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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02778009
Other study ID # BHS-1153
Secondary ID
Status Completed
Phase N/A
First received April 8, 2016
Last updated August 16, 2017
Start date July 7, 2016
Est. completion date June 3, 2017

Study information

Verified date July 2017
Source New York Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Using fitness trackers and exercise testing, it will determine if participating in a novel program that incorporates wellness into the academic term will improve fitness.

An estimate, 120 students will enroll in this study. Men and women aged 18-55 years of age that are just entering medical school. Students who are currently pregnant will not be allowed to participate in this study.

Participation will involve 2 visits at the start of the academic school year, and two visits at the end of the academic school year.

These visits will entail you undergoing a body composition scan measured by an duel energy x-ray absorptiometry (iDEXA) machine. The scan takes approximately 15 minutes. Subjects may be asked to perform an exercise stress test on a treadmill. The exercise test is approximately 40 minutes. Subjects may be asked to participate in a fitness program 2x a week, and may be asked to wear a Fitbit Flex™ activity tracker on the wrist for the duration of the school year. Investigators will be accessing academic grades to use for statistical purposes only. Subject names will never be given to any other party other than the investigators involved.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date June 3, 2017
Est. primary completion date June 3, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- First year medical students

- Must have smartphone

Exclusion Criteria:

- Medical conditions that prohibit exercise

- pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
iDEXA Scan
Subjects will receive pre study and post study scans to assess body mass composition
Other:
Wellness Lectures
Subjects in the Fit Physician Arm will be required to attend monthly wellness lectures
Exercise intervention
Subjects in the Fit Physician Arm will be required to attend weekly exercise interventions
Activity monitor
Subjects in the Fit physician arm and the activity monitor arm will receive activity monitors to assess their activity level throughout the academic year

Locations

Country Name City State
United States NYIT Old Westbury New York

Sponsors (1)

Lead Sponsor Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Steps per day measured daily by FitBit Flex 10 months
Secondary Body Mass Composition assessed by iDEXA scan 10 months
Secondary Academic Performance assessed by numeric grade point average 10 months
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