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Effects of a Postural Education Multicomponent Intervention in Primary School Children.

NCT ID: NCT06668129

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

849 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-06-11

Brief Summary

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The present study, named PEPE project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. As well as, this project aims to examine the effectiveness of the intervention on teachers. Total of 2000 children aged 10 to 12 and 20 schools will be randomized into an intervention group (N=1000 children, N=10 schools) and a control group (N=1000 children, N=10 schools). A 9-months intervention program will be implemented. Participants will be evaluated three times: before the intervention (baseline, Month 0), after the intervention (post-test, Month 9) and 6 months after the intervention finished (follow-up, Month 15). The intervention will consist on: (1) nine oral presentations delivered at school, (2) multisubject teaching unit, (3) information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.), and (4) The Back-Care Day at school. The effectiveness of the intervention will be evaluated by means of primary outcomes which include the back-care knowledge of schoolchildren. As well as, a set of secondary outcomes such as daily postural habits, use of a backpack, and LBP prevalence in schoolchildren and among teachers involved will be studied. This intervention will provide new insights into the prevention of childhood LBP which may lead to a better management of this health problem throughout an individuals lifetime.

Detailed Description

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Conditions

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Physical Activity Back Pain Lower Back

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Back care intervention program

Group Type EXPERIMENTAL

Back care intervention program

Intervention Type BEHAVIORAL

The back care intervention consists of:

1. Nine oral presentations. Include "Programa Suma't" programme developed by the Provincial Council of Majorca.
2. Multisubject Teaching Unit.
3. Information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.)
4. "The Back Care Day" at school.

Control condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Back care intervention program

The back care intervention consists of:

1. Nine oral presentations. Include "Programa Suma't" programme developed by the Provincial Council of Majorca.
2. Multisubject Teaching Unit.
3. Information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.)
4. "The Back Care Day" at school.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children aged between 10 and 12 years, who belonged to the fifth and sixth grades of primary school.

Exclusion Criteria

* Children with some type of medical condition that may affect the results of the measurements or that present some limitation of their abilities that prevents the intervention program from developing normally.
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State Research Agency, Spain

OTHER_GOV

Sponsor Role collaborator

European Regional Development Fund

OTHER

Sponsor Role collaborator

Ministry of Science and Innovation, Spain

OTHER_GOV

Sponsor Role collaborator

University of the Balearic Islands

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of the Balearic Islands

Palma, Balearic Islands, Spain

Site Status

Countries

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Spain

Other Identifiers

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RTI2018-101023-A-I00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

130CER19

Identifier Type: -

Identifier Source: org_study_id