- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119076
The Effect of a Curriculum-based Physical Activity Intervention on Physical Activity in Schoolchildren
October 4, 2019 updated by: Alison Innerd, Teesside University
The Effect of a Curriculum-based Physical Activity Intervention on Accelerometer-assessed Physical Activity in Schoolchildren: a Non-randomised Mixed Methods Controlled Before-and-after Study
A non-randomised mixed methods controlled before-and-after study.
The study evaluated the effects of a classroom-based physical activity intervention in primary school children on physical activity.
Two schools were allocated to deliver the classroom-based intervention for eight weeks, and three schools continued with their usual school routine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary aim of this study was to test the feasibility and potential effect of a classroom-based, curriculum-embedded intervention - ExCiTE; Exercise Classes in the Teaching Environment- on total physical activity and moderate to vigorous physical activity.
The secondary aim was to measure and describe health-related quality of life and physical fitness components, and to gain understanding of the experiences, views and attitudes towards the ExCiTE intervention among participating children and schoolteachers.
Study Type
Interventional
Enrollment (Actual)
152
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
10 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parental Consent
- Child Assent
Exclusion Criteria:
Respiratory infections; or.
- Condition of injury affecting child's ability to undertake exercise
- Allergic to sticky tape
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: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Teacher delivered a 10 minute classroom-based physical activity on school days for eight weeks.
|
|
|
Other: Control Group
Children in the control schools continued with their usual school routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of time spent in moderate to vigorous physical activity (MVPA)
Time Frame: Accelerometer (ActiGraph GT3X) worn for 7 days. Analysed using Evenson cutpoints.
|
Daily moderate to vigorous physical activity (minutes) collected by wearing an accelerometer for 7 consecutive days.
|
Accelerometer (ActiGraph GT3X) worn for 7 days. Analysed using Evenson cutpoints.
|
|
Total physical activity
Time Frame: Accelerometer (ActiGraph GT3X) worn on the hip for 7 consecutive days. Analysed using Evenson cutpoints
|
Total physical activity measured by counts per minute
|
Accelerometer (ActiGraph GT3X) worn on the hip for 7 consecutive days. Analysed using Evenson cutpoints
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aerobic Fitness
Time Frame: 1 Day of testing
|
Aerobic Endurance.
Multistage fitness test
|
1 Day of testing
|
|
Health-Related Quality of Life
Time Frame: Recall questionnaire. Questionnaire completed on one day of testing
|
27 -item KIDSCREEN questionnaire.
Assesses health-related quality of life across five dimensions: physical well-being, psychological well-being, parent relations and autonomy, social support and peers and school environment.
Likert Scale 1-5.
Test completed at baseline, post-intervention and 4 weeks follow up
|
Recall questionnaire. Questionnaire completed on one day of testing
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fitness Test:Balance
Time Frame: Balance for 30 seconds on each leg. Test completed on one day of testing. Participants balances on one leg on a beam for 30 seconds. The number of times the participants has to put the foot on the floor during the 30 seconds is the score.
|
Flamingo balance test (from Eurofit Protocol).
Stand on a wooden beam for 30 seconds and try to balance for 30 seconds.
Complete with each foot
|
Balance for 30 seconds on each leg. Test completed on one day of testing. Participants balances on one leg on a beam for 30 seconds. The number of times the participants has to put the foot on the floor during the 30 seconds is the score.
|
|
Fitness Test:Flexibility
Time Frame: Best of three attempts on one day of testing.
|
Sit and reach test.
Sit against the sit and reach box, lean forwards and stretch as far forward as possible.
Measured to the nearest cm.
The higher the number, the better the flexbility.
|
Best of three attempts on one day of testing.
|
|
Fitness Test: Speed Fitness Test: Speed
Time Frame: one attempt on one day of testing.
|
10 x 5m shuttle run (from Eurofit Protocol).
Run between two cones 5m apart 10 times.
The lower the score, the better
|
one attempt on one day of testing.
|
|
Fitness Test: Hand Eye Coordination
Time Frame: Best of three attempts, one one day of testing. Time is recorded. The faster the time the better the hand eye coordination
|
Plate tapping - tap the hand on two different colour spots - using the dominant hand.
|
Best of three attempts, one one day of testing. Time is recorded. The faster the time the better the hand eye coordination
|
|
Fitness Test: Explosive Strength
Time Frame: Best of three attempts, one one day of testing. Distance is recorded. The further the distance the better the explosive strength
|
Standing broad jump.
Jump as far forwards as possible keeping both feet together.
The measurement is taken from the heel on the furthest back landing foot
|
Best of three attempts, one one day of testing. Distance is recorded. The further the distance the better the explosive strength
|
|
Fitness Test: muscular strength and endurance
Time Frame: One day of testing. The number of sit ups completed in 30 seconds. The higher the number equates to a better performance
|
Sit up on a mat (from Eurofit Protocol)
|
One day of testing. The number of sit ups completed in 30 seconds. The higher the number equates to a better performance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
August 21, 2019
First Submitted That Met QC Criteria
October 4, 2019
First Posted (Actual)
October 8, 2019
Study Record Updates
Last Update Posted (Actual)
October 8, 2019
Last Update Submitted That Met QC Criteria
October 4, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- TU2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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