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

Primary Purpose

Body Weight Changes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Counseling
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Body Weight Changes

Eligibility Criteria

18 Years - 22 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • NYIT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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.

Control group will not have monthly contact with the physicians.

Outcomes

Primary Outcome Measures

RAND-36 Survey
Short form health survey

Secondary Outcome Measures

Patient Health Questionnaire 9
Depression scale. Indicates depression severity with higher scores meaning more severe depression.
Lean muscle mass
Percent lean muscle mass
Adipose tissue
Percent adipose tissue

Full Information

First Posted
December 20, 2017
Last Updated
May 2, 2018
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03389737
Brief Title
The Effects of the Novel "Step Up Your Game" Program on Men's Lacrosse
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group will not have monthly contact with the physicians.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Counseling on healthy behaviors with in person meetings.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Counseling on healthy behaviors with emails.
Primary Outcome Measure Information:
Title
RAND-36 Survey
Description
Short form health survey
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire 9
Description
Depression scale. Indicates depression severity with higher scores meaning more severe depression.
Time Frame
3 months
Title
Lean muscle mass
Description
Percent lean muscle mass
Time Frame
3 months
Title
Adipose tissue
Description
Percent adipose tissue
Time Frame
3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men's Lacrosse team at NYIT
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hallie Zwibel, D.O.
Organizational Affiliation
NYIT
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYIT
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Researchers may contact PI for details.
IPD Sharing Time Frame
1 year

Learn more about this trial

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

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