ClinicalTrials.gg
CompletedNCT03389737Updated May 7, 2018

The Effects of the Novel "Step Up Your Game" Program on Men's Lacrosse

An interventional study of Counseling and Counseling in Body Weight Changes, sponsored by New York Institute of Technology. Completed at 1 site in United States. Open to male participants aged 18 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-07.

Sponsored by New York Institute of Technology · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 22 Years
Sex
Male
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Study summary

For the purpose of this pilot study, the investigators hypothesize that the use of the Step Up Your Game protocol will result in statistically significant improvements in health and athletic performance. The key to this is the coordination of resources from a supervising physician, physical therapist, trainer, dietitian, coach, competitor, role model, psychologist, and spiritual leader. Notably, Step Up Your Game provides resources which would allow patients to find or be their own physical therapist, trainer, dietitian, coach, competitor, role model, psychologist, and spiritual leader. The role of the supervising physician, however, is meant for a qualified professional, who follows the osteopathic approach to medicine, in which the body is treated as an integrated whole, while also working to prevent and treat injuries. Though not limited solely to osteopathic physicians, it is critical to take into account every health aim and injury in the context of the athlete and how these affect all aspects of participants lives.

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Conditions studied

  • Body Weight Changes

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03

In context

Body Weight Changes

231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.

This study's enrollment of 25 is below the median of 80 across 179 interventional studies indexed under Body Weight Changes.

Browse Body Weight Changes studies →

Lead sponsor

New York Institute of Technology is the lead sponsor of 59 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 22 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals capable of giving consent between ages of 18 and 22.
  • Must be members of the NYIT lacrosse team.

Exclusion criteria

Exclusion Criteria:

  • Individuals who are not able to participate throughout the season whether it's due to a medical problem or academic probation.
  • Individuals who are receiving sports related medical care other than that from the physician in study.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Experimental

    Experimental group will have monthly contact with the physicians, during which the athletes will receive individualized care and guidance in support of their performance goals.

    Behavioral: Counseling

  • Active comparator
    Control

    Control group will not have monthly contact with the physicians.

    Behavioral: Counseling

Interventions

  • BehavioralCounseling

    Counseling on healthy behaviors with in person meetings.

  • BehavioralCounseling

    Counseling on healthy behaviors with emails.

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What researchers measure

Primary outcomes

  1. RAND-36 Survey

    Short form health survey

    Time frame: 3 months

Secondary outcomes

  1. Patient Health Questionnaire 9

    Depression scale. Indicates depression severity with higher scores meaning more severe depression.

    Time frame: 3 months

  2. Lean muscle mass

    Percent lean muscle mass

    Time frame: 3 months

  3. Adipose tissue

    Percent adipose tissue

    Time frame: 3 months

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Study locations

1 site
  • NYIT
    Old Westbury, New York 11568, United States
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References and documents

Individual participant data

Plan to share: Yes — Researchers may contact PI for details.

Supporting information: Study protocol

Time frame: 1 year

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in May 2017, 2 months.

Of 90 non-industry interventional studies with no phase under Body Weight Changes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 2 months is below that.

Counting every sponsor, half of 99 studies reached it within 12 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2017
First posted
Jan 4, 2018
StartActual
Mar 7, 2017
Primary completionActual
May 31, 2017
CompletionActual
May 31, 2017
Last update
May 7, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03389737
Lead sponsor
New York Institute of Technology
Responsible party
Hallie Zwibel (Assistant Professor, New York Institute of Technology) — Principal investigator
First posted
Jan 4, 2018
Start date
Mar 7, 2017
Primary completion
May 31, 2017
Completion
May 31, 2017
Last update
May 7, 2018

Study contacts

Hallie Zwibel, D.O.
principal investigator · NYIT

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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