Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/07/2017
Date assigned
23/08/2017
Last edited
08/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Regular participation in physical activity is associated with improved psychological health in children such as improved anxiety, depression and self-esteem. Yet children are insufficiently active and children of low socio-economic status are at an even higher risk of being inactive when in adulthood and developing health problems. School-based physical activity interventions have shown some success at increasing physical activity but their effect on well-being is not so clear. Possible reasons why the effect is not clear include measurement inconsistency of both well-being and physical activity. It has been recommended that future studies should apply a well-being measure that reflects a child’s perception of well-being and an objective measure of physical activity. In addition, the current intervention (Sport for LIFE:All Island (AI)) is the first ‘All Island’ (Northern Ireland and Republic of Ireland) collaboration between academic institutions aimed at promoting physical activity to children from disadvantaged areas in a school setting. Therefore, the aim of this study is to determine, using the recommended measures of well-being and physical activity, whether the Sport for LIFE:AI programme could improve physical activity, well-being and attitudes towards nutrition in 8-9 year old children from socially and economically disadvantaged areas of Northern Ireland and the Republic of Ireland.

Who can participate?
Children in Year 5 in Northern Ireland and in 3rd class in Republic of Ireland from primary schools in areas of low socio-economic status.

What does the study involve?
Participating schools from low socio-economic status across the four provinces of Ireland are randomly allocated to one of two groups. Those in the first group receive the Sport for LIFE programme for one hour a week for 12 weeks by a student volunteer from a participating academic institution. This does not replace normal Physical Education classes but are in addition to these classes. Control schools are asked to continue as normal. At baseline, mid-point (6 week), post intervention (week 13) and follow-up (3 months later), children complete measures on physical activity, nutritional attitudes and behaviours and well-being.

What are the possible benefits and risks of participating?
The benefits of participating include educating children on the importance of being physically active for health benefits and the importance of eating a healthy diet. The research also has indirect benefits for the participants, as the findings will help to inform interventions to increase physical activity in children and it’s effects on their well-being. In the long term, this could help with the prevention of poor mental health. Possible risks include a child may feel uncomfortable filling in the questionnaire if they have literacy problems, a child may be concerned about their privacy particularly if they have low levels of literacy and some children may become worried that their height and weight information may be disclosed to other children. Hence, researchers help children to fill out the questionnaire and ensure and tell children that their data is safe and will not be disclosed to other children.

Where is the study run from?
1. Ulster University (UK)
2. Dublin City University (IRL)
3. University College Cork (IRL)
4. Galway and Mayo Institute of Technology (IRL)

When is study starting and how long is it expected to run for?
September 2014 to July 2015

Who is funding the study?
The Coca-Cola Foundation

Who is the main contact?
Dr. Gavin Breslin
g.breslin1@ulster.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gavin Breslin

ORCID ID

http://orcid.org/0000-0003-2481-0860

Contact details

Ulster University
School of Sport
Shore Road
Newtownabbey
BT37 0QB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC/14/0070

Study information

Scientific title

The effect of Sport for LIFE: All Island on Physical Activity, Well-being and Nutrition of Children from Low Socio-economic Status- a Clustered Randomised Controlled Trial

Acronym

Study hypothesis

It was hypothesised that the intervention group would significantly increase their physical activity levels and nutritional attitudes and behaviours in comparison to the control group and a significant increase in physical activity would cause a concurrent significant improvement in the well-being of children in the intervention group in comparison to the control group.

Ethics approval

Ulster University Research Ethics Committee, 25/08/2014, ref: REC/14/0070

Study design

Interventional clustered randomised multi-centre controlled trial

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 participant information sheet.

Condition

Physical activity in healthy 8-9 year old children from low socioeconomic status.

Intervention

Sport for LIFE:AI is a 12-week physical activity and healthy eating programme designed to promote an active lifestyle and the importance of eating a healthy balanced diet to children from low socio-economic status across the four provinces of Ireland. The lessons are underpinned by components of Bandura’s Social Cognitive Theory. Each of the 12 week lessons are based on a specific educational theme on promoting health in schools.

Participating primary schools from areas of social and economic disadvantage in Northern Ireland and the Republic of Ireland across the four regions are randomly assigned to the intervention group and the control group by three members of the research team using a manual random number generator. One researcher placed a school’s name in a closed envelope. A second researcher shuffled the envelopes. Blinded to this procedure, a third researcher then selected an envelope representing a school and coded it as intervention or control. It was not possible to blind schools to their allocation as agreement was sought for the delivery of the intervention prior to data collection.

Intervention schools received the programme once a week for one hour by student volunteers from the academic institutions in partnership with the class teacher. This was in addition to their physical education class. The programme aimed to highlight the social, physical and psychological benefits of healthy eating and participating in sport and physical activity. It included a range of games and activities requiring basic fundamental movement skills appropriate for children aged 8-9 years that can be transferred to lifestyle behaviour. The control schools were asked to continue with their weekly physical education class as normal. The control schools received the programme when the study was completed.

Children’s physical activity levels, nutritional attitudes and behaviours and their well-being are assessed at baseline, mid (week 6) and post-intervention (week 13) and at three months follow-up post-intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Physical activity is assessed objectively using Actigraph GT3x accelerometers (Actigraph, GT3X California, AM 7164-2.2 by MTI Health Services, Fort Walton Beach, FL 32548, USA) at baseline, post-intervention (week 13) and at follow-up (three months post-intervention). Daily total and moderate-to-vigorous physical activity (MVPA) was measured at each timepoint
2. Nutritional Attitudes and Behaviours is assessed using the Australian Child Nutrition Questionnaire at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (three months post-intervention)

Secondary outcome measures

Health-related quality of life (HRQoL) is measured using the KIDSCREEN-27 instrument at baseline, mid-intervention (week 6), post-intervention (week 13) and at follow-up (three months post-intervention).

Overall trial start date

14/03/2014

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Children in Year 5 in Northern Ireland and in 3rd class in Republic of Ireland from primary schools in areas of low socio-economic status.

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

766 children

Participant exclusion criteria

Any disability, that may affect the child’s participation was taken into consideration and depending on parental consent excluded them from the study.

Recruitment start date

31/08/2014

Recruitment end date

09/01/2015

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Ulster University
Shore Road, Newtownabbey, Northern Ireland
BT37 OQB
United Kingdom

Trial participating centre

University College Cork
College Road, Co. Cork
na
Ireland

Trial participating centre

Dublin City University
Glasnevin, Dublin 9
na
Ireland

Trial participating centre

Galway-Mayo Institute of Technology
na
Ireland

Sponsor information

Organisation

Ulster University

Sponsor details

Shore Road
Newtownabbey
Co. Antrim
Newtownabbey
BT37 0QB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

The Coca-Cola Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in a high-impact peer reviewed journal is planned.
Communications at scientific conferences and at internal institutional seminars will provide valuable pathways to further disseminate the findings to academic and non-academic audiences. Findings will be of interest to various stakeholders and organisations, including practitioners and schools implementing healthy-lifestyle programmes.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Gavin Breslin g.breslin1@ulster.ac.uk

Intention to publish date

01/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes