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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05255250
Other study ID # PLAYshop2022
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 24, 2022
Est. completion date March 30, 2025

Study information

Verified date April 2024
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The PLAYshop program is a novel, brief, theory-based, parent-focused physical literacy intervention designed to address this major public health issue of childhood physical inactivity and to support families. Primary Research Question: Does the PLAYshop program increase preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment, compared to controls?


Description:

The overall goal for the proposed study is to examine the efficacy of the PLAYshop program, a novel, brief, theory-based, parent-focused physical literacy intervention, on child- and family-specific outcomes. Research Questions: Primary: Does the PLAYshop program increase preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment, compared to controls? Secondary: Does the PLAYshop program increase preschool-aged children's physical activity and co-participation in physical activity with parents, compared to controls? Tertiary: 1) Does the PLAYshop program increase parents' capability, motivation, and opportunity to support preschool-aged children's physical literacy development, compared to controls? 2) What is the level of, and factors that influence, implementation at the family and program delivery level? Hypotheses: Increases in preschool-aged children's fundamental movement skills, motivation and enjoyment, physical activity, and parent-child co-participation in physical activity will be greater in the intervention group, compared to the control group. Additionally, increase in parents' capability, motivation, and opportunity to support preschool-aged children's physical literacy development will be greater in the intervention group, compared to the control group.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 130
Est. completion date March 30, 2025
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - Children aged 3-5 years and their parents - Living in non-rural areas of Alberta or British Columbia, Canada as defined by Statistics Canada Exclusion Criteria: - Children diagnosed with developmental delay or disorder/condition that may affect gross motor development or limit their ability to be physically active. - Families with parents who do not comfortably speak or read English. - Families that do not have access to a smartphone/tablet with camera and microphone. - Families that have participated in prior PLAYshop pilot and feasibility trials.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PLAYshop
The intervention includes: 1. Educational Training - the 60 min virtual workshop will be delivered by a trained facilitator. Parents will be introduced to physical literacy via education, group discussion, and active participation in fundamental movement skills (FMS) based activities with their child. 2. Distribution of Education Resources- Parents will be sent physical literacy and physical activity printed resources. 3. Material resources -parents will also be provided a bag of inexpensive active play equipment (e.g., ball, bean bag, balloons). 4. Provide Follow-up Support- After the workshop, participants will gain access to an app with an online toolkit including new active play ideas, tips, and equipment they can make at home for active play. Additionally, participants will receive four bi-weekly booster lessons that include key workshop messages, support and encouragement for parents, reflection and check-in questions, and new activities to try with their child.

Locations

Country Name City State
Canada Kinesiology, Sport, and Recreation Edmonton Alberta

Sponsors (3)

Lead Sponsor Collaborator
University of Alberta University of Victoria, Women and Children's Health Research Institute (WCHRI)

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Cairney J, Clark HJ, James ME, Mitchell D, Dudley DA, Kriellaars D. The Preschool Physical Literacy Assessment Tool: Testing a New Physical Literacy Tool for the Early Years. Front Pediatr. 2018 Jun 7;6:138. doi: 10.3389/fped.2018.00138. eCollection 2018. — View Citation

Davison KK, Li K, Baskin ML, Cox T, Affuso O. Measuring parental support for children's physical activity in white and African American parents: the Activity Support Scale for Multiple Groups (ACTS-MG). Prev Med. 2011 Jan;52(1):39-43. doi: 10.1016/j.ypmed.2010.11.008. Epub 2010 Nov 25. — View Citation

Hall, L., Hume, C., & Tazzyman, S. (2016). Five Degrees of Happiness: Effective Smiley Face Likert Scales for Evaluating with Children. In Proceedings of the The 15th International Conference on Interaction Design and Children (311-321). ACM.

Heitzler CD, Martin SL, Duke J, Huhman M. Correlates of physical activity in a national sample of children aged 9-13 years. Prev Med. 2006 Apr;42(4):254-60. doi: 10.1016/j.ypmed.2006.01.010. Epub 2006 Feb 20. — View Citation

Masse LC, O'Connor TM, Lin Y, Carbert NS, Hughes SO, Baranowski T, Beauchamp MR. The physical activity parenting practices (PAPP) item Bank: a psychometrically validated tool for improving the measurement of physical activity parenting practices of parents of 5-12-year-old children. Int J Behav Nutr Phys Act. 2020 Nov 4;17(1):134. doi: 10.1186/s12966-020-01036-0. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in parents' capability to support preschool-aged children's physical literacy development Parental capability (i.e., knowledge), will be assessed via a parental questionnaire. This scale includes 9 items with values of 1-5; higher values mean more capability. Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
Other Change in parents' motivation to support preschool-aged children's physical literacy development Parental motivation (i.e., confidence (11 items), beliefs (4 items), outcome expectations (3 items), intentions (2 items), perceived behavioural control (4 items)) will be assessed via a parental questionnaire. Citation for beliefs and outcome expectations: Heitzler et al., 2006. Items have values of 1-5; higher values mean more parental motivation. Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
Other Change in parents' opportunity to support preschool-aged children's physical literacy development Parental opportunity (e.g., perceived availability of resources (1 item), perceived barriers (5 items)) will be assessed via a parental questionnaire. Items have values of 1-5; higher values mean less parental opportunity. Citation for perceived barriers: Heitzler et al., 2006 Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
Other Implementation: satisfaction and perceived usefulness (questionnaire) Satisfaction and perceived usefulness of the intervention will be assessed via a parental questionnaire in the intervention group only. This scale includes 3 items with values of 1-5; higher values mean more satisfaction and perceived usefulness. Intervention group: Immediately after the workshop
Other Implementation: satisfaction and perceived usefulness (parental interview) Satisfaction and perceived usefulness of the intervention will also be explored via brief semi-structured interviews with parents from the intervention group. Intervention group: 2-month follow-up
Other Implementation: facilitators and barriers (parental interview) Implementation facilitators and barriers will be explored via brief semi-structured interviews with parents from the intervention group. Intervention group: 2-month follow-up
Other Implementation: facilitators and barriers (workshop leader interview) Implementation facilitators and barriers will be explored via brief semi-structured interviews with workshop leaders. At study completion, approximately 1 year from first workshop.
Other Implementation: dose (parental interview) The dose of the intervention will be explored via brief semi-structured interviews with parents from the intervention group. Intervention group: 2-month follow-up
Other Implementation: dose (app check-in questions) The dose of the intervention will be assessed via check-in questions as part of the booster lessons in the intervention group. Intervention group: Bi-weekly after workshop (i.e., 1, 3, 5, and 7 weeks)
Other Implementation: dose (app usage data) The dose of the intervention will be assessed via tracking of app usage in the intervention group. Intervention group: 2-month follow-up
Primary Change in children's physical literacy (fundamental movement skills) Children's fundamental movement skills, including two manipulative skills (i.e., overhand throw, underhand throw), two locomotor skills (i.e., horizontal jump, hop), and one balance/stability skill (i.e., one leg balance), will be assessed in a recorded virtual meeting. The skills are from the Test of Gross Motor Development (TGMD) and the Movement Assessment Battery for Children-Second Edition (MABC-2). Baseline and 2 month follow-up
Primary Change in children's physical literacy (motivation and enjoyment; parental report) Children's motivation and enjoyment will be assessed via a parental questionnaire that includes items from the Preschool Physical Literacy Assessment (Pre PLAy). This scale includes 4 items with values of 1-5; higher values mean more motivation and enjoyment. Citation: Cairney et al. (2018) Baseline and 2 month follow-up
Primary Change in children's physical literacy (enjoyment; child report) Children's enjoyment will also be assessed via self-report using an adapted Five Degrees of Happiness Likert scale for children. This scale includes 1 item with a value of 1-5; a higher value means more enjoyment. Citation: Hall et al. (2016) Baseline and 2 month follow-up
Secondary Change in children's physical activity Children's physical activity will be assessed with Actigraph wGT3X-BT accelerometers worn for 7 consecutive days. Validated cut-points for preschool-aged children will be used to classify each 15 second count into sedentary time or physical activity. Baseline and 2 month follow-up
Secondary Change in parent-child co-participation in physical activity (accelerometer) Parent-child co-participation in physical activity will be assessed with Actigraph wGT3X-BT accelerometers worn for 7 consecutive days by children and designated parents. Validated cut-points for preschool-aged children and adults will be used to classify each 15 second count into sedentary time or physical activity. The Bluetooth proximity detection feature on the accelerometer will be enabled to determine the presence (e.g., same room in a house, at the park together) or absence of close proximity between two accelerometers. Baseline and 2 month follow-up
Secondary Change in parent-child co-participation in physical activity (questionnaire) Parent-child co-participation in physical activity will also be assessed with a parental questionnaire. This scale includes 4 items with values of 1-5; higher values mean more co-participation in PA. Citation: Mâsse et al., 2020 Baseline and 2 month follow-up
Secondary Change in parental physical activity modelling Parental physical activity modelling will be assess via a parental questionnaire. This scale includes 3 items with values of 1-4: higher values mean higher modelling. Citation: Davison et al., 2011 Baseline and 2 month follow-up
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