Physical ActivityNCT04119076
The Effect of a Curriculum-based Physical Activity Intervention on Physical Activity in Schoolchildren
A study testing Classroom-based physical activity in people with Physical Activity, run by Teesside University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Classroom-based physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parental Consent
- Child Assent
Who cannot join
- Respiratory infections; or.
- Condition of injury affecting child's ability to undertake exercise
- Allergic to sticky tape
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Classroom-based physical activity, Control Group
- Keywords
- school-based intervention, active classroom
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classroom-based physical activityOther
Control GroupOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Teacher delivered a 10 minute classroom-based physical activity on school days for eight weeks. Receives: Other: Classroom-based physical activity |
| Control Group | Other | Children in the control schools continued with their usual school routine Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of time spent in moderate to vigorous physical activity (MVPA)
Daily moderate to vigorous physical activity (minutes) collected by wearing an accelerometer for 7 consecutive days.
Measured: Accelerometer (ActiGraph GT3X) worn for 7 days. Analysed using Evenson cutpoints.
Total physical activity
Total physical activity measured by counts per minute
Measured: Accelerometer (ActiGraph GT3X) worn on the hip for 7 consecutive days. Analysed using Evenson cutpoints
Secondary outcomes (2)
Aerobic Fitness
Aerobic Endurance. Multistage fitness test
Measured: 1 Day of testing
Health-Related Quality of Life
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
Measured: Recall questionnaire. Questionnaire completed on one day of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two school allocated to receive the intervention, three schools allocated to the control group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Innerd, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119076
- Sponsor's protocol ID
- TU2019
- Status last verified
- Oct 2019
- First submitted
- 21 Aug 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04119076
- Acronym / sponsor ID
- TU2019
- Conditions
- Physical Activity
- Keywords
- school-based intervention, active classroom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two school allocated to receive the intervention, three schools allocated to the control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Classroom-based physical activityTeacher delivered a 10 minute classroom-based physical activity on school days for eight weeks. |
| Control Group | Other | Other: Control GroupChildren in the control schools continued with their usual school routine |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parental Consent
- Child Assent
Key exclusion criteria (3 listed)
- Respiratory infections; or.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classroom-based physical activity | Other | Intervention Group |
| Control Group | Other | Control Group |
Primary outcome
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.
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
2 secondary outcomes
Aerobic Fitness
Time frame: 1 Day of testing
Health-Related Quality of Life
Time frame: Recall questionnaire. Questionnaire completed on one day of testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Classroom-based physical activity in people with Physical Activity, run by Teesside University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of time spent in moderate to vigorous physical activity (MVPA) (time frame: Accelerometer (ActiGraph GT3X) worn for 7 days. Analysed using Evenson cutpoints.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.