Trial Outcomes & Findings for Increasing Activity Post-Kidney Transplant With SystemCHANGE (NCT NCT03191630)
NCT ID: NCT03191630
Last Updated: 2021-03-23
Results Overview
Steps were averaged per day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
(T2) 3months, (T3) 6months, & (T4)12 months
Results posted on
2021-03-23
Participant Flow
There was no pre-assignment.
Participant milestones
| Measure |
Control
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
This arm includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE \& activity tracker intervention
SystemCHANGE \& Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to be encouraged to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. Participants will continue for months, after which time there will be a final group session.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Control
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
This arm includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE \& activity tracker intervention
SystemCHANGE \& Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to be encouraged to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. Participants will continue for months, after which time there will be a final group session.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
Baseline Characteristics
We met our recruitment target
Baseline characteristics by cohort
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes..
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • We met our recruitment target
|
1 Participants
n=7 Participants • We met our recruitment target
|
1 Participants
n=5 Participants • We met our recruitment target
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • We met our recruitment target
|
0 Participants
n=7 Participants • We met our recruitment target
|
0 Participants
n=5 Participants • We met our recruitment target
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • We met our recruitment target
|
0 Participants
n=7 Participants • We met our recruitment target
|
0 Participants
n=5 Participants • We met our recruitment target
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants • We met our recruitment target
|
10 Participants
n=7 Participants • We met our recruitment target
|
20 Participants
n=5 Participants • We met our recruitment target
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants • We met our recruitment target
|
16 Participants
n=7 Participants • We met our recruitment target
|
30 Participants
n=5 Participants • We met our recruitment target
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants • We met our recruitment target
|
0 Participants
n=7 Participants • We met our recruitment target
|
2 Participants
n=5 Participants • We met our recruitment target
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • We met our recruitment target
|
0 Participants
n=7 Participants • We met our recruitment target
|
0 Participants
n=5 Participants • We met our recruitment target
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Steps per Day
|
4171 steps per day
STANDARD_DEVIATION 1709 • n=5 Participants
|
4432 steps per day
STANDARD_DEVIATION 1865 • n=7 Participants
|
4302 steps per day
STANDARD_DEVIATION 1787 • n=5 Participants
|
|
Systolic Blood Pressure
|
150.2 mmHg
STANDARD_DEVIATION 19.05 • n=5 Participants
|
141.8 mmHg
STANDARD_DEVIATION 24.28 • n=7 Participants
|
146 mmHg
STANDARD_DEVIATION 21.66 • n=5 Participants
|
|
Diastolic Blood Pressure (mmHg
|
79.64 mmHg
STANDARD_DEVIATION 10.02 • n=5 Participants
|
80.16 mmHg
STANDARD_DEVIATION 14.82 • n=7 Participants
|
80.1 mmHg
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Heart Rate (beats per minute)
|
74.36 beats per minute
STANDARD_DEVIATION 10.83 • n=5 Participants
|
70.68 beats per minute
STANDARD_DEVIATION 10.36 • n=7 Participants
|
72.62 beats per minute
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Weight (pounds)
|
194.4 pounds
STANDARD_DEVIATION 40.84 • n=5 Participants
|
189.4 pounds
STANDARD_DEVIATION 36.3 • n=7 Participants
|
191.6 pounds
STANDARD_DEVIATION 38.6 • n=5 Participants
|
|
Waist Circumference (centimeters
|
40.94 centimeters
STANDARD_DEVIATION 5.13 • n=5 Participants
|
40.54 centimeters
STANDARD_DEVIATION 5.21 • n=7 Participants
|
40.6 centimeters
STANDARD_DEVIATION 5.18 • n=5 Participants
|
|
Quality of Life Physical Function
|
43.03 scores on a scale, ranging from "0-100"
STANDARD_DEVIATION 10.07 • n=5 Participants
|
41.53 scores on a scale, ranging from "0-100"
STANDARD_DEVIATION 9.49 • n=7 Participants
|
42.3 scores on a scale, ranging from "0-100"
STANDARD_DEVIATION 9.78 • n=5 Participants
|
|
Quality of Life Mental Health
|
54.61 scores on a scale ranging from "0 - 100"
STANDARD_DEVIATION 9.38 • n=5 Participants
|
53.68 scores on a scale ranging from "0 - 100"
STANDARD_DEVIATION 9.17 • n=7 Participants
|
54.1 scores on a scale ranging from "0 - 100"
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Body mass index
|
30.5 kg/m^2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 5.9 • n=7 Participants
|
30.8 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: (T2) 3months, (T3) 6months, & (T4)12 monthsPopulation: Descriptive statistics were used to analyze the monthly average for daily steps at 12 months.
Steps were averaged per day.
Outcome measures
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. .
|
|---|---|---|
|
Steps Taken Per Day by Using an Activity Tracker
(T3) 6months
|
4157 average of steps per day
Standard Deviation 2931
|
4981 average of steps per day
Standard Deviation 3028
|
|
Steps Taken Per Day by Using an Activity Tracker
(T4) 12months
|
3608 average of steps per day
Standard Deviation 2985
|
4766 average of steps per day
Standard Deviation 3114
|
|
Steps Taken Per Day by Using an Activity Tracker
(T2) 3months
|
4710 average of steps per day
Standard Deviation 2628
|
5708 average of steps per day
Standard Deviation 3586
|
SECONDARY outcome
Timeframe: (T2) 3months, (T3) 6months, & (T4)12 monthsPopulation: Mixed-effects linear regression modeling was used to model the Six Minute Walk Test as a linear combination of the fixed-effects of group (intervention vs. attention-control).
A section of 98 feet was marked off on a hard flat surface using two orange cones. Participants were asked to walk at a comfortable pace for 6-minutes between the cones while being timed, and the distance walked was recorded in feet.
Outcome measures
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. .
|
|---|---|---|
|
Six Minute Walk Test
(T3) 6 Months
|
1204 Feet
Standard Deviation 266.6
|
1142 Feet
Standard Deviation 295.0
|
|
Six Minute Walk Test
(T2) 3Months
|
1142 Feet
Standard Deviation 337.1
|
1158 Feet
Standard Deviation 235.9
|
|
Six Minute Walk Test
(T4) 12 Months
|
1146 Feet
Standard Deviation 264.7
|
1120 Feet
Standard Deviation 259.4
|
SECONDARY outcome
Timeframe: (T2) 3months, (T3) 6months, & (T4)12 monthsPopulation: We used mixed-effects linear regression modeling to derive estimates for the resting blood pressure.
Resting blood pressure will be measured on each participant in a seated position using a Withings blood pressure cuff by the research staff. The research staff collecting the resting blood pressure reading will be a registered nurse. The research staff collecting the readings will be blinded to the study groups.
Outcome measures
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. .
|
|---|---|---|
|
Resting Blood Pressure
(T2) 3 months Systolic Blood Pressure (Unit of Measure: mmHg)
|
146.7 (mmHg)
Standard Deviation 18.61
|
140.7 (mmHg)
Standard Deviation 26.54
|
|
Resting Blood Pressure
(T2) 3 months Diastolic Blood Pressure (Unit of Measure: mmHg)
|
80.52 (mmHg)
Standard Deviation 12.73
|
79.52 (mmHg)
Standard Deviation 14.47
|
|
Resting Blood Pressure
(T3) 6 months Systolic Blood Pressure (Unit of Measure: mmHg)
|
142.2 (mmHg)
Standard Deviation 12.76
|
143.3 (mmHg)
Standard Deviation 19.69
|
|
Resting Blood Pressure
(T3) 6 months Diastolic Blood Pressure (Unit of Measure: mmHg)
|
77.20 (mmHg)
Standard Deviation 8.94
|
78.80 (mmHg)
Standard Deviation 13.10
|
|
Resting Blood Pressure
(T4) 12 months Systolic Blood Pressure (Unit of Measure: mmHg)
|
143.8 (mmHg)
Standard Deviation 16.59
|
132.2 (mmHg)
Standard Deviation 14.80
|
|
Resting Blood Pressure
(T4) 12 months Diastolic Blood Pressure (Unit of Measure: mmHg)
|
77.38 (mmHg)
Standard Deviation 10.21
|
74.05 (mmHg)
Standard Deviation 10.19
|
SECONDARY outcome
Timeframe: (T2) 3months, (T3) 6months, & (T4)12 monthsPopulation: We used mixed-effects linear regression modeling to derive estimates for the quality of life.
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 was used as study outcomes.
Outcome measures
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. .
|
|---|---|---|
|
Quality of Life: Physical (Functional) and Mental (Well-being) Health"
Quality of Life (T2) 3 months Physical Function
|
45.32 score from 0-100
Standard Deviation 7.84
|
40.37 score from 0-100
Standard Deviation 9.34
|
|
Quality of Life: Physical (Functional) and Mental (Well-being) Health"
Quality of Life (T3) 6 months Physical Function
|
44.69 score from 0-100
Standard Deviation 9.25
|
40.91 score from 0-100
Standard Deviation 9.97
|
|
Quality of Life: Physical (Functional) and Mental (Well-being) Health"
Quality of Life (T4) 12 months Physical Function
|
45.71 score from 0-100
Standard Deviation 7.93
|
40.02 score from 0-100
Standard Deviation 8.18
|
|
Quality of Life: Physical (Functional) and Mental (Well-being) Health"
Quality of Life Mental Health ( T2) 3 months
|
53.50 score from 0-100
Standard Deviation 8.03
|
54.68 score from 0-100
Standard Deviation 8.51
|
|
Quality of Life: Physical (Functional) and Mental (Well-being) Health"
Quality of Life Mental Health ( T3) 6 month
|
53.12 score from 0-100
Standard Deviation 9.87
|
51.30 score from 0-100
Standard Deviation 8.21
|
|
Quality of Life: Physical (Functional) and Mental (Well-being) Health"
Quality of Life Mental Health ( T4) 12 months
|
50.91 score from 0-100
Standard Deviation 10.69
|
51.56 score from 0-100
Standard Deviation 9.93
|
SECONDARY outcome
Timeframe: (T2) 3months, (T3) 6months, & (T4)12 monthsPopulation: We used mixed-effects linear regression modeling to derive estimates for the weight.
Weight was measured without shoes and in light clothing using a digital scale.
Outcome measures
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. .
|
|---|---|---|
|
Weight (Pounds)
(T2) 3 months (pounds)
|
193.1 pounds
Standard Deviation 36.63
|
188.5 pounds
Standard Deviation 37.11
|
|
Weight (Pounds)
(T6) 6 months (pounds)
|
192.6 pounds
Standard Deviation 36.06
|
186.6 pounds
Standard Deviation 37.67
|
|
Weight (Pounds)
(T4) 12 months (pounds)
|
189.0 pounds
Standard Deviation 35.91
|
189.3 pounds
Standard Deviation 37.17
|
SECONDARY outcome
Timeframe: (T2) 3months, (T3) 6months, & (T4)12 monthsPopulation: We used mixed-effects linear regression modeling to derive estimates the resting heart rate.
The research staff will obtain a radial pulse (heart rate) over a 60-second count while the participant remains seated. The research staff collecting the radial pulse reading will be a registered nurse and blinded to the study groups.
Outcome measures
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. .
|
|---|---|---|
|
Radial Pulse (Beats Per Minute)
(T3) 3 months(beats per minute)
|
70.20 (beats per minute)
Standard Deviation 12.11
|
69.08 (beats per minute)
Standard Deviation 8.82
|
|
Radial Pulse (Beats Per Minute)
(T3) 6 months(beats per minute)
|
70.20 (beats per minute)
Standard Deviation 11.11
|
67.56 (beats per minute)
Standard Deviation 11.30
|
|
Radial Pulse (Beats Per Minute)
(T4) 12 months(beats per minute)
|
67.21 (beats per minute)
Standard Deviation 8.20
|
66.82 (beats per minute)
Standard Deviation 7.76
|
SECONDARY outcome
Timeframe: (T2) 3months, (T3) 6months, & (T4)12 monthsPopulation: Mixed-effects linear regression modeling was used to model the BMI.
Body mass index (BMI; kg/m2) will be calculated as \[mass (lb)/ height (in)2 x 703
Outcome measures
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. .
|
|---|---|---|
|
Body Mass Index (BMI)kg/m2
(T2) 3 months kg/m2
|
30.3 kg/m2
Standard Error 5.5
|
31.3 kg/m2
Standard Error 6.1
|
|
Body Mass Index (BMI)kg/m2
(T3) 6 months kg/m2
|
29.5 kg/m2
Standard Error 4.6
|
30.7 kg/m2
Standard Error 6.4
|
|
Body Mass Index (BMI)kg/m2
(T4) 12months kg/m2
|
28.4 kg/m2
Standard Error 4.4
|
29.5 kg/m2
Standard Error 8.1
|
SECONDARY outcome
Timeframe: (T2) 3months, (T3) 6months, & (T4)12 monthsPopulation: We used mixed-effects linear regression modeling to derive estimates for each the WC.
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.
Outcome measures
| Measure |
Control
n=26 Participants
This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): 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. 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. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
|
Intervention
n=27 Participants
This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): 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. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. .
|
|---|---|---|
|
Health Outcome: Waist Circumference (cm)
(T2) 3 Months (cm)
|
39.76 cm
Standard Deviation 5.24
|
39.22 cm
Standard Deviation 5.00
|
|
Health Outcome: Waist Circumference (cm)
(T3) 6 Months (cm)
|
39.08 cm
Standard Deviation 4.92
|
38.68 cm
Standard Deviation 5.02
|
|
Health Outcome: Waist Circumference (cm)
(T4) 12 Months (cm)
|
38.42 cm
Standard Deviation 4.66
|
38.70 cm
Standard Deviation 5.42
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place