Condition category
Not Applicable
Date applied
05/09/2017
Date assigned
20/10/2017
Last edited
10/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The mental and physical health and wellbeing of children in Nova Scotia (NS) is in jeopardy, as a result of rates of chronic diseases that are among the highest in Canada. A modifiable risk factor in chronic disease prevention is physical activity (PA). Currently, only 7% of children achieve the recommended amount of PA. Historical declines in outdoor play, and in quality outdoor play experiences, have contributed to these trends. Changes in outdoor play spaces in early learning centres have restricted children’s opportunities to engage in unstructured, self-directed and “risky” play, movements necessary for children to develop physical literacy. Physical literacy is the confidence, physical competence, knowledge, and understanding to be physically active for life. For children’s curiosity to be sparked and heightened, they require environments that offer freedom, wonderment, and access to open-ended and natural materials like logs, sticks, rocks or leaves (“loose parts”). These loose parts can be moved, manipulated, stacked, carried or combined in various ways to encourage creative thinking, help children develop sensory awareness, and provide an opportunity for children to discover and master their environments. Loose parts can help children learn complex problem solving skills, provoke questions about scientific processes and concepts and encourage fine and gross motor skill development, balance and coordination, by manipulating, pushing, pulling, lifting and rolling objects. While there is evidence to support the effectiveness of embedding loose parts into school outdoor settings, there is limited published literature on whether this type of intervention could be applied to settings with younger children, such as early learning centres. The aim of this study is to determine if children who participate in active outdoor play, facilitated by educators trained in embedding loose parts into outdoor play spaces, develop greater physical literacy.

Who can participate?
Children aged three to five years old that attend one of the participating early childcare centres.

What does the study involve?
Participating schools are randomly allocated to one of two groups. Those in the first group receive the loose part kits (including items such as balls, wood planks, buckets and tubing) for use in their outdoor play equipment. Educators are instructed to encourage the use of these loose parts to their children but let them use it as they choose. After six months, the loose parts remain a part of the centres. Those in the second group receive similar loose part it’s after the six months. Participants are followed up to measure their physical activity and movement skills before study, and at three and six months.

What are the possible benefits and risks of participating?
There are no direct benefits to participating in this study. Indirect benefits for participating include an improved understanding of loose parts materials and their use in outdoor settings. For the children, this will provide an opportunity to use loose parts that may not have been part of the outdoor play setting prior to this intervention. Early childhood educators from across NS will have an opportunity to develop their knowledge and skills around promoting outdoor play, and will be able to support other educators in the province to achieve this goal. It may also contribute to the long-term health and development of young children, improve relationships within a community, and improve the supports available to families while parenting children between the ages of 3-4 years. There are no anticipated risks or safety concerns for participants. All of the movement assessment activities for the study are similar to what children would perform in their regular outdoor play at the centre. There are no invasive procedures. However, as with any type of physical activity, there is a small risk of a child falling or getting hurt. All of the research equipment is similar to what the children would use in their own centres’ play activities. In the event of an injury, standard organizational policies will be followed. Educators participating in focus groups and completing the questionnaire may feel uncomfortable sharing specific information and images (through photovoice) about planning and implementing the programs and services in the EYC site to which they are associated. In order to minimize the risk associated with the evaluation interviews, informed consent will be required from the educators. Interviews will be conducted in an environment comfortable to the participant. We will ensure focus group participants are aware that they are not obligated to respond to any questions they are not comfortable answering and may withdraw from the study at any time up to the point that data are analyzed. All identifying information will be removed and replaced with a code number. Any quotes from interviews used in reports, publications, or presentations will not contain identifiers. Parents participating in the interviews and completing the questionnaire may feel uncomfortable sharing information about their personal physical activity and outdoor play views as well as their child’s participation in physical activity. In order to minimize the risk associated with the evaluation, informed consent will be required from the parents. Interview participants are aware that they are not obligated to respond to any questions they are not comfortable answering and may withdraw from the study at any time up to the point that data are analysed. All identifying information will be removed and replaced with a code number. Any quotes from interviews used in reports, publications, or presentations will not contain identifiers.

Where is the study run from?
This study is being run by Dalhousie University (Canada) and takes place in child care centres in Nova Scotia (Canada).

When is the study starting and how long is it expected to run for?
April 2016 to December 2018

Who is funding the study?
Lawson Foundation (Canada)

Who is the main contact?
Dr Michelle Stone
michelle.stone@dal.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michelle Stone

ORCID ID

Contact details

School of Health and Human Performance
Dalhousie University
Stairs House
P.O. Box 15000
6230 South Street
Nova Scotia.
B3H 4R2
(Office location: Dalplex - Kinesiology Suite 215-G)
Halifax
B3H 4R2
Canada
+1 902 494 1167
michelle.stone@dal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GRT 2015-67

Study information

Scientific title

Physical Literacy in the Early Years (PLEY) Project

Acronym

PLEY project

Study hypothesis

The objectives of this research are to evaluate the efficacy of the loose parts intervention versus standard early years settings’ practice to:
1. Improve children’s physical literacy
2. Increase time in active outdoor play
3. Improve educators’ attitudes, beliefs, perceived competency, and intentions towards incorporating the intervention into practice, and
4. Increase educators’ and parents’ understanding of play in child health and development. Overall, this will determine if children who participate in active outdoor play, facilitated by educators trained in embedding loose parts into outdoor play spaces, develop greater physical literacy.

Ethics approval

Dalhousie University Research Ethics Board- Social Sciences and Humanities, 24/01/2017, ref: REB number 2016-3924

Study design

Quasi-experimental randomized, mixed-methods controlled trial, where quantitative and qualitative data will be collected pre- and post-intervention.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Physical inactivity in young children

Intervention

The quasi-experimental loose parts outdoor play intervention includes 16 preschools randomly assigned to the control or intervention group for the purpose of the study.

Preschools in the intervention are provided with loose parts kits (including items such as balls, wood planks, buckets, tubing,etc.) for use in their outdoor play environment. The goal of this intervention is to determine how loose parts play influences physical activity and movement skill development among three-five year old children. Upon receiving the materials, intervention site educators are instructed to encourage the use of these loose parts to their children, but otherwise let the children creatively use the materials as they choose. These materials are intended to be used in the designated outdoor play area at each centre. Educators are instructed to contact the research group if any changes to the loose parts materials (damages, additions, etc.) take place over the course of the intervention. The intervention is six months long, with measures taken at baseline, three-months, and six-months post intervention.

Upon completion of the six-month intervention, loose parts remain a part of the centre, and control centres also receive similar loose parts kits for their children to use.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Children’s physical activity is measured with accelerometers at baseline, 3-months, and 6-months post intervention
2. Children’s movement skill ability is measured with the TGMD-3 and PGMQ-balance at baseline, 3-months, and 6-months post intervention

Secondary outcome measures

1. Educators observations of outdoor active play is measured using photovoice and focus group interventions at 3-months and 6-months post-intervention
2. Parental views on outdoor active play, risky play, and their child’s physical literacy is measured using a questionnaire and interviews at 6-months post-intervention

Overall trial start date

01/04/2016

Overall trial end date

01/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Children between the ages of 3 and 5 years at the start of the intervention
2. Receive parental consent to participate and are attending one of the participating early childcare centres

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

Children who are physically or mentally unable to perform the movement skill assessment.

Recruitment start date

30/01/2017

Recruitment end date

01/06/2017

Locations

Countries of recruitment

Canada

Trial participating centre

Mawio'mi Child Care Centre
80 Mawiomi Place
Dartmouth, NS
B2Y 0A5
Canada

Trial participating centre

Leeds Street Child Care Centre
5685 Leeds Street PO Box 2210
Halifax, NS
B3K 2T3
Canada

Trial participating centre

Mount Pleasant Nursery School
39 Harris Avenue
Truro, NS
B2N 3N3
Canada

Trial participating centre

South End Community Day Care Centre
5594 Morris Street
Halifax, NS
B3J 1C8
Canada

Trial participating centre

Akerley Child Care Centre
21 Woodlawn Road
Dartmouth, NS
B2W 2R7
Canada

Trial participating centre

Beaver Bank Children's Learning Centre Ltd.
95 Kinsac Road
Beaver Bank, NS
B4G 1C5
Canada

Trial participating centre

Willowbrae Academy Hammonds Plains
21 Glen Arbour Way
Hammonds Plain, NS
B4B 0L8
Canada

Trial participating centre

Small World Children's Centre (in Bridgewater, NS)
352 York Street
Bridgewater, NS
B4V 0B4
Canada

Trial participating centre

Willow Creek Children's Centre
1702 Sackville Drive
Middle Sackville, NS
B4E 3A8
Canada

Trial participating centre

Creative Kids Education Centre
109 White Hills Run
Hammonds Plains, NS
B4B 1W6
Canada

Trial participating centre

Spring Garden Child Care Centre
2380 Spring Garden Road
Westville, NS
B0K 2A0
Canada

Trial participating centre

Point Pleasant Child Care Centre (SMU)
5845 Gorsebrook Avenue
Halifax, NS
B3H 1G3
Canada

Trial participating centre

Point Pleasant Child Care Centre
5651 Ogilvie Street
Halifax, NS
B3H 1B8
Canada

Trial participating centre

Wee Care Developmental Centre
5217 Young Street
Halifax, NS
B3K 6A6
Canada

Trial participating centre

Dartmouth Child Development Centre
61 Boland Road
Dartmouth, NS
B3A 1M9
Canada

Trial participating centre

University Children's Centre
6101 South
Halifax, NS
B3H 1T2
Canada

Sponsor information

Organisation

Healthy Populations Institute

Sponsor details

Dalhousie University
Halifax
B3H 4R2
Canada

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Lawson Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in high-impact peer-reviewed journals are intended upon the completion of this trial (01/12/2018). Specific papers will include topics such as a protocol paper, loose parts and physical activity in children, and educator perspectives on outdoor active play as determined by photovoice and focus group interviews. Currently, no additional documents are available. A protocol paper is intended to be written, but this has not been finalized as of now.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes