- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04905615
The Use of Data From Wearable Technology to Co-develop School-specific Physical Activity Interventions
The Use of Data From Wearable Technology to Co-develop School-specific Physical Activity Interventions in Children Aged 9-11
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Banes
-
Bath, Banes, United Kingdom, BA2
- University of Bath
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Baseline Measures
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.
|
|
Experimental: Data-Driven Strategy Based Intervention
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.
|
The intervention is individualised to each school, depending on the teacher led strategies which are data-informed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Step Count
Time Frame: 2-weeks baseline, compared to 2-weeks intervention period in each school
|
Changes in step counts from baseline
|
2-weeks baseline, compared to 2-weeks intervention period in each school
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate to Vigorous Physical Activity (MVPA)
Time Frame: 2-weeks baseline, compared to 2-weeks intervention period in each school
|
Changes in MVPA from baseline
|
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.
|
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.
|
Pupil Demographics and Physical Activity Measures
Time Frame: 4 weeks
|
Physical activity changes in different demographic groups (i.e., gender, free school meal, pupil premium and SEN)
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EP 1920 009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruiting