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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04905615
Other study ID # EP 1920 009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2021
Est. completion date November 29, 2021

Study information

Verified date October 2022
Source University of Bath
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 228
Est. completion date November 29, 2021
Est. primary completion date November 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 11 Years
Eligibility Inclusion Criteria: - Any pupil from the each respective UK-based school and class. Pupils in years 5 to 6 (aged 9-11 years old). Exclusion Criteria: - No exclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
United Kingdom University of Bath Bath Banes

Sponsors (4)

Lead Sponsor Collaborator
University of Bath Economic and Social Research Council, United Kingdom, Loughborough University, University of Bristol

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Step Count Changes in step counts from baseline 2-weeks baseline, compared to 2-weeks intervention period in each school
Secondary Moderate to Vigorous Physical Activity (MVPA) Changes in MVPA from baseline 2-weeks baseline, compared to 2-weeks intervention period in each school
Secondary 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. Interviews conducted at the end of each 2-week period with each class teacher.
Secondary Pupil Demographics and Physical Activity Measures Physical activity changes in different demographic groups (i.e., gender, free school meal, pupil premium and SEN) 4 weeks
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