PreventionPROTEGENCT06645574
Towards a Health Promotion for Children Engaged in Sport Intensive Practice for a Healthy Adult
A study testing The multidisciplinary preventive approach among young people involved in intensive sports activities. Athlete will see doctor and physiotherapist. in people with Prevention, run by Fondation Lenval.
Trial summary
This project aims to elucidate the complexities of the preventive approach among young people involved in intensive sports activities, providing valuable recommendations to optimize their physical, mental, and social health both in the present and in the long term. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention
- What is being tested?
- The multidisciplinary preventive approach among young people involved in intensive sports activities. Athlete will see doctor and physiotherapist.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 8 to 15 years old
- Intensive athletes: that is to say they practice a competitive sporting activity with a number of hours of weekly training greater than their age in years.(For example, a 10 year old child will need to train more than 10 hours per week to be included.)
- Sport at an early age
- Obtaining written and signed informed consent from one of the two parents or the holder of parental authority
- Affiliation to a social security system
- Exclusion Criteria: menstruation for more than a year at the time of inclusion
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This project aims to elucidate the complexities of the preventive approach among young people involved in intensive sports activities, providing valuable recommendations to optimize their physical, mental, and social health both in the present and in the long term. The multidisciplinary skills of a team of researchers in sports science and health will contribute their recognized disciplinary expertise through international publications, as well as solid experience in the demands of elite sports, along with a commitment to transferring innovative knowledge toward a preventive approach to sports training.
The main objective is to determine whether a somatotype aligned with the discipline's expectations protects the athlete in terms of self-perception and, consequently, reduces health-risk behaviors. Secondary objectives will include linking somatotype, growth, psychological changes (self-perception), and the emergence of health-risk behaviors or injuries in these young athletes.
- Conditions
- Prevention
- Being tested
- The multidisciplinary preventive approach among young people involved in intensive sports activities. Athlete will see doctor and physiotherapist.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The multidisciplinary preventive approach among young people involved in intensive sports activities. Athlete will see doctor and physiotherapist.Other
Athletes will have 2 times per years prevention examination:
- A standard medical examination
- A physiotherapy assessment with strength assessment
- They will complete psychometric evaluation self-questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Girls practizing gymnastics 8 to 15 yo | Experimental | Not described Receives: Other: The multidisciplinary preventive approach among young people involved in intensive sports activities. Athlete will see doctor and physiotherapist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether a somatotype in harmony with the expectations of the discipline protects the athlete in terms of self-perceptions and, consequently, reduces risky behaviors for her health.
frequency of occurrence of risky behavior depending on the somatotype of the athletes
Measured: 2 times a year for up to 84 months of follow-up
Secondary outcomes (1)
1. How does the somatotype of athletes change over time and in response to training? Are these modifications uniform among athletes of the same sex practicing the same sport?
The evolution of the somatotype of athletes over time and in response to training Relationship between athlete somatotype and growth acceleration at puberty Self-esteem and perception of physical appearance between athletes conforming and nonconforming to the ideal somatotype of their sport The prevalence of ACAD and excessive training practices among athletes with low self-esteem related to their physical appearance.
Correlation between athletes' somatotype and their predisposition to health problems, such as eating disorders and sports injuries
Measured: 2 times a year for up to 84 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study startSep 2025 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645574
- Sponsor's protocol ID
- 24-HPNCL-04
- Acronym
- PROTEGE
- Status last verified
- Mar 2025
- First submitted
- 15 Oct 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Health Promotion for Children Engaged in Sport Intensive Practice for a Healthy Adult
- ClinicalTrials.gov ID
- NCT06645574
- Acronym / sponsor ID
- PROTEGE / 24-HPNCL-04
- Conditions
- Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 17 Oct 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.
This project aims to elucidate the complexities of the preventive approach among young people involved in intensive sports activities, providing valuable recommendations to optimize their physical, mental, and social health both in the present and in the long term. The multidisciplinary skills of a team of researchers in sports science and health will contribute their recognized disciplinary expertise through international publications, as well as solid experience in the demands of elite sports, along with a commitment to transferring innovative knowledge toward a preventive approach to sports training.
The main objective is to determine whether a somatotype aligned with the discipline's expectations protects the athlete in terms of self-perception and, consequently, reduces health-risk behaviors. Secondary objectives will include linking somatotype, growth, psychological changes (self-perception), and the emergence of health-risk behaviors or injuries in these young athletes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Girls practizing gymnastics 8 to 15 yo | Experimental | Other: The multidisciplinary preventive approach among young people involved in intensive sports activities. Athlete will see doctor and physiotherapist. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 8 to 15 years old
- Intensive athletes: that is to say they practice a competitive sporting activity with a number of hours of weekly training greater than their age in years.(For example, a 10 year old child will need to train more than 10 hours per week to be included.)
- Sport at an early age
- Obtaining written and signed informed consent from one of the two parents or the holder of parental authority
- Affiliation to a social security system
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The multidisciplinary preventive approach among young people involved in intensive sports activities. Athlete will see doctor and physiotherapist.Athletes will have 2 times per years prevention examination: * A standard medical examination * A physiotherapy assessment with strength assessment * They will complete psychometric evaluation self-questionnaires | Other | Girls practizing gymnastics 8 to 15 yo |
Primary outcome
Determine whether a somatotype in harmony with the expectations of the discipline protects the athlete in terms of self-perceptions and, consequently, reduces risky behaviors for her health.
Time frame: 2 times a year for up to 84 months of follow-up
frequency of occurrence of risky behavior depending on the somatotype of the athletes
1 secondary outcome
1. How does the somatotype of athletes change over time and in response to training? Are these modifications uniform among athletes of the same sex practicing the same sport?
Time frame: 2 times a year for up to 84 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The multidisciplinary preventive approach among young people involved in intensive sports activities. Athlete will see doctor and physiotherapist. in people with Prevention, run by Fondation Lenval.
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 7 inclusion and 0 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginie RAMPAL, PhD (0033 4 92 03 05 41, virginie.rampal@hpu.lenval.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether a somatotype in harmony with the expectations of the discipline protects the athlete in terms of self-perceptions and, consequently, reduces risky behaviors for her health. (time frame: 2 times a year for up to 84 months of follow-up). 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 12 Mar 2025.