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Preschool Children's Physical Activity, Health and DevelopmentACTNOWNCT04048967

Active Learning Norwegian Preschool(er)s

A study testing Professional development in people with Preschool Children's Physical Activity, Health and Development, run by Western Norway University of Applied Sciences at 1 site in Norway.

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

Evidence is lacking about scalable, effective and sustainable interventions to increase physical activity and concomitant outcomes in young children. Therefore, the investigators will conduct a large cluster randomized controlled trial investigating the effects of physical activity professional development of… Read more about this study

Who is it for?
Ages 3 to 5 yearsHealthy volunteers can take part
What is being tested?
Professional development
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,265 participants
Where
1 siteNorway
Study dates
15 Aug 2019to 15 Jun 2022
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 3 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Attending a participating preschool
  • Born in 2014, 2015 or 2016 (wave 1) OR 2015, 2016, or 2017 (wave 2)

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Western Norway University of Applied Sciences

    Sogndal, 6856

Other trials in Norway

About this study

Evidence is lacking about scalable, effective and sustainable interventions to increase physical activity and concomitant outcomes in young children. Therefore, the investigators will conduct a large cluster randomized controlled trial investigating the effects of physical activity professional development of preschool staff on preschool physical activity practices and child health and development over 6 and 18 months. The aim is to recruit 60 preschools and 1200 children aged 3-5 years in one county in the western part of Norway to allow for detecting small to moderate effect sizes and ensuring a heterogeneous sample of preschools for the study of implementation. Children's physical development, children's socio-emotional and cognitive development, and intervention implementation will be investigated. The intervention will be developed with strong user involvement from municipalities and relevant stakeholders to facilitate the development of sustainable solutions.

Read the detailed description

There are growing concerns about low physical activity levels among preschoolers. As 97% of 3-5-year-olds in Norway attend preschool, preschools are unique arenas for intervention, laying the foundation for equitable development of health, human capital, and life opportunities. Yet, evidence of scalable, effective and sustainable interventions to increase physical activity and concomitant outcomes in preschoolers is lacking. Specifically, there is a need to study how the purposeful use of the preschool instructional context can be used to increase moderate-to-vigorous physical activity across a wide range of motor competences to enhance development, cognitively engaging play, and physically active learning. These aspects, in combination, have the potential to simultaneously affect various developmental and learning outcomes, but implementing such a program requires a highly coordinated effort by highly trained individuals. Therefore, the aim of this study is to investigate the effects of an education module, which is designed to result in highly competent preschool staffs having a good understanding of development of motor competence, provision of cognitively engaging play, physically active learning, and pedagogic/didactic approaches and teaching principles to foster physically active and learning preschoolers, on child developmental outcomes. Hopefully, this professional development will promote a physically active lifestyle in the early years that will favorably influence cognition and learning, and provide an efficient, acceptable, and feasible venue to build human capital and provide an early solution to lifelong public health and developmental challenges.

Two main research questions will be tested using both quantitative and qualitative methods, applied to both the child and organizational levels: 1) How does the intervention affect children's physical activity, physical fitness, motor competence, socio-emotional health, self-regulation, executive functions, and learning? 2) How does the intervention interact with different preschool contexts to produce various individual and organizational outcomes?

The proposed research questions will be investigated using a cluster RCT with randomization at the preschool level, including short- (6-month) and long-term (18-month) follow-up. The intervention development will include strong involvement from preschool owners and staff to provide broad support and anchor the project in the preschool sector. Thus, the investigators aim to combine a large-scale experimental study with continuous improvement effort in this sector allowing each preschool's contextual factors to be reflected within the larger cluster RCT. In this model, to make adaptations within each preschool is not considered a lack of fidelity; rather it is a desired process of institutionalization that balances internal and external validity. This balance also overcomes a common criticism of clinical trials as it increases the value for later scaling and dissemination to the real-world settings. In this way, the aim is to create sustainable solutions for improved child development and public health that can be disseminated in the long-term. Thus, the intervention's development, implementation, and evaluation are framed within a "realist RCT" approach. The intervention model is further framed within a socioecological model, placing the preschool as an influential factor for children's health and development. The intervention has two levels; the preschool level and the child level. In response to the challenge of low staff qualifications to implement physical activity, the main component will be a 7-month professional development offered to preschool staff. The intervention is structured as a 15-credit continuing education module that provide staff the opportunity to achieve credits for their efforts. The study is based on the logic model that this professional development will change preschool practices, which will in turn increase and improve children's physical activity opportunities and levels and lead to child developmental effects. Thus, the main aim of the professional development is to provide preschool staff the necessary expertise and resources to intervene on the child level. Researchers will not directly take part in the delivery of the intervention on the child level. The intervention at the child level is derived from hypotheses, theory and evidence relating to the beneficial effects of physical activity on physical, socio-emotional, and cognitive development and have four core components. Central to the ACTNOW intervention is opportunities for children to engage in a variety of meaningful physically active play that brings joy and supports the development of the whole child. By the integration of the four core components, the aim is to provide children opportunities to increase moderate-to-vigorous physical activity across a wide range of motor competencies to enhance development, cognitive engaging play/games, and physically active learning. As such, the core components and dosages promoted are 1) developmentally appropriate moderate-to-vigorous physical activity (60 min/day), 2) motor challenging physical activity (90 min/week), 3) cognitive engaging play/games (90 min/week), and 4) physical activity integrated with learning activities (90 min/week). The intervention will be delivered by the preschool teachers and staff through the use of a wide specter of types of physically active play; from child-initiated and directed free-play at the one end, to adult-initiated child-directed guided play, and adult-directed and initiated structured teacher-led physical activity at the other end.

The study have 2 waves, the first running from August 2019 to June 2021, and the second from August 2020 to June 2022. The professional development provided in Wave 2 will be adjusted based on experiences and findings from Wave 1. Data collection will have 3 main phases; pre-testing performed before randomization, 6-month follow-up performed at the end of the professional development, and 18-month follow-up performed 1 year after completing the professional development. In addition, process evaluation measures will be taken throughout the study.

Derived from a conservative sample size calculation using standard formulas, including correction for the cluster RCT design, it is an aim to recruit a minimum of 60 preschools and 1200 children to the study. This sample size will allow for uncovering statistical significant standardized effect sizes (Cohen's d) of 0.25-0.30.

A range of measures will be taken to examine the interventions effectiveness on a child level (physical activity, physical fitness, motor skills, adiposity, socio-emotional health, self-regulation, executive functions, and learning) and to describe the implementation and adaptation processes taking place in the preschools over 18 months. The realist evaluation includes both quantitative and qualitative data.

Being tested
Professional development
Keywords
Young children, Preschool, Professional development, Physical activity, Physical fitness, Motor skills, Cognition
Medical subject headings
Motor Activity

What participants receive

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

  • Professional developmentBehavioural

    professional development of preschool staff

Study groups in NCT04048967
Study groupRoleWhat they receive
InterventionExperimentalPreschool staffs will participate in 50 hours of professional development over 7 months focused on promotion of physical activity in the preschool setting. Staffs and investigators will work together to develop models to ensure children receive 60 minutes per day of moderate-to-vigorous physical activity, 90 minutes per week of motor challenging physical activity, 90 minutes per week of cognitively engaging games/play, and 90 minutes per week of physically active learning.
Receives: Behavioral: Professional development
ControlNo interventionStaffs receive no professional development and children will receive standard care.

What is being measured

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

  1. Executive function

    Inhibition, working memory, and cognitive flexibility by the Early Years Toolbox

    Measured: Change to 18 months

  2. Executive function

    Inhibition, working memory, and cognitive flexibility by the Early Years Toolbox

    Measured: Change to 6 months

  3. Learning

    Early math skills and expressive vocabulary by the Early Years Toolbox

    Measured: Change to 18 months

  4. Learning

    Early math skills and expressive vocabulary by the Early Years Toolbox

    Measured: Change to 6 months

  5. Children's socio-emotional health

    Child Self-regulation and Behavior Questionnaire (CSBQ), Early Years Toolbox. Includes 33 items rated 1-5 across subscales of cognitive self-regulation, behavioral self-regulation, emotional self-regulation, sociability, prosocial behavior, externalizing problems, and internalizing problems.

    Measured: Change to 18 months

  6. Children's socio-emotional health

    Child Self-regulation and Behavior Questionnaire (CSBQ), Early Years Toolbox. Includes 33 items rated 1-5 across subscales of cognitive self-regulation, behavioral self-regulation, emotional self-regulation, sociability, prosocial behavior, externalizing problems, and internalizing problems.

    Measured: Change to 6 months

  7. Children's self-regulation

    Head-Toes-Knees-Shoulders task (HTKS)

    Measured: Change to 18 months

  8. Children's self-regulation

    Head-Toes-Knees-Shoulders task (HTKS)

    Measured: Change to 6 months

Secondary outcomes (12)
  1. Children's physical activity

    ActiGraph GT3X+

    Measured: Change to 18 months

  2. Children's physical activity

    ActiGraph GT3X+

    Measured: Change to 6 months

  3. Children's aerobic fitness, muscle strength and power, and speed-agility

    PREFIT test battery

    Measured: Change to 18 months

  4. Children's aerobic fitness, muscle strength and power, and speed-agility

    PREFIT test battery

    Measured: Change to 6 months

  5. Children's motor skills

    Standardized observation and scoring tool guided by Test of Gross Motor Development-3 and the Preschooler Gross Motor Quality Scale including a total of 9 tasks across locomotor, object control, and balance skills.

    Measured: Change to 18 months

  6. Children's motor skills

    Standardized observation and scoring tool guided by Test of Gross Motor Development-3 and the Preschooler Gross Motor Quality Scale including a total of 9 tasks across locomotor, object control, and balance skills.

    Measured: Change to 6 months

  7. Children's waist circumference

    Cm

    Measured: Change to 18 months

  8. Children's waist circumference

    Cm

    Measured: Change to 6 months

  9. Children's body mass index

    Calculated from body mass (kg) and height (m); kgm2

    Measured: Change to 18 months

  10. Children's body mass index

    Calculated from body mass (kg) and height (m); kgm2

    Measured: Change to 6 months

  11. Staffs' physical activity

    ActiGraph GT3X+

    Measured: Change to 18 months

  12. Staffs' physical activity

    ActiGraph GT3X+

    Measured: Change to 6 months

Timeline

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

  1. First posted7 Aug 2019
  2. Study start15 Aug 2019
  3. Primary completion15 Jun 2022
  4. Study completion15 Jun 2022

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
Cluster randomization of 23 preschools to the intervention group (professional development) and 23 to the control group (standard of care).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04048967
Sponsor's protocol ID
ACTNOW
Acronym
ACTNOW
Status last verified
May 2023
First submitted
16 Jul 2019
Last updated
8 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aadland E, Kvalheim OM, Haugland ES, Vabo KB, Aadland KN. Investigating between-group effects of a physical activity intervention across the physical activity intensity spectrum using multivariate pattern analysis. BMC Public Health. 2025 Nov 24;26(1):3. doi: 10.1186/s12889-025-25722-5.

    PubMed 41286789
  • Vabo KB, Aadland KN, Okely AD, Pesce C, Aadland E. Longitudinal associations between preschoolers' 24-h movement behaviors and development of self-regulation, executive function, vocabulary, and numeracy. BMC Public Health. 2025 Oct 6;25(1):3241. doi: 10.1186/s12889-025-24605-z.

    PubMed 41047396
  • Aadland KN, Lervag A, Andersen JR, Howard SJ, Ommundsen Y, Aadland E. Effects of a staff physical activity professional development intervention on preschoolers' mental health and self-regulation: The active learning Norwegian Preschool(er)s (ACTNOW) cluster randomised controlled trial. Psychol Sport Exerc. 2024 Nov;75:102705. doi: 10.1016/j.psychsport.2024.102705. Epub 2024 Jul 18.

    PubMed 39029639
  • Haugland ES, Nilsen AKO, Vabo KB, Pesce C, Bartholomew J, Okely AD, Tjomsland HE, Aadland KN, Aadland E. Effects of a staff-led multicomponent physical activity intervention on preschooler's fundamental motor skills and physical fitness: The ACTNOW cluster-randomized controlled trial. Int J Behav Nutr Phys Act. 2024 Jul 3;21(1):69. doi: 10.1186/s12966-024-01616-4.

    PubMed 38961489
  • Aadland E, Tjomsland HE, Johannessen K, Nilsen AKO, Resaland GK, Glosvik O, Lykkebo O, Stokke R, Andersen LB, Anderssen SA, Pfeiffer KA, Tomporowski PD, Storksen I, Bartholomew JB, Ommundsen Y, Howard SJ, Okely AD, Aadland KN. Active Learning Norwegian Preschool(er)s (ACTNOW) - Design of a Cluster Randomized Controlled Trial of Staff Professional Development to Promote Physical Activity, Motor Skills, and Cognition in Preschoolers. Front Psychol. 2020 Jul 3;11:1382. doi: 10.3389/fpsyg.2020.01382. eCollection 2020.

    PubMed 32719636

Questions about this trial

What is this clinical trial studying?

A study testing Professional development in people with Preschool Children's Physical Activity, Health and Development, run by Western Norway University of Applied Sciences at 1 site in Norway.

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 2 inclusion and 1 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 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

Executive function (time frame: Change to 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04048967, which also lists 5 linked publications.

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 8 May 2023.

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