Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04555746 |
| Other study ID # |
1326 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
May 2016 |
Study information
| Verified date |
September 2020 |
| Source |
University of South-Eastern Norway |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The AK-AC study was designed as a two-arm, randomised by ECEC institution, evaluative
controlled trial with the overarching aim of increasing the children's PA level and reduce
sedentary time.
Description:
Background A growing body of evidence suggests that children's physical activity (PA) level
in childhood education and care (ECEC) settings is insufficient. Moreover, sedentary
behaviour, defined as any waking behaviour characterized by an energy expenditure ≤ 1.5
metabolic equivalents while in a sitting, reclining, or lying posture, is highly prevalent
and has been identified as detrimental to children's health. Although many children have
healthy and active lifestyles, there seems to be a relatively large group of children with a
low PA level. This could lead to negative developmental effects such as low fitness levels,
weak motor skills and obesity. This is especially worrying because it is known that PA level
often tracks from childhood into adulthood. Thus, early intervention is crucial given that PA
plays a pivotal role in children's overall health and is associated with many positive health
outcomes, including physical fitness, cardiovascular health, bone health and psychosocial and
cognitive development.
PA levels have been found to be highly variable among children in ECEC settings and may
therefore have great potential for effective interventions. Furthermore, since most children
attend ECEC settings for many hours on most days of the week, and these institutions reach
children across the socioeconomic spectrum, the ECEC setting may serve as an ideal avenue for
increasing PA level, reducing sedentary time and enhancing the overall health of young
children. However, early childhood educators identify parents rather than themselves as those
responsible for promoting children's PA and may assume that young children receive adequate
PA throughout the week regardless of their activities during their stay in the ECEC setting.
Thus, intervening with children and staff in ECEC settings to equip them with the knowledge,
abilities and motivation to promote PA in children during their ECEC time may provide
substantial public health benefits.
In earlier studies, PA interventions conducted in ECEC settings have shown only small to
moderate effects and were rather inconsistent across studies. Most PA interventions that have
been implemented in ECEC settings have been structured programmes developed by PA experts and
delivered by staff alone or with the strong influence of trained research personnel. In some
studies, staff-led interventions have been shown to be less effective in increasing PA than
interventions implemented by PA experts. Similar findings have emerged regarding intervention
effects on fundamental movement skills. The main explanation for the lower efficiency of
staff-led interventions may be that PA experts have more knowledge and competencies regarding
this issue. For staff-led programmes to succeed, the need for multiple staff training
sessions and maximizing the number of trained staff has been emphasized.
Recently, several reviews have summarized the body of knowledge regarding various aspects of
the contexts of and prerequisites for PA in different kinds of out-of-home services for
children of preschool age. A review including 34 studies revealed small but positive and
significant intervention effects for children's (5 years) moderate- to vigorous-intensity PA
(MVPA) but not for light-intensity PA. Based on their findings, the authors recommended
interventions tailored to the target group and noted that cultural considerations, community
needs and the provision of ongoing support should play key roles. Furthermore, they concluded
that daily structured PA sessions, integrated into the everyday activities in the
institutions (routines) and delivered through a hands-on approach, were most likely to
contribute to increasing children's MVPA.
A review of 24 PA interventions in childcare, mostly targeting children between three and
five years of age, where staff participated in professional development either before or
during the intervention period and provided children with opportunities for additional PA.
Less than half of the included studies had positive effects on children's PA level. For
further intervention studies in ECEC, the authors provided four recommendations, of which two
were based on the papers included in the review and two were based on evidence "from broader
ECEC literature". First, there is a need for high-quality professional development prior to
and during the intervention, and second, there is a need for "interventions that are 'outside
the box'" in terms of, e.g., blended professional development; the role of technology;
targeting the health, well-being and activity levels of the educators; focusing on PA
learning experiences, outdoor time, and energy breaks; and integrating interventions into the
institutions' daily routines. The third, broader-based recommendation addressed the
importance of developing meaningful and trustworthy cooperation and relationships between
staff and researchers. The fourth and final recommendation focused on the ECEC environment as
a key factor for providing good opportunities for PA that thus should be increasingly
emphasized in future interventions.
A missing perspective in recent studies focusing on PA interventions in ECEC settings might
be that they do not fully take into account the fact that ECEC teaching professional practice
has become increasingly complex due to increasingly diverse societies and multiple components
related to working conditions. Thus, top-down approaches and standardized solutions
(programmes) will possibly be difficult to implement in an ever more diverse environment in
terms of individual, social, cultural and physical differences within and between
institutions. Therefore, a suitable approach might be to establish organizational and
collaborative learning processes, a community of professional learning, to improve and
maintain staff competence. This means contextualizing pedagogical practice through continuous
negotiation and reflection between staff members and through collective responsibility for
improvement of practice instead of merely implementing structured programmes developed by
external experts. While expert-delivered interventions seem to be best suited for effect
studies, "real-world" approaches implemented by preschool teachers may have greater potential
for developing sustainable and improved long-term practice.
The current study therefore suggests a dialogical and bottom-up approach that takes into
account differences within and between local ECEC settings, such as child group
characteristics; staff competencies, personal preferences and practices for sustainable
implementation; differences in the physical indoor and outdoor environments; and available
equipment to promote physically active play. Interventions that can be adapted to specific
circumstances within an organization while maintaining overall fidelity are more likely to be
successful. Hence, the theoretical frame of the current intervention is based on Wenger's
theory on communities of practice (COP). Crucial for this theoretical perspective is the idea
that organizations are learning communities that share competence and experiences to develop
new practices. Such a community involves trusting in staff professionalism and their
knowledge about and sensitivity towards the individual child and child groups as well as
their awareness of barriers and possibilities in terms of environment and equipment. COP
includes three modes of belonging: engagement, imagination and alignment. Engagement is
actively participating in practice, revealing needs for learning and change and establishing
the collective development of the organization. Imagination connects to the staff's visions
and experience of meaning regarding the intervention, as well as their understanding of the
purpose. Alignment is about commitment to the entire project. To achieve positive changes
based on COP, these types of belonging must be linked to particular processes such as the
establishment of mutual engagement over time to promote change, self-awareness and reflection
on institutional practices. It is also important to transfer the knowledge and purpose of a
practice across boundaries in the institution. A further key element is to establish
practices where multiple perspectives are heard and appreciated to ensure that staff members
can take advantage of opportunities to develop and experience themselves as acknowledged
contributors to the institution. The current study, "Active Kindergarten - Active Children"
(AK-AC), aims to examine the potential of a staff-led and expert-supported intervention to
increase children's PA level and reduce sedentary time within the ECEC setting compared to
standard care.
Methods Participants All children attending one of the 11 public ECEC institutions in
Sandefjord municipality and born in 2011 (three- or four-year-olds) (n=130) were invited to
participate in the study. Parents of a total of 116 children (89%) signed the informed
consent form, and the children of these parents were included in the study. The intervention
and control groups were formed at the centre level; six ECEC institutions were randomly
assigned to the intervention group, and five institutions were assigned to the control group.
The ECEC institutions varied in size and number of children (range 28 to 100 children). Most
ECEC institutions follow the national recommended staff-child ratio of one staff member per
three children under the age of three and per six children over the age of three. The
regulations also demand one ECEC-educated teacher per nine children under the age of three
and per 18 children over the age of three. The distribution showed a mixture of centre sizes
in both the intervention and control group.
Intervention Four PA experts (researchers (PhD) within the field of PA and health in children
and physical education teachers) in collaboration with two members of the ECEC staff and two
members of the municipal health department (paediatric physiotherapists) developed a frame
for the intervention based on COP elements to be further developed, concretized and
implemented by the staff. The intervention lasted for four months and contained the following
components: pre-meetings and follow-up meetings in each ECEC institution; a start-up seminar
and two follow-up courses with all staff members; ongoing planning and collective reflection
practice in the ECEC institutions; a Facebook group; and an equipment package.
