NCT02871830

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

August 10, 2016

Last Update Submit

August 15, 2016

Conditions

Physical Activity

Keywords

Physical activityWalkingInterventionAdolescent girlsRandomised trial

Outcome Measures

Primary Outcomes (1)

  • Total daily physical activity

    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 Outcomes (10)

  • Physical activity intensity

    Change between baseline and post-intervention (12 weeks) and 4-months post-intervention

  • Self-reported physical activity

    Change between baseline and post-intervention (12 weeks) and 4-months post-intervention

  • Weight

    Change between baseline and post-intervention (12 weeks) and 4-months post-intervention

  • Blood pressure

    Change between baseline and post-intervention (12 weeks) and 4-months post-intervention

  • Cardiorespiratory fitness

    Change between baseline and post-intervention (12 weeks) and 4-months post-intervention

  • +5 more secondary outcomes

Study Arms (2)

Physical activity intervention group

EXPERIMENTAL
Behavioral: Physical Activity

Control group

NO INTERVENTION

Interventions

Physical ActivityBEHAVIORAL

15 mins physical activity per day within the school setting.

Physical activity intervention group

Eligibility Criteria

Age11 Years - 13 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Male pupils

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29325578DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 18, 2016

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

August 18, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share