- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01501994
Personalized Approach for Promoting Physical Activity in Mayo Clinic Physicians
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Walking workstation, counseling, accelerometry feedback
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
|
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.
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).
Andre navne:
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).
|
Andet: Control then crossover
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
|
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.
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).
Andre navne:
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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Activity units determined by accelerometer
Tidsramme: 26 weeks
|
26 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
weight in kilograms
Tidsramme: 26 weeks
|
26 weeks
|
|
Maximal oxygen consumption (VO2 max)
Tidsramme: 26 weeks
|
Fitness as determined by an oxygen consumption treadmill test
|
26 weeks
|
Percent body fat determined by bone density scan (DEXA)
Tidsramme: 26 weeks
|
26 weeks
|
|
Fasting glucose
Tidsramme: 26 weeks
|
26 weeks
|
|
Hemoglobin A1c
Tidsramme: 26 weeks
|
26 weeks
|
|
Fasting insulin
Tidsramme: 26 weeks
|
26 weeks
|
|
Fasting lipid profile
Tidsramme: 26 weeks
|
26 weeks
|
|
high sensitivity c-reactive protein
Tidsramme: 26 weeks
|
26 weeks
|
|
Well Being using National Center for Health Statistics (NCHS) Well Being Scale
Tidsramme: 26 weeks
|
26 weeks
|
|
Depression by Center for Epidemiologic Studies Depression (CES-D) Scale
Tidsramme: 26 weeks
|
26 weeks
|
|
Linear Analog Self Assessment Scale
Tidsramme: 26 weeks
|
26 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Warren G Thompson, MD, Mayo Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 07-007103
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