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HydrationNCT07669909

Multimedia Hydration Education During Physical Education in Schoolchildren

A study testing Multimedia hydration education programme in people with Hydration and Dehydration, run by The Higher Institute of Sport and Physical Education of Sfax at 2 sites in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Hydration, Dehydration, Health Behavior
What is being tested?
Multimedia hydration education programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
2 sitesTunisia
Study dates
7 Feb 2025to 2 Apr 2025
Phase
Interventional
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 6 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Tunisia2 sites
  • cole primaire Cité El Habib 1

    Sfax, Sfax Governorate, 3018

  • cole primaire Cité El Habib 1

    Sfax, 3018

Other trials in Tunisia

About this study

Official title: Effect of a COM-B Behaviour Change-Based Multimedia Educational Intervention on Hydration Knowledge, Behaviour, and Hydration Status in Schoolchildren: A Cluster-Randomized Controlled Trial

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.

Read more

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.

Being tested
Multimedia hydration education programme
Keywords
hydration, children, health education, multimedia learning, physical education, behaviour change, COM-B
Medical subject headings
Dehydration, Health Behavior, Drinking Behavior, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimedia hydration education programmeBehavioural

    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.

Study groups in NCT07669909
Study groupRoleWhat they receive
educational groupExperimentalFirst-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.
Receives: Behavioral: Multimedia hydration education programme
Control groupNo interventionFirst-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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Secondary outcomes (2)
  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start7 Feb 2025
  3. Primary completion2 Apr 2025
  4. Study completion2 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07669909
Sponsor's protocol ID
CPP SUD N° 0471/2022
Status last verified
Jun 2026
First submitted
21 Jun 2026
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Multimedia hydration education programme in people with Hydration and Dehydration, run by The Higher Institute of Sport and Physical Education of Sfax at 2 sites in Tunisia.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Tunisia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in hydration knowledge (time frame: Baseline (immediately before session 1) and immediately after session 6 (week 6)). The study lists 2 primary outcomes in all. 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 25 Jun 2026.

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