- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05669378
A Good Start Matters Intervention Study
A Good Start Matters: Do Supportive Childcare Centre Environments, Policies and Practices Enhance Physical Activity?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Louise C Masse, PhD
- Phone Number: 5563 604-875-2000
- Email: lmasse@bcchr.ubc.ca
Study Contact Backup
- Name: Patti-Jean Naylor, PhD
- Phone Number: 250-721-7844
- Email: pjnaylor@uvic.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3V4
- Recruiting
- BC Children's Hospital Research Institute
-
Contact:
- Olivia De-Jongh González, PhD
- Phone Number: 6393 604-875-2000
- Email: Olivia.DjGonzalez@bcchr.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for childcare center:
- Located in the Metro Vancouver region
- Provides care to at least 10 children aged 2 1/2 to 5 years
- Childcare program that is longer than 4 hours each day
Inclusion for child outcomes / measurement
- children must attend a childcare that has volunteered to participate in the study
- Child must be between 2 1/2 to 5 years of age
Inclusion Criteria for managers and staff childcare centers:
- Managers at licensed BC childcare facilities, working full time (at least 3 full days per week) in a facility for children aged 2½ to 5 years, defined as an Executive Director, supervisor, or program manager. Aged 19 years or older.
OR
- Childcare staff at licensed BC childcare facilities, working full time (at least 3 full days per week), defined as Early Childhood Educator, instructor, or staff that cares for 2½ to 5-year-old children. Aged 19 years or older.
Exclusion Criteria for childcare center:
- Located outside Metro Vancouver region
- Facilities caring only for children under 2 1/2 years old or older than 5 years
- Family or in-home multi-age childcare
Exclusion Criteria for managers and staff childcare centers:
- Do not care or supervise 2 ½ to 5 years old children
- Work less than 3 full days per week
- Administrative assistant/office manager
- Younger than 19 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
The experimental group will receive the Appetite to Play + intervention which is a capacity-building intervention that support childcare providers in implementing the best practices for active play.
It includes a 3 e-learning online modules and then the are supported with weekly .
bi-weekly emails.
|
In 2017 the province of BC enacted a provincial standard for physical activity, formally titled the Director of Licensing Standard of Practice - Active Play (Active Play Standards) that licensed childcare centers are required to adhere to.
Along with this, a provincial capacity-building intervention (Appetite to Play) was released to provide training and education to early years providers working in the province and support the implementation of the Active Play Standards.
The intervention, Appetite to Play +, will provide advanced training to early year educators on the Appetite to Play activities and resources.
The intervention will include workshops and training on physical literacy, fundamental movement skills, and creating a supportive environment to sustain Active Play practices.
As part of the intervention, managers will also be provided with resources to aid them with the integration of Active Play into their curriculums and schedules.
|
Other: Standard of care waitlist control
The standard of care waitlist control group will receive the intervention at 3-months post-randomization.
The standard of care group has access to the Appetite to Play materials which are available to everyone.
The site includes resources that childcare providers can use.
|
In 2017 the province of BC enacted a provincial standard for physical activity, formally titled the Director of Licensing Standard of Practice - Active Play (Active Play Standards) that licensed childcare centers are required to adhere to.
Along with this, a provincial capacity-building intervention (Appetite to Play) was released to provide training and education to early years providers working in the province and support the implementation of the Active Play Standards.
The intervention, Appetite to Play +, will provide advanced training to early year educators on the Appetite to Play activities and resources.
The intervention will include workshops and training on physical literacy, fundamental movement skills, and creating a supportive environment to sustain Active Play practices.
As part of the intervention, managers will also be provided with resources to aid them with the integration of Active Play into their curriculums and schedules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in practices (Facility level outcomes)
Time Frame: Two time points -baseline and 3-month post intervention
|
Staff reported assessment of practices based on questions developed by the Early Years Survey and the Environment and Policy Assessment and Observation tool (EPAO-SR).
|
Two time points -baseline and 3-month post intervention
|
Time spent in Active Play (Child outcomes)
Time Frame: Two time points -baseline and 3-month post intervention
|
Field observations using a modified version of the EPAO will be used to observed practices and child engagement in Active Play.
The EPAO we used for this study is adapted to specifically assess the practices targeted by the Active Plays Standards (e.g., outdoor time, provision of active play time, provision of fundamental movement skills activity).
|
Two time points -baseline and 3-month post intervention
|
Fundamental movement skills (child outcomes)
Time Frame: Two time points -baseline and 3-month post intervention
|
Children's FMS will be assessed with the validated Test of Gross Motor Development (TGMD-3 a norm-referenced tool for assessing 13 gross motor skills - locomotor (run, gallop, hop, leap, horizontal jump and slide) and object control (strike, dribble, kick, catch, throw, and roll a ball).
The measure takes 15-20 min per child to administer and provides standardized and percentile composite scores for the locomotor, object control, and gross motor quotient (GMQ) composites.
|
Two time points -baseline and 3-month post intervention
|
Physical activity behaviour (child outcomes)
Time Frame: Two time points -baseline and 3-month post intervention
|
Measurement of children's physical activity (min/hour) at light, moderate, and vigorous intensity, measured by accelerometry.
Children will wear the AX3 accelerometer (Axivity device Actigraph, Pensocola, FL)
|
Two time points -baseline and 3-month post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characteristics of childcare settings
Time Frame: Three time points -baseline and 3-month, and 6-month post intervention
|
Assessment of structural support and processing supporting implementation of Active Play policies and practices, as measured by the Early Years Survey and the Environment and Policy Assessment and Observation tool (EPAO-SR).
|
Three time points -baseline and 3-month, and 6-month post intervention
|
Characteristics of providers
Time Frame: Three time points -baseline and 3-month, and 6-month post intervention
|
Assessment of staff and manager's knowledge and skills, self-efficacy, and commitment to changes facility practices to implement Active Play standards , as measured by the Early Years Survey.
|
Three time points -baseline and 3-month, and 6-month post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Louise C Masse, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H18-01434
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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