Physical ActivityWISH projectNCT02871830
Effects of a Peer-led Walking In ScHools Intervention
A study testing Physical Activity in people with Physical Activity, run by University of Ulster.
Trial summary
Children and young people are recommended to undertake at least 60 minutes of moderate to vigorous intensity physical activity each day. However recent findings have indicated that only 51% of children aged 7 years were meeting these guidelines. Read more about this study
- Who is it for?
- Ages 11 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 11-13 years old
- Female
- Attend a school selected to take part in the study
- Healthy and free from any medical condition that limits their participation in a brisk walking intervention, for example, a musculoskeletal injury
Who cannot join
- Male pupils
- Those who are unable to walk or for whom walking is contraindicated will not be eligible for inclusion
About this study
Official title: Effects of a Peer-led Walking In ScHools Intervention on Physical Activity Levels of Adolescent Girls: a School-based Cluster Randomised Controlled Trial
Children and young people are recommended to undertake at least 60 minutes of moderate to vigorous intensity physical activity each day. However recent findings have indicated that only 51% of children aged 7 years were meeting these guidelines. Previous research has also highlighted girls are significantly less active than. Furthermore, children living in Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here reaching the recommended ≥ 60 minutes a day. The development of interventions which can successfully increase levels of physical activity in adolescent girls in Northern Ireland is of key importance. The aim of this intervention is to investigate whether or not girls (aged 11-13 years) can increase their daily levels of physical activity over a 12 week period by taking part in a school-based brisk walking intervention. The impact of participating in a school-based brisk walking intervention on a range of other outcome measures will also be investigated. A total sample of 200 adolescent females will be recruited onto the study, with recruitment of participants taking place at the school level. Following written consent from parents/guardians and assent from participants, participants will be randomised at the school level to either participate in the walking intervention or to act as controls. Objective physical activity will be assessed at 3 time points using an Actigraph accelerometer. At baseline, post-intervention (12 weeks) and follow up (4 months post-intervention) participants will also undergo measurements of height, weight, waist and hip circumference, bloody pressure, and cardiorespiratory fitness. Participants will also complete questionnaires assessing levels of physical activity and a number of psychosocial variables at each time point. Following completion of follow up measurements, a sub-sample of participants (n=45) will be invited to take part in focus groups to evaluate their experiences of the intervention.
- Conditions
- Physical Activity
- Being tested
- Physical Activity
- Keywords
- Physical activity, Walking, Intervention, Adolescent girls, Randomised trial
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
15 mins physical activity per day within the school setting.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention group | Experimental | Not described Receives: Behavioral: Physical Activity |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily physical activity
Measured for 7 consecutive days using Actigraph accelerometer at each time-point
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Secondary outcomes (10)
Physical activity intensity
Measured for 7 consecutive days using Actigraph accelerometer at each time-point
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Self-reported physical activity
Measured using Physical Activity Questionnaire for children
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Weight
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Blood pressure
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Cardiorespiratory fitness
Measured using the Queens College Step test
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Self-efficacy for physical activity
Psychosocial questionnaire - Children's physical activity self-efficacy scale
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Self-efficacy for walking
Psychosocial questionnaire - adapted walking self-efficacy scale
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Social support for physical activity and walking
Social support for physical activity and walking from male and female parents/guardians and friends scale
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Attitude to exercise
Psychosocial questionnaire - perceived benefits and barriers to exercise scale
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Waist hip ratio
Measured: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871830
- Sponsor's protocol ID
- REC/11/0236
- Acronym
- WISH project
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Carlin A, Murphy MH, Nevill A, Gallagher AM. Effects of a peer-led Walking In ScHools intervention (the WISH study) on physical activity levels of adolescent girls: a cluster randomised pilot study. Trials. 2018 Jan 11;19(1):31. doi: 10.1186/s13063-017-2415-4.
PubMed 29325578
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Peer-led Walking In ScHools Intervention on Physical Activity Levels of Adolescent Girls: a School-based Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02871830
- Acronym / sponsor ID
- WISH project / REC/11/0236
- Conditions
- Physical Activity
- Keywords
- Physical activity, Walking, Intervention, Adolescent girls, Randomised trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children and young people are recommended to undertake at least 60 minutes of moderate to vigorous intensity physical activity each day. However recent findings have indicated that only 51% of children aged 7 years were meeting these guidelines. Previous research has also highlighted girls are significantly less active than. Furthermore, children living in Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here reaching the recommended ≥ 60 minutes a day. The development of interventions which can successfully increase levels of physical activity in adolescent girls in Northern Ireland is of key importance. The aim of this intervention is to investigate whether or not girls (aged 11-13 years) can increase their daily levels of physical activity over a 12 week period by taking part in a school-based brisk walking intervention. The impact of participating in a school-based brisk walking intervention on a range of other outcome measures will also be investigated. A total sample of 200 adolescent females will be recruited onto the study, with recruitment of participants taking place at the school level. Following written consent from parents/guardians and assent from participants, participants will be randomised at the school level to either participate in the walking intervention or to act as controls. Objective physical activity will be assessed at 3 time points using an Actigraph accelerometer. At baseline, post-intervention (12 weeks) and follow up (4 months post-intervention) participants will also undergo measurements of height, weight, waist and hip circumference, bloody pressure, and cardiorespiratory fitness. Participants will also complete questionnaires assessing levels of physical activity and a number of psychosocial variables at each time point. Following completion of follow up measurements, a sub-sample of participants (n=45) will be invited to take part in focus groups to evaluate their experiences of the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention group | Experimental | Behavioral: Physical Activity |
| Control group | No intervention | – |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 11-13 years old
- Female
- Attend a school selected to take part in the study
- Healthy and free from any medical condition that limits their participation in a brisk walking intervention, for example, a musculoskeletal injury
Key exclusion criteria (2 listed)
- Male pupils
- Those who are unable to walk or for whom walking is contraindicated will not be eligible for inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity15 mins physical activity per day within the school setting. | Behavioural | Physical activity intervention group |
Primary outcome
Total daily physical activity
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Measured for 7 consecutive days using Actigraph accelerometer at each time-point
10 secondary outcomes
Physical activity intensity
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Self-reported physical activity
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Weight
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Blood pressure
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Cardiorespiratory fitness
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Self-efficacy for physical activity
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Self-efficacy for walking
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Social support for physical activity and walking
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Attitude to exercise
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Waist hip ratio
Time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Derived from this study: PubMed 29325578Carlin A, Murphy MH, Nevill A, Gallagher AM. Effects of a peer-led Walking In ScHools intervention (the WISH study) on physical activity levels of adolescent girls: a cluster randomised pilot study. Trials. 2018 Jan 11;19(1):31. doi: 10.1186/s13063-017-2415-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Physical Activity, run by University of Ulster.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total daily physical activity (time frame: Change between baseline and post-intervention (12 weeks) and 4-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.