NCT07050797

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
549

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

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

October 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

October 7, 2022

Last Update Submit

July 1, 2025

Conditions

Keywords

Mixed-methodsWhole-schoolWearable TechnologyCo-design

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Changes-1

    Daily step counts

    change between baseline (assessed for 3-weeks) and during intervention period (assessed for 3-weeks) within each school

Secondary Outcomes (2)

  • Qualitive Data

    following baseline and intervention measures (~1-2hr focus group workshop)

  • Physical Activity Changes-2

    changes from baseline (assessed for 3-weeks) and during intervention period (assessed for 3-weeks) within each school

Study Arms (2)

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.

Behavioral: Individualised whole-school intervention, developed using data sharing and co-design.

Interventions

Individualised whole-school intervention, developed using data sharing and co-design.

Whole-School Intervention

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any KS2 pupil from the UK schools recruited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

October 7, 2022

First Posted

July 3, 2025

Study Start

October 1, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations