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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Physical activity intervention group
Behavioral: Physical Activity
15 mins physical activity per day within the school setting.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulster

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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