NCT06361771

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 18, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

April 8, 2024

Last Update Submit

April 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation.

    january - december 2024

Secondary Outcomes (4)

  • The proportion of girls who declare adopting these behaviors, compared to the proportion in boys.

    january - december 2024

  • The proportion of Middle School students who declare adopting these behaviors, compared to the proportion in High School students.

    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).

    january - december 2024

  • The proportion of young athletes with disabilities who declare adopting these behaviors, compared to the proportion in young athletes without disabilities.

    january - december 2024

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • Primary School and College students
  • Refusal to participate
  • Significant mental or psychological disability, making it impossible to obtain reliable answers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Athletic InjuriesPsychological Well-Being

Condition Hierarchy (Ancestors)

Wounds and InjuriesPersonal SatisfactionBehavior

Central Study Contacts

Marie-Agnès GIROUX-METGES

CONTACT

Florent GUIMARD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 12, 2024

Study Start

January 8, 2024

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

April 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations