Condition category
Not Applicable
Date applied
12/04/2013
Date assigned
25/04/2013
Last edited
07/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many children do not do enough physical activity. Girls are less active than boys. Getting low-active girls to do more physical activity would improve their hearts, lungs, and mental well-being. There is a lack of studies that focus on ways to help girls to be physically active. Dance is an activity that appeals to many girls and could engage low-active girls in physical activity. The Bristol Girls Dance Project (BGDP) is a study that aims to examine; a) whether participating in an after-school dance programme positively affects the physical activity levels of Year 7 girls, and b) the cost-effectiveness of this approach.

Who can participate?
The study will take place in 18 state maintained secondary schools in the greater Bristol area. We aim to recruit up to 33 Year 7 girls from each school to take part in the study.

What does the study involve?
To determine how well the programme works on children, there will be nine schools that receive the after-school dance programme (intervention schools), and nine schools that do not (control schools). The schools will be randomly allocated to the 'intervention' or 'control' group of the study. The dance programme will be led by expert dance instructors, and there will be 2x75 minute sessions per week in each of the nine schools (40 sessions overall). We will examine whether the intervention results in higher levels of physical activity at the end of a 20-week dance programme. We will also assess if this effect is maintained once the programme has ended. We will monitor all financial expenditure against a formal checklist.

What are the possible benefits and risks of participating?
The main potential risk is that a girl may develop a minor sport injury

Where is the study run from?
18 state maintained secondary schools in the greater Bristol area

When is the study starting and how long is it expected to run for?
April 2013 to August 2015

Who is funding the study?
National Institute of Health Research (NIHR) Public Health Research Programme (UK)

Who is the main contact?
Dr Mark Edwards
m.j.edwards@bristol.ac.uk

Trial website

http://www.active-7.org

Contact information

Type

Scientific

Primary contact

Dr Mark Edwards

ORCID ID

Contact details

Centre for Exercise
Nutrition and Health Sciences
School for Policy Studies
8 Priory Road
Bristol
BS8 1TZ
United Kingdom
+44 (0)117 331 1011
m.j.edwards@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIHR PHR 11/3050/01

Study information

Scientific title

Bristol Girls Dance Project: a cluster randomised controlled trial of an after-school dance programme to increase physical activity among 11-12 year old girls

Acronym

Active7

Study hypothesis

The main hypothesis is that participating in an after-school dance intervention will increase the physical activity levels of Year 7 girls, and that these effects will be maintained a year after the baseline measures have been taken - when the intervention has been removed.

Ethics approval

School for Policy Studies Ethics Committee, University of Bristol, 07/02/2013

Study design

Cluster randomised controlled trial with school as the unit of randomisation

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

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

Condition

Physical activity

Intervention

2x75 minute after-school dance sessions per week for 20 weeks (i.e. 2 school terms).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Accelerometer-derived mean minutes of moderate to vigorous intensity physical activity (MVPA) on a weekday

Secondary outcome measures

1. Mean weekend minutes of MVPA
2. Mean weekday accelerometer counts per minute
3. Mean weekend accelerometer counts per minute
4. Mean minutes of sedentary time per weekday
5. Self-reported autonomy competence, relatedness, perceived parental support and self esteem
6. Mean EQ-5D-Y scores
7. Height and weight of study participants
8. Participant and programme costs

Overall trial start date

01/04/2013

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Year 7 girls in participating schools

Participant type

Other

Age group

Child

Gender

Female

Target number of participants

Between 450-594 Year 7 girls (who are physically able to participate in PE lessons) with a cluster size of 25-33 per school, from 18 secondary schools in the Greater Bristol area.

Participant exclusion criteria

Girls who are unable to take part in usual PE lessons will be excluded

Recruitment start date

01/04/2013

Recruitment end date

31/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 1TZ
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research and Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 928 8676
Red-Office@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bristol.ac.uk/red/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) Public Health Research Programme. Grant number: 11/3050/01

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24152257
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26437720
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27253002
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26747038

Publication citations

  1. Protocol

    Jago R, Edwards MJ, Sebire SJ, Cooper AR, Powell JE, Bird EL, Simon J, Blair PS, Bristol girls dance project (BGDP): protocol for a cluster randomised controlled trial of an after-school dance programme to increase physical activity among 11-12 year old girls., BMC Public Health, 2013, 13, 1003, doi: 10.1186/1471-2458-13-1003.

  2. Results

    Jago R, Edwards MJ, Sebire SJ, Tomkinson K, Bird EL, Banfield K, May T, Kesten JM, Cooper AR, Powell JE, Blair PS, Effect and cost of an after-school dance programme on the physical activity of 11-12 year old girls: The Bristol Girls Dance Project, a school-based cluster randomised controlled trial, Int J Behav Nutr Phys Act, 2015, 12, 128, doi: 10.1186/s12966-015-0289-y.

  3. Results

    Jago R, Edwards MJ, Sebire SJ, Bird EL, Tomkinson K, Kesten JM, Banfield K, May T, Cooper AR, Blair PS, Powell JE, Bristol Girls Dance Project: a cluster randomised controlled trial of an after-school dance programme to increase physical activity among 11- to 12-year-old girls, Public Health Research, 2016.

Additional files

Editorial Notes

07/10/2016: Publication reference added. 03/06/2016: Publication reference added. 05/08/2013: The target number of participants field was changed from "Between 450-540 Year 7 girls (who are physically able to participate in PE lessons) with a cluster size of 25-30 per school, from 18 secondary schools in the Greater Bristol area" to "Between 450-594 Year 7 girls (who are physically able to participate in PE lessons) with a cluster size of 25-33 per school, from 18 secondary schools in the Greater Bristol area"