NCT03548350

Brief Summary

A school based Physical Activity intervention for pupils (8-9 years old) to promote fitness and wellbeing

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

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

September 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

May 14, 2018

Last Update Submit

March 28, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in fitness

    Change from baseline in fitness as assessed as speed and agility (20 second shuttle run), core strength (timed lying leg raise) and flexibility and balance (single standing leg raise).

    Baseline and week 24

  • Change in health related quality of life measured by Kidscreen-10 quality of life and wellbeing in children

    KIDSCREEN is a validated self-report measure of children's subjective health and well-being. Kidscreen-10 is a 10 item instrument which gives a global health related quality of life score. Scores range from 10 to 50, with higher values indicate a higher health related quality of life.

    Baseline and week 24

  • Physical activity behaviour measured by the Physical Activity Questionnaire for Children (PAQ-C)

    The Physical Activity Questionnaire for Older Children (PAQ-C) is a validated self-report questionnaire designed to assess moderate to vigorous physical activity in children over a 7 day recall. Items are scored using a 5-point scale and a mean of all 9 items is used to create an overall PAQ-C activity summary score, with higher scores indicating higher levels of physical activity.

    Week 24

Secondary Outcomes (4)

  • Enjoyment of physical activity measured using the Shortened Physical Activity Enjoyment Scale (S-PACES).

    Week 24

  • Self efficacy measured by the Modified Physical Activity Self-Efficacy Scale (PASES)

    Week 24

  • Social support for physical activity measured by social support sub scale of the Social-Cognitive Measures for Physical Activity

    Week 24

  • Physical Self-perception measure by the Children's Physical Self-Perception Profile (CY-PSPP)

    Week 24

Study Arms (2)

Intervention

EXPERIMENTAL

The experimental group will participate in a 24 week multi-component programme that includes four strands: * A physical literacy programme focusing on core elements of strength, agility, speed, balance and flexibility. Delivered by external facilitators for one hour per week over 16 weeks of the programme (2 x8week blocks). * 'Golden Mile' - pupils and teachers participate 15min walk/run a min of 2 times per week * After schools club (not compulsory) featuring mind-set component delivered by external facilitators * Healthy kidz app with reward system

Behavioral: HealthyKidz physical activity programme

Control

NO INTERVENTION

The control group will continue doing physical activity including physical education as is normal for their school

Interventions

A 24 week physical activity intervention to promote fitness and wellbeing in primary schools

Intervention

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • aged 8-9 years
  • enrolled in participating school

You may not qualify if:

  • Unable to give informed consent
  • Presence of an underlying medical conditions
  • Already enrolled in a physical activity intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Public Health, Queen's University Belfast

Belfast, BT12 6BJ, United Kingdom

Location

MeSH Terms

Conditions

Motor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic supervisor

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 7, 2018

Study Start

September 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations