NCT06170554

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
259

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 16, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

April 17, 2024

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

November 23, 2023

Last Update Submit

April 16, 2024

Conditions

Keywords

WaterBeverageSportsChildrenMiddle school studentsAdolescentsdehydration

Outcome Measures

Primary Outcomes (1)

  • Proportion of middle school students adhering to current hydration recommendations among both athletic and non-athletic middle school students

    Response to the questionnaire

    baseline

Secondary Outcomes (1)

  • Proportion of middle school students adhering to current hydration recommendations

    baseline

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Middle school students with little or no sports involvement and middle school students with a moderate to intense level of physical activity

You may not qualify if:

  • Refusal of the middle school student to participate and parental opposition to their child's participation in this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Agnes Giroux-Metges, MD PhD

    Universitary Hospital of Brest

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 14, 2023

Study Start

November 16, 2023

Primary Completion

July 31, 2024

Study Completion

October 31, 2024

Last Updated

April 17, 2024

Record last verified: 2023-12

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