An interventional study of SuperQuinas in Preschool Programme in Physical Inactivity, Sedentariness and Sleep, sponsored by Lusofona University. Enrolling by invitation at 1 site in Portugal. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Lusofona University · Not applicable, Interventional, and Prevention
This protocol describes a quasi-experimental controlled study evaluating the effects of the Super Quinas in Preschool programme on 24-hour movement behaviours and motor development in preschool children aged 3-6 years. The intervention consists of one additional structured 60-minute physical activity session per week for 12 weeks, delivered by a qualified exercise professional in a public preschool in Maia, Portugal. Four classes (\~80 children) are allocated at the class level: two to the intervention condition and two to the control condition (usual curricular Physical Education). Baseline data collection (T0) was conducted between 4 and 18 March 2026; the intervention commenced on 25 March 2026. Subsequent assessments are planned for early May (T1, mid-intervention), end of June (T2, post-intervention), and mid-September 2026 (T3, follow-up). Primary outcomes are 24-hour movement behaviours (ActiGraph GT3X accelerometry) and motor competence and physical fitness (Motor Competence Assessment + PREFIT subtests). Secondary outcomes include executive function (HTKS; Day-Night Stroop) and socioemotional regulation (SDQ). Statistical analyses will use longitudinal linear mixed-effects models under an intention-to-treat framework.
BACKGROUND AND RATIONALE
Physical activity, sedentary behaviour, and sleep operate as a constrained, interdependent 24-hour composition: time reallocated to one behaviour necessarily displaces another. This integrated perspective underpins the WHO 24-hour movement guidelines for children under 5 years, which recommend at least 180 minutes per day of total physical activity (including at least 60 minutes of MVPA), limited sedentary screen time, and adequate sleep duration (WHO, 2019). Despite clear guidance, adherence is critically low. A large-scale systematic review across 23 countries found that only a small proportion of young children meet all three components simultaneously (Tapia-Serrano et al., 2022). In Portugal, accelerometer-based evidence from the PRESTYLE study showed that only 4.5% of preschool children met the combined 24-hour recommendations, with particularly low compliance for physical activity and screen-time thresholds (Vale \& Mota, 2020). Movement behaviour patterns formed in the preschool period show tracking into later childhood, with potential cumulative effects on health and learning trajectories.
From a developmental standpoint, early childhood is a sensitive period for the maturation of motor competence, executive functions, and socioemotional self-regulation. Motor competence is not only an outcome in its own right but a plausible mechanism linking physical activity exposure to broader developmental gains (Logan et al., 2015). Emerging evidence from compositional data analysis supports the premise that reallocating time away from sedentary behaviour towards physical activity and sleep is associated with more favourable cognitive and behavioural outcomes in preschool-aged children (Li et al., 2024; Xu et al., 2025). The SuperQuinas programme has demonstrated beneficial effects on motor competence and physical activity in primary school populations in Portugal (Costa et al., 2024; Rodrigues et al., 2025); however, its effectiveness in preschool-aged children has not yet been examined.
STUDY DESIGN
The study adopts a school-based, quasi-experimental, parallel-group, class-clustered controlled design. It is conducted at a single public preschool in Maia, northern Portugal (Gandra Basic School, Águas Santas School Cluster). Four intact preschool classes of approximately 20 children each (total N approximately 80) are allocated at the class level, with two classes assigned to the intervention condition and two to the control condition. Non-random class-level allocation was adopted due to organisational and pedagogical constraints inherent to the school context. All four classes receive an identical weekly dose of curricular Physical Education delivered by a qualified PE teacher. Baseline equivalence between conditions is formally assessed for all demographic and outcome variables, and observed imbalances are addressed through covariate adjustment in the primary analyses.
INTERVENTION
The experimental condition receives one additional 60-minute structured physical activity session per week for 12 consecutive weeks, delivered by the principal investigator during regular school hours. The programme adopts a play-based, child-centred approach integrating locomotor, object control, and stability tasks within activities that are developmentally appropriate for children aged 3 to 6 years. Task complexity, movement demands, and instructional cues are progressively adjusted across the intervention period to account for age-related differences in coordination, attentional capacity, and cognitive flexibility.
Each session follows a standardised three-phase structure. The session opens with a brief warm-up of exploratory movement and dynamic play to prepare children physically and cognitively. The central phase consists of structured motor activities and games designed to elicit sustained MVPA and repeated practice of key motor patterns; these activities frequently incorporate rule-based elements and inhibitory control demands, embedding cognitive stimulation within the physical tasks. The session closes with a short cool-down of low-intensity movement and guided reflection reinforcing positive movement behaviours. Each session also includes age-appropriate health messages delivered informally through storytelling and playful interaction, addressing the importance of physical activity, reduced sedentary time, and consistent sleep routines. The additional SuperQuinas session does not replace existing curricular PE but is added to the weekly schedule, increasing total structured physical activity exposure without reducing time allocated to other curricular areas.
Intervention fidelity is monitored through structured session checklists completed by the principal investigator after each session, documenting adherence to the planned structure, deviations, and child engagement. Individual attendance is recorded per session. Children attending fewer than 75% of sessions (fewer than 9 out of 12) are classified as low-adherence participants and included in the intention-to-treat primary analysis but excluded from the pre-specified per-protocol sensitivity analysis.
CONTROL CONDITION
Children allocated to the control condition continue exclusively with regular curricular Physical Education, delivered by a qualified PE teacher following national educational guidelines. No additional physical activity sessions, educational materials, or behaviour change strategies are introduced in control classes during the study period. The content, duration, and pedagogical focus of control-condition PE sessions are documented descriptively through consultation with teaching staff to contextualise intervention effects. At study completion, control classes are offered access to the SuperQuinas in Preschool materials and guidance.
PROCESS EVALUATION
A process evaluation is conducted alongside the outcome evaluation following the Medical Research Council framework for process evaluation of complex interventions (Moore et al., 2015). Three dimensions are monitored throughout the intervention period. Fidelity is assessed through structured session checklists completed after each of the 12 weekly sessions. Dose is quantified through individual attendance records, enabling calculation of per-participant intervention exposure. Acceptability is assessed through structured field notes capturing child engagement, motivation, and teacher feedback after each session. Process evaluation data are reported alongside primary outcome results to enable transparent assessment of implementation quality.
STATISTICAL ANALYSIS
The primary analytical framework uses longitudinal linear mixed-effects models under an intention-to-treat principle, with participants analysed according to their allocated condition regardless of attendance or compliance. Models include fixed effects for time (T0, T1, T2, T3), condition (intervention vs. control), and a time by condition interaction term as the primary test of intervention effect, with adjustment for baseline outcome values, age in months, and sex. Given the small number of clusters (four classes), class-level clustering is addressed through robust clustered standard errors. Missing data are handled using full-information maximum likelihood estimation under the missing-at-random assumption. A pre-specified per-protocol sensitivity analysis is conducted excluding low-adherence participants. For 24-hour movement behaviour data, exploratory compositional data analysis using isometric log-ratio coordinates is conducted to examine shifts in time-use profiles as compositions, complementing the univariate modelling approach.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
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Enrolled in preschool classes at Gandra Basic School. Aged between 3 and 6 years. Written provided by a parent or legal guardian.
Exclusion Criteria:
Diagnosed developmental disorder Diagnosed physical limitation
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.
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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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two intact preschool classes (approximately 40 children) continue exclusively with regular curricular Physical Education (PE) delivered by a qualified PE teacher following national educational guidelines. No additional physical activity sessions, educational materials, or behaviour change strategies are introduced during the study period.
Two intact preschool classes (approximately 40 children aged 3 to 6 years) receive one additional 60-minute structured physical activity session per week for 12 consecutive weeks, delivered by the principal investigator during regular school hours, in addition to their regular curricular Physical Education. Sessions are play-based and child-centred, targeting locomotor, object control, and stability skills with progressively adjusted task complexity. Each session includes informal health messages addressing physical activity, sedentary behaviour, and sleep. The additional session does not replace existing curricular Physical Education but is added to the weekly schedule, increasing total structured physical activity exposure. Individual attendance is recorded at each session.
Behavioral: SuperQuinas in Preschool Programme
One additional 60-minute structured physical activity session delivered once per week for 12 consecutive weeks during regular school hours by the principal investigator, a qualified exercise professional. Sessions follow a standardised three-phase structure: a warm-up of exploratory movement and dynamic play, a central phase of structured motor tasks targeting locomotor, object control, and stability skills with progressive task complexity and embedded inhibitory control demands, and a cool-down with low-intensity movement and guided reflection. Each session includes informal age-appropriate health messages addressing physical activity, sedentary behaviour, and sleep routines. The intervention is added to existing curricular Physical Education and does not replace it. Fidelity is monitored through structured session checklists completed after each session.
24-Hour Movement Behaviours
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
Time frame: 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 and Physical Fitness
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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).
Plan to share: Yes — Anonymised individual participant data underlying the findings reported in the primary results manuscript will be made available upon reasonable request to the corresponding author following publication, subject to ethical and data protection requirements (GDPR, Regulation EU 2016/679). Data will be deposited in the Open Science Framework (OSF; osf.io) no later than 12 months after publication of the primary manuscript. Requests will be evaluated on a case-by-case basis to ensure appropriate use and protection of participant confidentiality.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Beginning 12 months after publication of the primary results manuscript and available for at least 5 years thereafter.
Access criteria: Upon reasonable request to the corresponding author (p8881@ulusofona.pt). Requests must include a brief description of the proposed use of the data. Access is subject to ethical and data protection requirements under GDPR (Regulation EU 2016/679) and applicable Portuguese national legislation. Data sharing agreements may be required prior to data transfer.
Data sharing details ↗ · osf.io
Started Mar 2026 (actual). Primary completion is estimated for Nov 2026, 8 months after the start.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 8 months is below that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
Primary completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 21, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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