Condition category
Not Applicable
Date applied
01/05/2020
Date assigned
06/05/2020
Last edited
15/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Fundamental movement skills (FMS) are the foundational building blocks for lifetime participation in physical activity (PA). Programs to promote FMS development have been primarily delivered in childcare and school-based settings. But no studies have evaluated the effectiveness of an interactive digital application, designed to be co-used by the parent and child, to increase FMS proficiency in preschool-aged children.

This study will evaluate the effectiveness of a digital application called Moovosity to promote FMS in 3- to 6-year-old children.

Who can participate?
Children aged 3 to 6 years and their parents/caregivers living in the greater Brisbane metropolitan region

What does the study involve?
Half of the families will be randomly assigned to have free use of the Moovosity app for the 8-week program and half will be randomly assigned to the waiting list for access to the app. Participants will complete assessments of FMS proficiency, physical activity, and parental support for physical activity before and after the 8 week period. After these assessments, the wait-listed group will be given free access to the app.

What are the possible benefits and risks of participating?
The outcomes of this research project may benefit families with preschool-aged children. The results will tell us if the app is effective in increasing FMS proficiency in 3 to 6-year olds and enhancing parental support for physical activity. If we can confirm that the digital platform provides children with fun, developmentally-appropriate physical activity and significantly improves FMS proficiency, families with young children will be able to access a new evidence-based app to promote active play and regular physical activity as part of a healthy lifestyle.

Participants may experience a mild discomfort and/or anxiety from being assessed on FMS proficiency. There is a minimal risk that participants may fall or receive a minor injury during any games chosen to play while using the app. However, the likelihood of these occurring is very low, and the level of discomfort/anxiety associated with these risks is low. The risk of injury using the game-based app session is no greater than the risk of playing outside in the backyard or playing while attending preschool or other childcare.

Where is the study run from?
Queensland University of Technology (Australia)

When is the study starting and how long is it expected to run for?
From June 2018 to May 2019

Who is funding the study?
The study is investigator-initiated and funded

Who is the main contact?
Prof Stewart Trost
s.trost@qut.edu.au

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stewart Trost

ORCID ID

http://orcid.org/0000-0001-9587-3944

Contact details

62 Graham Street
South Brisbane
4101
Australia
+61 401368975
s.trost@qut.edu.au

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Effectiveness of a novel digital application for the development of fundamental movement skills in 3- to 6-year-old children: A randomised controlled trial

Acronym

Moovosity

Study hypothesis

Families randomised to the 8-week intervention will demonstrate significantly greater changes in fundamental movement skills, child physical activity, and parental support for physical activity than families allocated to the wait list control condition.

Ethics approval

Approved 17/08/2018, the Queensland University of Technology Human Research Ethics Committee (Research Ethics Advisory Team, Office of Research Ethics & Integrity on behalf of the Chairperson, UHREC Level 4, 88 Musk Avenue, Kelvin Grove, QLD 4059, Australia; +61 7 3138 5123; humanethics@qut.edu.au), ref: 1800000675

Study design

Randomized, wait-list controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Physical inactivity

Intervention

Participants will be randomized to either the treatment group or the wait-listed control group. The treatment group receives immediate access to the Moovosity app over 8-weeks. The wait-listed control group receives access to the app after completing post-test assessments.

Participants will undergo baseline testing prior to allocation which will be repeated after 8 weeks of either access to the Moovosity app, or no access in the wait-list.

A permutated block randomization method was used for allocation, with four parent-child dyads in each block. The allocation sequence has been generated by a researcher who was not involved in participant recruitment or outcome assessments. The allocation sequence will be concealed in a set of sealed opaque envelopes labeled with the participant number. Data collection and Fundamental movement skill (FMS) assessments will be conducted by trained research assistants blinded to group allocation.

Moovosity™ is a mobile application (app) designed to promote the development of FMS and increase physical activity in young children. The app is designed as a digital library of age-appropriate active games that promote child and parent co-participation in physical activity. Games are designed to be fun, engaging, and establish a positive relationship with physical activity.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Fundamental movement skill proficiency, and object control and locomotor skills will be measured using the Test of Gross Motor Development 2nd Edition at baseline and 8 weeks

Secondary outcome measures

1. Child physical activity will be measured using the Burdette Outdoor Play Checklist at baseline and 8 weeks
2. Parental support for physical activity will be measured using the parent support scale (by Trost et al 2003) at baseline and 8 weeks

Overall trial start date

15/06/2018

Overall trial end date

15/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 3 to 6 years
2. Free from any chronic conditions that affect their growth and development
3. Able to participant in activities of daily living
4. Resident in the greater Brisbane metropolitan region

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

34

Total final enrolment

34

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

15/10/2018

Recruitment end date

15/01/2019

Locations

Countries of recruitment

Australia

Trial participating centre

Queensland Centre for Children’s Health Research
62 Graham Street
South Brisbane
4101
Australia

Sponsor information

Organisation

Queensland University of Technology

Sponsor details

2 George Street
Brisbane
4001
Australia
+61 730697301
s.trost@qut.edu.au

Sponsor type

University/education

Website

https://www.qut.edu.au/

Organisation

Moovosity Pty Ltd

Sponsor details

L10
15 Green Square Close
Fortitude Valley
Brisbane
4006
Australia
-
scott@moovosity.com

Sponsor type

Industry

Website

https://moovosity.com/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish the impact of the intervention on object control skills, locomotor skills, child physical activity, and parental support for physical activity. We will do so in a peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Stewart Trost (s.trost@qut.edu.au). Interested parties will be asked to state why they are interested in the dataset, their proposed research question, and proposed analytical strategies. Due to the conditions stipulated in the research agreement between Moovosity Pty Ltd and Queensland University of Technology, any request for the dataset must also be approved by Moovosity Pty Ltd. Approved parties will be emailed a password protected csv file comprising a completely de-identified dataset and data dictionary.

Intention to publish date

15/06/2020

Participant level data

Available on request

Basic results (scientific)

See additional files (ISRCTN12852968_BasicResults_06May20.pdf)

Publication list

Publication citations

Additional files

Editorial Notes

15/05/2020: The basic results of this trial have been uploaded as an additional file. 06/05/2020: Trial’s existence confirmed by Queensland University of Technology Human Research Ethics Committee.