NCT03999619

Brief Summary

Move 2 Learn (M2L) is a 10-week movement and pre-literacy program for preschool aged children and their parents designed to improve both movement and reading skills as well as support their overall cognitive, physical, and psychological development. This study will be using a randomized wait-list controlled trial design to evaluate the program on several outcomes: motor skills, pre-literacy skills, cognitive function, perceived physical competence, and physical activity. Children ages 3 to 4 years with typical development will be randomized to either start the program immediately or enter the wait-list control group to begin the program after a 10-week control period. The outcomes will be assessed for all children three times, at week 0, week 11, and week 21 to evaluate change over time in both groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

June 12, 2019

Last Update Submit

December 16, 2020

Conditions

Keywords

Pre-Literacy Skills

Outcome Measures

Primary Outcomes (2)

  • Change in Motor skills

    Movement skill competency (Peabody Developmental Motor Scales- 2nd ed; total gross motor scores range from 0 to 286 with higher scores representing higher motor skill)

    Change from week 0 to 11

  • Change in Pre-literacy skills

    Print Concept Knowledge (Preschool Word and Print Awareness Tool; standardized scores range from 0 to 181 with higher scores representing higher pre-literacy skill)

    Change from week 0 to 11

Secondary Outcomes (14)

  • Change in Perceived Physical Competence

    Change from week 0 to 11

  • Change in Perceived Physical Competence

    Change from week 11 to 21

  • Change in Executive function - Attention

    Change from week 0 to 11

  • Change in Executive function - Attention

    Change from week 11 to 21

  • Executive function - Inhibition

    Change from week 0 to 11

  • +9 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Children will enter into the Move 2 Learn program immediately following their first assessment (between week 0 to 10)

Behavioral: Move 2 Learn

Wait-list Control

OTHER

Children will not participate in the program until after their second assessment (between week 11 to 21). Their control period will take place between week 0 and 10.

Behavioral: Move 2 Learn

Interventions

Move 2 LearnBEHAVIORAL

10-week (1 hour/week) program designed to target fundamental movement and pre-literacy skills with active parent involvement.

Also known as: M2L
ExperimentalWait-list Control

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Between the ages of 3 and 4 years with typical development

You may not qualify if:

  • Developmental delay
  • Physical conditions that prohibit safe participation in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 2W6, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • John Cairney, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will not be aware of the group status of children
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Wait-list Controlled Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 26, 2019

Study Start

January 7, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

December 19, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations