Physical InactivityNCT07050797
Using Data-driven Insights From Wearable Technologies to Inform Whole School Physical Activity Interventions.
A study testing Individualised whole-school intervention, developed using data sharing and co-design. in people with Physical Inactivity, run by University of Bath at 1 site in United Kingdom.
Trial summary
This is a whole-school study using co-design to inform tailored school-based interventions. Schools will be allocated either to a control or intervention group and KS2 pupils will be asked to wear a wrist-worn physical activity monitor for a total of 5-weeks. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Individualised whole-school intervention, developed using data sharing and co-design.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 549 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 1 Mar 2024
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any KS2 pupil from the UK schools recruited.
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Data-driven Insights From Wearable Technologies to Inform Whole School Physical Activity Interventions
This is a whole-school study using co-design to inform tailored school-based interventions. Schools will be allocated either to a control or intervention group and KS2 pupils will be asked to wear a wrist-worn physical activity monitor for a total of 5-weeks. During this time the PI will be present in schools to collect notes regarding school practices and daily variation. In the control groups pupils will wear monitors for 5-weeks (blinded to data) and school practice will continue as normal; school staff will be asked not to make any changes within school. After these 5-weeks, schools' will receive a detailed report about pupils' physical activity, and a researcher will come in to discuss findings. In the intervention groups pupils will wear monitors for 2-weeks (blinded to data). After this time the PI will present staff with pupils' physical activity during a focus group in the form of user-friendly graphs and a summary report. Staff will be asked to reflect on school practices and co-design feasible and practical strategies to improve pupils' physical activity. These strategies will then be implemented over the following 3-weeks, with immediate physical activity feedback on the accompanying software application, which will be installed on school computers, and support from the PI. At the end of the 5th week, during another focus group, schools will be given a summary of the data and changes in pupils' physical activity. This is where staff can reflect on the project and highlight challenges or barriers, and strategies they believed to be successful. The researcher will not prescribe any changes, this will be at the initiation of the school and staff members.
Read the detailed description
This is a whole-school study which will follow a randomised controlled design and use co-design to inform tailored school-based interventions. Stratified randomisation will be used to allocate each school to either control or intervention groups. Interventions will be co-designed during focus groups in which pupils' baseline physical activity data will be discussed with their school staff members.
After the first two schools have been randomly assigned, minimisation will be used to allocate schools to either intervention or control groups. Minimising aims at specifically minimising differences in group variates. After the first two schools have been randomly allocated, it will be determined whether the subsequent allocation of schools would lead to a better balance in the variables of interest between control and intervention groups. For this study the variables of interest will be the school size (grouped into small, medium, and large) and free school meal (used as a marker of deprivation and grouped into low, medium, or high). The imbalance of these variables between control and intervention groups will be minimised by allocating schools to the group with the smaller total of the relevant variable (or at random if the totals are the same). When initially recruiting, schools will be informed about the possibility of being assigned to either the control or intervention group. Consent forms will be obtained from staff and parents/carers before the school is assigned to control or intervention.
All schools involved in the project will complete 2-weeks of baseline physical activity measures. During this time pupils involved in the project will wear Moki Technology physical activity bands within school hours only. Pupils and teachers will be blinded to the physical activity data, receiving no feedback or insights into how active they are. During this time the lead researcher will also fill out a diary each week with the help of teachers and staff members to detail what happens each school day and other factors, including weather. The purpose of this is so that when presented with the physical activity data members of staff can recall more easily what happened within the school day to explain any physical activity differences. Using a diary is not intended to prompt staff members to reflect on, or change physical activity within the school day, therefore, staff members will be told this is to detail all the commitments within the school day and to understand normal school practices.
Observational methods/ ethnographic style research will also be carried out during this time by the lead researcher to gain a greater insight into school practices and physical activity opportunities. The notes collected will be used to inform the later focus group and co-design of strategies.
Control Group: Those involved in the control group will continue to wear the bands for another 3-weeks following the baseline measures, receiving no feedback on their physical activity. Following this 5-week period in total, control groups will get a detailed overview of their pupils' physical activity in the form of user-friendly, visually appealing graphs, alongside personalised suggestions for improving physical activity metrics, and the opportunity to discuss results with the researcher if they wish. This is so they also get value from the project and can use the data to inform their future school practices. However, for the purpose of this study, no changes will be made to school practices for the duration they are involved with the project. Control schools will be told not to make any changes to policy or practices; it will be explained that we are trying to get an accurate representation of schools' physical activity, rather than making any changes at this stage.
Intervention Group: Staff members in intervention schools will be involved in focus groups where pupils' physical activity data from baseline measures and a reference data set will be shared, and an intervention co-designed during the focus groups conducted after the 2-week baseline measures. The focus groups will be conducted with teachers, leadership, and wider staff and lead by the researcher. A member of staff (i.e., P.E. lead) will be asked to act as school lead for the project, their role to ensure the research design and intervention are followed. They will be asked about their views of children's physical activity and school's influence before getting their views on the physical activity data, what they think are the barriers and facilitators to physical activity within their school, and what they think could be done to help encourage activity and address inequalities. The Creating Active School Framework (Daly-Smith et al., 2020) will be used during focus groups to help individuals think of aspects of the school day which could be adapted to improve pupils' physical activity outcomes. At the end of this focus group an intervention, which is co-designed, and contains at least 3 strategies which map onto the creating active schools' framework, will be implemented in the following 3-weeks.
During the 3-weeks intervention phase, the school staff will have access to the live physical activity data returned from the activity bands through the accompanying software application (which will be installed on their computers). This will be to enable self-monitoring by feeding back physical activity data. During the first week the researcher will support the schools in how to use the software, understand the data, and will provide guidance on how it could be used to further develop their practices at both school and class level.
Observational/ ethnographic methods will be conducted throughout the 5-week duration in both control and intervention schools to gain an understanding of school practices, the opportunities for children's physical activity and to ensure either normal school practices are being maintained or to assess intervention fidelity. Handwritten notes will be taken, before more detailed notes are subsequently typed up; no personal or sensitive information will be collected.
Daly-Smith A, Quarmby T, Archbold VS, Corrigan N, Wilson D, Resaland GK, et al. Using a multi-stakeholder experience-based design process to co-develop the Creating Active Schools Framework. Int J Behav Nutr Phy. 2020;17(1):13.
- Conditions
- Physical Inactivity
- Being tested
- Individualised whole-school intervention, developed using data sharing and co-design.
- Keywords
- Mixed-methods, Whole-school, Wearable Technology, Co-design
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised whole-school intervention, developed using data sharing and co-design.Behavioural
Individualised whole-school intervention, developed using data sharing and co-design.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The first two-weeks within each school children's baseline physical activity data will be collected. Children and school staff 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. In control groups pupils will continue to wear the monitors for another 3-weeks, with children and school staff continuing to be blinded to the data. |
| Whole-School Intervention | Experimental | After the 2-week baseline, schools will be assigned to either control or intervention groups. For schools in the intervention group pupils' baseline physical activity data will be shared with staff during focus groups and strategies which aim to improve pupils' physical activity will be co-designed with the PI. These individualised whole-school strategies will then be implemented over the subsequent 3-weeks. During this time staff will be able to access pupils' physical activity data through the accompanying software application, which will be installed on school computers, with the ability to continue refining strategies. Receives: Behavioral: Individualised whole-school intervention, developed using data sharing and co-design. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Changes-1
Daily step counts
Measured: change between baseline (assessed for 3-weeks) and during intervention period (assessed for 3-weeks) within each school
Secondary outcomes (2)
Qualitive Data
During focus groups teachers and staff will be asked for their responses to physical activity data, what strategies they believe would be feasible and acceptable to implement within their school environment, what challenges, barriers were faced when implementing and which strategies they perceived as successful.
Measured: following baseline and intervention measures (~1-2hr focus group workshop)
Physical Activity Changes-2
Moderate to Vigorous Physical Activity (MVPA) minutes
Measured: changes from baseline (assessed for 3-weeks) and during intervention period (assessed for 3-weeks) within each school
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Oct 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 549 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
- NCT07050797
- Sponsor's protocol ID
- EP 22 018
- Status last verified
- Jul 2025
- First submitted
- 7 Oct 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Data-driven Insights From Wearable Technologies to Inform Whole School Physical Activity Interventions
- ClinicalTrials.gov ID
- NCT07050797
- Acronym / sponsor ID
- EP 22 018
- Conditions
- Physical Inactivity
- Keywords
- Mixed-methods, Whole-school, Wearable Technology, Co-design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 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
- 1 Oct 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 3 Jul 2025 (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.
This is a whole-school study using co-design to inform tailored school-based interventions. Schools will be allocated either to a control or intervention group and KS2 pupils will be asked to wear a wrist-worn physical activity monitor for a total of 5-weeks. During this time the PI will be present in schools to collect notes regarding school practices and daily variation. In the control groups pupils will wear monitors for 5-weeks (blinded to data) and school practice will continue as normal; school staff will be asked not to make any changes within school. After these 5-weeks, schools' will receive a detailed report about pupils' physical activity, and a researcher will come in to discuss findings. In the intervention groups pupils will wear monitors for 2-weeks (blinded to data). After this time the PI will present staff with pupils' physical activity during a focus group in the form of user-friendly graphs and a summary report. Staff will be asked to reflect on school practices and co-design feasible and practical strategies to improve pupils' physical activity. These strategies will then be implemented over the following 3-weeks, with immediate physical activity feedback on the accompanying software application, which will be installed on school computers, and support from the PI. At the end of the 5th week, during another focus group, schools will be given a summary of the data and changes in pupils' physical activity. This is where staff can reflect on the project and highlight challenges or barriers, and strategies they believed to be successful. The researcher will not prescribe any changes, this will be at the initiation of the school and staff members.
Detailed description
This is a whole-school study which will follow a randomised controlled design and use co-design to inform tailored school-based interventions. Stratified randomisation will be used to allocate each school to either control or intervention groups. Interventions will be co-designed during focus groups in which pupils' baseline physical activity data will be discussed with their school staff members.
After the first two schools have been randomly assigned, minimisation will be used to allocate schools to either intervention or control groups. Minimising aims at specifically minimising differences in group variates. After the first two schools have been randomly allocated, it will be determined whether the subsequent allocation of schools would lead to a better balance in the variables of interest between control and intervention groups. For this study the variables of interest will be the school size (grouped into small, medium, and large) and free school meal (used as a marker of deprivation and grouped into low, medium, or high). The imbalance of these variables between control and intervention groups will be minimised by allocating schools to the group with the smaller total of the relevant variable (or at random if the totals are the same). When initially recruiting, schools will be informed about the possibility of being assigned to either the control or intervention group. Consent forms will be obtained from staff and parents/carers before the school is assigned to control or intervention.
All schools involved in the project will complete 2-weeks of baseline physical activity measures. During this time pupils involved in the project will wear Moki Technology physical activity bands within school hours only. Pupils and teachers will be blinded to the physical activity data, receiving no feedback or insights into how active they are. During this time the lead researcher will also fill out a diary each week with the help of teachers and staff members to detail what happens each school day and other factors, including weather. The purpose of this is so that when presented with the physical activity data members of staff can recall more easily what happened within the school day to explain any physical activity differences. Using a diary is not intended to prompt staff members to reflect on, or change physical activity within the school day, therefore, staff members will be told this is to detail all the commitments within the school day and to understand normal school practices.
Observational methods/ ethnographic style research will also be carried out during this time by the lead researcher to gain a greater insight into school practices and physical activity opportunities. The notes collected will be used to inform the later focus group and co-design of strategies.
Control Group: Those involved in the control group will continue to wear the bands for another 3-weeks following the baseline measures, receiving no feedback on their physical activity. Following this 5-week period in total, control groups will get a detailed overview of their pupils' physical activity in the form of user-friendly, visually appealing graphs, alongside personalised suggestions for improving physical activity metrics, and the opportunity to discuss results with the researcher if they wish. This is so they also get value from the project and can use the data to inform their future school practices. However, for the purpose of this study, no changes will be made to school practices for the duration they are involved with the project. Control schools will be told not to make any changes to policy or practices; it will be explained that we are trying to get an accurate representation of schools' physical activity, rather than making any changes at this stage.
Intervention Group: Staff members in intervention schools will be involved in focus groups where pupils' physical activity data from baseline measures and a reference data set will be shared, and an intervention co-designed during the focus groups conducted after the 2-week baseline measures. The focus groups will be conducted with teachers, leadership, and wider staff and lead by the researcher. A member of staff (i.e., P.E. lead) will be asked to act as school lead for the project, their role to ensure the research design and intervention are followed. They will be asked about their views of children's physical activity and school's influence before getting their views on the physical activity data, what they think are the barriers and facilitators to physical activity within their school, and what they think could be done to help encourage activity and address inequalities. The Creating Active School Framework (Daly-Smith et al., 2020) will be used during focus groups to help individuals think of aspects of the school day which could be adapted to improve pupils' physical activity outcomes. At the end of this focus group an intervention, which is co-designed, and contains at least 3 strategies which map onto the creating active schools' framework, will be implemented in the following 3-weeks.
During the 3-weeks intervention phase, the school staff will have access to the live physical activity data returned from the activity bands through the accompanying software application (which will be installed on their computers). This will be to enable self-monitoring by feeding back physical activity data. During the first week the researcher will support the schools in how to use the software, understand the data, and will provide guidance on how it could be used to further develop their practices at both school and class level.
Observational/ ethnographic methods will be conducted throughout the 5-week duration in both control and intervention schools to gain an understanding of school practices, the opportunities for children's physical activity and to ensure either normal school practices are being maintained or to assess intervention fidelity. Handwritten notes will be taken, before more detailed notes are subsequently typed up; no personal or sensitive information will be collected.
Daly-Smith A, Quarmby T, Archbold VS, Corrigan N, Wilson D, Resaland GK, et al. Using a multi-stakeholder experience-based design process to co-develop the Creating Active Schools Framework. Int J Behav Nutr Phy. 2020;17(1):13.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The first two-weeks within each school children's baseline physical activity data will be collected. Children and school staff 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. In control groups pupils will continue to wear the monitors for another 3-weeks, with children and school staff continuing to be blinded to the data. |
| Whole-School Intervention | Experimental | Behavioral: Individualised whole-school intervention, developed using data sharing and co-design.After the 2-week baseline, schools will be assigned to either control or intervention groups. For schools in the intervention group pupils' baseline physical activity data will be shared with staff during focus groups and strategies which aim to improve pupils' physical activity will be co-designed with the PI. These individualised whole-school strategies will then be implemented over the subsequent 3-weeks. During this time staff will be able to access pupils' physical activity data through the accompanying software application, which will be installed on school computers, with the ability to continue refining strategies. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any KS2 pupil from the UK schools recruited.
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 |
|---|---|---|
| Individualised whole-school intervention, developed using data sharing and co-design.Individualised whole-school intervention, developed using data sharing and co-design. | Behavioural | Whole-School Intervention |
Primary outcome
Physical Activity Changes-1
Time frame: change between baseline (assessed for 3-weeks) and during intervention period (assessed for 3-weeks) within each school
Daily step counts
2 secondary outcomes
Qualitive Data
Time frame: following baseline and intervention measures (~1-2hr focus group workshop)
Physical Activity Changes-2
Time frame: changes from baseline (assessed for 3-weeks) and during intervention period (assessed for 3-weeks) within each school
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 3 Jul 2025.
- Individual participant dataSharing planned: Yes
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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 Individualised whole-school intervention, developed using data sharing and co-design. in people with Physical Inactivity, 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 3 Jul 2025. 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?
Physical Activity Changes-1 (time frame: change between baseline (assessed for 3-weeks) and during intervention period (assessed for 3-weeks) within 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 3 Jul 2025.