Condition category
Not Applicable
Date applied
26/06/2019
Date assigned
02/07/2019
Last edited
05/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The immediate and future health benefits of regular physical activity (PA) are well established. Despite this, many children and adolescents on the island of Ireland fail to meet current PA recommendations. The transition from primary to second-level education represents a time when physical activity decreases, especially in adolescent girls. School-based activities that increase opportunities for PA are needed, particularly for those left out of other sporting activities because of the competitive selection process for school teams, and for types of activity that can be easily maintained into adulthood, such as walking.

Walking is a low-cost, effective means of increasing PA in adults and, after active play, is the greatest contributor to PA in children. It is the most prevalent PA among active adults. The potential of walking to promote PA in low-active adolescent girls encouraging a lifelong walking habit has not been explored. In addition, the school environment is an important health-promoting setting, overcoming many of the health inequalities found in other settings.

The study aims to assess the effectiveness of a low-cost school-based, peer-led brisk walking intervention in increasing PA in adolescent girls when delivered across the school year in a fully-powered trial in schools across Northern Ireland and the Border region of Ireland.

Who can participate?
All female pupils who attend a school selected to take part in the study and are aged 12-14 years (i.e. in Year 9 or 10 (NI) / First Year or Second Year (ROI) of post-primary education) will be invited to take part in this study. As this study aims to increase the amount of physical activity, only pupils who are healthy and free from any medical condition that may limit their ability to take part in a brisk walking programme will be eligible to take part in the study.

What does the study involve?
To assess the impact of this walking programme on physical activity and other factors, we would like to carry out a number of measurements at different time points throughout the study.

At baseline (week 0) we will take the first set of measurements in a semi-screened area. We will firstly measure height and weight, and then take measurements of waist and hip circumference. We will also ask participants to complete a series of questionnaires which will involve general questions about physical activity, as well as some scales to assess attitudes towards physical activity and walking. We will also collect some information on wellbeing, sleep and social media usage.

In the week before these measurements, we would like to collect some information about physical activity levels using a device known as an accelerometer. An accelerometer is a device that measures the amount and the direction of any activity that someone does. We will ask participants to wear this device for one week; it is small in size (about the size of a matchbox) and we will provide pupils with an information sheet on how to correctly wear the device. Participants will be asked to remove the accelerometer when bathing, taking part in water-based activities such as swimming and when asleep. This measurement of physical activity is non-invasive and will not impede on participants’ daily routine in any way.

Once our first set of measurements are complete, schools will be randomly allocated to either 1) the walking programme (intervention), or 2) continue with usual physical activity habits (control).

1. Walking intervention: If a school is randomly selected to take part in the walking programme, participants will have the opportunity to attend a number of group-led walks throughout the school week. These walks will be led by older students who have been trained as walk leaders and these older students will be under the supervision of a member of school staff. During the programme, participants will be encouraged to attend as many walking sessions as possible. The actual walking intervention will last a minimum of 20 and a maximum of 22 weeks.

2. Control group: If a school is randomly selected not to take part in the walking programme, pupils will not have to take part in any further physical activity as a result of this study. Although pupils will not take part in the walking programme, we will still collect take measurements at the time points outlined below.

Regardless of being assigned to either the intervention or control group, all participants will be involved in the study for approximately 1 year (to allow for follow up measurements), which will be conducted at a number of time points throughout the study.

Participants may be selected to take part in some evaluation work about the study. This is in the form of a focus group, which is an informal group discussion, where we would ask your participants to share their experiences of taking part in the walking programme. Participants will be randomly selected and asked to take part in the focus groups at the beginning and/or end of the intervention. The focus groups will discuss topics including physical activity, breaktime activities and social media.

What are the possible benefits and risks of participating?
We would hope that participants will enjoy taking part in this research study and find it a fun and enjoyable activity. Although participation in the study may not bring direct benefits to participants, the results of this study will help researchers further understand what approaches are useful when trying to encourage this age group to take part in more physical activity.

As with all physical activity, there is a minimal risk of injury or discomfort however walking is a very safe form of physical activity, and the walks not be performed at a high intensity. Risk assessments will be conducted at each school before the study takes place.

Where is the study run from?
1. Ulster University, UK
2. Letterkenny Institute of Technology (LYIT), Ireland
3. University of Bristol, UK
4. University of Wolverhampton, UK

When is the study starting and how long is it expected to run for?
Participant recruitment is due to begin in September 2019 and the study is expected to run until 31st May 2022.

Who is funding the study?
The WISH Study is funded by the CHITIN project. The CHITIN project has received funding from the Department of Health NI and the Health Service Executive (ROI)) from the EU’s INTERREG VA Programme, which is managed by the Special EU Programmes Body (SEUPB).

Who is the main contact?
Public: Dr Maria O’Kane (m.okane@ulster.ac.uk)
Scientific: Professor Marie Murphy (mh.murphy@ulster.ac.uk)
Scientific: Professor Alison Gallagher (am.gallagher@ulster.ac.uk)

Trial website

Contact information

Type

Public

Primary contact

Dr Maria O'Kane

ORCID ID

http://orcid.org/0000-0002-2632-0083

Contact details

Room MC128
Ulster University
Magee Campus
Northland Road
Londonderry
BT48 7JL
United Kingdom
028 7167 5519
m.okane@ulster.ac.uk

Type

Scientific

Additional contact

Prof Marie Murphy

ORCID ID

http://orcid.org/0000-0003-3482-3323

Contact details

Ulster University
Room 14G15
Jordanstown Campus
Shore Road
Newtownabbey
Co. Antrim
Belfast
BT37 0QB
United Kingdom
028 9036 6669
mh.murphy@ulster.ac.uk

Type

Scientific

Additional contact

Prof Alison Gallagher

ORCID ID

http://orcid.org/0000-0003-2109-3472

Contact details

Room L246
Ulster University
Magee Campus
Northland Road
Londonderry
BT48 7JL
United Kingdom
028 7012 3178
am.gallagher@ulster.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

REC/19/0020

Study information

Scientific title

The Walking In ScHools (WISH) Trial: a cross-border trial to evaluate a walking intervention in adolescent girls.

Acronym

WISH

Study hypothesis

To conduct a fully-powered clustered randomised controlled trial to evaluate the effectiveness of a novel, low-cost, peer-led school-based walking intervention, delivered across the school year, at increasing objectively measured PA levels of adolescent girls in schools within NI and the border counties of Ireland.

It is hypothesised that intervention participants will increase daily physical activity and reduce time spent sedentary by replacing sedentary behaviour with walking.

Ethics approval

Aproved 20/06/2019, Ulster University Research Ethics Committee (Research Governance, Room 26A20, Ulster University, Shore Road, Newtownabbey, Co Antrim, BT37 OQB; +44 28 9036 6629), ref: REC/19/0020.

Study design

Clustered randomised 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 below to request a participant information sheet

Condition

Physical activity

Intervention

Schools will be randomised to either receive the walking intervention, or to act as controls.
Following baseline measurements, the intervention will be delivered for the whole school year. Allowing for holidays, exams, educational trips and other school events this will vary from one school to another however the minimum intervention will be a minimum 20 and a maximum of 22 weeks.

INTERVENTION: In intervention schools, female pupils (identified by school staff) aged 16-18yrs (peer role models) will be trained as walk leaders to lead younger pupils (aged 12-14rs) in 10-15 min walks before school and at break and lunch recess. All walks will occur in school grounds and pupils will be encouraged to participate in many walks as possible each week. Reward cards, stamped for each walk completed and exchanged for small rewards with low monetary value will be used for self-monitoring. Walking routes will be pre-determined and a risk assessment will be completed for each school site. Peer walk leaders will be trained to ensure they consider safety concerns of facilitating the walks and the training programme will emphasize the importance of the walks being performed at a brisk pace, i.e. at a pace sufficient to elicit moderate intensity PA in participants. Training will also include information on providing and encouraging social support amongst participants to align with Self Determination Theory (SDT). Two walk leaders will accompany each walk, one at the front and one at the back of the group. Leaders will set the pace of the walk and ensure the safety of pupils. Walks will take place in a one of the pre-planned routes around the school grounds. At the end of each walk, walk leaders will stamp each participants’ card and note attendees to monitor compliance with the intervention.

As part of the social support component of the intervention, participants and walk leaders will be invited to be part of separate closed social media groups designed to include opportunities for social support in the form of capabilities to share progress with friends. In addition, social support and encouragement to continue to participate will be provided to participants via weekly updates which will include: strategies to address barriers and recognize progress; links to websites and resources; and vignettes of support and advice from others who have successfully increased their physical activity levels. These pages will only be accessible to those in the intervention and will be moderated by named members of the research team to ensure data protection.

CONTROL: During the intervention period, schools (and participants) in the control group will be instructed to continue with their normal PA habits.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Objectively measured total physical activity (counts per minute) of participants is measured using the Actigraph GT3X accelerometer device for 7 consecutive days at baseline, end of intervention and 13 months post-follow-up.

Secondary outcome measures

1. Body Mass Index (BMI) (height and weight) is measured at baseline, end of intervention and 13 months post-follow-up.
2. Waist:hip ratio (waist and hip circumference) is measured at baseline, end of intervention and 13 months post-follow-up.
3. Sedentary behaviour and light, moderate and vigorous intensity physical activity are measured using accelerometer data at baseline, mid- and end of the intervention and 13 months post-follow-up.
4. Proportion of pupils meeting current physical activity recommendations is measured using accelerometer data at baseline, mid- and end of the intervention and 13 months post-follow-up.
5. Wellbeing, sleep and social media usage are measured using the following validated questionnaires at baseline, end of intervention and 13 months post-follow-up
5.1. Emotion regulation questionnaire for children and adolescents
5.2. Pittsburgh Sleep Quality Index.
5.3. Social media use integration scale.
5.4. Body weight and appearance satisfaction.
6. Reasons for participating in physical activity is measured using BREQ-2 at baseline, end of intervention and 13 months post-follow-up.
7. Self-efficacy for physical activity and walking is measured using the Children’s PA self- efficacy scale at baseline, end of intervention and 13 months post-follow-up.
8. Health-related quality of life is measured using KIDSCREEN 10 at baseline, end of intervention and 13 months post-follow-up.
9. Effect of social networks on physical activity behaviour is measured using friendship nominations at baseline, end of intervention and 13 months post-follow-up.
10. The motivation for change and how elements of the environment may have affected the delivery of the intervention are measured using interviews with walk leaders at baseline, mid- and end of intervention.
11. How participants currently spend their break/lunchtimes, levels of physical activity during the school day and social media usage are measured using focus groups in each school.
11.1 Factors that affected participation, motivation and enjoyment of the intervention are measured using a focus group at the end of the intervention.
12. Key elements that might have affected the implementation of the intervention are measured using an in-depth interview with one school contact per intervention school at the end of the intervention.

Overall trial start date

01/04/2019

Overall trial end date

31/05/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Female pupils attending schools selected to participate.
2. Aged 12-14 years (i.e. Year 9/10 (NI) or First/Second Year (RoI)).
3. Healthy and free from any medical condition that limits their participation in a brisk walking intervention.

Participant type

Healthy volunteer

Age group

Child

Gender

Female

Target number of participants

450 (18 schools will be recruited and within each school at least 24 children will be recruited)

Participant exclusion criteria

None

Recruitment start date

01/09/2019

Recruitment end date

30/09/2020

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Ulster University
Magee Campus Northland Road
Londonderry
BT48 7JL
United Kingdom

Trial participating centre

Letterkenny Institute of Technology
Port Road
Letterkenny
F92 FC93
Ireland

Trial participating centre

University of Bristol
Senate House Tyndall Ave
Bristol
BS8 1TH
United Kingdom

Trial participating centre

University of Wolverhampton
Wulfruna St
Wolverhampton
WV1 1LY
United Kingdom

Sponsor information

Organisation

Ulster University

Sponsor details

Research Governance
Jordanstown Campus
Newtownabbey
Belfast
BT37 0QB
United Kingdom
028 9036 6518 - Research Governance Officer
researchgovernance@ulster.ac.uk

Sponsor type

University/education

Website

https://www.ulster.ac.uk/

Funders

Funder type

Government

Funder name

Department of Health, Northern Ireland

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Funder name

Health Service Executive (ROI)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To ensure the results are disseminated to the scientific community and policy makers, it is planned that there will be at least four publications in high-impact peer-reviewed journals. In addition to publication of a protocol paper, a paper outlining the main findings (physical activity), a paper detailing the results of the process evaluation and a paper including which includes the findings on the qualitative evaluation of the intervention will be published. All papers will be submitted for publication in open access journals.

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

Intention to publish date

31/05/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/07/2019: Internal review. 03/07/2019: The recruitment start date was updated from 01/05/2019 to 01/09/2019. 02/07/2019: Trial's existence confirmed by the Ulster University Research Ethics Committee.