Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/02/2017
Date assigned
06/03/2017
Last edited
06/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Regular exercise helps keep teenagers fit and lowers their risk of heart disease. However, many teenagers do not have enough money to pay for activities and they feel there is too much focus on organised, competitive sports. This study aims to see whether giving teenagers vouchers to spend on activities of their choice can reduce the time they spend sedentary (inactive), improve their fitness, lower their risk of heart disease and improve general health.

Who can participate?
Pupils aged 13 - 14 at seven participating schools

What does the study involve?
Participating schools are randomly allocated to either the intervention group or the control group. Intervention school pupils receive £20 of vouchers per month over a 12-month period, and work to set up community activities and meet with local government to change activity opportunities available for teenagers. Control school pupils receive a course on dealing with stress. The intervention lasts for 12 months, with measurements of fitness, activity and heart health taken at the start of the study and after 6, 12 and 18 months. The control group continue normal practice during this 12-month period but measurements are taken at the same time points for comparison. In addition, the researchers look at who uses the scheme and how friendship networks influence activity levels.

What are the possible benefits and risks of participating?
The local council intends to use the findings of this study to inform their future strategy, such as reallocating funds to continue the intervention locally. If findings are favourable then the intervention could be used in other areas of the UK. Minimal risks to participants are expected, although measures have been put in place to minimise any risks. Participation is voluntary and participants are able to withdraw at any point without giving a reason and at no disadvantage to themselves. The fitness test can cause some physical distress, but it is widely used among young people and the participants may be familiar with the task having previously performed the test within the PE curriculum. Any participant suffering from asthma is encouraged to carry an asthma inhaler. For focus groups, the headteacher's advice is sought to check there are no potential issues with the group of pupils who have been chosen to take part. Should a pupil become distressed during the intervention, the first port of call is initially a member of staff identified before the start of the focus group. Once the pupil has calmed down they are asked if they wish to continue with the study after being made clear that they are free to withdraw at any stage. Any issues are signposted to the same member of staff and dealt with in accordance with the school's existing policies.

Where is the study run from?
1. Cefn Hengoed Community School (UK)
2. Birchgrove Comprehensive School (UK)
3. Bishop Vaughan R.C. School (UK)
4. Ysgol Gyfun Gymraeg Bryn Tawe (UK)
5. Morriston Comprehensive School (UK)
6. Dylan Thomas Community School (UK)
7. Pentrehafod School (UK)

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

Who is funding the study?
British Heart Foundation (UK)

Who is the main contact?
Michaela James
m.l.james@swansea.ac.uk

Trial website

https://www.facebook.com/ActiveProjectSwansea/

Contact information

Type

Scientific

Primary contact

Miss Michaela James

ORCID ID

Contact details

Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 606716
m.l.james@swansea.ac.uk

Type

Scientific

Additional contact

Prof Sinead Brophy

ORCID ID

http://orcid.org/0000-0001-7417-2858

Contact details

Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

090516

Study information

Scientific title

Randomised controlled trial of Active Children Through Individual Vouchers Evaluation (ACTIVE)

Acronym

ACTIVE

Study hypothesis

The provision of vouchers will increase physical activity and fitness levels of adolescents from low socio-economic backgrounds and improve socialisation.

Ethics approval

College of Human and Health Science, College of Medicine at Swansea University, ref: 12/05/2016, 20/04/2016

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Teenage obesity; heart disease

Intervention

ACTIVE is a randomized control trial by mixed methods where participating schools are assigned to either the control or intervention group via simple randomization:

Intervention: All Year 9 pupils receive £20 of vouchers per month over a 12-month period, and work to set up community activities and meet with local government to change activity opportunities available for teenagers
Control: Year 9 pupils receive a non-activity based course on dealing with stress (mindfulness)

Intervention duration will be 12 months (from January 2017 to December 2017) with fitness, activity and cardiovascular measures taken at baseline, 6 months, 12 months and 18 months (follow-up) in order to track changes in fitness and heart health during voucher usage. The control group will continue normal practice during this twelve month period but measurements will be taken at the same time points for comparison.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Fitness, measured using the cooper run test (CRT) at baseline, 6 months, 12 months and 18 months (follow up)
2. Activity, measured using accelerometers at baseline, 6 months, 12 months and 18 months (follow up)
3. Cardiovascular health, measured using blood pressure and pulse wave analysis at baseline, 6 months, 12 months and 18 months (follow-up)

Secondary outcome measures

Uptake of the scheme by local authorities, measured using a number of advocacy and stakeholder meetings throughout the project but most notably at 18 months (follow up)

Overall trial start date

01/06/2016

Overall trial end date

01/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants must be aged 13 - 14 years old
2. Must be from one of the 7 schools selected (selected via FSM eligibility)
3. Must provide informed consent

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

900

Participant exclusion criteria

Unable to provide informed consent

Recruitment start date

01/09/2016

Recruitment end date

14/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cefn Hengoed Community School
SA1 7HX

Trial participating centre

Birchgrove Comprehensive School
SA7 9NB

Trial participating centre

Bishop Vaughan R.C. School
SA6 7QG

Trial participating centre

Ysgol Gyfun Gymraeg Bryn Tawe
SA5 7BU

Trial participating centre

Morriston Comprehensive School
SA6 6NH

Trial participating centre

Dylan Thomas Community School
SA2 0FR

Trial participating centre

Pentrehafod School
SA1 2NN

Sponsor information

Organisation

Swansea University

Sponsor details

Singleton Park
Swansea
SA2 8PP
Saint Barthelemy

Sponsor type

University/education

Website

http://www.swansea.ac.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol will be published in November 2017 and the results will be published in February 2019.

IPD sharing plan
The datasets generate and/or analysed during the current study is not expected to be made available due to participant confidentiality and certain characteristics of the groups (e.g. age) making them vulnerable.

Intention to publish date

01/02/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes