NCT04905615

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2021

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

May 24, 2021

Last Update Submit

October 5, 2022

Conditions

Keywords

Physical ActivityPrimary School ChildrenWearable TechnologyData Driven InterventionSchool-based InterventionCo-design

Outcome Measures

Primary Outcomes (1)

  • Step Count

    Changes in step counts from baseline

    2-weeks baseline, compared to 2-weeks intervention period in each school

Secondary Outcomes (3)

  • Moderate to Vigorous Physical Activity (MVPA)

    2-weeks baseline, compared to 2-weeks intervention period in each school

  • Qualitative Data

    Interviews conducted at the end of each 2-week period with each class teacher.

  • Pupil Demographics and Physical Activity Measures

    4 weeks

Study Arms (2)

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.

Other: Data-driven and teacher led school based strategies.

Interventions

The intervention is individualised to each school, depending on the teacher led strategies which are data-informed

Data-Driven Strategy Based Intervention

Eligibility Criteria

Age9 Years - 11 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTeachers input the gender pupils identify with into the physical activity data collection software.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any pupil from the each respective UK-based school and class. Pupils in years 5 to 6 (aged 9-11 years old).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, Banes, BA2, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 27, 2021

Study Start

April 19, 2021

Primary Completion

November 29, 2021

Study Completion

November 29, 2021

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations