Condition category
Not Applicable
Date applied
01/12/2016
Date assigned
01/12/2016
Last edited
13/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Active children are more likely to be healthier and feel better. The government recommends that all children should do an hour of physical activity that makes them feel slightly out of breath and sweaty each day. Many children do not meet this guideline. Teaching Assistants are school staff members who could be trained to deliver physical activity clubs after-school, which would be a low-cost, sustainable public health programme. The aim of this study is to find out whether after-school clubs that are delivered by trained Teaching Assistants can increase the physical activity levels of Year 4 and 5 pupils.

Who can participate?
Year 4 and 5 pupils attending participating schools

What does the study involve?
Schools are randomly allocated to one of two groups. In the first group, Teaching Assistants are treained to deliver physical activity sessions in the after school club (Action 3:30 clubs). They then run the clubs twice a week for an hour for a total of 15 weeks. The sessions involve enjoyable activities that are designed to build confidence to be active and physical activity skills. Schools in the second group continue as normal for the duration of the study. In both groups, at the start of the study and for the last three weeks the clubs are running, all children answer a survey and wear an accelerometer, which is a small device that accurately records physical activity. Information from children in the schools that deliver Action 3:30 and the comparison schools is then compared to see if there are differences in the amount of physical activity that the two groups take part in and if there are differences in the survey responses.

What are the possible benefits and risks of participating?
Participants who receive the program benefit from being provided with a new physical activity opportunity in the after-school period. There are no known risks involved with participating.

Where is the study run from?
The study is run from University of Bristol and takes place in 12 primary schools in the Greater Bristol area (UK)

When is the study starting and how long is it expected to run for?
September 2016 to September 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Russell Jago
russ.jago@bristol.ac.uk

Trial website

http://www.bristol.ac.uk/sps/action330/

Contact information

Type

Public

Primary contact

Prof Russell Jago

ORCID ID

http://orcid.org/0000-0002-3394-0176

Contact details

Centre for Exercise
Nutrition & Health Sciences
School for Policy Studies
University of Bristol
8 Priory Road
Bristol
BS8 1TZ
United Kingdom
+44 (0)117 9546603
russ.jago@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Action 3:30 R: A cluster randomised feasibility study of a teaching assistant led, extracurricular physical activity intervention for 8 to 10 year olds

Acronym

Action 3:30

Study hypothesis

Participating in after-school clubs that are delivered by trained Teaching Assistants will increase the physical activity levels of Year 4 and 5 pupils.

Ethics approval

School for Policy Studies Ethics Committee, University of Bristol, 12/10/2016, ref: SPSREC16-17.B2

Study design

Cluster randomised controlled study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

Physical activity

Intervention

Schools will be randomised to one of two study arms in a 1:1 ratio by an independent statistician

Intervention arm: Participants in the intervention schools will be provided with new Action 3:30 clubs which will run for an hour, twice a week after-school. The program will run for 15 weeks. The sessions involve enjoyable activities that are designed to build confidence to be active and physical activity skills.

Control arm: Participants in the control schools will continue as normal for the duration of the study.

Follow up involves physical activity monitoring with accelerometers and the completion of surveys, and takes place at during the last 3 weeks of the intervention period (intervention weeks 13-15) for participants in both study groups.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Mean minutes of moderate to vigorous intensity physical activity (MVPA) per day is measured using an accelerometer at baseline and during weeks 13-15 of when the intervention is running.

Secondary outcome measures

1. Mean minutes of sedentary time per day is measured by accelerometer at baseline and during weeks 13-15 of when the intervention is running.
2. Autonomy will be assessed using the Action 330 scale at baseline and during weeks 13-15 of when the intervention is running.
3. Competence will be assessed using the Action 330 scale at baseline and during weeks 13-15 of when the intervention is running
4. Relatedness will be assessed using the Action 330 scale at baseline and during weeks 13-15 of when the intervention is running
5. Enjoyment will be assessed using the Action 330 scale at baseline and during weeks 13-15 of when the intervention is running
6. Self-esteem will be assessed using the Self Description Questionnaire at baseline and during weeks 13-15 of when the intervention is running
7. Subjective well-being and health related quality of life will be self-reported using KIDSCREEN-10 and Child Health Utility 9D scores at baseline and during weeks 12-15 of when the intervention is running
8. Body Mass Index (BMI) Standard Deviation Score (SDS) is calculated from height and weight measurements at baseline and during weeks 12-15 of when the intervention is running
9. Participant and programme costs are measured using during the intervention period by resource logs (intervention group only) for the duration of the 15 week intervention period

Overall trial start date

23/09/2016

Overall trial end date

30/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Year 4/5 pupils
2. Attending participating schools

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

Up to 360 Year 4 and 5 pupils from 12 primary schools in the Greater Bristol, area will be recruited at baseline. We will also allow a second enrolment in the intervention schools during the mid-point of the intervention period to fill any gaps in intervention schools that might have occurred by children not attending the clubs. Participants recruited at the mid-point will be expected to provide data at the second assessment.

Participant exclusion criteria

Children who are unable to take part in usual PE lessons

Recruitment start date

01/04/2017

Recruitment end date

01/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
School for Policy Studies
Bristol
BS8 1TZ
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research and Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

www.bristol.ac.uk/red

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results will be published in an NIHR monograph and in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/09/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29225913

Publication citations

Additional files

Editorial Notes

30/01/2018: Publication reference added.