Trial Outcomes & Findings for A Smartphone App to Improve Physical Activity (NCT NCT03417440)
NCT ID: NCT03417440
Last Updated: 2022-11-21
Results Overview
Step counts (objective physical activity) were measured using the activPAL thigh-worn accelerometer during a 72-hour monitoring period. Estimated average change is computed as the change in activPAL-tracked mean daily steps at Month 4 relative to baseline; this outcome is analyzed in a linear regression analysis model. All randomized participants who started the intervention and had valid activity monitor data were utilized in the model (ITT analysis)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
111 participants
Primary outcome timeframe
72-hour monitoring periods at Month 4 relative to baseline
Results posted on
2022-11-21
Participant Flow
197 screened for eligibility. 111 signed consent. 107 were randomized. 105 included in intent-to-treat analysis.
Two participants withdrew from the study after the study team randomized them but before the participants learned what group to which they were assigned. These two individuals were not included in the intent-to-treat analysis.
Participant milestones
| Measure |
AT App+ On Your Feet+ CoachMe+ Proof Pos
Basic activity tracker (AT) app in conjunction with the following 3 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (3) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
AT App: app auto-monitors PA and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + On Your Feet + Coach Me
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
AT App: app auto-monitors PA and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
|
AT App + On Your Feet + Proof Positive
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
AT App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + On Your Feet
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following feature: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions).
AT App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
|
AT App + Coach Me + Proof Positive
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following 2 features: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
AT App: This physical activity tracker app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + Coach Me
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following feature: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
AT App: This physical activity tracker app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
|
AT App + Proof Positive
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following feature: (1) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
AT App: This physical activity tracker app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App
Participants in this arm will use a basic physical activity (PA) tracker app without any additional features.
AT App: This physical activity tracker app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
14
|
14
|
14
|
12
|
15
|
12
|
|
Overall Study
Non-completer But Included in ITT
|
1
|
1
|
1
|
1
|
2
|
0
|
0
|
1
|
|
Overall Study
Non-completer But NOT Included in ITT
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
11
|
12
|
12
|
13
|
12
|
12
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
1
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
AT App+ On Your Feet+ CoachMe+ Proof Pos
Basic activity tracker (AT) app in conjunction with the following 3 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (3) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
AT App: app auto-monitors PA and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + On Your Feet + Coach Me
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
AT App: app auto-monitors PA and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
|
AT App + On Your Feet + Proof Positive
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
AT App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + On Your Feet
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following feature: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions).
AT App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
|
AT App + Coach Me + Proof Positive
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following 2 features: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
AT App: This physical activity tracker app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + Coach Me
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following feature: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
AT App: This physical activity tracker app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
|
AT App + Proof Positive
Participants in this arm will use a basic activity tracker (AT) app in conjunction with the following feature: (1) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
AT App: This physical activity tracker app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App
Participants in this arm will use a basic physical activity (PA) tracker app without any additional features.
AT App: This physical activity tracker app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Smartphone App to Improve Physical Activity
Baseline characteristics by cohort
| Measure |
AT App + On Your Feet+ CoachMe+ Proof Pos
n=12 Participants
Basic physical activity tracker (AT) app in conjunction with the following 3 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (3) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + On Your Feet + Coach Me
n=13 Participants
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
|
AT App + On Your Feet + Proof Positive
n=13 Participants
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + On Your Feet
n=14 Participants
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
|
AT App + Coach Me + Proof Positive
n=14 Participants
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following 2 features: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + Coach Me
n=12 Participants
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
|
AT App + Proof Positive
n=15 Participants
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App
n=12 Participants
Participants in this arm will use a basic physical activity tracker (AT) app without any additional features.
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 5.3 • n=93 Participants
|
72.1 years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
71.6 years
STANDARD_DEVIATION 3.4 • n=27 Participants
|
72.7 years
STANDARD_DEVIATION 4.6 • n=483 Participants
|
71.5 years
STANDARD_DEVIATION 4.3 • n=36 Participants
|
72.2 years
STANDARD_DEVIATION 4.2 • n=10 Participants
|
72.4 years
STANDARD_DEVIATION 4.2 • n=115 Participants
|
74.4 years
STANDARD_DEVIATION 6.4 • n=40 Participants
|
72.2 years
STANDARD_DEVIATION 4.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
11 Participants
n=40 Participants
|
77 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
98 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
64 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
105 Participants
n=8 Participants
|
|
Education
High school or some college/trade school
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
25 Participants
n=8 Participants
|
|
Education
College graduate
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
80 Participants
n=8 Participants
|
|
Self-rated smartphone ability
|
7.6 units on a scale
STANDARD_DEVIATION 1.8 • n=93 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 2.7 • n=4 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 1.3 • n=27 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 1.4 • n=483 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 2.1 • n=36 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.5 • n=10 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 2.1 • n=115 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 2.1 • n=40 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 1.9 • n=8 Participants
|
|
Health Conditions
Arthritis
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
38 Participants
n=8 Participants
|
|
Health Conditions
Cancer
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
23 Participants
n=8 Participants
|
|
Health Conditions
Depression
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
19 Participants
n=8 Participants
|
|
Health Conditions
High blood pressure
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
43 Participants
n=8 Participants
|
|
Health Conditions
High cholesterol
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
45 Participants
n=8 Participants
|
|
Health Conditions
Diabetes
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
14 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 72-hour monitoring periods at Month 4 relative to baselinePopulation: ITT population: all randomized participants who started the intervention and who had at least one valid activity monitoring period. Participants included underactive older adults who own a smartphone. Change in physical activity patterns of these individuals was measured.
Step counts (objective physical activity) were measured using the activPAL thigh-worn accelerometer during a 72-hour monitoring period. Estimated average change is computed as the change in activPAL-tracked mean daily steps at Month 4 relative to baseline; this outcome is analyzed in a linear regression analysis model. All randomized participants who started the intervention and had valid activity monitor data were utilized in the model (ITT analysis)
Outcome measures
| Measure |
Proof Positive On
n=49 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=47 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=46 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=50 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions
|
-343.5 Average change in steps per day
Standard Deviation 2689.5
|
-324.5 Average change in steps per day
Standard Deviation 2263.1
|
-859.9 Average change in steps per day
Standard Deviation 2588.6
|
149.5 Average change in steps per day
Standard Deviation 2289.6
|
-424.8 Average change in steps per day
Standard Deviation 2101.2
|
-243.5 Average change in steps per day
Standard Deviation 2822.8
|
SECONDARY outcome
Timeframe: 72-hour monitoring periods at Month 4 relative to baselinePopulation: ITT population: all randomized participants who started the intervention and who had valid activity monitoring periods at baseline and post-test. Participants included underactive older adults who own a smartphone. Change in physical activity patterns of these individuals was measured.
Objective sedentary activity time was measured using the activPAL thigh-worn accelerometer during a 72-hour monitoring period. Expressed as average minutes/day.
Outcome measures
| Measure |
Proof Positive On
n=49 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=47 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=46 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=50 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Daily Sitting Time (activPAL) Change From Baseline to Month 4
|
-11.6 Change in minutes/day
Standard Deviation 108.1
|
11.4 Change in minutes/day
Standard Deviation 128.9
|
19.3 Change in minutes/day
Standard Deviation 123.6
|
-18.4 Change in minutes/day
Standard Deviation 112.2
|
25.7 Change in minutes/day
Standard Deviation 117.3
|
-26.3 Change in minutes/day
Standard Deviation 115.5
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change in physical activity patterns of these individuals was measured.
Self-reported physical activity will be measured via the Physical Activity Scale for the Elderly (PASE). PASE is a ten-item instrument designed to assess engagement in physical activities commonly pursued by older adults, including those related to leisure, household, and occupational tasks. The tool is a valid and reliable measure of physical activity engagement in the older adult population. Scores range from 0 to 361. Higher scores indicate a higher level of activity.
Outcome measures
| Measure |
Proof Positive On
n=50 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=48 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=47 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=51 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=50 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Self-reported Physical Activity (PASE) Change From Baseline to Month 4
|
4.0 score on a scale
Standard Deviation 41.6
|
3.2 score on a scale
Standard Deviation 59.3
|
6.2 score on a scale
Standard Deviation 44.2
|
1.2 score on a scale
Standard Deviation 56.5
|
5.6 score on a scale
Standard Deviation 54.4
|
1.7 score on a scale
Standard Deviation 47.5
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had walk test data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured. Note: very few data were available due to COVID-19 restrictions negating continuation of data collection for this variable.
Functional mobility will be assessed through a four-meter walk test, a commonly used, validated measure of physical and functional performance in older adults.
Outcome measures
| Measure |
Proof Positive On
n=5 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=8 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=5 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=8 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=4 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=9 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Gait Speed (4-m Walk Test) Change From Baseline to Month 4
|
-0.7 meters/second
Standard Deviation 0.9
|
-0.1 meters/second
Standard Deviation 1.0
|
-0.2 meters/second
Standard Deviation 1.2
|
-0.4 meters/second
Standard Deviation 0.9
|
-0.5 meters/second
Standard Deviation 1.0
|
-0.2 meters/second
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
The potential mediators of physical activity self-efficacy, self-regulation, outcome expectation, and social support will each be measured separately using subscales of the 78-item physical activity portion of the Health Beliefs Survey. Subscales demonstrate sufficient internal consistencies (Cronbach's α=0.68-0.90) and are predictive of physical activity. Higher scores indicate greater self-efficacy. Possible scores for the self-efficacy subscale range from 0-100.
Outcome measures
| Measure |
Proof Positive On
n=50 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=48 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=47 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=51 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=50 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline
|
-4.8 units on a scale
Standard Deviation 18.5
|
-2.9 units on a scale
Standard Deviation 19.8
|
-4.4 units on a scale
Standard Deviation 17.4
|
-3.4 units on a scale
Standard Deviation 20.7
|
-1.4 units on a scale
Standard Deviation 16.7
|
-6.2 units on a scale
Standard Deviation 21
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
The potential mediators of physical activity self-efficacy, self-regulation, outcome expectation, and social support will each be measured separately using subscales of the 78-item physical activity portion of the Health Beliefs Survey. Subscales demonstrate sufficient internal consistencies (Cronbach's α=0.68-0.90) and are predictive of physical activity. Higher scores indicate greater self-regulation behaviors. Possible scores for the self-regulation subscale range from 1-5.
Outcome measures
| Measure |
Proof Positive On
n=50 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=48 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=47 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=51 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=50 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
|
0.8 score on a scale
Standard Deviation 1.0
|
1.2 score on a scale
Standard Deviation 1.0
|
0.9 score on a scale
Standard Deviation 1.0
|
1.0 score on a scale
Standard Deviation 1.1
|
1.1 score on a scale
Standard Deviation 1.2
|
0.9 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
The potential mediators of physical activity self-efficacy, self-regulation, outcome expectation, and social support will each be measured separately using subscales of the 78-item physical activity portion of the Health Beliefs Survey. Subscales demonstrate sufficient internal consistencies (Cronbach's α=0.68-0.90) and are predictive of physical activity. Higher scores indicate greater family social support for physical activity. Possible scores for the family social support subscale range from 1 - 5.
Outcome measures
| Measure |
Proof Positive On
n=47 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=47 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=45 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=49 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=46 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
|
0.2 score on a scale
Standard Deviation 1.2
|
0.2 score on a scale
Standard Deviation 1.3
|
-0.0 score on a scale
Standard Deviation 1.1
|
0.4 score on a scale
Standard Deviation 1.3
|
0.2 score on a scale
Standard Deviation 1.1
|
0.2 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
The potential mediators of physical activity self-efficacy, self-regulation, outcome expectation, and social support will each be measured separately using subscales of the 78-item physical activity portion of the Health Beliefs Survey. Subscales demonstrate sufficient internal consistencies (Cronbach's α=0.68-0.90) and are predictive of physical activity. Higher scores indicate greater outcome expectations. Possible scores for the outcome expectation subscale range from 1-25
Outcome measures
| Measure |
Proof Positive On
n=47 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=47 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=46 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=48 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=46 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
|
-0.4 score on a scale
Standard Deviation 4.2
|
-0.5 score on a scale
Standard Deviation 4.8
|
-1.1 score on a scale
Standard Deviation 4.0
|
0.2 score on a scale
Standard Deviation 4.8
|
-0.1 score on a scale
Standard Deviation 3.8
|
-0.8 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
Aging self-perceptions will be assessed by the Attitudes Toward Own Aging subscale of the Philadelphia Geriatrics Center Morale Scale. This five-question tool captures the subjective aging experience, shows moderate internal consistency (Cronbach's α=0.61-0.64), and predicts mortality risk. Scores can range from 0 to 5. A higher score indicates more positive aging self-perceptions.
Outcome measures
| Measure |
Proof Positive On
n=50 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=48 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=47 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=51 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=50 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline
|
0.2 score on a scale
Standard Deviation 1.1
|
0.4 score on a scale
Standard Deviation 1.1
|
0.1 score on a scale
Standard Deviation 0.9
|
0.5 score on a scale
Standard Deviation 1.3
|
0.4 score on a scale
Standard Deviation 1.2
|
0.2 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
Views of aging will be measured using the Attitudes to Ageing Questionnaire. This 24-item assessment identifies subjective views about age-related changes in multiple domains, is cross-culturally valid, and is psychometrically sound (Cronbach's α=0.68-0.84). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score for psychosocial loss indicates more negative attitude (min 8; max 40).
Outcome measures
| Measure |
Proof Positive On
n=50 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=47 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=47 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=50 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=47 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=50 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline
|
-0.6 score on a scale
Standard Deviation 3.8
|
-0.1 score on a scale
Standard Deviation 4.8
|
-0.3 score on a scale
Standard Deviation 5.0
|
-0.3 score on a scale
Standard Deviation 3.6
|
0.3 score on a scale
Standard Deviation 4.0
|
-0.9 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
Views of aging will be measured using the Attitudes to Ageing Questionnaire. This 24-item assessment identifies subjective views about age-related changes in multiple domains, is cross-culturally valid, and is psychometrically sound (Cronbach's α=0.68-0.84). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score on physical change indicates more positive attitude (min 8; max 40)
Outcome measures
| Measure |
Proof Positive On
n=48 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=45 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=45 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=48 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=46 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=47 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline
|
0.6 score on a scale
Standard Deviation 4.2
|
0.4 score on a scale
Standard Deviation 4.1
|
0.1 score on a scale
Standard Deviation 3.2
|
0.9 score on a scale
Standard Deviation 4.9
|
0.5 score on a scale
Standard Deviation 4.6
|
0.6 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: baseline and 4 monthsPopulation: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
Views of aging will be measured using the Attitudes to Ageing Questionnaire. This 24-item assessment identifies subjective views about age-related changes in multiple domains, is cross-culturally valid, and is psychometrically sound (Cronbach's α=0.68-0.84). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score on psychological growth indicates more positive attitude (min 8; max 40).
Outcome measures
| Measure |
Proof Positive On
n=48 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=48 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=45 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=51 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline
|
0.0 score on a scale
Standard Deviation 4.0
|
-0.1 score on a scale
Standard Deviation 3.9
|
-0.0 score on a scale
Standard Deviation 3.7
|
-0.0 score on a scale
Standard Deviation 4.1
|
-0.1 score on a scale
Standard Deviation 4.1
|
0.1 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: from baseline through Month 4 (daily)Population: ITT population: all randomized participants who started the intervention and who had at least one app usage data point. Participants included underactive older adults who own a smartphone.
Usage behavior is defined as the proportion of days the app was opened across the 4-month trial period
Outcome measures
| Measure |
Proof Positive On
n=54 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=51 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=51 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=54 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=52 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=53 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
App Usage Behavior
|
0.73 proportion of days
Standard Deviation 0.28
|
0.68 proportion of days
Standard Deviation 0.29
|
0.71 proportion of days
Standard Deviation 0.29
|
0.71 proportion of days
Standard Deviation 0.28
|
0.68 proportion of days
Standard Deviation 0.30
|
0.73 proportion of days
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: ITT population: all randomized participants who had valid questionnaire data at post-test. Participants included underactive older adults who own a smartphone.
The Mobile App Rating Scale User Version (uMARS) was used to measure user satisfaction with the app, particularly participant's ratings for app quality. The uMARS includes a usability feedback subindex which is comprised of the average of item responses for 4 subsections (engagement, functionality, aesthetics, information), to yield a total quality score. Ratings are on a scale of 1 (low perceived quality, min) to 5 (high perceived quality, max).
Outcome measures
| Measure |
Proof Positive On
n=49 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
n=47 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
n=46 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
n=50 Participants
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
n=48 Participants
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Perceived App Quality (uMARS)
|
3.8 score on a scale
Standard Deviation 0.5
|
4.0 score on a scale
Standard Deviation 0.6
|
3.9 score on a scale
Standard Deviation 0.5
|
4.0 score on a scale
Standard Deviation 0.5
|
4.0 score on a scale
Standard Deviation 0.5
|
3.9 score on a scale
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to Month 4 changePopulation: ITT population: all randomized subjects who started the intervention and had both pre- and post-test values were considered for analyses. Missing values were excluded pairwise within the correlation matrix (i.e., If a data point was missing from either a hypothesized mediator (e.g., family social support for physical activity) OR from activity monitor steps data, then the subject's data point was not included in that particular correlational analysis. Data points available range n=91 to n=96.
Spearman Correlation coefficients were calculated to assess correlations between change in the primary outcome (change in daily steps) and change in hypothesized mediators (i.e., Self-efficacy for Physical Activity Change, Self-regulation of Physical Activity Change, Family Social Support for Physical Activity Change, Outcome Expectation for Physical Activity Change, Aging Self-perceptions (Attitude Toward Own Aging) Change, Views of Aging--Psychosocial Loss Change, Views of Aging--Physical Change Change, Views of Aging--Psychological Growth Change).
Outcome measures
| Measure |
Proof Positive On
n=96 Participants
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those who had the Proof Positive feature ON, regardless of what other features they may have also received, and also valid activity monitor data.
|
Proof Positive Off
All participants either received Proof Positive app feature (ON) or did not (OFF). This group represents all those whose Proof Positive feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me On
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those who had the Coach Me feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
Coach Me Off
All participants either received Coach Me app feature (ON) or did not (OFF). This group represents all those whose Coach Me feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet On
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those who had the On Your Feet feature ON, regardless of what other features they may have also received, and also had valid activity monitor data.
|
On Your Feet Off
All participants either received On Your Feet app feature (ON) or did not (OFF). This group represents all those whose On Your Feet feature was OFF, regardless of what other features they may have also received, and also had valid activity monitor data.
|
|---|---|---|---|---|---|---|
|
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Self-regulation of Physical Activity Change
|
0.8 change in daily steps
Interval -0.8 to 4.0
|
—
|
—
|
—
|
—
|
—
|
|
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Views of Aging--Psychosocial Loss Change
|
0.0 change in daily steps
Interval -22.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
|
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Self-efficacy for Physical Activity Change
|
-4.8 change in daily steps
Interval -57.8 to 50.0
|
—
|
—
|
—
|
—
|
—
|
|
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Family Social Support for Physical Activity Change
|
0.1 change in daily steps
Interval -3.3 to 3.9
|
—
|
—
|
—
|
—
|
—
|
|
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Outcome Expectation for Physical Activity Change
|
0.0 change in daily steps
Interval -12.8 to 15.4
|
—
|
—
|
—
|
—
|
—
|
|
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Aging Self-perceptions (Attitude Toward Own Aging) Change
|
0.0 change in daily steps
Interval -3.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
|
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Views of Aging--Physical Change Change
|
0.0 change in daily steps
Interval -15.0 to 13.0
|
—
|
—
|
—
|
—
|
—
|
|
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Views of Aging--Psychological Growth Change
|
0.0 change in daily steps
Interval -10.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
AT App + On Your Feet+ CoachMe+ Proof Pos
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AT App + On Your Feet + Coach Me
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AT App + On Your Feet + Proof Positive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AT App + On Your Feet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AT App + Coach Me + Proof Positive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AT App + Coach Me
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AT App + Proof Positive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AT App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AT App + On Your Feet+ CoachMe+ Proof Pos
n=12 participants at risk
Basic physical activity tracker (AT) app in conjunction with the following 3 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (3) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + On Your Feet + Coach Me
n=13 participants at risk
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
|
AT App + On Your Feet + Proof Positive
n=13 participants at risk
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + On Your Feet
n=14 participants at risk
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
|
AT App + Coach Me + Proof Positive
n=14 participants at risk
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following 2 features: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App + Coach Me
n=12 participants at risk
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
|
AT App + Proof Positive
n=15 participants at risk
Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) "Proof Positive" (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task.
|
AT App
n=12 participants at risk
Participants in this arm will use a basic physical activity tracker (AT) app without any additional features.
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Excessive weight loss
|
0.00%
0/12 • Adverse events were reported to the PI within 24 hours of their occurrence across the 4-month trial.
All potential adverse events were reported to the PI to determine reporting to the USC IRB.
|
0.00%
0/13 • Adverse events were reported to the PI within 24 hours of their occurrence across the 4-month trial.
All potential adverse events were reported to the PI to determine reporting to the USC IRB.
|
0.00%
0/13 • Adverse events were reported to the PI within 24 hours of their occurrence across the 4-month trial.
All potential adverse events were reported to the PI to determine reporting to the USC IRB.
|
0.00%
0/14 • Adverse events were reported to the PI within 24 hours of their occurrence across the 4-month trial.
All potential adverse events were reported to the PI to determine reporting to the USC IRB.
|
0.00%
0/14 • Adverse events were reported to the PI within 24 hours of their occurrence across the 4-month trial.
All potential adverse events were reported to the PI to determine reporting to the USC IRB.
|
8.3%
1/12 • Number of events 1 • Adverse events were reported to the PI within 24 hours of their occurrence across the 4-month trial.
All potential adverse events were reported to the PI to determine reporting to the USC IRB.
|
0.00%
0/15 • Adverse events were reported to the PI within 24 hours of their occurrence across the 4-month trial.
All potential adverse events were reported to the PI to determine reporting to the USC IRB.
|
0.00%
0/12 • Adverse events were reported to the PI within 24 hours of their occurrence across the 4-month trial.
All potential adverse events were reported to the PI to determine reporting to the USC IRB.
|
Additional Information
Stacey Schepens Niemiec
University of Southern California Chan Division of OS-OT
Phone: 3234422069
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place