Condition category
Not Applicable
Date applied
23/02/2015
Date assigned
04/03/2015
Last edited
03/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Physical activity has important health benefits for children, but many children do not meet recommended guidelines for the amount of physical activity they take each day. The purpose of this study is to investigate whether an active smart phone game (called FitQuest) which involves running in a playground can motivate children to become more enthusiastic about exercising, and whether that enthusiasm might change their behaviour.

Who can participate?
Year 7 pupils attending a state-funded primary school in Edinburgh, Scotland.

What does the study involve?
Schools are randomly allocated to one of two groups: Exergame group or no exergame group. Pupils from the schools in the exergame group play the FitQuest game during Physical Education lessons in their school for five weeks. Pupils from the schoos in the no exergame group take part in the normal Physical Education classes as provided by the school.

What are the possible benefits and risks of participating?
The potential benefits are improvements in confidence towards exercise and possibly increased levels of physical activity. The potential risks are very low - minor risk of tripping and falling similar to any out of door Physical Education class.

Where is the study run from?
Selected Edinburgh primary schools were invited to take part by development officers within Edinburgh City Council.

When is the study starting and how long is it expected to run for?
From May 2013 to May 2014.

Who is funding the study?
Funded by an Engineering and Physical Sciences Research Council
(EPSRC) Impact Acceleration Account at Heriot-Watt University. Note that the Principal Investigator has now moved to University of Edinburgh.

Who is the main contact?
Dr Judy Robertson
judy.robertson@ed.ac.uk

Trial website

http://judyrobertson.typepad.com/judy_robertson/data-for-exergame-for-childrens-activity-rct-and-qualitative-study-paper.html

Contact information

Type

Public

Primary contact

Prof Judy Robertson

ORCID ID

Contact details

School of Education
Simon Laurie House
University of Edinburgh
Edinburgh
EH8 8AQ
United Kingdom

Type

Scientific

Additional contact

Prof Judy Robertson

ORCID ID

Contact details

School of Education
Simon Laurie House
University of Edinburgh
Edinburgh
EH8 8AQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

F12R10074

Study information

Scientific title

A cluster randomised trial and qualitative study of the effectiveness of a location-based exergame on school children’s physical activity

Acronym

Study hypothesis

Participants who use FitQuest (an exergame) for a 5 week intervention (for one hour per week during Physical Education lessons) will have increased step count, time spent in MVPA and self-efficacy scores post-test than participants who take part in normal Physical Education lessons as provided by the school.

Ethics approval

This study was approved by the School of Life Sciences Ethics Committee at Heriot-Watt University, Scotland on 04/09/13. Written permission to conduct a study in the schools was given by Edinburgh City Council, Scotland (25/06/2013).

Study design

Single centre interventional trial with a cluster randomised control design

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

http://judyrobertson.typepad.com/judy_robertson/data-for-exergame-for-childrens-activity-rct-and-qualitative-study-paper.html

Condition

This study is about the promotion of sustained physical activity in children.

Intervention

Participants in the intervention arm played an exergame for one hour per week during Physical Education Lessons. Control arm participants took part in the normal Physical Education classes as provided by the school.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Step count (as measured by NL1000 accelerometer)
2. Minutes spent in MVPA (as measured by NL1000 accelerometer)
3. Self-Efficacy for physical activity, as measured by Pender questionnaire

All measures will be taken in the weeks immediately before and after the intervention (or equivalent time elapsed for control)

Secondary outcome measures

Qualitative data will be gathered from interviews with children, teachers. Observation notes will be recorded at each session.

Overall trial start date

01/05/2013

Overall trial end date

01/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary seven pupils (usually aged 10-11)
2. Attending a state-funded primary school in Edinburgh, Scotland.
3. The school head teacher and PE must have agreed to take part.
4. Both male or female participants are eligible

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

10 clusters (5 intervention, 5 control), 30 participants per cluster.

Participant exclusion criteria

Lack of parental consent

Recruitment start date

01/06/2013

Recruitment end date

01/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Heriot-Watt University
Earl Mounbatten Building Heriot Watt University
Edinburgh
EH14 4AS
United Kingdom

Sponsor information

Organisation

Heriot-Watt University

Sponsor details

Research Enterprise Services
Riccarton Campus
Edinburgh
EH14 4AS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Engineering and Physical Sciences Research Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the cluster RCT and qualitative study will be submitted to Public Library of Science

Intention to publish date

01/04/2015

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes