and other study staff 
members, adhere to the study protocol and all FDA/GCP/NCI regulations and guidelines regarding 
clinical trials both during and after study completion. 
 
The Principal Investigator at each institution or site will be responsible for assuring that all the required 
data will be collected and entered onto the Case Report Forms. Periodically, monitoring visits will be 

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conducted and the Principal Investigator will provide access to his/her original records to permit 
verification of proper entry of data. At the completion of the study, all case report forms will be 
reviewed by the Principal Investigator and will require his/her final signature to verify the accuracy of 
the data. 
10.0 REFERENCES 
1. 
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7-30. doi: 10.3322/caac.21332. 
PubMed PMID: 26742998. 
2. 
Ko EM, Walter P, Clark L, Jackson A, Franasiak J, Bolac C, Havrilesky L, Secord AA, Moore DT, Gehrig PA, Bae-Jump 
VL. The complex triad of obesity, diabetes and race in Type I and II endometrial cancers: Prevalence and prognostic 
significance. Gynecol Oncol. 2014;133(1):28-32. Epub 2014/04/01. doi: 10.1016/j.ygyno.2014.01.032. PubMed PMID: 
24680588. 
3. 
Ko E, Franasiak, J, Sink, K, Brewster, WR, Gehrig, PA, Bae-Jump, VL. Obesity, diabetes, and race in Type 1 and Type 
2 endometrial cancers. J Clin Oncol. 2011;29:suppl; abstr 5111. 
4. 
Schmandt RE, Iglesias DA, Co NN, Lu KH. Understanding obesity and endometrial cancer risk: opportunities for 
prevention. Am J Obstet Gynecol. 2011;205(6):518-25. Epub 2011/08/02. doi: 10.1016/j.ajog.2011.05.042. PubMed PMID: 
21802066. 
5. 
Calle EE, Kaaks R. Overweight, obesity and cancer: epidemiological evidence and proposed mechanisms. Nat Rev 
Cancer. 2004;4(8):579-91. doi: 10.1038/nrc1408. PubMed PMID: 15286738. 
6. 
Chia VM, Newcomb PA, Trentham-Dietz A, Hampton JM. Obesity, diabetes, and other factors in relation to survival 
after endometrial cancer diagnosis. Int J Gynecol Cancer. 2007;17(2):441-6. PubMed PMID: 17362320. 
7. 
Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a 
prospectively studied cohort of U.S. adults. The New England journal of medicine. 2003;348(17):1625-38. PubMed PMID: 
12711737. 
8. 
Steiner E, Plata K, Interthal C, Schmidt M, Faldum A, Hengstler JG, Sakuragi N, Watari H, Yamamoto R, Kolbl H. 
Diabetes mellitus is a multivariate independent prognostic factor in endometrial carcinoma: a clinicopathologic study on 
313 patients. Eur J Gynaecol Oncol. 2007;28(2):95-7. PubMed PMID: 17479668. 
9. 
Arem H, Park Y, Pelser C, Ballard-Barbash R, Irwin ML, Hollenbeck A, Gierach GL, Brinton LA, Pfeiffer RM, Matthews 
CE. Prediagnosis body mass index, physical activity, and mortality in endometrial cancer patients. Journal of the National 
Cancer Institute. 2013;105(5):342-9. Epub 2013/01/09. doi: 10.1093/jnci/djs530. PubMed PMID: 23297041; PMCID: 
3589256. 
10. 
Ward KK, Shah NR, Saenz CC, McHale MT, Alvarez EA, Plaxe SC. Cardiovascular disease is the leading cause of 
death among endometrial cancer patients. Gynecol Oncol. 2012;126(2):176-9. doi: 10.1016/j.ygyno.2012.04.013. PubMed 
PMID: 22507532. 
11. 
Clark LH, Ko EM, Kernodle A, Harris A, Moore DT, Gehrig PA, Bae-Jump V. Endometrial Cancer Survivors' 
Perceptions of Provider Obesity Counseling and Attempted Behavior Change: Are We Seizing the Moment? Int J Gynecol 
Cancer. 2016;26(2):318-24. doi: 10.1097/IGC.0000000000000596. PubMed PMID: 26588234. 
12. 
Demark-Wahnefried W, Aziz NM, Rowland JH, Pinto BM. Riding the crest of the teachable moment: promoting 
long-term health after the diagnosis of cancer. J Clin Oncol. 2005;23(24):5814-30. doi: 10.1200/JCO.2005.01.230. PubMed 
PMID: 16043830; PMCID: PMC1550285. 
13. 
Jones LW, Courneya KS, Fairey AS, Mackey JR. Effects of an oncologist's recommendation to exercise on self-
reported exercise behavior in newly diagnosed breast cancer survivors: a single-blind, randomized controlled trial. Ann 
Behav Med. 2004;28(2):105-13. doi: 10.1207/s15324796abm2802_5. PubMed PMID: 15454357. 
14. 
Goodpaster BH, Delany JP, Otto AD, Kuller L, Vockley J, South-Paul JE, Thomas SB, Brown J, McTigue K, Hames KC, 
Lang W, Jakicic JM. Effects of diet and physical activity interventions on weight loss and cardiometabolic risk factors in 
severely obese adults: a randomized trial. JAMA. 2010;304(16):1795-802. doi: 10.1001/jama.2010.1505. PubMed PMID: 
20935337; PMCID: PMC3082279. 
15. 
Lee DC, Sui X, Church TS, Lavie CJ, Jackson AS, Blair SN. Changes in fitness and fatness on the development of 
cardiovascular disease risk factors hypertension, metabolic syndrome, and hypercholesterolemia. J Am Coll Cardiol. 
2012;59(7):665-72. doi: 10.1016/j.jacc.2011.11.013. PubMed PMID: 22322083; PMCID: PMC3293498. 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
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Page | 15 
 
16. 
Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, 
Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy 
men and women: a meta-analysis. JAMA. 2009;301(19):2024-35. doi: 10.1001/jama.2009.681. PubMed PMID: 19454641. 
17. 
Yates T, Haffner SM, Schulte PJ, Thomas L, Huffman KM, Bales CW, Califf RM, Holman RR, McMurray JJ, Bethel 
MA, Tuomilehto J, Davies MJ, Kraus WE. Association between change in daily ambulatory activity and cardiovascular 
events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis. Lancet. 2014;383(9922):1059-66. 
doi: 10.1016/S0140-6736(13)62061-9. PubMed PMID: 24361242. 
18. 
Musto A, Jacobs K, Nash M, DelRossi G, Perry A. The effects of an incremental approach to 10,000 steps/day on 
metabolic syndrome components in sedentary overweight women. J Phys Act Health. 2010;7(6):737-45. PubMed PMID: 
21088304. 
19. 
Freak-Poli RL, Cumpston M, Peeters A, Clemes SA. Workplace pedometer interventions for increasing physical 
activity. Cochrane Database Syst Rev. 2013;4:CD009209. doi: 10.1002/14651858.CD009209.pub2. PubMed PMID: 
23633368. 
20. 
Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using 
pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007;298(19):2296-304. doi: 
10.1001/jama.298.19.2296. PubMed PMID: 18029834. 
21. 
Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change 
techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol 
Health. 2011;26(11):1479-98. doi: 10.1080/08870446.2010.540664. PubMed PMID: 21678185. 
22. 
Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical 
Activity Intervention for Women. Am J Prev Med. 2015;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. PubMed PMID: 
26071863; PMCID: PMC4993151. 
23. 
Greaves CJ, Sheppard KE, Abraham C, Hardeman W, Roden M, Evans PH, Schwarz P, Group IS. Systematic review 
of reviews of intervention components associated with increased effectiveness in dietary and physical activity 
interventions. BMC Public Health. 2011;11:119. doi: 10.1186/1471-2458-11-119. PubMed PMID: 21333011; PMCID: 
PMC3048531. 
24. 
Laboratories ATSCoPSfCPF. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 
2002;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. PubMed PMID: 12091180. 
25. 
Huxley R, Mendis S, Zheleznyakov E, Reddy S, Chan J. Body mass index, waist circumference and waist:hip ratio as 
predictors of cardiovascular risk--a review of the literature. Eur J Clin Nutr. 2010;64(1):16-22. doi: 10.1038/ejcn.2009.68. 
PubMed PMID: 19654593. 
26. 
Organization WH. Waist Circumference and Waist Hip Ratio: A Report of a WHO Expert Consultation. 2008 
December 8-11, 2008. Report No. 
27. 
Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The 
Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 
1993;11(3):570-9. PubMed PMID: 8445433. 
28. 
Bull FC, Maslin TS, Armstrong T. Global physical activity questionnaire (GPAQ): nine country reliability and validity 
study. J Phys Act Health. 2009;6(6):790-804. PubMed PMID: 20101923. 
29. 
Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, 
Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification 
in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015;314(12):1255-63. doi: 
10.1001/jama.2015.10945. PubMed PMID: 26393848. 
30. 
Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, 
Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity 
Promotion. J Am Heart Assoc. 2015;4(11). doi: 10.1161/JAHA.115.002239. PubMed PMID: 26553211. 
31. 
Shapiro JR, Koro T, Doran N, Thompson S, Sallis JF, Calfas K, Patrick K. Text4Diet: a randomized controlled study 
using text messaging for weight loss behaviors. Prev Med. 2012;55(5):412-7. doi: 10.1016/j.ypmed.2012.08.011. PubMed 
PMID: 22944150. 

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32. 
Monroe CM, Bassett DR, Jr., Fitzhugh EC, Raynor HA, Thompson DL. Effect of Adding Online Social Support Tools 
to an Adult Walking Program: A Pilot Randomized Controlled Trial. Health Promot Pract. 2016. doi: 
10.1177/1524839915626674. PubMed PMID: 26895847. 
33. 
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and 
regression analyses. Behav Res Methods. 2009;41(4):1149-60. doi: 10.3758/BRM.41.4.1149. PubMed PMID: 19897823. 
34. 
Yang CH, Maher JP, Conroy DE. Acceptability of mobile health interventions to reduce inactivity-related health risk 
in central Pennsylvania adults. Prev Med Rep. 2015;2:669-72. doi: 10.1016/j.pmedr.2015.08.009. PubMed PMID: 
26844135; PMCID: PMC4721363. 
 
 
11.0 APPENDICES 
 
Appendix 1: UNC CHART Feedback Message Library  
 
PROJECT: MOVES 
SUBJECT: FEEDBACK INFORMATION 
 
Data input 
• 
Data will be input into the feedback systems in two ways from FitBIT through Validic 
• 
One physical activity variable will be used for feedback for each participant. 
o Steps per day 
 
Used to compute: Average steps per day (average over days provided for that week) 
• 
Data structure 
o The raw data will include steps and MVPA minutes for each day of the week.  
o Each weekly report will be updated based on the data retrieved for the previous 7 days.  
 
Example: data below would be used to create report opened to participant on Monday MAR 
14th. 
o Data will be used to compute weekly summary variables that will be used to control the CHART 
feedback.  
 
Daily data for 1 participant over first 2 weeks of intervention 
PID 
Date 
Day of 
week 
Steps 
NOTE 
1562 
3/07/2016 
MON 
0 
Sync, but no Wear Steps < 2000, not used 
1562 
3/08/2016 
TUE 
6000 
OK 
1562 
3/09/2016 
WED 
6000 
OK 
1562 
3/10/2016 
THU 
8000 
OK 
1562 
3/11/2016 
FRI 
4000 
OK 
1562 
3/12/2016 
SAT 
. 
No Sync, not 0 
1562 
3/13/2016 
SUN 
. 
No Sync, not 0 
1562 
3/14/2016 
MON 
5000 
OK 

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1562 
3/15/2016 
TUE 
7000 
OK 
1562 
3/16/2016 
WED 
8000 
OK 
1562 
3/17/2016 
THU 
1000 
Sync, but no wear steps <2000, not used 
1562 
3/18/2016 
FRI 
9000 
OK 
1562 
3/19/2016 
SAT 
4000 
OK 
1562 
3/20/2016 
SUN 
6000 
OK 
 
Weekly summary variables computed from daily data. 
intWEEK 
WKStartdate 
nDaysMonitor 
nDaysSync 
StepPERday 
goalSTEP 
NOTmeetSTEP 
NEWgoalstep 
1 
3/07/16 
4 
5 
6000 
5000 
0 
6500 
2 
3/14/16 
6 
7 
6500 
6500 
0 
7000 
 
 

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Computed Variables and Criteria 
 
Weekly summary variables computed from daily data. 
intWEEK 
WKStartdate 
nDaysMonitor 
nDaysSync 
StepPERday 
goalSTEP 
NOTmeetSTEP 
NEWgoalste
p 
1 
3/07/16 
4 
5 
6000 
5000 
0 
6500 
2 
3/14/16 
6 
7 
6500 
6500 
0 
7000 
 
Variables for Feedback 
Variable name 
Limit 
Compute 
Description 
intWEEK 
1 to 6 
 
Week of intervention 
nDayMonitor 
0 to 7 
number of days with more than 2000 steps 
Number of Days monitored 
 
nDaySync 
0 to 7 
FITBIT only: 
number of non-missing days 
Number of Days synced 
 
StepPERday 
Only computed if: 
nDAYSmonitored > 2 
Average steps for days with more than 2000 steps 
STEPS per Day 
 
goalSTEP 
5000 to 12000 
Based on previous weeks step average and goal achievement.   
Weekly Goal for Steps Step Goal for Current 
intervention WEEK 
NotmeetSTEP 
0 to 6 
This value is carried forward from previous intweek 
If (STEPperday/goalSTEP) >= 0.90 then NOTmeetSTEP = 0 
If (STEPperday/goalSTEP) < 0.90 then NOTmeetSTEP =  NOTmeetstep+1 
Number of consecutive weeks not meeting step 
goal. 
NEWgoalSTEP 
5000 to 12000 
see “New Goal” section 
New step goal  
 

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FEEDBACK for WEEKLY Report 
 
SECTION: No title: bar graphs showing progress 
VARIABLES:  
used to control and provide Feedback 
• 
INTweek 
• 
nDayMonitor 
• 
STEPperDAY 
• 
goalSTEP 
FEEDBACK and CONTROLS: INTweek  
• 
1-6 
nDayMonitor  
• 
0-2 
• 
3+ 
 
FOR STEPS (per day): 
Figure: 
See PDF from Regina 
 
 
Criteria 1 
FEEDBACK 
nDayMonitor 
 
IF nDaymonitor < 3  
Your Week [intweek] goal was [goalstep] steps each day. You did not sync or wear 
your Fitbit enough last week to give you good feedback. 
IF nDaymonitor >= 3 
Your Week [intweek] goal was [goalstep] steps each day. You took about 
[stepPERday] steps each day. 
 
 
 

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SECTION: My NEW Goals (feedback) 
VARIABLES:  
used to Control Feedback 
intWEEK 
nDaymonitor 
StepPERday 
goalSTEP 
 
FEEDBACK and CONTROLS: NOTE: 
• 
IF nDaymonitor < 3 then… 
o [Blank bar with only intweek label at bottom] 
o Other weeks and goal line stay same 
 
Criteria 1 
Criteria 2 
Criteria 3 
Criteria 4 
 
 
intWEEK 
nDayMonitor 
Meeting GOAL 
(Steps 90%+ of Goal) 
NOTmeetSTEP 
Description 
FEEDBACK 
1 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
Make your health a priority after getting your cancer diagnosis. We need to know 
where you’re starting in order to help you reach 10,000 steps each day.  
 
You did not wear your fitbit enough, or sync, last week to give you a personal goal 
and meaningful feedback.  
 
Please be sure to wear your Fitbit each day, keep it charged, and sync using the app 
or your home computer. 
 
1 
IF 
nDaymonitor 
>= 3 
ALL 
ALL 
Wore 
monitored 
Let’s get on track to take 10,000 steps each day to improve your health! Now that 
you have finished all your cancer treatment, it is an important time to focus on your 
health! Start with a small change. 
 
You can meet your goal by making every little move count! You will get about 1000 
steps by taking a brisk 10-minute walk. Fit in 10 minutes of activity when you can. 
Walk on your work breaks. Make other small changes to your daily routine like 
parking farther from the store or your work, or taking the stairs. 
 
 
 
 
 
 

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2 
IF 
nDaymonitor 
< 3  
- 
- 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
 
Please be sure to wear your Fitbit each day, keep it charged, and sync using the app 
or your home computer. 
2 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
 
Wore 
monitor 
Meeting 
Goal 
 
Congratulations on your success last week! Every little move you make helps to 
strengthen your heart and gives you more energy. Getting healthy after a diagnosis 
of endometrial cancer is so important. What did you do last week that helped you fit 
more steps into your day? Use what you learned last week to help you meet your 
goal next week.  
2 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Some weeks it can be hard to fit in all of the activity that you’d like. Plan out your 
week in advance to find time to be active. Mark your calendar and stick with it. On 
very busy days, a few brisk 10-minute walks, can really help refresh and de-stress. 
Focusing on your health after your cancer diagnosis is so important. 
 
 
 
 
 
 
3 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
 
Please be sure to wear your Fitbit each day, keep it charged, and sync using the app 
or your home computer. 
3 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
Great job! You are making excellent progress toward 10,000 steps and a healthier 
life! Find an exercise buddy to make your physical activity more fun. Ask a coworker, 
friend, or family member to go for a walk or bike ride with you. See if you can make 
it a weekly date. 
3 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Having an exercise buddy can help you meet your steps goal. Ask a coworker, friend, 
or family member to go for a walk with you. Exercise is more fun with a buddy, and 
you will be less likely to skip if you know someone’s counting on you.  
3 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Think about what has been getting in the way of your walking. What can you do to 
get moving in the right direction? If time is an issue, think about how you can you fit 
three, 10-minute walks into your day. Every step you take will add up to a healthier, 
happier you! 
 
 
 
 
 
 
4 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
 
Please be sure to wear your Fitbit each day, keep it charged, and sync using the app 
or your home computer. 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 22 
 
4 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
Way to go! You met your steps target last week! Keep your activity interesting by 
trying something new next week. Dust off that bicycle or find a Zumba class or 
video.  
4 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Finding fun exercise options will help you stay on track and feel great! Try a Zumba 
video, dance to your favorite music, or take a hike with friends. 
4 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Imagine yourself feeling, looking, and being your absolute best! Being more 
physically active can help you get there! People who are active are happier and 
energized. How will physical activity help you be your best? Use this as motivation 
to get stepping. 
 
 
 
 
 
 
5 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
5 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
Great job meeting your steps goal last week. Make the most out of your walks this 
week by making them “brisk!” Brisk walking has been shown to lower people’s risk 
of high blood pressure and diabetes and help them keep from gaining weight. Even 
if it’s a 10-minute walk, really try to get your heart and lungs working.  
5 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Make the most out of your walks this week by making them “brisk!” Brisk walking 
has been shown to lower people’s risk of high blood pressure and diabetes and help 
them keep from gaining weight. Even if it’s a 10-minute walk, really try to get your 
heart and lungs working.  
5 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Taking care of yourself helps you be your best and take good care of others. Getting 
active is an important way you can take care of yourself. Exercise will leave you 
feeling strong and refreshed. Give yourself time each day to get moving – you 
deserve it! 
 
 
 
 
 
 
6 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
 
Please be sure to wear your Fitbit each day, keep it charged, and sync using the app 
or your home computer. 
6 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
Great job! You are making excellent progress toward 10,000 steps and a healthier 
life! Find an exercise buddy to make your physical activity more fun. Ask a coworker, 
friend, or family member to go for a walk or bike ride with you. See if you can make 
it a weekly date. 
6 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
Having an exercise buddy can help you meet your steps goal. Ask a coworker, friend, 
or family member to go for a walk with you. Exercise is more fun with a buddy, and 
you will be less likely to skip if you know someone’s counting on you.  

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 23 
 
NOT meeting 
goal 
NOT stuck 
6 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Think about what has been getting in the way of your walking. What can you do to 
get moving in the right direction? If time is an issue, think about how you can you fit 
three, 10-minute walks into your day. Every step you take will add up to a healthier, 
happier you! 
 
 
 
 
 
 
 
7 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
 
Please be sure to wear your Fitbit each day, keep it charged, and sync using the app 
or your home computer. 
7 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
Way to go! You met your steps target last week! Keep your activity interesting by 
trying something new next week. Dust off that bicycle or find a Zumba class or 
video.  
7 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Finding fun exercise options will help you stay on track and feel great! Try a Zumba 
video, dance to your favorite music, or take a hike with friends. 
7 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Imagine yourself feeling, looking, and being your absolute best! Being more 
physically active can help you get there! People who are active are happier and 
energized. How will physical activity help you be your best? Use this as motivation 
to get stepping. 
 
 
 
 
 
 
8 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
8 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
Great job meeting your steps goal last week. Make the most out of your walks this 
week by making them “brisk!” Brisk walking has been shown to lower people’s risk 
of high blood pressure and diabetes and help them keep from gaining weight. Even 
if it’s a 10-minute walk, really try to get your heart and lungs working.  
8 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Make the most out of your walks this week by making them “brisk!” Brisk walking 
has been shown to lower people’s risk of high blood pressure and diabetes and help 
them keep from gaining weight. Even if it’s a 10-minute walk, really try to get your 
heart and lungs working.  

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 24 
 
8 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Taking care of yourself helps you be your best and take good care of others. Getting 
active is an important way you can take care of yourself. Exercise will leave you 
feeling strong and refreshed. Give yourself time each day to get moving – you 
deserve it! 
 
 
 
 
 
 
9 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
 
Please be sure to wear your Fitbit each day, keep it charged, and sync using the app 
or your home computer. 
9 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
Way to go! You met your steps target last week! Keep your activity interesting by 
trying something new next week. Dust off that bicycle or find a Zumba class or 
video.  
9 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Finding fun exercise options will help you stay on track and feel great! Try a Zumba 
video, dance to your favorite music, or take a hike with friends. 
9 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Imagine yourself feeling, looking, and being your absolute best! Being more 
physically active can help you get there! People who are active are happier and 
energized. How will physical activity help you be your best? Use this as motivation 
to get stepping. 
 
 
 
 
 
 
10 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
You did not wear, or sync, your Fitbit enough last week to give you a personal goal 
and meaningful feedback.  
10 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
Great job meeting your steps goal last week. Make the most out of your walks this 
week by making them “brisk!” Brisk walking has been shown to lower people’s risk 
of high blood pressure and diabetes and help them keep from gaining weight. Even 
if it’s a 10-minute walk, really try to get your heart and lungs working.  
10 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Make the most out of your walks this week by making them “brisk!” Brisk walking 
has been shown to lower people’s risk of high blood pressure and diabetes and help 
them keep from gaining weight. Even if it’s a 10-minute walk, really try to get your 
heart and lungs working.  
10 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Taking care of yourself helps you be your best and take good care of others. Getting 
active is an important way you can take care of yourself. Exercise will leave you 
feeling strong and refreshed. Give yourself time each day to get moving – you 
deserve it! 
 
 
 
 
 
 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
Page | 25 
 
11 
IF 
nDaymonitor 
< 3  
 
 
Not enough 
days 
monitored 
Congratulations on finishing this study! You have made some great progress over 
the last few weeks. Remember, small steps are important. Being active will help you 
be healthier and look and feel your best. 
11 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
>= 0.90  
NA 
Wore 
monitor 
Meeting 
Goal 
 
You met your steps goal this week. Congratulations on finishing this study strong! 
You should be proud of all of your hard work and how it will improve your health. 
Take a moment to think about how moving more is changing your life for the better. 
Use this as motivation to stay active. 
11 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP <= 2 
Wore 
monitor 
NOT meeting 
goal 
NOT stuck 
Congratulations on finishing this study strong! You should be proud of all of your 
hard work and it will improve your health. Take a moment to think about how 
moving more is changing your life for the better. Use this as motivation to stay 
active. 
11 
IF 
nDaymonitor 
>= 3 
(STEPperday/goalSTEP) 
< 0.90  
NOTmeetSTEP > 2 
Wore 
monitor 
NOT meeting 
goal 
Stuck 
Congratulations on finishing this study! You have made some great progress over 
the last few weeks that will help make you healthier. Remember, small steps are 
important. Being active will help you look and feel your best. 

LCCC 1614 
 
CONFIDENTIAL 
PI: Victoria Bae-Jump 
 
UNIVERSITY OF NORTH CAROLINA 
September 13, 2019 
 
 
 
1 
 
 
SECTION: My NEW Goals: 
(continued) 
VARIABLES:  
used to Control Feedback 
1. ndaysMonitor 
2. StepPERday 
3. goalSTEP 
 
 
 
 
 
 
Weeks 
Feedback 
1 – 6 
Next Week’s Goal: 
Take [NEWgoalSTEP] steps each day 
 
You Can Do it !  
 
 
 
Computing new Goal For STEPS [NEWgoalstep]: 
Criteria 1 
Criteria 2 
COMPUTE 
[nDayMonitor] 
[stepPERday] AND [goalSTEP] 
[NEWgoalSTEP]= 
IF nDaymonitor <   3 
 
NEWgoalSTEP = goalSTEP 
IF nDaymonitor >= 3 
IF (STEPperday/goalSTEP) <   0.90  NEWgoalSTEP = goalSTEP 
IF nDaymonitor >= 3 
IF (STEPperday/goalSTEP) >= 0.90  NEWgoalSTEP = stepperday +500 
IF nDaymonitor >= 3 
IF stepperday >= 12,000 
NEWgoalSTEP = 12,000