Body Weight ChangesNCT03389737
The Effects of the Novel "Step Up Your Game" Program on Men's Lacrosse
A study testing Counseling in people with Body Weight Changes, run by New York Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 22 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2017to 31 May 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 22 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals capable of giving consent between ages of 18 and 22.
- Must be members of the NYIT lacrosse team.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Counseling
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Counseling on healthy behaviors with in person meetings.
CounselingBehavioural
Counseling on healthy behaviors with emails.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Counseling |
| Control | Active comparator | Control group will not have monthly contact with the physicians. Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAND-36 Survey
Short form health survey
Measured: 3 months
Secondary outcomes (3)
Patient Health Questionnaire 9
Depression scale. Indicates depression severity with higher scores meaning more severe depression.
Measured: 3 months
Lean muscle mass
Percent lean muscle mass
Measured: 3 months
Adipose tissue
Percent adipose tissue
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start7 Mar 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hallie Zwibel, New York Institute of Technology
- Investigators
- Hallie Zwibel, D.O., Principal investigator, NYIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389737
- Sponsor's protocol ID
- BHS-1261
- Status last verified
- May 2018
- First submitted
- 20 Dec 2017
- Last updated
- 7 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers may contact PI for details.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03389737
- Acronym / sponsor ID
- BHS-1261
- Conditions
- Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 4 Jan 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: CounselingExperimental 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 | Active comparator | Behavioral: CounselingControl group will not have monthly contact with the physicians. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals capable of giving consent between ages of 18 and 22.
- Must be members of the NYIT lacrosse team.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| CounselingCounseling on healthy behaviors with in person meetings. | Behavioural | Experimental |
| CounselingCounseling on healthy behaviors with emails. | Behavioural | Control |
Primary outcome
RAND-36 Survey
Time frame: 3 months
Short form health survey
3 secondary outcomes
Patient Health Questionnaire 9
Time frame: 3 months
Lean muscle mass
Time frame: 3 months
Adipose tissue
Time frame: 3 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 7 May 2018.
- Individual participant dataSharing planned: Yes. Researchers may contact PI for details.
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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.
Hallie Zwibel, D.O. principal investigator
NYIT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in people with 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 7 May 2018. 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?
RAND-36 Survey (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2018.