The Effect of a Curriculum-based Physical Activity Intervention on Physical Activity in Schoolchildren

October 4, 2019 updated by: Alison Innerd, Teesside University

The Effect of a Curriculum-based Physical Activity Intervention on Accelerometer-assessed Physical Activity in Schoolchildren: a Non-randomised Mixed Methods Controlled Before-and-after Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary aim of this study was to test the feasibility and potential effect of a classroom-based, curriculum-embedded intervention - ExCiTE; Exercise Classes in the Teaching Environment- on total physical activity and moderate to vigorous physical activity. The secondary aim was to measure and describe health-related quality of life and physical fitness components, and to gain understanding of the experiences, views and attitudes towards the ExCiTE intervention among participating children and schoolteachers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parental Consent
  • Child Assent

Exclusion Criteria:

  • Respiratory infections; or.

    • Condition of injury affecting child's ability to undertake exercise
    • Allergic to sticky tape

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Teacher delivered a 10 minute classroom-based physical activity on school days for eight weeks.
Other: Classroom-based physical activity
Other: Control Group
Children in the control schools continued with their usual school routine
Other: Control Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amount of time spent in moderate to vigorous physical activity (MVPA)
Time Frame: Accelerometer (ActiGraph GT3X) worn for 7 days. Analysed using Evenson cutpoints.
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
Time Frame: Accelerometer (ActiGraph GT3X) worn on the hip for 7 consecutive days. Analysed using Evenson cutpoints
Total physical activity measured by counts per minute
Accelerometer (ActiGraph GT3X) worn on the hip for 7 consecutive days. Analysed using Evenson cutpoints

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aerobic Fitness
Time Frame: 1 Day of testing
Aerobic Endurance. Multistage fitness test
1 Day of testing
Health-Related Quality of Life
Time Frame: Recall questionnaire. Questionnaire completed on one day of testing
27 -item KIDSCREEN questionnaire. Assesses health-related quality of life across five dimensions: physical well-being, psychological well-being, parent relations and autonomy, social support and peers and school environment. Likert Scale 1-5. Test completed at baseline, post-intervention and 4 weeks follow up
Recall questionnaire. Questionnaire completed on one day of testing

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fitness Test:Balance
Time Frame: 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.
Flamingo balance test (from Eurofit Protocol). Stand on a wooden beam for 30 seconds and try to balance for 30 seconds. Complete with each foot
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
Time Frame: Best of three attempts on one day of testing.
Sit and reach test. Sit against the sit and reach box, lean forwards and stretch as far forward as possible. Measured to the nearest cm. The higher the number, the better the flexbility.
Best of three attempts on one day of testing.
Fitness Test: Speed Fitness Test: Speed
Time Frame: one attempt on one day of testing.
10 x 5m shuttle run (from Eurofit Protocol). Run between two cones 5m apart 10 times. The lower the score, the better
one attempt on one day of testing.
Fitness Test: Hand Eye Coordination
Time Frame: Best of three attempts, one one day of testing. Time is recorded. The faster the time the better the hand eye coordination
Plate tapping - tap the hand on two different colour spots - using the dominant hand.
Best of three attempts, one one day of testing. Time is recorded. The faster the time the better the hand eye coordination
Fitness Test: Explosive Strength
Time Frame: Best of three attempts, one one day of testing. Distance is recorded. The further the distance the better the explosive strength
Standing broad jump. Jump as far forwards as possible keeping both feet together. The measurement is taken from the heel on the furthest back landing foot
Best of three attempts, one one day of testing. Distance is recorded. The further the distance the better the explosive strength
Fitness Test: muscular strength and endurance
Time Frame: One day of testing. The number of sit ups completed in 30 seconds. The higher the number equates to a better performance
Sit up on a mat (from Eurofit Protocol)
One day of testing. The number of sit ups completed in 30 seconds. The higher the number equates to a better performance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teesside University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TU2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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