Condition category
Mental and Behavioural Disorders
Date applied
23/11/2017
Date assigned
29/11/2017
Last edited
29/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and Study Aim
Regular physical activity is important for children’s health and development. It is recommended that children and young people engage in 60 minutes of moderate to vigorous physical activity per day and engage in muscle strengthening activities 3 times a week. It is well known that a large proportion of children and young people are not meeting the guidelines. Thus, these children and young people are at an adverse risk to poorer health outcomes. Additionally, these children are not obtaining the numerous physical, psychological and social benefits that regular physical activity provides. The aim of the current project is to assess the effectiveness of a new school-based physical activity intervention lead by students within their schools.

Who can participate?
Adolescent girls aged 13-14 years (Year 9 in English secondary schools).

What does the study involve?
There are three schools involved in the project. All three schools receive the same leadership training programme which is delivered to a group of Year 9 leaders in each school. This programme provides the leaders with information and advice on physical activity, health and wellbeing and helps them support their friends to be more physically active. The leadership training programme are delivered by 3rd year Physical Education and School Sport undergraduate students from Edge Hill University. These university students act as mentors to Year 9 leaders. The mentors deliver training and educational sessions to the leaders and provided them with support throughout the project. The leaders role is to provide information they learn pertaining to physical activity and health and wellbeing to their peers and friends. In addition to the leadership training programme two out of the three schools have new after-school clubs which are used as an opportunity for the girls to do more physical activity on the school premises straight after the school day finishes. The school that does not receive the after-school club during the project will be given an after-school programme once the project has finished.

What are the possible benefits and risks of participating?
There is potential for girls to increase their knowledge of physical activity and health as part of the project. There is also potential for the girls to increase their physical activity levels and therefore potentially benefit their physical and mental health as a result of increased activity. There are no anticipated risks from taking part in the current project.

Where is the study run from?
This project will be run by members of the Physical Activity and Health Research Group from the Department of Sport and Physical Activity at Edge Hill University (UK).

When is study starting and how long is it expected to run for?
September 2015 to June 2018

Who is the main contact?
Professor Stuart Fairclough
Stuart.Fairclough@edgehill.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stuart Fairclough

ORCID ID

http://orcid.org/0000-0001-8358-1979

Contact details

Edge Hill University
Department Sport and Physical Activity
St Helens Road
Ormskirk
L39 4QP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n/a

Study information

Scientific title

A Novel Peer-led School-based Physical Activity Intervention for Adolescent Girls: The Girls’ Peer-ACTivity Project (G-PACT)

Acronym

G-PACT

Study hypothesis

1. As a result of the intervention there will be favourable changes in the primary and secondary outcomes.
2. These favourable changes will be greater among girls that receive a stronger intervention dose (i.e., peer leaders plus after-school activities) compared to those that receive just the peer leaders element.

Ethics approval

Edge Hill University, Faculty of Arts and Sciences, Department of Sport and Physical Activity, Department Research Ethics Committee, 01/12/2016, ref: SPA-REC-2016-340

Study design

Single centre non randomised three group study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Schools

Trial type

Prevention

Patient information sheet

See additional files

Condition

Psycho-social wellbeing and obesity-related

Intervention

The treatment is a novel peer-led school-based physical activity intervention. Schools indicated their willingness and capability to engage with the different levels of the three proposed interventions (i.e., time, availability of facilities, etc). After considering these factors the schools were allocated to the interventions so each had the best chance of being implemented as planned. No follow-up measures were taken post-intervention. However, each school received school and project-level feedback.

Each of the three schools receive the same peer-led school based leadership programme across a 7-week period. Each of the three schools receive a different after-school club physical activity component; school one received a 6-week structured exercise class which includes body weight and movement exercises, school two receives a 6-week after-school club which provide a choice of physical activities which participants had previously selected, and school three does not receive any additional after-school club component until after the intervention and post testing had been completed.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Daily minutes of moderate-to-vigorous physical activity and sedentary time is measured using the ActiGraph GT9X accelerometer device at baseline and 10 weeks.

Secondary outcome measures

1. Body mass index z-scores is measured using anthropometric measures of height and weight at baseline and 10 weeks
2. Waist-to-height ratio is measured using anthropometric measures of height and waist circumference at baseline and 10 weeks
3. Social support is measured using the 10-item Social Support and Exercise Survey (Sallis, 1987) at baseline and 10 weeks
4. Physical activity enjoyment is measured using the 7-item Physical Activity Enjoyment Scale (Motl et al. 2000; Ward et al., 2007) at baseline and 10 weeks
5. Self-efficacy is measured using the 8-item Physical Activity Self-efficacy Scale (Motl et al., 2000) at baseline and 10 weeks
6. Wellbeing is measured using the 7-item Warwick-Edinburgh Wellbeing Scale (Angold et al., 1995) at baseline and 10 weeks

Overall trial start date

01/09/2015

Overall trial end date

01/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Aged 13-14 years
3. Attending intervention school
4. Able to participate in regular physical activities (e.g., Physical Education class)

Participant type

Healthy volunteer

Age group

Child

Gender

Female

Target number of participants

180

Participant exclusion criteria

1. Male
2. Aged >14 years
3. Aged <13 years
4. Did not attend intervention school for the duration of the intervention
5. Unable to participate in regular physical activities (e.g., Physical Education class)

Recruitment start date

01/09/2016

Recruitment end date

01/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Edge Hill University
St Helens Road
Ormskirk
L39 4QP
United Kingdom

Sponsor information

Organisation

Edge Hill University

Sponsor details

St Helens Road
Ormskirk
L39 4QP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Edge Hill University

Alternative name(s)

EHU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publications in high-impact peer reviewed journals

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available because this level of data sharing was not included in the approved ethics application, and the trial participants did not consent to their data being made publically available.

Intention to publish date

01/02/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes