Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04048967 |
| Other study ID # |
ACTNOW |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2019 |
| Est. completion date |
June 15, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
Western Norway University of Applied Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
