NCT04618822

Brief Summary

The PLAYMORE study aims to investigate the effects of two interventions focusing on a close and meaningful coupling between bodily movement and academic content on early pre-reading and word recognition skills in children. Further, the study aims to compare two interventions involving either hand movements (i.e. using arms and hands) or whole-body movements (i.e. using the whole body). Potential mediating factors underlying the potential effect of bodily movement on early pre-reading and word recognition skills will be explored. The PLAYMORE study will be conducted as a three-armed randomized controlled trial including children aged five to six years recruited from four schools in the Copenhagen area, Denmark. Stratified by class, children will be randomly allocated to one of three 8-week intervention/control periods: 1) teaching involving whole-body movements, 2) teaching involving hand movements (i.e. arms and hands) or 3) teaching involving minimal motor movements (i.e. seated on a chair using paper and pencil). Outcome measurements, including pre-reading and word recognition skills, will be collected before and after the intervention period to assess the intervention effects. This study protocol follows the SPIRIT guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

October 26, 2020

Last Update Submit

November 7, 2022

Conditions

Keywords

motor-enriched learningembodied learningphysically active lessonspre-reading skillsword recognitionpreschool children

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 8 weeks, computer-based test

    This word reading test consist of 18 presentations of targets words; one target word per presentation. Below the target word are placed four pictures of which one illustrates the target word. For the children to give a correct answer, they will have to touch the picture matching the target word on the touch screen. They are asked to touch the correct picture as fast as possible. The three remaining pictures represents words (distractors) that have either the initial (two pictures) or the final (one picture) sound in common with the target word. The presentations of target words and the order of the four pictures are randomized between subjects and time points. During the test, children are allowed to ask questions concerning the pictures (e.g. what is shown on this picture?) but not regarding the target word (e.g. what is the sound of this letter?). The results from the test constitute mean response time for correct answers and number of correct answers.

    Baseline and 8-weeks

  • Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 8 weeks, paper and pencil test

    The test consists of 15 trials. In each trial, a sound corresponding to a standard or a conditional pronunciation of a letter is said out loud by the assessor. Children are instructed to identify the correct letter matching the sound from a row of four letters. Before the test trials, children will be provided with one practice trial. The 15 sounds represent both standard and conditional pronunciations of the letters a, e, o, r, u and v. Results are numbers of correct letter-sound correspondences.

    Baseline and 8-weeks

Secondary Outcomes (12)

  • Change from baseline in word reading accuracy (reading of 12 untrained words) at 8 weeks, computer-based test

    Baseline and 8-weeks

  • Change from baseline in letter naming fluency accuracy at 8 weeks

    Baseline and 8-weeks

  • Change from baseline in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] at 8 weeks

    Baseline and 8-weeks

  • Change from baseline in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] at 8 weeks

    Baseline and 8-weeks

  • Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 18 weeks, computer-based test

    Baseline and 18-weeks

  • +7 more secondary outcomes

Other Outcomes (10)

  • Change in 1-back task accuracy and reaction time

    Baseline, 8-weeks and 18-weeks

  • Change in digit span forwards and backwards accuracy (number of correctly remembered sequences and the number of digits in the longest correctly remembered sequence)

    Baseline, 8-weeks and 18-weeks

  • Intrinsic motivation questionnaire

    Four times during study completion, immediately after one session in week two, four, six and eight

  • +7 more other outcomes

Study Arms (3)

Teaching involving whole-body movements

EXPERIMENTAL
Behavioral: Teaching involving whole-body movements

Teaching involving hand movements

EXPERIMENTAL

i.e. arms and hands

Behavioral: Teaching involving hand movements

teaching involving minimal motor movements

ACTIVE COMPARATOR

i.e. seated on a chair using paper and pencil

Behavioral: Teaching involving minimal motor movements (control)

Interventions

The intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve whole-body movements and have been developed with the embodied learning theory in mind, linking movement closely to the learning content.

Teaching involving whole-body movements

The intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve movements using hands and arms and have been developed with the embodied learning theory in mind, linking movement closely to the learning content.

Teaching involving hand movements

The control condition consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in groups of app. twelve children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities are completed seated on a chair using paper and pencil.

teaching involving minimal motor movements

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children five to six years old who have just started school

You may not qualify if:

  • Children who do not speak any Danish
  • Children with cognitive or physical disabilities hindering participation in the project activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (1)

  • Gejl AK, Malling ASB, Damsgaard L, Veber-Nielsen AM, Wienecke J. Motor-enriched learning for improving pre-reading and word recognition skills in preschool children aged 5-6 years - study protocol for the PLAYMORE randomized controlled trial. BMC Pediatr. 2021 Jan 4;21(1):2. doi: 10.1186/s12887-020-02430-0.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A three-armed randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 6, 2020

Study Start

September 1, 2020

Primary Completion

February 19, 2021

Study Completion

April 14, 2021

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations