Motor ActivityFitPhysicianNCT02778009
Fit Physicians: Use of Activity Monitors and Activity Integration Program in First Year Medical Students
A study testing iDEXA Scan, Wellness Lectures and Exercise intervention in people with Motor Activity and Body Weight Changes, run by New York Institute of Technology at 1 site in United States.
Trial summary
Using FitBit activity monitors, physical activity levels will be monitored in first year medical students. Body Composition will be measured as well. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Body Weight Changes
- What is being tested?
- iDEXA Scan, Wellness Lectures and Exercise intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2016to 3 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- First year medical students
- Must have smartphone
Who cannot join
- Medical conditions that prohibit exercise
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fit Physicians: A Novel Physical Activity Integration Program to Improve Fitness and Activity in Medical Students: A Randomized Pilot Study
Using FitBit activity monitors, physical activity levels will be monitored in first year medical students. Body Composition will be measured as well.
Read the 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.
- Conditions
- Motor Activity, Body Weight Changes
- Being tested
- iDEXA Scan, Wellness Lectures, Exercise intervention, Activity monitor
- Keywords
- Medical student, Activity Monitor, Medical school, Fitness
- Medical subject headings
- Motor Activity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDEXA ScanRadiation
Subjects will receive pre study and post study scans to assess body mass composition
Wellness LecturesOther
Subjects in the Fit Physician Arm will be required to attend monthly wellness lectures
Exercise interventionOther
Subjects in the Fit Physician Arm will be required to attend weekly exercise interventions
Activity monitorOther
Subjects in the Fit physician arm and the activity monitor arm will receive activity monitors to assess their activity level throughout the academic year
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: iDEXA Scan; Other: Wellness Lectures; Other: Exercise intervention; Other: 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
) Receives: Radiation: iDEXA Scan; Other: 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 Receives: Radiation: iDEXA Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps per day measured daily by FitBit Flex
Measured: 10 months
Secondary outcomes (2)
Body Mass Composition assessed by iDEXA scan
Measured: 10 months
Academic Performance assessed by numeric grade point average
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start7 Jul 2016
- Primary completion3 Jun 2017
- Study completion3 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne DiFrancisco-Donoghue, New York Institute of Technology
- Investigators
- Brian Harper, MD, Study chair, NYIT College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778009
- Sponsor's protocol ID
- BHS-1153
- Acronym
- FitPhysician
- Status last verified
- Jul 2017
- First submitted
- 8 Apr 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will not be shared with individual participants
Publications
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.
PubMed 30234000
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit Physicians: A Novel Physical Activity Integration Program to Improve Fitness and Activity in Medical Students: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02778009
- Acronym / sponsor ID
- FitPhysician / BHS-1153
- Conditions
- Motor Activity, Body Weight Changes
- Keywords
- Medical student, Activity Monitor, Medical school, Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 3 Jun 2017 (actual)
- Study completion
- 3 Jun 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using FitBit activity monitors, physical activity levels will be monitored in first year medical students. Body Composition will be measured as well.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fit Physician Group | Experimental | Radiation: iDEXA Scan, Other: Wellness Lectures, Other: Exercise intervention, Other: Activity monitorSubjects 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 |
| Activity Monitor Only Group | Active comparator | Radiation: iDEXA Scan, Other: Activity monitorSubjects will receive an activity monitor without any intervention Every subject will undergo an iDEXA scan to measure body mass composition ) |
| Control Group | Other | Radiation: iDEXA ScanSubjects will not an activity monitor nor will they receive any intervention Every subject will undergo an iDEXA scan to measure body mass composition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- First year medical students
- Must have smartphone
Key exclusion criteria (2 listed)
- Medical conditions that prohibit exercise
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iDEXA ScanSubjects will receive pre study and post study scans to assess body mass composition | Radiation | Activity Monitor Only Group, Control Group, Fit Physician Group |
| Wellness LecturesSubjects in the Fit Physician Arm will be required to attend monthly wellness lectures | Other | Fit Physician Group |
| Exercise interventionSubjects in the Fit Physician Arm will be required to attend weekly exercise interventions | Other | Fit Physician Group |
| Activity monitorSubjects in the Fit physician arm and the activity monitor arm will receive activity monitors to assess their activity level throughout the academic year | Other | Activity Monitor Only Group, Fit Physician Group |
Primary outcome
Steps per day measured daily by FitBit Flex
Time frame: 10 months
2 secondary outcomes
Body Mass Composition assessed by iDEXA scan
Time frame: 10 months
Academic Performance assessed by numeric grade point average
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Derived from this study: PubMed 30234000DiFrancisco-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.
- Individual participant dataSharing planned: No. Data will not be shared with individual participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Harper, MD study chair
NYIT College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iDEXA Scan, Wellness Lectures and Exercise intervention in people with Motor Activity and Body Weight Changes, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps per day measured daily by FitBit Flex (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017; AzTrials last refreshed its copy on 29 Oct 2026.