- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02778009
Fit Physicians: Use of Activity Monitors and Activity Integration Program in First Year Medical Students (FitPhysician)
Fit Physicians: A Novel Physical Activity Integration Program to Improve Fitness and Activity in Medical Students: A Randomized Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Old Westbury, New York, United States, 11568568
- NYIT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- First year medical students
- Must have smartphone
Exclusion Criteria:
- Medical conditions that prohibit exercise
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fit Physician Group
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 |
Subjects will receive pre study and post study scans to assess body mass composition
Subjects in the Fit Physician Arm will be required to attend monthly wellness lectures
Subjects in the Fit Physician Arm will be required to attend weekly exercise interventions
Subjects in the Fit physician arm and the activity monitor arm will receive activity monitors to assess their activity level throughout the academic year
|
|
Active Comparator: Activity Monitor Only Group
Subjects will receive an activity monitor without any intervention Every subject will undergo an iDEXA scan to measure body mass composition ) |
Subjects will receive pre study and post study scans to assess body mass composition
Subjects in the Fit physician arm and the activity monitor arm will receive activity monitors to assess their activity level throughout the academic year
|
|
Other: Control Group
Subjects will not an activity monitor nor will they receive any intervention Every subject will undergo an iDEXA scan to measure body mass composition
|
Subjects will receive pre study and post study scans to assess body mass composition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Steps per day measured daily by FitBit Flex
Time Frame: 10 months
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body Mass Composition assessed by iDEXA scan
Time Frame: 10 months
|
10 months
|
|
Academic Performance assessed by numeric grade point average
Time Frame: 10 months
|
10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Brian Harper, MD, NYIT College of Osteopathic Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHS-1153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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