Physical Activity
Conditions
Brief summary
Decreased physical activity is not only associated with multiple chronic medical conditions, including obesity, but also with depressed mood, and other negative emotions. As many employed adults spend a great deal of time at work where we are predominantly sedentary, strategies to increase physical activity at work are being pursued to help improve the physical and mental health of Americans. This 17 week randomized controlled trial will investigate changes of occupational physical activity in three groups: those provided with a FitBit® but not able to monitor their activity level, and those provided with activity goals and individual physical activity challenges, and those who do not use a FitBit®.
Detailed description
All subjects will be entered into a 4 week run-in phase where subjects will wear a blinded Fitbit during work hours. The baseline work activity is collected at this time. This phase is followed by a randomization to one of 3 groups: the blinded Fitbit group, the unblinded Fitbit group, and the group which will not wear any activity monitors. During these 12 weeks we will collect data on activity levels during work hours. Everyone will have a final contact at week 17 to close out the study.
Interventions
DEVICEBlinded Fitbit
Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
DEVICEUnblinded Fitbit
Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Be between 18 - 65 years of age * Be a Mayo Clinic employee at 0.75 FTE or more * Have no previous use of any activity monitor for 14 consecutive days or more * Not be pregnant by subject self report * Have a stable weight - defined as self-reported weight that has not changed more than 10% in the past 3 months * Not have any previous history of joint problems that limit free movement, as determined by the PI * Be able to participate fully in all aspects of the study * Have understood and signed study informed consent.
Exclusion criteria
* Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence or skew data collection - such as a position where they predominantly provide transport as part of their job.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fitbit Step Count Per Day | Baseline through Week 16 | change in number of daily steps as measured by the fitbit monitor |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 46 |
| No Fitbit Subjects will not wear any activity monitor for 12 weeks. | 45 |
| Total | 135 |
Baseline characteristics
| Characteristic | Blinded Fitbit | Unblinded Fitbit | No Fitbit | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 46 Participants | 45 Participants | 135 Participants |
| Age, Continuous | 41.8 years STANDARD_DEVIATION 10.3 | 40.4 years STANDARD_DEVIATION 9.7 | 45.5 years STANDARD_DEVIATION 9.8 | 42.6 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized other | 6 Participants | 4 Participants | 2 Participants | 12 Participants |
| Race/Ethnicity, Customized white, non-hispanic | 38 Participants | 42 Participants | 43 Participants | 123 Participants |
| Sex: Female, Male Female | 37 Participants | 38 Participants | 39 Participants | 114 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 6 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 46 | 0 / 45 |
| other Total, other adverse events | 6 / 44 | 4 / 46 | 3 / 45 |
| serious Total, serious adverse events | 0 / 44 | 0 / 46 | 1 / 45 |
Outcome results
Primary
Change in Fitbit Step Count Per Day
change in number of daily steps as measured by the fitbit monitor
Time frame: Baseline through Week 16
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Blinded Fitbit | Change in Fitbit Step Count Per Day | -323.5 steps | Standard Error 90.5 |
| Unblinded Fitbit | Change in Fitbit Step Count Per Day | 321.2 steps | Standard Error 88.4 |