Physical ActivityNCT01287208
Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
A study testing Activity monitor and Activity device in people with Physical Activity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main objective of this study is to test an intervention to increase the physical activity of medical residents, an employee population with little time for exercise. Specifically, the aims of this study are: 1. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Activity monitor and Activity device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2011
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Massachusetts General Hospital medicine resident
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The main objective of this study is to test an intervention to increase the physical activity of medical residents, an employee population with little time for exercise. Specifically, the aims of this study are:
- To determine if providing medical residents with an activity device that measures steps, distance, and calories burned and tracks this information over time on a website increases residents' physical activity levels as measured by number of steps per day compared to a control group using a blinded activity device (no feedback).
- To determine if an unblinded team competition using the activity device directly following the randomized phase increases residents' activity level compared to baseline.
- To determine if activity level is associated with change in weight during the residency year.
- To determine if the average hours of sleep per week is associated with changes in weight and with activity level.
- Conditions
- Physical Activity
- Being tested
- Activity monitor, Activity device
- Keywords
- Physical activity, Accelerometer, Steps, Medical residents
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity monitorDevice
Also called Fitbit
The activity monitor is an accelerometer that records steps, distance, calories, and sleep
Activity deviceDevice
Also called Fitbit
Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject
| Study group | Role | What they receive |
|---|---|---|
| Unblinded activity monitor | Active comparator | Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded. Receives: Device: Activity monitor |
| Blinded activity monitor | Placebo comparator | Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded. Receives: Device: Activity device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps Per Day
Steps will be recorded on the activity device
Measured: 12 weeks
Secondary outcomes (4)
Distance Per Day
Distance in miles recorded on activity device.
Measured: 12 weeks
Calories Burned Per Day
Total calories burned per day recorded on activity device. This secondary outcome was not measured in the trial.
Measured: 12 weeks
Weight
Measured: 6 months
Hours of Sleep Per Night
Number of hours slept per night as recorded on activity device.
This secondary outcome was not measured in the trial.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
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 Massachusetts General HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
- Investigators
- Anne N Thorndike, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287208
- Sponsor's protocol ID
- 2010-P-001271
- Other IDs
- 1K23HL093221
- Status last verified
- Dec 2017
- First submitted
- 28 Jan 2011
- Last updated
- 7 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Thorndike AN, Mills S, Sonnenberg L, Palakshappa D, Gao T, Pau CT, Regan S. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial. PLoS One. 2014 Jun 20;9(6):e100251. doi: 10.1371/journal.pone.0100251. eCollection 2014.
PubMed 24950218
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
- ClinicalTrials.gov ID
- NCT01287208
- Acronym / sponsor ID
- 2010-P-001271
- Conditions
- Physical Activity
- Keywords
- Physical activity, Accelerometer, Steps, Medical residents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2010 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Posted 29 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to test an intervention to increase the physical activity of medical residents, an employee population with little time for exercise. Specifically, the aims of this study are:
- To determine if providing medical residents with an activity device that measures steps, distance, and calories burned and tracks this information over time on a website increases residents' physical activity levels as measured by number of steps per day compared to a control group using a blinded activity device (no feedback).
- To determine if an unblinded team competition using the activity device directly following the randomized phase increases residents' activity level compared to baseline.
- To determine if activity level is associated with change in weight during the residency year.
- To determine if the average hours of sleep per week is associated with changes in weight and with activity level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unblinded activity monitor | Active comparator | Device: Activity monitorSubjects wear the activity device and can see the data on the device and on a website where the data is uploaded. |
| Blinded activity monitor | Placebo comparator | Device: Activity deviceSubjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Massachusetts General Hospital medicine resident
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Activity monitorAlso: FitbitThe activity monitor is an accelerometer that records steps, distance, calories, and sleep | Device | Unblinded activity monitor |
| Activity deviceAlso: FitbitAccelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject | Device | Blinded activity monitor |
Primary outcome
Steps Per Day
Time frame: 12 weeks
Steps will be recorded on the activity device
4 secondary outcomes
Distance Per Day
Time frame: 12 weeks
Calories Burned Per Day
Time frame: 12 weeks
Weight
Time frame: 6 months
Hours of Sleep Per Night
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24950218Thorndike AN, Mills S, Sonnenberg L, Palakshappa D, Gao T, Pau CT, Regan S. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial. PLoS One. 2014 Jun 20;9(6):e100251. doi: 10.1371/journal.pone.0100251. eCollection 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.
Anne N Thorndike, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity monitor and Activity device in people with Physical Activity, run by Massachusetts General Hospital 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 1 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 7 Dec 2017. 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 Nov 2012). 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?
Steps Per Day (time frame: 12 weeks). 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 NCT01287208, 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 7 Dec 2017.