Physical ActivityAS:SkNCT03283904
Active Schools: Skelmersdale
A study testing Multicomponent physical activity intervention in people with Physical Activity and Sedentary Lifestyle, run by Edge Hill University at 1 site in United Kingdom.
Trial summary
The aim of AS:Sk is to improve physical activity levels and health-related outcomes of children from the Skelmersdale area of West Lancashire through a school-based physical activity multi-component intervention. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Lifestyle
- What is being tested?
- Multicomponent physical activity intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Sep 2017to 30 Jun 2018
- 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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Year 5 pupil attending participating schools
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of AS:Sk is to improve physical activity levels and health-related outcomes of children from the Skelmersdale area of West Lancashire through a school-based physical activity multi-component intervention.
Read the detailed description
The multi-component intervention is the third and final phase of the AS:Sk project. It will be implemented and evaluated in four of the seven participating schools. The remaining three schools will act as controls and will not implement any physical activity intervention during the period of the research project. Schools will be randomly assigned to either intervention or control conditions. The multi-component intervention will involve multiple areas of the schools' curricula, environments, or policies being targeted. Decisions regarding these intervention components will be influenced by what was deemed effective, and feasible within phase 2 of the project. Phase 2 included a four week trial of three different single component physical activity interventions across all participating schools. Phase 3 will be implemented for at least eight weeks and if successful, it would then be rolled out in the control schools at the end of the project. Participants from both intervention and control schools will take part in the measures for evaluation in this third and final phase of the project.
- Conditions
- Physical Activity, Sedentary Lifestyle
- Being tested
- Multicomponent physical activity intervention
- Keywords
- Children, Schools
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent physical activity interventionOther
School-based multicomponent intervention
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent PA intervention | Experimental | Intervention schools will adopt a multicomponent intervention by integrating physical activities into different parts of the school day Receives: Other: Multicomponent physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
School-day moderate-to-vigorous physical activity (MVPA)
Minutes of school-day MVPA accrued
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start13 Sep 2017
- Primary completion15 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Control vs Intervention clusters of schools
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edge Hill University
- Sponsor type
- University, hospital or other
- Collaborators
- West Lancashire Sport Partnership, West Lancashire Leisure Trust
- Responsible party
- Sponsor
- Investigators
- Stuart J Fairclough, Principal investigator, Edge Hill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283904
- Sponsor's protocol ID
- KIDSMOVE
- Acronym
- AS:Sk
- Status last verified
- Feb 2020
- First submitted
- 13 Sep 2017
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taylor SL, Curry WB, Knowles ZR, Noonan RJ, McGrane B, Fairclough SJ. Predictors of Segmented School Day Physical Activity and Sedentary Time in Children from a Northwest England Low-Income Community. Int J Environ Res Public Health. 2017 May 16;14(5):534. doi: 10.3390/ijerph14050534.
PubMed 28509887Fairclough SJ, Dumuid D, Taylor S, Curry W, McGrane B, Stratton G, Maher C, Olds T. Fitness, fatness and the reallocation of time between children's daily movement behaviours: an analysis of compositional data. Int J Behav Nutr Phys Act. 2017 May 10;14(1):64. doi: 10.1186/s12966-017-0521-z.
PubMed 28486972
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Schools: Skelmersdale
- ClinicalTrials.gov ID
- NCT03283904
- Acronym / sponsor ID
- AS:Sk / KIDSMOVE
- Conditions
- Physical Activity, Sedentary Lifestyle
- Keywords
- Children, Schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Edge Hill UniversityUniversity, hospital or other
- Collaborators
- West Lancashire Sport Partnership, West Lancashire Leisure Trust
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Sep 2017 (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.
The aim of AS:Sk is to improve physical activity levels and health-related outcomes of children from the Skelmersdale area of West Lancashire through a school-based physical activity multi-component intervention.
Detailed description
The multi-component intervention is the third and final phase of the AS:Sk project. It will be implemented and evaluated in four of the seven participating schools. The remaining three schools will act as controls and will not implement any physical activity intervention during the period of the research project. Schools will be randomly assigned to either intervention or control conditions. The multi-component intervention will involve multiple areas of the schools' curricula, environments, or policies being targeted. Decisions regarding these intervention components will be influenced by what was deemed effective, and feasible within phase 2 of the project. Phase 2 included a four week trial of three different single component physical activity interventions across all participating schools. Phase 3 will be implemented for at least eight weeks and if successful, it would then be rolled out in the control schools at the end of the project. Participants from both intervention and control schools will take part in the measures for evaluation in this third and final phase of the project.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Control vs Intervention clusters of schools
| Arm | Type | Receives |
|---|---|---|
| Multicomponent PA intervention | Experimental | Other: Multicomponent physical activity interventionIntervention schools will adopt a multicomponent intervention by integrating physical activities into different parts of the school day |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Year 5 pupil attending participating schools
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Multicomponent physical activity interventionSchool-based multicomponent intervention | Other | Multicomponent PA intervention |
Primary outcome
School-day moderate-to-vigorous physical activity (MVPA)
Time frame: 7 days
Minutes of school-day MVPA accrued
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 10 Feb 2020.
- Results publication: PubMed 28509887Taylor SL, Curry WB, Knowles ZR, Noonan RJ, McGrane B, Fairclough SJ. Predictors of Segmented School Day Physical Activity and Sedentary Time in Children from a Northwest England Low-Income Community. Int J Environ Res Public Health. 2017 May 16;14(5):534. doi: 10.3390/ijerph14050534.
- Results publication: PubMed 28486972Fairclough SJ, Dumuid D, Taylor S, Curry W, McGrane B, Stratton G, Maher C, Olds T. Fitness, fatness and the reallocation of time between children's daily movement behaviours: an analysis of compositional data. Int J Behav Nutr Phys Act. 2017 May 10;14(1):64. doi: 10.1186/s12966-017-0521-z.
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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.
Stuart J Fairclough principal investigator
Edge Hill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent physical activity intervention in people with Physical Activity and Sedentary Lifestyle, run by Edge Hill University at 1 site in United Kingdom.
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 1 inclusion and 1 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
School-day moderate-to-vigorous physical activity (MVPA) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03283904, which also lists 2 linked publications.
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 10 Feb 2020.