Active Schools: Skelmersdale

Active Schools: Skelmersdale



Sponsors


Source

Edge Hill University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

The aim of AS:Sk is to improve physical activity levels and health-related outcomes of
children from the Skelmersdale area of West Lancashire through a school-based physical
activity multi-component intervention.

Detailed Description

The multi-component intervention is the third and final phase of the AS:Sk project. It will
be implemented and evaluated in four of the seven participating schools. The remaining three
schools will act as controls and will not implement any physical activity intervention during
the period of the research project. Schools will be randomly assigned to either intervention
or control conditions. The multi-component intervention will involve multiple areas of the
schools' curricula, environments, or policies being targeted. Decisions regarding these
intervention components will be influenced by what was deemed effective, and feasible within
phase 2 of the project. Phase 2 included a four week trial of three different single
component physical activity interventions across all participating schools. Phase 3 will be
implemented for at least eight weeks and if successful, it would then be rolled out in the
control schools at the end of the project. Participants from both intervention and control
schools will take part in the measures for evaluation in this third and final phase of the
project.

Overall Status

Enrolling by invitation

Start Date

2017-09-13

Completion Date

2017-12-15

Primary Completion Date

2017-12-15

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Physical Activity Levels
7 days

Enrollment

250

Conditions


Intervention

Intervention Type

Other

Intervention Name


Description

School-based multicomponent intervention

Arm Group Label

Multicomponent PA intervention


Eligibility

Criteria

Inclusion Criteria:

- Year 5 pupil attending participating schools

Exclusion Criteria:

Gender

All

Minimum Age

9 Years

Maximum Age

10 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Stuart J Fairclough
Principal Investigator
Edge Hill University

Location

Facility

Edge Hill University
Ormskirk Lancs L39 4QP United Kingdom

Location Countries

Country

United Kingdom


Verification Date

2017-09-01

Lastchanged Date

2017-09-13

Firstreceived Date

2017-09-13

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Number Of Arms

1

Arm Group

Arm Group Label

Multicomponent PA intervention

Arm Group Type

Experimental

Description

Intervention schools will adopt a multicomponent intervention by integrating physical activities into different parts of the school day


Results Reference

Citation

Taylor SL, Curry WB, Knowles ZR, Noonan RJ, McGrane B, Fairclough SJ. Predictors of Segmented School Day Physical Activity and Sedentary Time in Children from a Northwest England Low-Income Community. Int J Environ Res Public Health. 2017 May 16;14(5). pii: E534. doi: 10.3390/ijerph14050534.

PMID

28509887


Citation

Fairclough SJ, Dumuid D, Taylor S, Curry W, McGrane B, Stratton G, Maher C, Olds T. Fitness, fatness and the reallocation of time between children's daily movement behaviours: an analysis of compositional data. Int J Behav Nutr Phys Act. 2017 May 10;14(1):64. doi: 10.1186/s12966-017-0521-z.

PMID

28486972



Firstreceived Results Date

N/A

Acronym

AS:Sk

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Intervention Model Description

Control vs Intervention clusters of schools

Primary Purpose

Prevention

Masking

None (Open Label)



ClinicalTrials.gov processed this data on September 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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