- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02871830
Effects of a Peer-led Walking In ScHools Intervention (WISH project)
August 15, 2016 updated by: University of Ulster
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Male pupils
- Those who are unable to walk or for whom walking is contraindicated will not be eligible for inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Physical activity intervention group
|
15 mins physical activity per day within the school setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity intensity
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
|
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
|
Measured using Physical Activity Questionnaire for children
|
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
|
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
|
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
|
Measured using the Queens College Step test
|
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
|
Psychosocial questionnaire - Children's physical activity self-efficacy scale
|
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
|
Psychosocial questionnaire - adapted walking self-efficacy scale
|
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
|
Social support for physical activity and walking from male and female parents/guardians and friends scale
|
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
|
Psychosocial questionnaire - perceived benefits and barriers to exercise scale
|
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
|
Change between baseline and post-intervention (12 weeks) and 4-months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
August 10, 2016
First Submitted That Met QC Criteria
August 15, 2016
First Posted (Estimate)
August 18, 2016
Study Record Updates
Last Update Posted (Estimate)
August 18, 2016
Last Update Submitted That Met QC Criteria
August 15, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- REC/11/0236
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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