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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05359536
Other study ID # R4368A35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2022
Est. completion date August 28, 2023

Study information

Verified date March 2024
Source Western University, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine the effect of delivering a physical activity e-learning course to early childhood educators on young children's physical activity and sedentary behaviour while at childcare. It is hypothesized that levels of physical activity will increase and levels of sedentary behaviours will decrease during time spent in childcare in a sample of children who attend early childcare centres where early childhood educators have completed the physical activity e-learning course compared to children in centres where early childhood educators are randomized to not receive the intervention. Differences in changes in several secondary outcomes including fundamental movement skills, parent's perceptions of children's fundamental movement skills, children's cognitive development, emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviours will also be examined.


Description:

In this cluster randomized controlled trials, early childhood educators from childcare centres in London, Ontario, Canada will be randomized to complete a 4 module e-learning course with content on physical activity and sedentary guidelines, physical activity and sedentary behaviours in the childcare environment, how to promote physical activity and reduce sedentary behaviours in young children, and a resource library, or to continue with their usual practices. Early childhood educators randomized to the intervention group will be asked to complete this course over a 2-week intervention period. In both the intervention and control groups, preschoolers physical activity and sedentary behaviours will be measured at baseline, post-intervention (2-weeks) and 3-months follow-up using Actigraph GT3X+ accelerometers. Preschoolers will also complete tasks at baseline and 3-month follow-up to measure their cognitive development, and a subgroup of randomly selected children from each group will complete the Tests of Gross Motor Development - Third Edition to assess their fundamental movement skill proficiency at baseline and follow-up. Parents of children in both groups will complete a questionnaire to measure their perception of their children's proficiency at fundamental movement skills. Parents will also be asked to report on their child's emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviours by completing the Strength and Difficulties Questionnaire


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date August 28, 2023
Est. primary completion date August 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Months to 60 Months
Eligibility Inclusion Criteria: Childcare Centres: - Located in London, ON, Canada - Have at least 1 preschool classroom - Open every weekday - Operate for at least 8 hours on weekdays - All early childhood educators are willing to participate in the study - Staff are English speaking Early Childhood Educators: - Employed at a participating childcare centre - English speaking Children: - Enrolled at a participating childcare centre - Between the ages 2.5-5 years at baseline - Are expected to remain at the childcare centre for the duration of the study period Exclusion Criteria: Childcare Centres: - Not located in London, ON, Canada - Do not have at least 1 preschool classroom - Not open every weekday - Do not operate for at least 8 hours on weekdays - Not all early childhood educators are willing to participate in the study - Staff do not speak English Early Childhood Educators: - Not employed at a participating childcare centre - Do not speak English Children: - Not enrolled at a participating childcare centre - Not between the ages 2.5-5 years at baseline - Not expected to remain at the childcare centre for the duration of the study period

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Training Early Childhood educators in PA
The four module e-learning course was developed using the Delphi technique and covers physical activity and sedentary guidelines, physical activity and sedentary behaviours in the childcare environment, how to promote physical activity and reduce sedentary behaviours in young children, and a resource library.

Locations

Country Name City State
Canada Child Health and Physical Activity Lab London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in children's device measured moderate-to-vigorous physical activity while at childcare measured Assessed using ActiGraph GT3X+ accelerometers worn on each child's right hip for 5 consecutive days (Monday-Friday) while at childcare. Age-specific validated accelerometer cut-points will be used to calculate time spent in moderate-to-vigorous physical activity (i.e. >420 counts/15-second epoch). Children will be considered to have valid accelerometer data if they have at least 5 hours of accelerometer data on 2 days. Accelerometer non-wear time will be identified as any period with 20 consecutive minutes of zero counts. Baseline, post-intervention (2-weeks), and 3-months follow-up
Secondary Change in children's device sedentary behaviours while at childcare Assessed using ActiGraph wGT3X-BT accelerometers worn on each child's right hip for 5 consecutive days (Monday-Friday) while at childcare. Age-specific validated accelerometer cut-points will be used to calculate time spent in moderate-to-vigorous physical activity (i.e. <48 counts/15-second epoch). Children will be considered to have valid accelerometer data if they have at least 5 hours of accelerometer data on 2 days. Accelerometer non-wear time will be identified as any period with 20 consecutive minutes of zero counts. Baseline, post-intervention (2-weeks), and 3-months follow-up
Secondary Change in children's fundamental movement skills Assessed in a sub-sample of randomly selected children using the Test of Gross Motor Development - Third Edition. Test of Gross Motor Development - Third Edition tests six locomotor skills (run, gallop, hop, skip, jump, and slide) and 7 object control skills (two handed strike, forehand strike, dribble, catch, kick, overhand throw, and underhand throw). Each skill was assessed and scored twice on between 3-5 performance criteria where a child was given a 1 if the skill is performed correctly and a 0 if performed incorrectly. A total score between 0-100 is calculated with a higher score indicating a better outcome. Baseline and 3-months follow-up
Secondary Change in parent's perceptions of fundamental movement skill proficiency Parents of children will be asked to report their perceptions of their child's fundamental movement skills. The self-reported scale will measure the same 13 fundamental movement skills measured in the Test of Gross Motor Development - Third Edition. The will rate their Childs proficiency for each skill on a scale from 1 = not that good, 2 = sort of good, 3 = pretty good and 4 = really good. Eah skill is presented with a picture of the skill being performed. The range of possible scores for this scale are 13-52, with higher scores indicating a better outcome. Baseline and 3-months follow-up
Secondary Changes in scores on the Strengths and Difficulties Questionnaire Parents will report on their child's emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviours. Each item is scored on a scale from 0 =not true, 1 =somewhat true, and 2 = certainly true, with positively worded questions being reversed scored for the emotional symptoms, conduct problems, hyperactivity/inattention, and peers relationship problem subscales. Higher scores on these four subscales indicates a worse outcome, while a higher score on the emotional symptoms subscale indicates a better outcome. Each subscale is scored on a scale from 0-10. Baseline and 3-months follow-up
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