Trial Outcomes & Findings for Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents (NCT NCT01287208)

Results Overview

Steps will be recorded on the activity device

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-12-07

Participant Flow

Medical residents were recruited during ambulatory care blocks from July 2010 through November 2010.

Subjects were randomized at the end of December 2010. Four residents withdrew prior to randomization (1 changed mind, 2 said they did not have time, 1 did not complete baseline assessment).

Participant milestones

Participant milestones
Measure	Unblinded Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.	Blinded 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.
Phase 1: Randomized Phase STARTED	52	52
Phase 1: Randomized Phase COMPLETED	50	49
Phase 1: Randomized Phase NOT COMPLETED	2	3
Phase 2: Team Competition STARTED	50	49
Phase 2: Team Competition COMPLETED	50	49
Phase 2: Team Competition NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unblinded n=52 Participants Activity monitor with visible and on-line feedback	Blinded n=52 Participants Activity monitor with no feedback	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 0.3 • n=5 Participants	29 years STANDARD_DEVIATION 0.4 • n=7 Participants	29 years STANDARD_DEVIATION 0.2 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	52 participants n=7 Participants	104 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: We excluded 4 participants who withdrew prior to randomization and 5 who withdrew after randomization.

Steps will be recorded on the activity device

Outcome measures

Outcome measures
Measure	Unblinded n=50 Participants Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.	Blinded n=49 Participants 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.
Steps Per Day	6369 steps per day Interval 1999.0 to 8796.0	6063 steps per day Interval 1299.0 to 8723.0

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome was not collected because of logistical issues with obtaining this data without using an API.

Distance in miles recorded on activity device.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome was not collected because of logistical issues with obtaining this data without using an API.

Total calories burned per day recorded on activity device. This secondary outcome was not measured in the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Unblinded n=50 Participants Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.	Blinded n=49 Participants 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.
Weight	155 Pounds Standard Deviation 28.5	155 Pounds Standard Deviation 26.3

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome was not collected because of logistical issues with obtaining this data without using an API.

Number of hours slept per night as recorded on activity device. This secondary outcome was not measured in the trial.

Outcome measures

Outcome data not reported

Adverse Events

Unblinded

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blinded

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne Thorndike, MD, MPH

Massachusetts General Hospital

Phone: 617-724-4608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place