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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®.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded Fitbit | Sham Comparator | Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display. |
|
| Unblinded Fitbit | Active Comparator | 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. |
|
| No Fitbit | No Intervention | Subjects will not wear any activity monitor for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinded Fitbit | Device | Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fitbit Step Count Per Day | change in number of daily steps as measured by the fitbit monitor | Baseline through Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivana T Croghan, PhD | Mayo Cinic | Study Chair |
| Ryan T Hurt, MD, PhD | Mayo Clinic | Study Director |
| Sanjeev Nanda, MD | Mayo Clinic | Principal Investigator |
| Sara Bonnes, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31993569 | Result | Nanda S, Hurt RT, Croghan IT, Mundi MS, Gifford SL, Schroeder DR, Fischer KM, Bonnes SL. Improving Physical Activity and Body Composition in a Medical Workplace Using Brief Goal Setting. Mayo Clin Proc Innov Qual Outcomes. 2019 Oct 16;3(4):495-505. doi: 10.1016/j.mayocpiqo.2019.07.002. eCollection 2019 Dec. |
| Label | URL |
|---|---|
| pub med link to published study data | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | No Fitbit | Subjects will not wear any activity monitor for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Unblinded Fitbit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Fitbit Step Count Per Day | change in number of daily steps as measured by the fitbit monitor | Posted | Least Squares Mean | Standard Error | steps | Baseline through Week 16 |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization due to unprovoked pulmonary embolism |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| musculoskeletal pain/trauma | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjeev Nanda, MD | Mayo Clinic | 507-284-2511 | nanda.sanjeev@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2019 | Apr 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Unblinded Fitbit | Device | Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals. |
|
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. |
| BG002 | No Fitbit | Subjects will not wear any activity monitor for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 6 |
| 44 |
| EG001 | 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. | 0 | 46 | 0 | 46 | 4 | 46 |
| EG002 | No Fitbit | Subjects will not wear any activity monitor for 12 weeks. | 0 | 45 | 1 | 45 | 3 | 45 |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| dental implant/root canal | Surgical and medical procedures | Non-systematic Assessment |
|
| basal cell carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| foot nerve pain | Nervous system disorders | Non-systematic Assessment |
|
| hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
|
| ear/sinus infection | Infections and infestations | Non-systematic Assessment |
|
| GI pain | Gastrointestinal disorders | Non-systematic Assessment |
|
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