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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01501994
Other study ID # 07-007103
Secondary ID
Status Completed
Phase N/A
First received November 29, 2011
Last updated June 5, 2014
Start date July 2009
Est. completion date November 2010

Study information

Verified date June 2014
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
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.
walking workstation
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).
Procedure:
exercise counseling
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary Activity units determined by accelerometer 26 weeks No
Secondary weight in kilograms 26 weeks No
Secondary Maximal oxygen consumption (VO2 max) Fitness as determined by an oxygen consumption treadmill test 26 weeks No
Secondary Percent body fat determined by bone density scan (DEXA) 26 weeks No
Secondary Fasting glucose 26 weeks No
Secondary Hemoglobin A1c 26 weeks No
Secondary Fasting insulin 26 weeks No
Secondary Fasting lipid profile 26 weeks No
Secondary high sensitivity c-reactive protein 26 weeks No
Secondary Well Being using National Center for Health Statistics (NCHS) Well Being Scale 26 weeks No
Secondary Depression by Center for Epidemiologic Studies Depression (CES-D) Scale 26 weeks No
Secondary Linear Analog Self Assessment Scale 26 weeks No
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