NCT02778009

Brief Summary

Using FitBit activity monitors, physical activity levels will be monitored in first year medical students. Body Composition will be measured as well.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

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

First Submitted

Initial submission to the registry

April 8, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2017

Completed
Last Updated

August 21, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

April 8, 2016

Last Update Submit

August 16, 2017

Conditions

Keywords

Medical studentActivity MonitorMedical schoolFitness

Outcome Measures

Primary Outcomes (1)

  • Steps per day measured daily by FitBit Flex

    10 months

Secondary Outcomes (2)

  • Body Mass Composition assessed by iDEXA scan

    10 months

  • Academic Performance assessed by numeric grade point average

    10 months

Study Arms (3)

Fit Physician Group

EXPERIMENTAL

Subjects will receive activity monitor and will be required to attend monthly wellness lectures and weekly exercise intervention. Every subject will undergo an iDEXA scan to measure body mass composition

Radiation: iDEXA ScanOther: Wellness LecturesOther: Exercise interventionOther: Activity monitor

Activity Monitor Only Group

ACTIVE COMPARATOR

Subjects will receive an activity monitor without any intervention Every subject will undergo an iDEXA scan to measure body mass composition )

Radiation: iDEXA ScanOther: Activity monitor

Control Group

OTHER

Subjects will not an activity monitor nor will they receive any intervention Every subject will undergo an iDEXA scan to measure body mass composition

Radiation: iDEXA Scan

Interventions

iDEXA ScanRADIATION

Subjects will receive pre study and post study scans to assess body mass composition

Activity Monitor Only GroupControl GroupFit Physician Group

Subjects in the Fit Physician Arm will be required to attend monthly wellness lectures

Fit Physician Group

Subjects in the Fit Physician Arm will be required to attend weekly exercise interventions

Fit Physician Group

Subjects in the Fit physician arm and the activity monitor arm will receive activity monitors to assess their activity level throughout the academic year

Activity Monitor Only GroupFit Physician Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • First year medical students
  • Must have smartphone

You may not qualify if:

  • Medical conditions that prohibit exercise
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYIT

Old Westbury, New York, 11568568, United States

Location

Related Publications (1)

  • DiFrancisco-Donoghue J, Jung MK, Stangle A, Werner WG, Zwibel H, Happel P, Balentine J. Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. Prev Med Rep. 2018 Sep 11;12:122-127. doi: 10.1016/j.pmedr.2018.09.004. eCollection 2018 Dec.

MeSH Terms

Conditions

Motor ActivityBody Weight Changes

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

BehaviorBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Brian Harper, MD

    NYIT College of Osteopathic Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Ph. D.

Study Record Dates

First Submitted

April 8, 2016

First Posted

May 19, 2016

Study Start

July 7, 2016

Primary Completion

June 3, 2017

Study Completion

June 3, 2017

Last Updated

August 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Data will not be shared with individual participants

Locations