Trial Outcomes & Findings for Physical Activity in the Medical Workplace (NCT NCT02794727)
NCT ID: NCT02794727
Last Updated: 2020-04-29
Results Overview
change in number of daily steps as measured by the fitbit monitor
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
135 participants
Primary outcome timeframe
Baseline through Week 16
Results posted on
2020-04-29
Participant Flow
Participant milestones
| Measure |
Blinded Fitbit
Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.
Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
|
Unblinded Fitbit
Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.
Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
|
No Fitbit
Subjects will not wear any activity monitor for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
45
|
|
Overall Study
COMPLETED
|
44
|
46
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Activity in the Medical Workplace
Baseline characteristics by cohort
| Measure |
Blinded Fitbit
n=44 Participants
Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.
Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
|
Unblinded Fitbit
n=46 Participants
Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.
Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
|
No Fitbit
n=45 Participants
Subjects will not wear any activity monitor for 12 weeks.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
135 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
40.4 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
45.5 years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
42.6 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
114 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
white, non-hispanic
|
38 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
123 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
other
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 16change in number of daily steps as measured by the fitbit monitor
Outcome measures
| Measure |
Blinded Fitbit
n=44 Participants
Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.
Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
|
Unblinded Fitbit
n=46 Participants
Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.
Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
|
|---|---|---|
|
Change in Fitbit Step Count Per Day
|
-323.5 steps
Standard Error 90.5
|
321.2 steps
Standard Error 88.4
|
Adverse Events
Unblinded Fitbit
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
No Fitbit
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Blinded Fitbit
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Unblinded Fitbit
n=46 participants at risk
Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.
Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
|
No Fitbit
n=45 participants at risk
Subjects will not wear any activity monitor for 12 weeks.
|
Blinded Fitbit
n=44 participants at risk
Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.
Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/46 • 16 weeks
|
2.2%
1/45 • Number of events 1 • 16 weeks
|
0.00%
0/44 • 16 weeks
|
Other adverse events
| Measure |
Unblinded Fitbit
n=46 participants at risk
Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.
Unblinded Fitbit: Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
|
No Fitbit
n=45 participants at risk
Subjects will not wear any activity monitor for 12 weeks.
|
Blinded Fitbit
n=44 participants at risk
Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.
Blinded Fitbit: Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain/trauma
|
0.00%
0/46 • 16 weeks
|
2.2%
1/45 • Number of events 1 • 16 weeks
|
6.8%
3/44 • Number of events 3 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
2.2%
1/46 • Number of events 1 • 16 weeks
|
0.00%
0/45 • 16 weeks
|
0.00%
0/44 • 16 weeks
|
|
Surgical and medical procedures
dental implant/root canal
|
2.2%
1/46 • Number of events 1 • 16 weeks
|
2.2%
1/45 • Number of events 1 • 16 weeks
|
0.00%
0/44 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
basal cell carcinoma
|
0.00%
0/46 • 16 weeks
|
0.00%
0/45 • 16 weeks
|
2.3%
1/44 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
foot nerve pain
|
0.00%
0/46 • 16 weeks
|
0.00%
0/45 • 16 weeks
|
2.3%
1/44 • Number of events 1 • 16 weeks
|
|
Endocrine disorders
hyperthyroidism
|
0.00%
0/46 • 16 weeks
|
0.00%
0/45 • 16 weeks
|
2.3%
1/44 • Number of events 1 • 16 weeks
|
|
Infections and infestations
ear/sinus infection
|
4.3%
2/46 • Number of events 2 • 16 weeks
|
2.2%
1/45 • Number of events 1 • 16 weeks
|
0.00%
0/44 • 16 weeks
|
|
Gastrointestinal disorders
GI pain
|
0.00%
0/46 • 16 weeks
|
0.00%
0/45 • 16 weeks
|
2.3%
1/44 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place