NCT07669909

Brief Summary

Here's a plain-language Brief Summary ready to paste - it follows the PRS lay-language style (short sentences, explains the "why," avoids jargon) and fits well within 5,000 characters: Staying well hydrated helps children stay healthy and concentrate, and it matters most during physical activity. Yet many young children do not drink enough water during physical education (PE) lessons, and some begin the school day already short of fluid. This study tested whether a short, fun teaching programme could help young children learn about hydration and drink more during PE. The programme used slideshows with simple words, pictures, and short animations, delivered by the children's own teacher for 15 minutes at the start of each PE class, once a week for six weeks. The study took place in two public primary schools in Sfax, Tunisia, and involved 204 first-grade children aged 6 to 7 years. Twelve classes took part. Whole classes (not individual children) were placed by chance into one of two groups: six classes received the teaching programme, and six classes continued their usual PE with no hydration lessons. Comparing whole classes in this way is called a cluster-randomized trial. The researchers measured three things each week: how much the children knew about hydration (using a simple yes/no questionnaire), whether they drank water during the PE session, and the small change in each child's body weight across the session, which is an indirect sign of fluid loss. The aim was to see whether learning about hydration in an engaging way actually changes children's drinking behaviour during activity, not just what they know.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 21, 2026

Last Update Submit

June 21, 2026

Conditions

Keywords

hydrationchildrenhealth educationmultimedia learningphysical educationbehaviour changeCOM-B

Outcome Measures

Primary Outcomes (2)

  • Change in hydration knowledge

    Hydration knowledge measured with an Arabic adaptation of a validated 22-item awareness questionnaire, scored as a proportion of correct answers from 0 to 1. Analysed as the change from baseline to post-intervention using a cluster-adjusted mixed-effects model with a random intercept for class, adjusted for baseline score, age, and sex.

    Baseline (immediately before session 1) and immediately after session 6 (week 6)

  • Proportion of children drinking water during PE

    Proportion of children who drank any water during the PE session, determined by weighing each child's labelled bottle before and after the session (a recorded value of zero denotes non-drinking). Analysed with a cluster-robust logistic model testing the group-by-week interaction across the six sessions.

    Weekly across the six-week intervention (weeks 1 to 6)

Secondary Outcomes (2)

  • Volume of water consumed among children who drank

    Weekly across the six-week intervention (weeks 1 to 6)

  • Acute within-session body-mass change

    Weekly across the six-week intervention (weeks 1 to 6)

Study Arms (2)

educational group

EXPERIMENTAL

First-grade classes that received the six-week multimedia hydration education programme: a 15-minute teacher-delivered session (slideshow with text, images, and short animations) at the start of each weekly PE class, followed by a standard 60-minute PE session. Six classes; 101 children.

Behavioral: Multimedia hydration education programme

Control group

NO INTERVENTION

First-grade classes that continued their usual 60-minute PE with no hydration-related content. The programme was offered to these classes after the trial for ethical equity. Six classes; 103 children.

Interventions

Six weekly 15-minute multimedia education sessions delivered in Arabic by the regular PE teacher before the physical-activity component of PE, grounded in the Behaviour Change Wheel / COM-B model. Content progressed from foundational hydration concepts to applied drinking behaviour and contextual factors.

educational group

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in a first-grade class at a participating school
  • Signed parental/guardian informed consent
  • Able to attend all planned data-collection sessions

You may not qualify if:

  • Exemption from physical education for medical or injury-related reasons
  • Grade repetition
  • Absence from one or more data-collection sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

cole primaire Cité El Habib 1

Sfax, Sfax Governorate, 3018, Tunisia

Location

cole primaire Cité El Habib 1

Sfax, 3018, Tunisia

Location

MeSH Terms

Conditions

DehydrationHealth BehaviorDrinking BehaviorHealth Education

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors and the data analyst were blinded to group allocation; questionnaires were scored from anonymised, identification-coded forms. Children and teachers could not be blinded given the educational nature of the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: luster-randomized design. Intact first-grade classes were the unit of randomization (12 clusters, 6 per arm), and the individual child was the unit of analysis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

February 7, 2025

Primary Completion

April 2, 2025

Study Completion

April 2, 2025

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

e-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request to the principal investigator, subject to institutional approval and a data-sharing agreement. Data will be available beginning after publication of the main results, with no fixed end date.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Available beginning 6 months after publication of the main results, with no specified end date.
Access Criteria
De-identified individual participant data and the supporting documents indicated above will be made available to qualified researchers who provide a methodologically sound proposal. Requests should be directed to the principal investigator and are subject to institutional approval and a signed data-sharing agreement. Approved requesters will receive the data and documents by secure electronic transfer.

Locations