ClinicalTrials.gg
CompletedNCT07669909Updated Jun 25, 2026

Multimedia Hydration Education During Physical Education in Schoolchildren

An interventional study of Multimedia hydration education programme in Hydration, Dehydration and Health Behavior, sponsored by The Higher Institute of Sport and Physical Education of Sfax. Completed at 2 sites in Tunisia. Open to participants aged 6 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by The Higher Institute of Sport and Physical Education of Sfax · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Feb 2025, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
6 Years to 7 Years
Sex
All
01

Study 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.

Read the detailed description

Background and rationale. Adequate hydration supports children's health, cognition, and physical performance, yet many children fail to drink enough fluid, particularly during physical education (PE). A prior six-week trial in the same population, using an adapted board game delivered before PE, improved hydration knowledge and behaviour but allocated only eight classes (clusters), which precluded cluster-adjusted modelling. This trial was designed to address that limitation by using a larger number of clusters and a cluster-adjusted analytical framework, while substituting a scalable multimedia format, deliverable with standard classroom equipment, for the physical board game. The intervention was grounded in the Behaviour Change Wheel and its COM-B model (Capability, Opportunity, Motivation-Behaviour), targeting children's hydration knowledge (capability), the social and physical conditions that normalise drinking during PE (opportunity), and willingness to adopt the behaviour (motivation).

Design. This was a cluster-randomized controlled trial conducted in two public primary schools in Sfax, Tunisia, during the 2021-2022 academic year (February to April 2022). The school class served as the unit of randomization (the cluster) and the individual child as the unit of analysis. All eligible first-grade classes in the two schools were enrolled, giving twelve clusters (six per arm) with an average of approximately seventeen children per cluster.

Participants. First-grade children aged 6-7 years were assessed for eligibility. Eligibility required signed parental consent and the ability to participate in all planned data-collection sessions. Children were excluded for exemption from PE on medical or injury grounds, grade repetition, or absence from one or more data-collection sessions. Of 241 children initially assessed, 204 were retained for analysis (101 in the educational arm across six classes; 103 in the control arm across six classes).

Randomization and blinding. Classes were allocated using a computer-generated sequence stratified by school, with three classes per school assigned to each arm. Allocation at the level of the intact class prevented contamination between conditions. Because the intervention was educational, children and teachers could not be blinded; however, outcome assessors and the data analyst remained blinded to allocation, and questionnaires were scored from anonymised, identification-coded forms.

Intervention. The educational arm received six weekly 15-minute multimedia sessions delivered by the regular PE teacher in Arabic, using slideshow presentations combining short written text, static and annotated images, and brief animations, shown immediately before the physical-activity component of PE. Session content progressed from foundational concepts to applied behaviour and contextual factors. Following the educational component, intervention children completed a standard 60-minute PE session identical in structure and duration to the control arm. Control classes continued usual PE with no hydration content and were offered the programme after the trial for ethical equity.

Outcome measurement. Hydration knowledge was assessed with an Arabic adaptation of a validated 22-item awareness questionnaire, scored as a proportion from 0 to 1, administered immediately before the first session and immediately after the sixth. Water consumption during each session was quantified by weighing each child's individually labelled bottle before and after the session, with a recorded value of zero denoting non-drinking. Acute within-session body-mass change, an indirect indicator of hydration status, was computed from calibrated pre- and post-session weighing. Ambient temperature and relative humidity were recorded at each session as covariates.

Statistical analysis. Analyses were performed in Python (statsmodels). Continuous variables were summarised as median (interquartile range) and categorical variables as counts and percentages. Because intact classes were randomized, confirmatory between-group inferences were derived from models accounting for the non-independence of children within classes, using a random intercept for class and, for repeated-measures outcomes, an additional child-level random effect. Hydration knowledge was analysed by mixed-effects analysis of covariance adjusting for baseline score, age, and sex. Water behaviour was modelled as a two-part outcome (the probability of drinking and the volume consumed among those who drank). Body-mass change was modelled with group, session, and their interaction. Intraclass correlation coefficients were estimated for each outcome, and a cluster-level analysis comparing the twelve class means provided a small-sample sensitivity check. Non-parametric tests were used as further sensitivity analyses.

02

Conditions studied

  • Hydration
  • Dehydration
  • Health Behavior
  • Drinking Behavior

Keywords

  • hydration
  • children
  • health education
  • multimedia learning
  • physical education
  • behaviour change
  • COM-B
03

In context

Dehydration

201 studies on the registry are indexed under Dehydration; 28 are open to participants now.

This study's enrollment of 204 is above the median of 43 across 145 interventional studies indexed under Dehydration.

Browse Dehydration studies →

Lead sponsor

The Higher Institute of Sport and Physical Education of Sfax is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Exemption from physical education for medical or injury-related reasons
  • Grade repetition
  • Absence from one or more data-collection sessions
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
204 participants (actual)

Study arms

  • Experimental
    educational group

    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

  • No intervention
    Control group

    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

  • BehavioralMultimedia hydration education programme

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (immediately before session 1) and immediately after session 6 (week 6)

  2. 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.

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

Secondary outcomes

  1. Volume of water consumed among children who drank

    Volume of water consumed during the PE session (grams, approximately equal to millilitres) among children who drank, from pre- and post-session bottle weighing. Reported as median (interquartile range) and compared between arms.

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

  2. Acute within-session body-mass change

    Percentage change in body mass across a single PE session, computed as \[(pre-session mass - post-session mass) / pre-session mass\] × 100, using calibrated weighing with children in light clothing without shoes; an indirect indicator of hydration status. Analysed with a cluster-adjusted mixed-effects model including group, session, and their interaction.

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

07

Study locations

2 sites
  • cole primaire Cité El Habib 1
    Sfax, Sfax Governorate 3018, Tunisia
  • cole primaire Cité El Habib 1
    Sfax, 3018, Tunisia
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Apr 2025, 1 month.

Of 65 non-industry interventional studies with no phase under Dehydration, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 1 month is below that.

Counting every sponsor, half of 73 studies reached it within 9 months; a quarter within 5 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2026
First posted
Jun 25, 2026
StartActual
Feb 7, 2025
Primary completionActual
Apr 2, 2025
CompletionActual
Apr 2, 2025
Last update
Jun 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07669909
Lead sponsor
The Higher Institute of Sport and Physical Education of Sfax
Collaborators
University of Sfax
Responsible party
Sana Kacem (Principal Investigator, The Higher Institute of Sport and Physical Education of Sfax) — Principal investigator
First posted
Jun 25, 2026
Start date
Feb 7, 2025
Primary completion
Apr 2, 2025
Completion
Apr 2, 2025
Last update
Jun 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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