WeightNCT01501994
Personalized Approach for Promoting Physical Activity in Mayo Clinic Physicians
A study testing GRUVE accelerometer (MUVE, inc.), walking workstation and exercise counseling in people with Weight and Well Being, run by Mayo Clinic.
Trial summary
The purpose of the study is to determine if providing physicians with a walking workstation, exercise counseling, and accelerometer feedback about activity will increase physician activity. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight, Well Being
- What is being tested?
- GRUVE accelerometer (MUVE, inc.), walking workstation and exercise counseling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians working in the Department of Medicine at Mayo Clinic Rochester
- Age 25 to 70 years
- BMI > 25
- Sedentary (exercise for 30 minutes less than 3 times weekly)
Who cannot join
- Metastatic cancer
- Unable to complete a Bruce protocol exercise stress test
- Planning on retiring in the next 6 months
- Planning on more than 3 weeks of vacation during the 6 month study
- Women of child-bearing age who are pregnant or planning on becoming pregnant.
About this study
The purpose of the study is to determine if providing physicians with a walking workstation, exercise counseling, and accelerometer feedback about activity will increase physician activity.
Read the detailed description
20 physicians will be given an activity monitoring accelerometer (GRUVE from MUVE, inc.) for 2 weeks prior to starting the study (without feedback) and will continue to have their activity monitored for the duration of the study. The accelerometer (monitors movement and accurately estimates physical activity energy expenditure). The physicians will be randomized to 12 weeks with accelerometer monitoring but no feedback or counseling (control) or to 12 weeks of accelerometer monitoring (experimental) with feedback about activity levels and 20 minute weekly counseling sessions on how to increase activity (including walking while working). In the 12 week period where physicians receive feedback and counseling, they will also be provided a walking workstation. The walking workstation (assembled by the investigators) has a computer keyboard, computer monitor and telephone attached to an exercise treadmill. This allows the user to walk at 1 mile per hour while dictating, typing, responding to e-mail, etc. The treadmill can be placed in an examining room if the physician wishes to use it while dictating notes or it can be placed in a separate office.
Those physicians assigned to monitoring only for the first 12 weeks will then receive monitoring plus feedback, counseling, and walking workstation use for the next 12 weeks. Those physicians assigned to feedback, counseling, and walking workstation use for the first 12 weeks will continue to receive accelerometer feedback but will no longer receive counseling or use a walking workstation for the subsequent 12 weeks.
Ten physicians will complete the above for the first 26 weeks of the study and 10 physicians will complete the above for the last 26 weeks of the study.
The time line of the study is as follows:
12 Wks Experimental → 12 Wks Control 10 MDs (Wk 1-26) → 2 wks Monitor 12 Wks control → 12 Wks Experimental
12 Wks Experimental → 12 Wks Control 10 MDs (Wk 27-52) → 2 wks Monitor 12 Wks control → 12 Wks Experimental
In summary, physicians use an accelerometer without feedback while in the control group. In the experimental group physicians receive three interventions: accelerometer with feedback, exercise counseling, and the use of a walking workstation (treadmill desk).
- Conditions
- Weight, Well Being
- Being tested
- GRUVE accelerometer (MUVE, inc.), walking workstation, exercise counseling
- Keywords
- Activity level, Weight, Body Fat, Well Being
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRUVE accelerometer (MUVE, inc.)Other
Physicians in the experimental group will be given an accelerometer for 2 weeks (without feedback) prior to starting the study and will continue to have their activity monitored for the duration of the study. The accelerometer monitors movement and accurately estimates physical activity energy expenditure. They will receive feedback about their activity for the remainder of the trial. Physicians in the control group will wear the accelerometer but not receive feedback for the first 14 weeks of the trial. They will receive feedback for the last 12 weeks of the trial as they crossover to the experimental group.
walking workstationOther
Also called treadmill desk
The physicians in the experimental group will be provided with a walking workstation. The walking workstation has a computer keyboard, computer monitor and telephone attached to an exercise treadmill (assembled by the investigators). This allows the user to walk at 1 mile per hour while dictating, typing, responding to e-mail, etc. The treadmill can be placed in an examining room if the physician wishes to use it while dictating notes or it can be placed in a separate office. For the last 12 weeks of the study the experimental group will not use the walking workstation while the control grop will use the workstation (crossover).
exercise counselingProcedure or surgery
After the first two weeks of baseline data collection, the experimental group will receive exercise counseling for the next 12 weeks. They will be advised to make use of the accelerometer and the walking workstation as well as how to increase their activity in other ways. This group will not receive exercise counseling for the last 12 weeks of the study while the control group will cross over and receive exercise counseling for the last 12 weeks of the study (the control group will not receive exercise counseling for the first 14 weeks of the study).
| Study group | Role | What they receive |
|---|---|---|
| Walking workstation, counseling, accelerometry feedback | Experimental | 2 week baseline: accelerometer with no feedback 12 experimental: Use of the walking workstation, counseling on increasing activity levels, feedback from the accelerometer 12 week crossover: Feedback from accelerometer, no counseling or walking workstation Receives: Other: GRUVE accelerometer (MUVE, inc.); Other: walking workstation; Procedure: exercise counseling |
| Control then crossover | Other | 2 week baseline: accelerometer with no feedback 12 week control period: accelerometer with no feedback 12 week crossover period: accelerometer with feedback, counseling on increasing activity, and use of a walking workstation Receives: Other: GRUVE accelerometer (MUVE, inc.); Other: walking workstation; Procedure: exercise counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity units determined by accelerometer
Measured: 26 weeks
Secondary outcomes (11)
weight in kilograms
Measured: 26 weeks
Maximal oxygen consumption (VO2 max)
Fitness as determined by an oxygen consumption treadmill test
Measured: 26 weeks
Percent body fat determined by bone density scan (DEXA)
Measured: 26 weeks
Fasting glucose
Measured: 26 weeks
Hemoglobin A1c
Measured: 26 weeks
Fasting insulin
Measured: 26 weeks
Fasting lipid profile
Measured: 26 weeks
high sensitivity c-reactive protein
Measured: 26 weeks
Well Being using National Center for Health Statistics (NCHS) Well Being Scale
Measured: 26 weeks
Depression by Center for Epidemiologic Studies Depression (CES-D) Scale
Measured: 26 weeks
Linear Analog Self Assessment Scale
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeightStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warren G. Thompson, Mayo Clinic
- Investigators
- Warren G Thompson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501994
- Sponsor's protocol ID
- 07-007103
- Status last verified
- Jun 2014
- First submitted
- 29 Nov 2011
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Approach for Promoting Physical Activity in Mayo Clinic Physicians
- ClinicalTrials.gov ID
- NCT01501994
- Acronym / sponsor ID
- 07-007103
- Conditions
- Weight, Well Being
- Keywords
- Activity level, Weight, Body Fat, Well Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if providing physicians with a walking workstation, exercise counseling, and accelerometer feedback about activity will increase physician activity.
Detailed description
20 physicians will be given an activity monitoring accelerometer (GRUVE from MUVE, inc.) for 2 weeks prior to starting the study (without feedback) and will continue to have their activity monitored for the duration of the study. The accelerometer (monitors movement and accurately estimates physical activity energy expenditure). The physicians will be randomized to 12 weeks with accelerometer monitoring but no feedback or counseling (control) or to 12 weeks of accelerometer monitoring (experimental) with feedback about activity levels and 20 minute weekly counseling sessions on how to increase activity (including walking while working). In the 12 week period where physicians receive feedback and counseling, they will also be provided a walking workstation. The walking workstation (assembled by the investigators) has a computer keyboard, computer monitor and telephone attached to an exercise treadmill. This allows the user to walk at 1 mile per hour while dictating, typing, responding to e-mail, etc. The treadmill can be placed in an examining room if the physician wishes to use it while dictating notes or it can be placed in a separate office.
Those physicians assigned to monitoring only for the first 12 weeks will then receive monitoring plus feedback, counseling, and walking workstation use for the next 12 weeks. Those physicians assigned to feedback, counseling, and walking workstation use for the first 12 weeks will continue to receive accelerometer feedback but will no longer receive counseling or use a walking workstation for the subsequent 12 weeks.
Ten physicians will complete the above for the first 26 weeks of the study and 10 physicians will complete the above for the last 26 weeks of the study.
The time line of the study is as follows:
12 Wks Experimental → 12 Wks Control 10 MDs (Wk 1-26) → 2 wks Monitor 12 Wks control → 12 Wks Experimental
12 Wks Experimental → 12 Wks Control 10 MDs (Wk 27-52) → 2 wks Monitor 12 Wks control → 12 Wks Experimental
In summary, physicians use an accelerometer without feedback while in the control group. In the experimental group physicians receive three interventions: accelerometer with feedback, exercise counseling, and the use of a walking workstation (treadmill desk).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking workstation, counseling, accelerometry feedback | Experimental | Other: GRUVE accelerometer (MUVE, inc.), Other: walking workstation, Procedure: exercise counseling2 week baseline: accelerometer with no feedback 12 experimental: Use of the walking workstation, counseling on increasing activity levels, feedback from the accelerometer 12 week crossover: Feedback from accelerometer, no counseling or walking workstation |
| Control then crossover | Other | Other: GRUVE accelerometer (MUVE, inc.), Other: walking workstation, Procedure: exercise counseling2 week baseline: accelerometer with no feedback 12 week control period: accelerometer with no feedback 12 week crossover period: accelerometer with feedback, counseling on increasing activity, and use of a walking workstation |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physicians working in the Department of Medicine at Mayo Clinic Rochester
- Age 25 to 70 years
- BMI > 25
- Sedentary (exercise for 30 minutes less than 3 times weekly)
Key exclusion criteria (5 listed)
- Metastatic cancer
- Unable to complete a Bruce protocol exercise stress test
- Planning on retiring in the next 6 months
- Planning on more than 3 weeks of vacation during the 6 month study
- Women of child-bearing age who are pregnant or planning on becoming pregnant.
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 |
|---|---|---|
| GRUVE accelerometer (MUVE, inc.)Physicians in the experimental group will be given an accelerometer for 2 weeks (without feedback) prior to starting the study and will continue to have their activity monitored for the duration of the study. The accelerometer monitors movement and accurately estimates physical activity energy expenditure. They will receive feedback about their activity for the remainder of the trial. Physicians in the control group will wear the accelerometer but not receive feedback for the first 14 weeks of the trial. They will receive feedback for the last 12 weeks of the trial as they crossover to the experimental group. | Other | Control then crossover, Walking workstation, counseling, accelerometry feedback |
| walking workstationAlso: treadmill deskThe physicians in the experimental group will be provided with a walking workstation. The walking workstation has a computer keyboard, computer monitor and telephone attached to an exercise treadmill (assembled by the investigators). This allows the user to walk at 1 mile per hour while dictating, typing, responding to e-mail, etc. The treadmill can be placed in an examining room if the physician wishes to use it while dictating notes or it can be placed in a separate office. For the last 12 weeks of the study the experimental group will not use the walking workstation while the control grop will use the workstation (crossover). | Other | Control then crossover, Walking workstation, counseling, accelerometry feedback |
| exercise counselingAfter the first two weeks of baseline data collection, the experimental group will receive exercise counseling for the next 12 weeks. They will be advised to make use of the accelerometer and the walking workstation as well as how to increase their activity in other ways. This group will not receive exercise counseling for the last 12 weeks of the study while the control group will cross over and receive exercise counseling for the last 12 weeks of the study (the control group will not receive exercise counseling for the first 14 weeks of the study). | Procedure or surgery | Control then crossover, Walking workstation, counseling, accelerometry feedback |
Primary outcome
Activity units determined by accelerometer
Time frame: 26 weeks
11 secondary outcomes
weight in kilograms
Time frame: 26 weeks
Maximal oxygen consumption (VO2 max)
Time frame: 26 weeks
Percent body fat determined by bone density scan (DEXA)
Time frame: 26 weeks
Fasting glucose
Time frame: 26 weeks
Hemoglobin A1c
Time frame: 26 weeks
Fasting insulin
Time frame: 26 weeks
Fasting lipid profile
Time frame: 26 weeks
high sensitivity c-reactive protein
Time frame: 26 weeks
Well Being using National Center for Health Statistics (NCHS) Well Being Scale
Time frame: 26 weeks
Depression by Center for Epidemiologic Studies Depression (CES-D) Scale
Time frame: 26 weeks
Linear Analog Self Assessment Scale
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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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.
Warren G Thompson, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing GRUVE accelerometer (MUVE, inc.), walking workstation and exercise counseling in people with Weight and Well Being, run by Mayo Clinic.
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 4 inclusion and 5 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 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Activity units determined by accelerometer (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2014.