- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03548350
School Based Physical Activity Interventions and Its Impact on Wellbeing and Educational Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
The control group will continue doing physical activity including physical education as is normal for their school
All groups will participate in fitness assessments at week 1 and week 24 of the programme and pupils will also complete questionnaires based on measures described above at week 1 and week 24.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Belfast, United Kingdom, BT12 6BJ
- Centre for Public Health, Queen's University Belfast
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged 8-9 years
- enrolled in participating school
Exclusion Criteria:
- Unable to give informed consent
- Presence of an underlying medical conditions
- Already enrolled in a physical activity intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
The experimental group will participate in a 24 week multi-component programme that includes four strands:
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A 24 week physical activity intervention to promote fitness and wellbeing in primary schools
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|
No Intervention: Control
The control group will continue doing physical activity including physical education as is normal for their school
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fitness
Time Frame: Baseline and week 24
|
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).
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Baseline and week 24
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Change in health related quality of life measured by Kidscreen-10 quality of life and wellbeing in children
Time Frame: Baseline and week 24
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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
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Physical activity behaviour measured by the Physical Activity Questionnaire for Children (PAQ-C)
Time Frame: Week 24
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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.
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Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enjoyment of physical activity measured using the Shortened Physical Activity Enjoyment Scale (S-PACES).
Time Frame: Week 24
|
Validated scale consisting of seven negatively worded items from the PACES study.
Seven items are rated on a 5-point Likert-type type scale ranging from 1 (disagree a lot) to 5 (agree a lot).
Items are summed to generate the S-PACES score, and higher scores reflect greater levels of enjoyment.
|
Week 24
|
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Self efficacy measured by the Modified Physical Activity Self-Efficacy Scale (PASES)
Time Frame: Week 24
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A validated 8-item measure of self-efficacy using 5 point likert scale for increased sensitivity.
The mean score of all eight items is used to indicate the children's PA self-efficacy with lower scores indicating lower self-efficacy.
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Week 24
|
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Social support for physical activity measured by social support sub scale of the Social-Cognitive Measures for Physical Activity
Time Frame: Week 24
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The original scale was based on friend and family only.
However, teacher social support scale was devised for the purpose of the study and follows the structure and wording of the family and friends social support for physical activity scales.
Each of the 11 items is scored from 1 to 5, where a score of 1 indicates low levels of social support.
Scores are summed and then averaged, resulting in a scale mean.
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Week 24
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Physical Self-perception measure by the Children's Physical Self-Perception Profile (CY-PSPP)
Time Frame: Week 24
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The CY-PSPP is a 36 item instrument consisting of six scales which represent a hierarchical arrangement of self-worth factors ranging from a global general self-worth scale (GSW) through a global physical self-worth scale (PSW) to four specific physical competence-adequacy sub domains.
Item scores for the scale range from 1-4 with the average score being used to represent the value of the scale.
Higher values indicate a better self-perception.
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Week 24
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HealthyKidz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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