Effects of a School-Based Physical Activity Intervention on 24-Hour Movement Behaviours and Motor Development in Preschool Children - Study Protocol
NCT07553507, Not applicable, Enrolling by invitation, Lusofona University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of a School-Based Physical Activity Intervention on 24-Hour Movement Behaviours and Motor Development in Preschool Children - Study Protocol | ClinicalTrials.gov |
| NCT number | NCT07553507 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Lusofona University | ClinicalTrials.gov |
| Conditions | Physical Inactivity, Sedentariness, Sleep, Motor Skills, Executive Function, Emotional Regulation | ClinicalTrials.gov |
| Interventions | SuperQuinas in Preschool Programme | ClinicalTrials.gov |
| First posted | 2026-04-28 | ClinicalTrials.gov |
| Last updated | 2026-10-21 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 24-Hour Movement Behaviours | Assessed at four time points: baseline (T0, Week 0), mid-intervention (T1, Week 6), post-intervention (T2, Week 12), and follow-up (T3, Week 24). | 24-hour movement behaviours are assessed objectively using two simultaneously worn triaxial accelerometers (ActiGraph GT3X) over seven consecutive days at each time point. DEVICE 1: Non-dominant wrist (worn continuously for 24 hours). One ActiGraph GT3X is worn on the non-dominant wrist throughout the entire 24-hour period, including during sleep. This device captures the full movement profile across waking and sleeping hours. Wrist-worn data are used to estimate sleep outcomes via validated automated sleep-detection algorithms applied within the parent-reported time-in-bed window, yielding estimates of sleep onset, sleep offset, total sleep duration, and sleep efficiency. DEVICE 2: Right hip (worn during waking hours only). A second ActiGraph GT3X is worn on the right hip using an elastic belt during all waking hours. The device is removed before sleep. Raw data are collected at 30 Hz, aggregated into 15-second epochs, and processed using age-appropriate cut-points validat | ClinicalTrials.gov |
| Primary | Motor Competence and Physical Fitness | Assessed at four time points: baseline (T0, Week 0), mid-intervention (T1, Week 6), post-intervention (T2, Week 12), and follow-up (T3, Week 24). | Motor competence is assessed using the Motor Competence Assessment (MCA), a validated performance-based battery comprising six tasks organised into three subdomains: Stability (lateral jumps and shifting platforms), Locomotor (standing long jump and shuttle run), and Manipulative (ball throwing and ball kicking). Each child completes practice trials followed by two recorded trials per task; the best performance is retained. Raw scores are converted into age- and sex-adjusted standard scores using normative reference values, enabling derivation of domain-specific scores and an overall motor competence composite score. Physical fitness is assessed using two subtests from the PREFIT battery. Cardiorespiratory fitness is assessed using the 20-metre shuttle run test adapted for preschool children, with performance recorded as total laps completed. Upper-limb muscular strength is assessed using a child-adapted handgrip dynamoter. | ClinicalTrials.gov |
| Secondary | Cognitive Competence | Assessed at four time points: baseline (T0, Week 0), mid-intervention (T1, Week 6), post-intervention (T2, Week 12), and follow-up (T3, Week 24). | Cognitive competence is assessed through two individually administered performance-based tasks targeting executive function and self-regulation, conducted in a standardised order by trained researchers in a familiar school setting. The Head-Toes-Knees-Shoulders (HTKS) task assesses behavioural self-regulation and inhibitory control. Children perform the motor opposite of a verbal instruction across a series of progressively complex stimulus-response mappings. Responses are scored from 0 to 2 per trial, yielding a total score of 0 to 40, with higher scores indicating greater self-regulation. The Day-Night Stroop Test assesses attentional regulation and inhibitory control. Children say "night" when shown a sun card and "day" when shown a moon card, suppressing the automatic response. Performance is recorded as the number of correct responses across 16 trials. | ClinicalTrials.gov |
| Secondary | Socioemotional Regulation | Assessed at four time points: baseline (T0, Week 0), mid-intervention (T1, Week 6), post-intervention (T2, Week 12), and follow-up (T3, Week 24). | Socioemotional regulation is assessed using the Strengths and Difficulties Questionnaire (SDQ) in the validated Portuguese teacher-report version. The SDQ comprises 25 items across five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity and Inattention, Peer Relationship Problems, and Prosocial Behaviour. A Total Difficulties Score is derived from the first four subscales. Classroom teachers complete the questionnaire independently for each child at each assessment time point, based on their direct observations during school activities and routines. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Day-Night Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)