NCT07553507

Brief Summary

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 23 February and 16 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress11%
Mar 2026Nov 2027

Study Start

First participant enrolled

March 4, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

12 days

First QC Date

April 14, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

physical activity24-h movement behaviourssedentary behavioursleepmotor competenceexecutive functionsocioemotional developmentschool-based interventionSuperQuinas

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    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).

Secondary Outcomes (2)

  • 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).

  • 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).

Study Arms (2)

Usual Curricular Practice (Control)

NO INTERVENTION

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.

SuperQuinas in Preschool (Intervention)

EXPERIMENTAL

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

Interventions

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.

SuperQuinas in Preschool (Intervention)

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in preschool classes at Gandra Basic School. Aged between 3 and 6 years. Written informed consent provided by a parent or legal guardian.

You may not qualify if:

  • Diagnosed developmental disorder Diagnosed physical limitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gandra Basic School (Escola Básica de Gandra)

Maia, Porto District, 4415-307, Portugal

Location

Related Links

MeSH Terms

Conditions

Sedentary BehaviorEmotional RegulationMotor Activity

Condition Hierarchy (Ancestors)

BehaviorSelf-ControlSocial Behavior

Study Officials

  • Inês M Aleixo, PhD

    CIDEFES, Universidade Lusófona, Lisbon, Portugal

    STUDY CHAIR
  • Maurício S Fernandes, Master Degree / PhD Candidact

    CIDEFES, Universidade Lusófona / Federação Portuguesa de Futebol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Blinding of participants, teachers, and the principal investigator is not feasible given the nature of a structured physical activity intervention. To minimise assessment bias, outcome assessors are trained staff not involved in intervention delivery, standardised assessment protocols are used across all conditions and time points, and data analysts work with anonymised coded datasets during the primary modelling phase. Accelerometry outcomes are objectively measured, further reducing the potential for observer bias.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two intact preschool classes are allocated to the intervention condition and two intact classes are allocated to the control condition at the class level within a single school. Both groups are followed simultaneously across four assessment time points (baseline, mid-intervention, post-intervention, and follow-up). Non-random class-level allocation was adopted due to organisational and pedagogical constraints inherent to the school setting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Researcher / Doctoral Candidate

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 28, 2026

Study Start

March 4, 2026

Primary Completion

March 16, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.
More information

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