Physical ActivityNCT04905615
The Use of Data From Wearable Technology to Co-develop School-specific Physical Activity Interventions
A study testing Data-driven and teacher led school based strategies. in people with Physical Activity, run by University of Bath at 1 site in United Kingdom.
Trial summary
Increasing physical activity is vital for children's physical and mental health. It is important to address inactivity early and engage children in positive behaviours which can be sustained throughout life. Teachers are well placed to understand and influence in-school factors impacting children's physical activity. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Data-driven and teacher led school based strategies.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2021to 29 Nov 2021
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any pupil from the each respective UK-based school and class. Pupils in years 5 to 6 (aged 9-11 years old).
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Data From Wearable Technology to Co-develop School-specific Physical Activity Interventions in Children Aged 9-11
Increasing physical activity is vital for children's physical and mental health. It is important to address inactivity early and engage children in positive behaviours which can be sustained throughout life. Teachers are well placed to understand and influence in-school factors impacting children's physical activity. As wearable technologies continue to improve and become more accessible, they offer the opportunity to engage schools in the data collection process, as well as providing them with the capacity to monitor strategies designed to improve physical activity. This study is a within-subject, pre-post, co-developed intervention design.
Read the detailed description
Previous interventions have not successfully increased physical activity levels in primary schools. This is arguably due to a lack of comprehensive data collection methods and the lack of co-involvement of teachers and children in intervention design. In previous research, accelerometers have been used by researchers to quantify children's physical activity levels. However, these have been research-grade devices which require a more complex analysis to extract results; because of this, these types of measurement tools have not been utilised by schools. This study will aim to utilise user-friendly technologies which can engage schools in the data collection process and be employed by schools to implement and measure strategies designed to increase physical activity by providing immediate feedback.
This project aims to investigate whether data from wearable technologies can be used to inform primary school-based practices and improve children's physical activity within school hours using co-developed interventions. This project is a participatory mixed-methods design in two phases. 7-9 schools will be recruited. The first phase in each school involves baseline measures of pupils' physical activity for 2-weeks, using accelerometers which have been specifically designed for school use. Pupils will be blinded to the physical activity data during this period. During this 2-week baseline teachers will be instructed to carry out lessons as normal, not changing their behaviour, or encouraging the pupils' physical activity. Data visualisations will be created from the 2-weeks of physical activity data collected within each school. Teachers will then be interviewed online, using Microsoft Teams, and encouraged to reflect on the physical activity data and co-develop 3-5 action points or strategies to increase children's physical activity. Teachers will then be asked to implement these action points over the subsequent 2-weeks, where again children's physical activity will be measured with the accelerometers. This time children will not be blinded to the data and can receive physical activity feedback if this is a strategy selected by their teacher. These changes will be at each schoolteacher's discretion and managed in a way they deem most appropriate. Following these 2-week changes teachers will be interviewed again about their experiences of using the technology and implementing strategies to encourage physical activity. They will then be shown similar data visualisations as before, comparing changes in pupils' physical activity between each 2-week period.
- Conditions
- Physical Activity
- Being tested
- Data-driven and teacher led school based strategies.
- Keywords
- Physical Activity, Primary School Children, Wearable Technology, Data Driven Intervention, School-based Intervention, Co-design
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data-driven and teacher led school based strategies.Other
The intervention is individualised to each school, depending on the teacher led strategies which are data-informed
| Study group | Role | What they receive |
|---|---|---|
| Baseline Measures | No intervention | The first two-weeks within each school children's baseline physical activity data will be collected. Children will be blinded to the data, receiving no feedback. Teachers will be instructed not to change normal school practices or encourage children's physical activity. |
| Data-Driven Strategy Based Intervention | Experimental | During the following 2-weeks teachers will be implementing strategies to improve their class' physical activity. These are individualised strategies which will be co-developed during semi-structured interviews where teachers will discuss data visualisations with the researcher which depicts their class' physical activity over the 2-week baseline period. Teachers will then implement these strategies over the subsequent 2-weeks. During this time teachers are able to share the physical activity data with their pupils if they wish. Receives: Other: Data-driven and teacher led school based strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Count
Changes in step counts from baseline
Measured: 2-weeks baseline, compared to 2-weeks intervention period in each school
Secondary outcomes (3)
Moderate to Vigorous Physical Activity (MVPA)
Changes in MVPA from baseline
Measured: 2-weeks baseline, compared to 2-weeks intervention period in each school
Qualitative Data
The first interview with teachers is conducted following the 2-week baseline measures, during which their class' physical activity data will be discussed and action points co-developed. The second interview will take place after the 2-week intervention period. Teachers will be presented with their class' physical activity data changes, which will be discussed alongside the successes and challenges of the implemented action points.
Measured: Interviews conducted at the end of each 2-week period with each class teacher.
Pupil Demographics and Physical Activity Measures
Physical activity changes in different demographic groups (i.e., gender, free school meal, pupil premium and SEN)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start19 Apr 2021
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom, University of Bristol, Loughborough University
- Responsible party
- Principal investigator, Georgina Wort, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905615
- Sponsor's protocol ID
- EP 1920 009
- Status last verified
- Oct 2022
- First submitted
- 24 May 2021
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Data From Wearable Technology to Co-develop School-specific Physical Activity Interventions in Children Aged 9-11
- ClinicalTrials.gov ID
- NCT04905615
- Acronym / sponsor ID
- EP 1920 009
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Primary School Children, Wearable Technology, Data Driven Intervention, School-based Intervention, Co-design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom, University of Bristol, Loughborough University
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 27 May 2021 (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.
Increasing physical activity is vital for children's physical and mental health. It is important to address inactivity early and engage children in positive behaviours which can be sustained throughout life. Teachers are well placed to understand and influence in-school factors impacting children's physical activity. As wearable technologies continue to improve and become more accessible, they offer the opportunity to engage schools in the data collection process, as well as providing them with the capacity to monitor strategies designed to improve physical activity. This study is a within-subject, pre-post, co-developed intervention design.
Detailed description
Previous interventions have not successfully increased physical activity levels in primary schools. This is arguably due to a lack of comprehensive data collection methods and the lack of co-involvement of teachers and children in intervention design. In previous research, accelerometers have been used by researchers to quantify children's physical activity levels. However, these have been research-grade devices which require a more complex analysis to extract results; because of this, these types of measurement tools have not been utilised by schools. This study will aim to utilise user-friendly technologies which can engage schools in the data collection process and be employed by schools to implement and measure strategies designed to increase physical activity by providing immediate feedback.
This project aims to investigate whether data from wearable technologies can be used to inform primary school-based practices and improve children's physical activity within school hours using co-developed interventions. This project is a participatory mixed-methods design in two phases. 7-9 schools will be recruited. The first phase in each school involves baseline measures of pupils' physical activity for 2-weeks, using accelerometers which have been specifically designed for school use. Pupils will be blinded to the physical activity data during this period. During this 2-week baseline teachers will be instructed to carry out lessons as normal, not changing their behaviour, or encouraging the pupils' physical activity. Data visualisations will be created from the 2-weeks of physical activity data collected within each school. Teachers will then be interviewed online, using Microsoft Teams, and encouraged to reflect on the physical activity data and co-develop 3-5 action points or strategies to increase children's physical activity. Teachers will then be asked to implement these action points over the subsequent 2-weeks, where again children's physical activity will be measured with the accelerometers. This time children will not be blinded to the data and can receive physical activity feedback if this is a strategy selected by their teacher. These changes will be at each schoolteacher's discretion and managed in a way they deem most appropriate. Following these 2-week changes teachers will be interviewed again about their experiences of using the technology and implementing strategies to encourage physical activity. They will then be shown similar data visualisations as before, comparing changes in pupils' physical activity between each 2-week period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Measures | No intervention | –The first two-weeks within each school children's baseline physical activity data will be collected. Children will be blinded to the data, receiving no feedback. Teachers will be instructed not to change normal school practices or encourage children's physical activity. |
| Data-Driven Strategy Based Intervention | Experimental | Other: Data-driven and teacher led school based strategies.During the following 2-weeks teachers will be implementing strategies to improve their class' physical activity. These are individualised strategies which will be co-developed during semi-structured interviews where teachers will discuss data visualisations with the researcher which depicts their class' physical activity over the 2-week baseline period. Teachers will then implement these strategies over the subsequent 2-weeks. During this time teachers are able to share the physical activity data with their pupils if they wish. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any pupil from the each respective UK-based school and class. Pupils in years 5 to 6 (aged 9-11 years old).
Key exclusion criteria (1 listed)
- No exclusion criteria.
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 |
|---|---|---|
| Data-driven and teacher led school based strategies.The intervention is individualised to each school, depending on the teacher led strategies which are data-informed | Other | Data-Driven Strategy Based Intervention |
Primary outcome
Step Count
Time frame: 2-weeks baseline, compared to 2-weeks intervention period in each school
Changes in step counts from baseline
3 secondary outcomes
Moderate to Vigorous Physical Activity (MVPA)
Time frame: 2-weeks baseline, compared to 2-weeks intervention period in each school
Qualitative Data
Time frame: Interviews conducted at the end of each 2-week period with each class teacher.
Pupil Demographics and Physical Activity Measures
Time frame: 4 weeks
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 6 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data-driven and teacher led school based strategies. in people with Physical Activity, run by University of Bath 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 6 Oct 2022. 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?
Step Count (time frame: 2-weeks baseline, compared to 2-weeks intervention period in each school). 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 6 Oct 2022.