Physical ActivityOPANCT02794727
Physical Activity in the Medical Workplace
A study testing Blinded Fitbit and Unblinded Fitbit in people with Physical Activity, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Blinded Fitbit and Unblinded Fitbit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Physical Activity in the Medical Workplace- a Way to Improve Physical and Mental Well-being?
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®.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Blinded Fitbit, Unblinded Fitbit
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded FitbitDevice
Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
Unblinded FitbitDevice
Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
| Study group | Role | What they receive |
|---|---|---|
| Blinded Fitbit | Sham comparator | Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display. Receives: Device: Blinded Fitbit |
| 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. Receives: Device: Unblinded Fitbit |
| No Fitbit | No intervention | Subjects will not wear any activity monitor for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fitbit Step Count Per Day
change in number of daily steps as measured by the fitbit monitor
Measured: Baseline through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivana Croghan, Mayo Clinic
- Investigators
- Ivana T Croghan, PhD, Study chair, Mayo CinicRyan T Hurt, MD, PhD, Study director, Mayo ClinicSanjeev Nanda, MD, Principal investigator, Mayo ClinicSara Bonnes, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794727
- Sponsor's protocol ID
- 15-003049
- Acronym
- OPA
- Status last verified
- Apr 2020
- First submitted
- 2 Jun 2016
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31993569
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in the Medical Workplace- a Way to Improve Physical and Mental Well-being?
- ClinicalTrials.gov ID
- NCT02794727
- Acronym / sponsor ID
- OPA / 15-003049
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blinded Fitbit | Sham comparator | Device: Blinded FitbitSubjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display. |
| Unblinded Fitbit | Active comparator | Device: Unblinded FitbitSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinded FitbitSubjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks. | Device | Blinded Fitbit |
| Unblinded FitbitSubjects will be unblinded to the Fitbit display for 12 weeks with set activity goals. | Device | Unblinded Fitbit |
Primary outcome
Change in Fitbit Step Count Per Day
Time frame: Baseline through Week 16
change in number of daily steps as measured by the fitbit monitor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31993569Nanda 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.
- pub med link to published study dataLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana T Croghan, PhD study chair
Mayo Cinic
Ryan T Hurt, MD, PhD study director
Mayo Clinic
Sanjeev Nanda, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinded Fitbit and Unblinded Fitbit in people with Physical Activity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fitbit Step Count Per Day (time frame: Baseline through Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.