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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01287208
Enrollment
104
Registered
2011-02-01
Start date
2010-10-31
Completion date
2011-06-30
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

Physical activity, Accelerometer, Steps, Medical residents

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

Interventions

DEVICEActivity monitor

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

DEVICEActivity device

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Massachusetts General Hospital medicine resident

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Steps Per Day12 weeksSteps will be recorded on the activity device

Secondary

MeasureTime frameDescription
Distance Per Day12 weeksDistance in miles recorded on activity device.
Calories Burned Per Day12 weeksTotal calories burned per day recorded on activity device. This secondary outcome was not measured in the trial.
Weight6 months
Hours of Sleep Per Night12 weeksNumber of hours slept per night as recorded on activity device. This secondary outcome was not measured in the trial.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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).

Participants by arm

ArmCount
Unblinded
Activity monitor with visible and on-line feedback
52
Blinded
Activity monitor with no feedback
52
Total104

Baseline characteristics

CharacteristicBlindedUnblindedTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
52 Participants52 Participants104 Participants
Age, Continuous29 years
STANDARD_DEVIATION 0.4
29 years
STANDARD_DEVIATION 0.3
29 years
STANDARD_DEVIATION 0.2
Region of Enrollment
United States
52 participants52 participants104 participants
Sex: Female, Male
Female
29 Participants27 Participants56 Participants
Sex: Female, Male
Male
23 Participants25 Participants48 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 520 / 52
serious
Total, serious adverse events
0 / 520 / 52

Outcome results

Primary

Steps Per Day

Steps will be recorded on the activity device

Time frame: 12 weeks

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

ArmMeasureValue (MEDIAN)
UnblindedSteps Per Day6369 steps per day
BlindedSteps Per Day6063 steps per day
p-value: 0.16Wilcoxon (Mann-Whitney)
Secondary

Calories Burned Per Day

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

Time frame: 12 weeks

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

Secondary

Distance Per Day

Distance in miles recorded on activity device.

Time frame: 12 weeks

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

Secondary

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.

Time frame: 12 weeks

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

Secondary

Weight

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
UnblindedWeight155 PoundsStandard Deviation 28.5
BlindedWeight155 PoundsStandard Deviation 26.3
p-value: 0.59t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026