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

NCT03389737 | Completed

• 1 other identifier: BHS-1261
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight Changes

Outcome Measures

Primary Outcomes (1)

• RAND-36 Survey

  Short form health survey

  3 months

Secondary Outcomes (3)

• Patient Health Questionnaire 9

  3 months

• Lean muscle mass

  3 months

• Adipose tissue

  3 months

Study Arms (2)

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

Control

ACTIVE COMPARATOR

Control group will not have monthly contact with the physicians.

Behavioral: Counseling

Interventions

Counseling BEHAVIORAL

Counseling on healthy behaviors with in person meetings.

Experimental

Eligibility Criteria

• Age: 18 Years - 22 Years
• Gender Eligibility Details: Men's Lacrosse team at NYIT
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

NYIT

Old Westbury, New York, 11568, United States

Location

MeSH Terms

Conditions

Body Weight Changes

Interventions

Counseling

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hallie Zwibel, D.O.

  NYIT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 4, 2018
• Study Start: March 7, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year

Locations

US (1)