Sports InjuryPRICELESSNCT06361771
Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities (PRICELESS)
An observational study of Sports Injury and Prevention, run by University Hospital, Brest at 1 site in France.
Trial summary
The investigators define the Invisible Preparation (IP) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. This includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Injury, Prevention, Training
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2024to 20 Dec 2024
- Phase
- Observational
- 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 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Middle and High School students who are part of a Sports Institution (Club, Sport Section at School, Local Training Institution, or Elite Training Institution), in Brest, Brittany, France, and its surroundings
Who may be able to join
- Middle and High School students
- Being part of a Sports Institution (Club, Sport Section at School, Local Training Institution, or Elite Training Institution)
- Absence of opposition from the patients or their legal representatives
Who cannot join
- Primary School and College students
- Refusal to participate
- Significant mental or psychological disability, making it impossible to obtain reliable answers
Trial locations and contacts
1 site in 1 country.
Florent GUIMARD contact
France1 site, 1 recruiting
- Recruiting
Chu Brest
Brest, 29609
Marie-Agnès GIROUX-METGES, PhD, 0298347366 ext. +33, marie-agnes.metges@chu-brest.fr
Florent GUIMARD, Resident, 02 98 33 53 40 ext. +33, florent.guimard@chu-brest.fr
About this study
Official title: Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities
The investigators define the Invisible Preparation (IP) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. This includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. If some studies have reported a lack of compliance in young athletes regarding sleep and hydration recommendations, the literature is poor in this field.
The CMS (Brest Metropolitan Area Sports Medicine Centre, France) aims at preserving the health of young athletes. Prior to their medical examination, the patients will be asked, all along the year 2024, to fill out a form that question them about their health behaviors in the four areas of the IP.
Under the direction of the Brest University Hospital, PRICELESS (Invisible Preparation of Middle and High School Students in Sports Institutions) study will try, based on their answers, to estimate the proportion of young athletes who declare adopting the health behaviors recommended in the IP.
- Conditions
- Sports Injury, Prevention, Training, Hydration, Nutrition, Sleep
- Medical subject headings
- Athletic Injuries, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation.
Measured: january - december 2024
Secondary outcomes (4)
The proportion of girls who declare adopting these behaviors, compared to the proportion in boys.
Measured: january - december 2024
The proportion of Middle School students who declare adopting these behaviors, compared to the proportion in High School students.
Measured: january - december 2024
The proportion of young athletes practicing an intensive sporting activity (10 hours or more per week), compared to the proportion in young athletes practicing a non-intensive sporting activity (less than 10 hours per week).
Measured: january - december 2024
The proportion of young athletes with disabilities who declare adopting these behaviors, compared to the proportion in young athletes without disabilities.
Measured: january - december 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start8 Jan 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361771
- Sponsor's protocol ID
- 29BRC24.0079 - PRICELESS
- Acronym
- PRICELESS
- Status last verified
- Mar 2024
- First submitted
- 8 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities
- ClinicalTrials.gov ID
- NCT06361771
- Acronym / sponsor ID
- PRICELESS / 29BRC24.0079 - PRICELESS
- Conditions
- Sports Injury, Prevention, Training, Hydration, Nutrition, Sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 12 Apr 2024 (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.
The investigators define the Invisible Preparation (IP) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. This includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. If some studies have reported a lack of compliance in young athletes regarding sleep and hydration recommendations, the literature is poor in this field.
The CMS (Brest Metropolitan Area Sports Medicine Centre, France) aims at preserving the health of young athletes. Prior to their medical examination, the patients will be asked, all along the year 2024, to fill out a form that question them about their health behaviors in the four areas of the IP.
Under the direction of the Brest University Hospital, PRICELESS (Invisible Preparation of Middle and High School Students in Sports Institutions) study will try, based on their answers, to estimate the proportion of young athletes who declare adopting the health behaviors recommended in the IP.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Middle and High School students who are part of a Sports Institution (Club, Sport Section at School, Local Training Institution, or Elite Training Institution), in Brest, Brittany, France, and its surroundings
Key inclusion criteria (3 listed)
- Middle and High School students
- Being part of a Sports Institution (Club, Sport Section at School, Local Training Institution, or Elite Training Institution)
- Absence of opposition from the patients or their legal representatives
Key exclusion criteria (3 listed)
- Primary School and College students
- Refusal to participate
- Significant mental or psychological disability, making it impossible to obtain reliable answers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation.
Time frame: january - december 2024
4 secondary outcomes
The proportion of girls who declare adopting these behaviors, compared to the proportion in boys.
Time frame: january - december 2024
The proportion of Middle School students who declare adopting these behaviors, compared to the proportion in High School students.
Time frame: january - december 2024
The proportion of young athletes practicing an intensive sporting activity (10 hours or more per week), compared to the proportion in young athletes practicing a non-intensive sporting activity (less than 10 hours per week).
Time frame: january - december 2024
The proportion of young athletes with disabilities who declare adopting these behaviors, compared to the proportion in young athletes without disabilities.
Time frame: january - december 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Florent GUIMARD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Injury and Prevention, run by University Hospital, Brest at 1 site in France.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Agnès GIROUX-METGES (0298347366 ext. +33, marie-agnes.metges@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation. (time frame: january - december 2024). 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 18 Apr 2024.