HydrationEHCNCT06170554
Study of Hydration Levels in Sports and Non-sports Schoolchildren (EHC)
An observational study of Hydration, run by University Hospital, Brest at 1 site in France.
Trial summary
New knowledge regarding the negative impact of poor hydration on health highlights the need to provide recent epidemiological data on the water intake of the French population, especially among middle school students, a group that has been minimally studied until now. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- How many people
- 259 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2023to 31 Oct 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The studied population includes middle school students from two classes of 6th, 5th, 4th, and 3rd grades at Sainte Anne College in Brest, as well as middle school students from two classes of 6th, 5th, 4th, and 3rd grades at Pays des Abers College in Lannilis.
Who may be able to join
- Middle school students with little or no sports involvement and middle school students with a moderate to intense level of physical activity
Who cannot join
- Refusal of the middle school student to participate and parental opposition to their child's participation in this research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Hydration Levels in Sports and Non-sports Schoolchildren
New knowledge regarding the negative impact of poor hydration on health highlights the need to provide recent epidemiological data on the water intake of the French population, especially among middle school students, a group that has been minimally studied until now. Given the crucial role of adequate hydration in sports performance, it is essential to assess fluid intake and hydration habits among middle school students, who often engage in intense physical activities. The primary outcome of this study is to evaluate whether the proportion of middle school students hydrating adequately according to current recommendations is higher among those engaging in moderate to intense sports compared to those who do little or no sports. The goal is to determine if daily fluid intake is significantly influenced by physical activity among this population. To achieve this, investigators have developed a questionnaire to gather information on the physical activity levels of middle school students, their daily hydration habits, and their liquid intake in relation to their sports activities, using appropriate visuals. This study involves distributing the questionnaire in two middle schools in Brittany between November 2023 and January 2024.
- Conditions
- Hydration
- Keywords
- Water, Beverage, Sports, Children, Middle school students, Adolescents, dehydration
- Medical subject headings
- Dehydration
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of middle school students adhering to current hydration recommendations among both athletic and non-athletic middle school students
Response to the questionnaire
Measured: baseline
Secondary outcomes (1)
Proportion of middle school students adhering to current hydration recommendations
Response to the questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start16 Nov 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Agnes Giroux-Metges, MD PhD, Principal investigator, Universitary Hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170554
- Sponsor's protocol ID
- 29BRC23.0201 - EHC
- Acronym
- EHC
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 17 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hydration Levels in Sports and Non-sports Schoolchildren
- ClinicalTrials.gov ID
- NCT06170554
- Acronym / sponsor ID
- EHC / 29BRC23.0201 - EHC
- Conditions
- Hydration
- Keywords
- Water, Beverage, Sports, Children, Middle school students, Adolescents, dehydration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 259 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 14 Dec 2023 (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.
New knowledge regarding the negative impact of poor hydration on health highlights the need to provide recent epidemiological data on the water intake of the French population, especially among middle school students, a group that has been minimally studied until now. Given the crucial role of adequate hydration in sports performance, it is essential to assess fluid intake and hydration habits among middle school students, who often engage in intense physical activities. The primary outcome of this study is to evaluate whether the proportion of middle school students hydrating adequately according to current recommendations is higher among those engaging in moderate to intense sports compared to those who do little or no sports. The goal is to determine if daily fluid intake is significantly influenced by physical activity among this population. To achieve this, investigators have developed a questionnaire to gather information on the physical activity levels of middle school students, their daily hydration habits, and their liquid intake in relation to their sports activities, using appropriate visuals. This study involves distributing the questionnaire in two middle schools in Brittany between November 2023 and January 2024.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The studied population includes middle school students from two classes of 6th, 5th, 4th, and 3rd grades at Sainte Anne College in Brest, as well as middle school students from two classes of 6th, 5th, 4th, and 3rd grades at Pays des Abers College in Lannilis.
Key inclusion criteria (1 listed)
- Middle school students with little or no sports involvement and middle school students with a moderate to intense level of physical activity
Key exclusion criteria (1 listed)
- Refusal of the middle school student to participate and parental opposition to their child's participation in this research
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
Proportion of middle school students adhering to current hydration recommendations among both athletic and non-athletic middle school students
Time frame: baseline
Response to the questionnaire
1 secondary outcome
Proportion of middle school students adhering to current hydration recommendations
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Marie-Agnes Giroux-Metges, MD PhD principal investigator
Universitary Hospital of Brest
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 Hydration, 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 1 inclusion and 1 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 17 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?
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?
Proportion of middle school students adhering to current hydration recommendations among both athletic and non-athletic middle school students (time frame: baseline). 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 17 Apr 2024.