NCT04119076

Brief Summary

A non-randomised mixed methods controlled before-and-after study. The study evaluated the effects of a classroom-based physical activity intervention in primary school children on physical activity. Two schools were allocated to deliver the classroom-based intervention for eight weeks, and three schools continued with their usual school routine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

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

January 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

August 21, 2019

Last Update Submit

October 4, 2019

Conditions

Keywords

school-based interventionactive classroom

Outcome Measures

Primary Outcomes (2)

  • Amount of time spent in moderate to vigorous physical activity (MVPA)

    Daily moderate to vigorous physical activity (minutes) collected by wearing an accelerometer for 7 consecutive days.

    Accelerometer (ActiGraph GT3X) worn for 7 days. Analysed using Evenson cutpoints.

  • Total physical activity

    Total physical activity measured by counts per minute

    Accelerometer (ActiGraph GT3X) worn on the hip for 7 consecutive days. Analysed using Evenson cutpoints

Secondary Outcomes (2)

  • Aerobic Fitness

    1 Day of testing

  • Health-Related Quality of Life

    Recall questionnaire. Questionnaire completed on one day of testing

Other Outcomes (6)

  • Fitness Test:Balance

    Balance for 30 seconds on each leg. Test completed on one day of testing. Participants balances on one leg on a beam for 30 seconds. The number of times the participants has to put the foot on the floor during the 30 seconds is the score.

  • Fitness Test:Flexibility

    Best of three attempts on one day of testing.

  • Fitness Test: Speed Fitness Test: Speed

    one attempt on one day of testing.

  • +3 more other outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Teacher delivered a 10 minute classroom-based physical activity on school days for eight weeks.

Other: Classroom-based physical activity

Control Group

OTHER

Children in the control schools continued with their usual school routine

Other: Control Group

Interventions

Intervention Group
Control Group

Eligibility Criteria

Age10 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parental Consent
  • Child Assent

You may not qualify if:

  • Respiratory infections; or.
  • Condition of injury affecting child's ability to undertake exercise
  • Allergic to sticky tape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two school allocated to receive the intervention, three schools allocated to the control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2019

First Posted

October 8, 2019

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share