NCT01287208

Brief 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. 1.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).
  2. 2.To determine if an unblinded team competition using the activity device directly following the randomized phase increases residents' activity level compared to baseline.
  3. 3.To determine if activity level is associated with change in weight during the residency year.
  4. 4.To determine if the average hours of sleep per week is associated with changes in weight and with activity level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 29, 2012

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

January 28, 2011

Results QC Date

October 31, 2012

Last Update Submit

December 4, 2017

Conditions

Physical Activity

Keywords

Physical activityAccelerometerStepsMedical residents

Outcome Measures

Primary Outcomes (1)

  • Steps Per Day

    Steps will be recorded on the activity device

    12 weeks

Secondary Outcomes (4)

  • Distance Per Day

    12 weeks

  • Calories Burned Per Day

    12 weeks

  • Weight

    6 months

  • Hours of Sleep Per Night

    12 weeks

Study Arms (2)

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.

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.

Device: Activity device

Interventions

Activity monitorDEVICE

The activity monitor is an accelerometer that records steps, distance, calories, and sleep

Also known as: Fitbit
Unblinded activity monitor
Activity deviceDEVICE

Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject

Also known as: Fitbit
Blinded activity monitor

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Massachusetts General Hospital medicine resident

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 24950218DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Limitations and Caveats

Wearing the device may have increased steps in both groups and decreased ability to see a difference. Unable to collect some secondary outcomes due to logistical issues with obtaining this data without an applications program interface (API).

Results Point of Contact

Title
Anne Thorndike, MD, MPH
Organization
Massachusetts General Hospital
athorndike@partners.org
617-724-4608

Study Officials

  • Anne N Thorndike, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 28, 2011

First Posted

February 1, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 7, 2017

Results First Posted

November 29, 2012

Record last verified: 2017-12

Locations

US(1)