Increasing physical activity levels in children: the ACTIVE project
| ISRCTN | ISRCTN75594310 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75594310 |
| Secondary identifying numbers | 090516 |
- Submission date
- 02/02/2017
- Registration date
- 06/03/2017
- Last edited
- 26/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
| Phone | +44 (0)1792 606716 |
|---|---|
| m.l.james@swansea.ac.uk |
Scientific
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
 ORCID ID |
0000-0001-7417-2858 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised controlled trial of Active Children Through Individual Vouchers Evaluation (ACTIVE) |
| Study 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(s) | College of Human and Health Science, College of Medicine at Swansea University, ref: 12/05/2016, 20/04/2016 |
| 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 |
| Primary outcome measure | 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 study start date | 01/06/2016 |
| Overall study end date | 01/06/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 900 |
| Total final enrolment | 986 |
| 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 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
- Wales
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
University/education
Singleton Park
Swansea
SA2 8PP
Wales
United Kingdom
| Website | http://www.swansea.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/053fq8t95 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/07/2017 | Yes | No | |
| Basic results | 04/06/2019 | 14/06/2019 | No | No | |
| Results article | qualitative results | 20/03/2018 | 14/06/2019 | Yes | No |
| Results article | qualitative results | 10/05/2019 | 14/06/2019 | Yes | No |
| Results article | results | 01/02/2020 | 23/12/2019 | Yes | No |
| Interim results article | 28/10/2019 | 26/04/2023 | Yes | No |
Additional files
- ISRCTN75594310_BasicResults_04June19.pdf
- uploaded 14/06/2019
Editorial Notes
26/04/2023: Publication reference added.
22/01/2020: Internal review.
23/12/2019: Publication reference added.
14/06/2019: The following changes were made to the trial record:
1. Publication references added.
2. The total final enrolment was added.
3 The basic results of this trial have been uploaded as an additional file.
15/02/2018: Publication reference added.
