- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06170554
Study of Hydration Levels in Sports and Non-sports Schoolchildren (EHC) (EHC)
April 16, 2024 updated by: University Hospital, Brest
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
259
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brest, France, 29609
- CHRU de Brest
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Middle school students with little or no sports involvement and middle school students with a moderate to intense level of physical activity
Exclusion Criteria:
- Refusal of the middle school student to participate and parental opposition to their child's participation in this research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of middle school students adhering to current hydration recommendations
Time Frame: baseline
|
Response to the questionnaire
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-Agnes Giroux-Metges, MD PhD, Universitary Hospital of Brest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2023
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
October 31, 2024
Study Registration Dates
First Submitted
November 23, 2023
First Submitted That Met QC Criteria
December 12, 2023
First Posted (Actual)
December 14, 2023
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 29BRC23.0201 - EHC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
IPD Sharing 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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