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临床试验/NCT07553507
NCT07553507Enrolling By Invitation不适用

Super Quinas in Preschool: A Quasi-Experimental Controlled Study of the Effects of a Structured School-Based Physical Activity Programme on 24-Hour Movement Behaviours, Motor Competence, Physical Fitness, Cognitive and Socioemotional Outcomes in Preschool Aged Children - A Study Protocol

Lusofona University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
80
试验地点
1
主要终点
24-Hour Movement Behaviours

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

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.

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Diagnosed developmental disorder Diagnosed physical limitation

研究组 & 干预措施

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.

干预措施: SuperQuinas in Preschool Programme (Behavioral)

结局指标

主要结局

24-Hour Movement Behaviours

时间窗: 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

Motor Competence and Physical Fitness

时间窗: 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.

次要结局

  • 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).)

研究者

发起方
Lusofona University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maurício Sousa Fernandes

PhD Researcher / Doctoral Candidate

Lusofona University

研究点 (1)

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