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

Study Overview
=================
Brief 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.

Official Title
-----------------
The Effects of the Novel Step Up Your Game Program on Men's Collegiate Lacrosse Players: A Comparative Study of a Comprehensive Osteopathic Approach on Performance

Conditions
-----------------
Body Weight Changes

Intervention / Treatment
-----------------
* Behavioral: Counseling
* Behavioral: Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals capable of giving consent between ages of 18 and 22. Must be members of the NYIT lacrosse team. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br>* Counseling on healthy behaviors with in person meetings.<br>|
| Active Comparator: Control<br>Control group will not have monthly contact with the physicians. | Behavioral: Counseling<br>* Counseling on healthy behaviors with emails.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAND-36 Survey | Short form health survey | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 9 | Depression scale. Indicates depression severity with higher scores meaning more severe depression. | 3 months | 
| Lean muscle mass | Percent lean muscle mass | 3 months | 
| Adipose tissue | Percent adipose tissue | 3 months |