Increasing Activity Post-Kidney Transplant With SystemCHANGE
Phase: NA
Conditions: Kidney Transplant; Complications, Physical Activity, Cardiorenal; Change, Cardiovascular Diseases
Sponsor: Ohio State University

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
 
 I. Objectives  
The purpose of this study is to determine the best way to help people that have had a 
kidney transplant perform daily physical activity. Currently, we do not know the best way 
to help people who have had a kidney transplant to remember to perform regular 
physical activity. This study will help us explore how to promote routine daily physical 
activity. 
  
(a) Determine if perceptions (usability, sustainability, and acceptability) of activity 
tracker use differs for older adult KTRs participating in a SystemCHANGETM 
intervention compared to a control group at 1, 2, 3, 6, &12 months. 
(b)  Determine the degree to which a SystemCHANGE™ + activity tracker 
intervention improves physical activity, health outcomes, and quality of life for 
older adult KTRs from baseline to 3, 6, & 12 months, compared to a control 
group using only activity trackers. 
 
 
II. Background and Rationale  
The combination of the SystemCHANGE TM and activity tracker intervention 
holds promise for increasing and sustaining activity among older kidney transplant 
recipients. This study will incorporate with an accessible popular device with a simple 
intervention in a population of kidney transplant recipients who are at particularly high 
risk of cardiovascular disease and death. The findings from this study would have a 
significant impact on the lives of these individuals and costs associated with their 
ongoing care.  
 
We will conduct a randomized study with intervention and control arms. Sixty kidney 
transplant recipients age 65 and older will be recruited and randomized into two groups. 
Participants in the intervention group will receive the combination of the 
SystemCHANGE TM and activity tracker intervention while participants in the control 
group will use activity trackers only. Intervention and control groups will receive the 
same instruction on use of the activity tracker, and have the same number of study 
contacts. Study procedures include group sessions with 10-12 participants for 6 months 
and a 6-month maintenance phase without contact from study personnel until month 12. 
Outcome analyses will be conducted at baseline, 1, 2, 3, 6, and 12 months. Outcome 
measures include perception of activity tracker use, physical activity, functional ability, 
health outcomes, and quality of life.   
 
It is possible that those enrolled in this study may experience improved functional ability 
and quality of life. Moreover, the general population of kidney transplant recipients is 
likely to benefit from the knowledge to be gained about the effectiveness of 
interventions to increase physical activity and sustain it over time. Potential risks include 
psychological and social risks associated with the study intervention. It is possible that 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
participants could experience distress or discomfort as a result of discussing issues 
relating to changing their routines during the intervention. 
 
Rationale: While previous SystemCHANGETM studies have made use of electronic 
devices to monitor outcomes, none have employed a widely available, popular 
consumer-based technology which could facilitate more widespread and rapid adoption 
of a critically important self-management practice. The rationale for using Fitbit activity 
trackers is that they are affordable, unobtrusive devices which have become popular 
with consumers and can assist individuals to become aware of their daily physical 
activity. 
 
III. Procedures  
The procedures should include the following:  
A. Research Design 
 
We will conduct a single-center randomized pilot study with intervention and control 
arms and outcome analyses conducted at baseline, 1, 2, 3, 6, and 12 months. 
 
B. Sample  
 
Setting. The study will be conducted with The Ohio State University Medical Wexner 
Center Kidney Transplant Program. This Midwest transplant program performs 300 
kidney transplants annually (see Appendix A.1 for Letter of Support). Situated in 
Columbus, Ohio, the transplant program functions as a regional referral center, serving 
a highly racially diverse population from both urban and rural communities.  
Sample. Our study sample will be recruited from patients receiving care at The Ohio 
State University Medical Wexner Center Kidney Transplant Program. Our goal is to 
recruit 60 KTRs in a manner that will yield a sample reflective of the racially diverse 
population served by the Transplant Institute and is consistent with recommendations 
for the conduct of pilot studies that evaluate effects of an intervention. 
 
Recruitment .A list of all kidney transplant recipients with scheduled clinic 
appointments will be generated weekly and reviewed by the health care providers who 
will be seeing the patients and research staff to identify patients who meet inclusion 
criteria. The health care providers seeing the patients will inform possible participants 
about the study during their clinic appointment; if participants express interest, the 
health care providers will then inform the investigator. The investigator will coordinate 
the best time during the clinic visit to approach the potential study participant to explain 
the study, answer questions, and solicit consent to participate in the study. In addition, 
at support group gatherings, transplant staff hosting the event will introduce the PI who 
will tell the audience about the study, welcome their questions, and provide information 
about study enrollment if requested. Following the meeting, those who expressed 
interest in the study will the investigator will schedule a time to meet with them to 
explain the study, answer questions, and solicit consent to participate in the study. 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
Questions will be answered, and if verbal agreement is obtained, inclusion/exclusion 
criteria will be reviewed and a cognitive screening test using the 6-item Mini-Mental 
Status (Appendix B.1).39 If eligible for study participation, the potential study participant 
will be scheduled for the first group meeting at which time informed consent will be 
obtained. 
Inclusion Criteria 
a) age 65 or older; (b) functioning kidney transplant (not on dialysis); (c) clearance by 
healthcare provider for  study participation; (d) ability to speak, read, and hear English; 
(e) possession of a smartphone capable of accessing mobile activity tracker data; (f) no 
cognitive impairment; (g) ability to secure a device similar to a watch to the wrist; (h) no 
use of assistive devices for walking (cane or walker); (i) greater than 3 months post-
transplant to ensure recovery; and (j) not hospitalized 
 
 Exclusion Criteria 
a) disability of arms or legs (activity trackers require movement of the arms and 
legs); (b) participation in a weight loss program; (c) participation in a structured 
exercise program; (d) currently wearing an activity tracker; or (e) planning to 
move out of the area within the next 6 months. 
 
  
Characteristics of the Sample 
 
Estimated Age of Kidney Transplant Recipients Based on 2015 Health Resources 
and Services Administration, U.S. Department of Health & Human Services Data: 
United States, and, The Ohio State University Transplant Program (1988-2016)14 
Age 
United States 
OSU 
18-34 years 
72,768 
19% 
898 
18% 
35-49 years  
124,303 32% 
1,696 
33.1% 
50-64 years 
140,669 37% 
1,961 
38.2% 
65+years 
48,005 
12% 
514 
10% 
All ages 
385,745 100% 
5,127 
100% 
 
 
 Estimated Race of Kidney Transplant Recipients 65 and Older Based on 2015 
Health Resources and Services Administration, U.S. Department of Health & 
Human Services Data: The Ohio State University Transplant Program (1988-
2016)14 
Race 
United States 
(N = 48,005) 
OSU 
(N = 514) 
White 
30,898  64% 
409 
80% 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
Black 
8,923 
19% 
96 
19% 
Hispanic 
4,928 
10% 
2 
0.4% 
Asian 
2,542 
5% 
4 
0.7% 
American Indian/Alaska 
Native 
376 
.8% 
0 
0% 
Pacific Islander  
144 
.3% 
0 
0% 
Other Race 
194 
.4% 
3  
0.6 % 
 
 
Purposive Enrollment Schema 
Number ( n = 60) 
Black (n = 12 ) White ( n =48 
) 
Male Intervention  
4 
16 
Female Intervention 
3 
9 
Male Control 
3 
15 
Female Control 
2 
8 
Total 
12 
48 
 
 
 
C. Measurement / Instrumentation  
Identify the variables of interest and study endpoints (where applicable). Justify 
measurement techniques selected. Provide validity and reliability data for selected 
measures.  
 
Study Measures: In addition to 
demographic and 
inclusion/exclusion 
screening (including 
cognitive screening), the 
following measures will be 
collected: perception of 
activity trackers use 
(Appendix C.1), Six-
Minute Walk Test, blood 
pressure, heart rate, body 
mass index, waist 
circumference, and Short 
Form Health Survey (SF-12) (Appendix C.2). An iPad will be used to administer all 
questions that will enable direct data entry into REDCap. RAs will provide assistance as 
needed by reading questions to participants and assisting with indicating responses on 
the iPad. Outcome data from both study groups will be collected at the appropriate 
Data Collection
Baseline 1
2
3
4
5
6
7
8
9 10 11 12
  Basic Demographic
X
  Cognitive Screening
X
  Perception of Activity Tracker
X
X
X
X
X
  SF-12 
X
X
X
X
  Number of Steps
X
X
X
X
  Six-Minute Walk Test
X
X
X
X
  Blood Pressure
X
X
X
X
  Heart Rate
X
X
X
X
  BMI 
X
X
X
X
  Waist Circumference 
X
X
X
X
Data Collection Timeline
Months
Measurement Timeline 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
sessions as shown in the Table 6. 
Demographic or Sample Measures: Demographic information will be obtained during 
the screening phone call and will include: gender, race, marital status, income, 
education, transplant date, prescribed medications, type of diet, smoking status, and co-
morbidities. 
Outcome Measures: (Aim 1) Perception of activity tracker use (Appendix C.1) (15 
minutes) will be assessed using 9 open-ended questions to determine participants’ 
perceptions (usability, sustainability, and acceptability) of using mobile activity trackers.  
(Aim 2a) Number of steps will be recorded continuously each day by a mobile wristband 
activity tracker called “Fitbit Charger HR” that will sync data from the participant’s 
cellular phone into the Fitabase each day. Fitabase step-data will be downloaded 
directly into REDCap. The Fitbit Charger HR uses a 3-axis accelerometer to record 
activity. The device turns movement (acceleration) of a body into digital measurements 
(step-data) when attached to the non-dominant wrist. In addition, the Fitbit Charger HR 
provides information about the frequency, duration, intensity, and patterns of movement 
to determine the number of steps taken each day. In a study comparing the validity of 
two activity tracker accelerometers, the Fitbit Charger HR and the Physical Activity 
Monitor (PAM), the Fitbit Charger HR performed more accurately (r =.77) than the PAM 
(r = .41) for measuring energy expenditure.44 In another study45 with 30 adults, no 
difference was found between the Fitbit Charger HR for steps counted and actual steps 
observed (ICC >.95). 
(Aim 2b) Functional Ability will be assessed with The Six-Minute Walk Test 
(6MWT)46 (10 minutes) which measures the distance walked on a hard flat surface in 6 
minutes. A section of 30 meters will be marked off using two orange cones and 
participants will be asked to walk at a comfortable pace for a 6-minute period between 
the cones while being timed. Test-retest reliability has been documented as high as .90 
at baseline, .88 at 18 weeks, and .91 at 43 weeks47 for older patients with heart 
failure.47 Participants may have different levels of current activity. In order to control for 
this, step-data will be adjusted for baseline.  
(Aim 2c) Health Outcomes (10 minutes). Resting blood pressure will be 
measured on each participant in a seated position using a Withings blood pressure cuff 
by the RA who will be a registered nurse. The RAs will be blinded to the study groups. 
The RAs will also obtain a radial pulse (heart rate) over a 60-second count while the 
participant remains seated. Weight for determining Body Mass Index (BMI) will be 
measured without shoes and in light clothing and be calculated to the nearest 0.1 pound 
using a digital scale that will be calibrated prior to testing.48 Height will be measured 
without shoes using a self-retracting tape measure and rounded to the nearest 0.1 cm. 
Body mass index (BMI; kg/m2) will be calculated as [mass (lb)/ height (in)2 x 703]. Waist 
circumference (WC) will be obtained by measuring the individual’s circumference 
halfway between the illac crest and the lower anterior ribs with the person standing 
upright during expiration.49  
(Aim 2d) Quality of Life. The Short Form Health Survey (SF-12) (5 minutes) 
(Appendix C.2) contains 12 questions that explore a person’s physical (functional) and 
mental (well-being) health over the previous 4 weeks.50 The SF-12 includes 8 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
domains—Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, 
Social Functioning, Role-Emotional, and Mental Health50—and uses a Likert-like scale 
from 1 to 3 for the physical function items which focus on bodily pain, social function, 
vitality, mental, and general health perceptions. A dichotomous yes/no scale is used for 
emotional and physical role function items.51 Physical and mental component scores, 
ranging from 0 (lowest level of health) to 100 (highest level of health), are derived from 
the individual items and will be used as study outcomes. The questionnaire has been 
found to have high internal consistency (Cronbach’s alpha coefficients of .72 to .89) and 
adequate test-retest reliability (r = .73-.86).51,52 
 
 
 
 
D. Detailed study procedures  
 
All study data will be entered directly into electronic research forms using Research 
Electronic Data Capture system (REDCap, surveys, and other instruments by study 
participants and research staff that will automatically upload into REDCap. Similarly, 
mobile activity tracker data (steps) aggregated by the secure Fitabase will also upload 
into REDCap. The REDCap Admin will provide technical support for project duration. 
 
Overview of Intervention and Control Groups 
Intervention and control groups will be enrolled in the study in the same manner, receive 
the same instruction on use of the Fitbit Charge HR, and have the same number of 
study contacts. Study procedures include group sessions at the OSU Transplant Clinic 
with 10-12 participants for 6 months and a 6-month maintenance phase without contact 
from study personnel until month 12. One research assistant will be assigned to the 
intervention group and one to the control group. 
 
Intervention Group Active Phase, Group Session 1 (1 hour, 20 minutes)  Dr. O’Brien and a 
research assistant (RA) will demonstrate proper Fitbit Charger HR activity tracker use, set up 
the smartphone application, and assist entry of daily step goals into the smartphone application. 
Fitbits will be set up with Gmail accounts with unique unidentifiable codes. Participants will be 
taught how to sync to their smartphone and retrieve data from their Fitbit. Participants will 
perform a return demonstration to confirm they can apply the activity tracker to their wrist, 
access their Fitbit account, and charge the activity tracker. One week following this session, 
participants will be called to troubleshoot problems and be encourage to increase their step goal 
5% each month (total phone time 15 minutes).   
Figure 3. Intervention/Control Group Timeline 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
Intervention Active Phase, Group Session 2 (1 hour) This session will begin with brief 
introductions of research staff and study participants followed by a session overview. The first 
topic to be reviewed will be Fitbit activity tracker reports (Appendix B.2). Participants will be 
oriented to the report, including the steps being monitored, the range of dates for the report, and 
general information (number of monitored days, number of daily steps taken, and number of 
activity minutes per day). Consistent with SystemCHANGETM, phrases such as “opportunities 
for improvement” and “possibilities for doing 
better” will be employed when discussing 
the report with participants. Questions will 
be solicited and answered before 
proceeding to delivery of the 
SystemCHANGETM component of the 
intervention. 
 
A PowerPoint presentation will briefly 
introduce SystemCHANGETM component of 
the intervention followed by participants 
being divided into small groups of 5 each. 
In these small groups and with the aid of a 
workbook (see Appendix B.3), RAs and the 
PI will guide participants through the 4 
steps of SystemCHANGETM. 
 
During Step 1, participants will be asked to 
identify important people that influence their 
physical activity. This information will be noted on the Important People Form. In Step 2, 
participants will be helped to identify activities or habits that routinely occur daily, weekly, or 
monthly, focusing on the impact of these routines on physical activity. This process starts by 
asking participants to describe activities that routinely occur on a daily, weekly, and monthly 
basis along with the time most likely for their occurrences. Participants will also include things 
that influence their participation in physical activity (e.g., availability of facilities as a walking path 
getting home from work late, or sleeping late on a weekend). Social activities and any rituals 
associated with physical activity such as gardening, housecleaning, shopping, and hobbies will 
also be noted. This information is documented on the Life Routines Form. During Step 3, RAs 
will place the collaboratively identified routines (daily, weekly, monthly) identified in Step 2 into 
the Cycles Figure, a graphic format that helps participants understand how routines are related 
to each other and can work for, or against, changing physical activity behavior. The daily, 
weekly, and monthly cycles will be discussed to help understanding of how a routine involving 
family demands, for example, may influence participation in physical activity. The discussion 
during Step 3 informs Step 4 at which time RAs and participants, together, consider possible 
approaches (solutions) to achievement of their daily steps goal. These possible solutions are 
documented on the Possible Solutions Form and rated on the Possible Solutions Scale for the 
perceived level of a systems-oriented versus personal effort/motivation required for 
implementation. If greater personal effort/motivation is required than systems orientation, 
participants will be guided in identifying another solution. Participants will be encouraged to 
discuss ideas with the person identified as most involved in their physical activity. As 
implementation of the solution is discussed, goals for increasing steps will be mutually agreed 
upon (generally, a 5% increase) and use of their activity tracker reports for monitoring progress 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
toward improvement will be discussed and demonstrated. In this session and throughout the 
Active Phase of the intervention, participants will be encouraged to look beyond personal 
motivation and explore their life routines and the people who shape those routines.  
Intervention Active Phase, Group Sessions 3-7 (1 hour/session) Participants’ progress will 
be reviewed using the Plan-Do-Study-Act Model33 that employs small participant-designed 
experiments. Prior to each session, the participants’ activity tracker reports will be given to them 
(Appendix B.2) and reviewed during the group session. Participants will be asked to “Tell me 
what you are learning about physical activity, and do you think changes that you have made to 
your routines are changing the level and consistency of your physical activity? Do you need to 
make other changes to your physical activity routines?” If the participant and RA agree that 
changes are warranted, participants will be encouraged to identify and try another solution. At 
the last monthly meeting, participants will be asked to describe their improvements and be 
encouraged to continue using the activity tracker for the next 6 months during the maintenance 
phase (see Figure 3). 
Intervention Maintenance (6 months) At the final monthly session, participants will be 
instructed to continue with intervention and reminded that the research team will not be in 
contact for 6 months, after which time there will be a final group session. 
Control Group 
Control Active Phase, Group Session 1  
Session 1 for the control group will be identical to the Intervention with the only exception being 
that participants in the control group will NOT be asked to increase their step goal 5% each 
month based on the step-data we receive from baseline to week 1. 
Control Active Phase Group Session 2-7, (1 hour/ session) Session 2 will be used to 
troubleshoot and discuss any problems with the Fitbit activity trackers. In subsequent sessions, 
educational information about healthy living as a transplant recipient will be presented, including 
topics such as diet, taking medication, risk for skin cancer, gastrointestinal side effects, dental 
care, and new onset post-transplant diabetes. The meeting time will be equivalent to those of 
the intervention group 
Control Maintenance Phase, (6 months) Identical to the intervention group; at the final month 
7, group session participants will be reminded to continue to use the Fitbit activity tracker and 
that the research team will not be in contact with them for 6 months, after which time there will 
be a final group session. 
Study Measures: In addition to 
demographic and 
inclusion/exclusion 
screening (including 
cognitive screening), the 
following measures will be 
collected: perception of 
activity trackers use (Six-
Minute Walk Test, blood 
pressure, heart rate, body 
mass index, waist 
circumference, and Short 
Form Health Survey (SF-12) 
An iPad will be used to 
administer all questions that will enable direct data entry into REDCap. RAs will provide 
Data Collection
Baseline 1
2
3
4
5
6
7
8
9 10 11 12
  Basic Demographic
X
  Cognitive Screening
X
  Perception of Activity Tracker
X
X
X
X
X
  SF-12 
X
X
X
X
  Number of Steps
X
X
X
X
  Six-Minute Walk Test
X
X
X
X
  Blood Pressure
X
X
X
X
  Heart Rate
X
X
X
X
  BMI 
X
X
X
X
  Waist Circumference 
X
X
X
X
Data Collection Timeline
Months
Table 6. Measurement Timeline 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
assistance as needed by reading questions to participants and assisting with indicating 
responses on the iPad. Outcome data from both study groups will be collected at the 
appropriate sessions as shown in the Table 6. 
 
 
1. See document for details describing what will happen at each intervention group 
meeting. 
2. See document for details describing  what will happen at each control group 
meeting 
 
Retention: Text messages will be sent to participants during months when they are not 
attending a face-to-face session to provide encouragement and reinforcement for their 
participation in the study. In addition, phone calls will be made during each month to each 
participant to provide updates on their progress in the study as well as encouragement and 
support. Participants who complete the study will be allowed to keep their activity tracker. 
E. Internal Validity  
Treatment fidelity43 for both study groups will be assured first, though the use of a 
scripted manual for each group session will be used during RA training sessions which 
will include role-playing with simulated participants until competency in delivery of group 
sessions is demonstrated. A log of the time taken for each group session will be kept to 
ensure equivalent treatment dose across all sessions. Debriefing will be conducted 
following each session to identify any areas for improvement. A protocol checklist will be 
used to ensure that content is completely and consistently covered and all outcome 
measures are collected at baseline, 1,2, 3, 6, and 12 months. 
 
 
 
  
 
F. Data Analysis  
The overall analytic design is a mixed design model where participants are randomly assigned 
to one of two intervention or comparison arms. The response over time of the participants will 
likely be correlated, therefore covariance patterns over time to be considered include compound 
symmetry, autoregressive, exponential (allows for unequally spaced times) and unstructured. 
The unstructured covariance pattern allows for less variation in the outcome variable (e.g., days 
engaged in activities) at baseline—a condition which may occur and will be evaluated.  
Aim 1: Perception of activity trackers will be determined by participants’ responses to 
open-end surveys. The responses from these surveys will be analyzed using content analysis to 
explore narrative responses for each open-ended question for commonalities and placed in 
emerging patterns or themes. 
Aim 2: The test of effectiveness for each intervention arm is assessed by evaluating the 
treatment group by time interaction with two a priori contrasts (one for each arm) comparing the 
one-year follow-up mean to the baseline mean (essentially a paired t-test in the context of 
ANOVA). If an intervention is effective, we expect an initial rapid and sustained increase in the 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
numbers of steps/day; a subsequent return to near baseline levels would indicate that the 
intervention is not effective. To quantify the effectiveness of each arm and compare the 
effectiveness of the two arms at one-year follow-up, we will compute 95% confidence intervals 
of the changes in the primary outcome variable. The same approach will be used to quantify the 
effectiveness of the intervention and control groups on the secondary outcome variables. For 
Aim 2, the primary outcome will be the number of steps per day; secondary outcomes include 
distance traveled in 6 minutes, health outcomes (blood pressure, heart rate, body mass index, 
waist circumference) and quality of life (SF-12). Baseline characteristics of participants will be 
ascertained prior to randomization and all outcomes measured at baseline, 3 months (Follow-up 
1), 6 months (Follow-up 2) and 12 months (Follow-up 3). A total of 60 participants will be 
randomized to either the SystemCHANGETM + activity tracker intervention or activity tracker 
control group. Thus, the study has a classical repeated-measures design. Power calculations 
are based on two-sided t-tests with type-I error rates of 0.05. Effect sizes within arm will be 
small with standardized differences ranging from 0.37 to 0.58; we assumed a correlation 
between repeated measures of 0.7. While we used changes from baseline to 12 months to 
calculate power, we will analyze data for this aim by evaluating the average number of 
steps/day at baseline and at each follow-up. Results will be analyzed based on intention-to-
treat. Using means and standard deviations for accelerometer-based numbers of steps per day 
from Dontje and colleagues,7 we estimate the activity tracker control group to record 6326 + 
2906 steps/day at baseline and 7562 + 3785 steps/day at 12-months follow-up. In the context of 
repeated measures ANOVA, using a t-test within arm to detect change from baseline to 12-
months, power is 0.575. Because no data exist for determining the effect on steps/day of the 
SystemCHANGETM + activity tracker intervention, we assumed that the differences between the 
means of the two arms at 12 months might conservatively be between 346 and 662 steps/day. 
Thus, we expect the intervention group to record 6326 + 2906 steps/day at baseline and 
between 7908 + 3785 and 8224 + 3785 steps/day at 12-months follow-up. Using a within arm t-
test, power is 0.798 to 0.918. Change from baseline in each arm will quantify the effectiveness 
of each in improving the primary outcome. Although this study is not powered to detect 
differences between the arms at 12 months, we will be able to compare the relative 
effectiveness of each arm at one-year follow-up and will compute 95% confidence intervals of 
the changes in outcome variables. We expect that each of these confidence intervals will 
include the mean of the comparison intervention. If differences between interventions are 
detected, we expect that the difference will be attributable to (1) fewer numbers of steps/day at 
baseline compared to the Dontje study7 and/or (2) a larger effect on the number of steps/day of 
the SystemCHANGETM + activity tracker intervention at 12 months. Data loss due to participant 
failure to complete all measures is a serious concern in every clinical investigation. Any missing 
data will be identified at the time of collection and rectified by asking participants to provide the 
necessary information. However, because subjects have the right to refuse to answer questions 
(informed consent), we will code null values differently from ‘refuse to answer’ and ‘not 
applicable’. We will also explore demographics of participants for the effects of influencing 
outcomes. Missing step-data will occur when participants forget to wear or charge devices 
overnight; we will identify these missing data prior to the group visit so participants can give 
information on the reasons for missingness. 
 
IV. Bibliography  
References 
 

Study Title: Increasing Activity Post-Kidney Transplant with SystemCHANGE TM 
IRB Protocol Number: 2017B0084 
Approval Date: 10-22-18 
NCT03191630  
                                                 
Version: 08/28/2018 
 
 
1. 
Zelle DM, Kok T, Dontje ML, et al. The role of diet and physical activity in post-transplant 
weight gain after renal transplantation. Clin. Transplant. Jul-Aug 2013;27(4):E484-490. 
2. 
Cashion A, Hathaway D, Stanfill A, et al. Pre-transplant predictors of one year weight 
gain after kidney transplantation. Clin. Transplant. Aug 26 2014. 
3. 
Fernandes JF, Leal PM, Rioja S, et al. Adiposity and cardiovascular disease risk factors 
in renal transplant recipients: Are there differences between sexes? Nutrition. Oct 
2013;29(10):1231-1236. 
4. 
Abecassis M, Bridges ND, Clancy CJ, et al. Solid-organ transplantation in older adults: 
current status and future research. Am. J. Transplant. Oct 2012;12(10):2608-2622. 
5. 
Romano G, Lorenzon E, Montanaro D. Effects of exercise in renal transplant recipients. 
World j. transplant. Aug 24 2012;2(4):46-50. 
6. 
Hartmann EL, Kitzman D, Rocco M, et al. Physical function in older candidates for renal 
transplantation: an impaired population. Clin. J. Am. Soc. Nephrol. Mar 2009;4(3):588-
594. 
7. 
Dontje ML, de Greef MH, Krijnen WP, et al. Longitudinal measurement of physical 
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