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

NCT06668129 | Completed

• 2 other identifiers: 130CER19RTI2018-101023-A-I00
• Study Type: interventional
• Target: 849
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Activity; Back Pain Lower Back

Outcome Measures

Primary Outcomes (1)

• Knowledge of back health

  Validated questionnaire with Spanish children (Cronbach's alpha = 0.82) will be used to ascertain children's' level of knowledge on back care in daily life physical activities. Specifically, this questionnaire has 24 multiple choice items associated with one of the following categories according to conceptual knowledge: topographicalanatomical knowledge (items 1, 2, 3 and 6); functional-anatomical knowledge (items 4, 5 and 7); habits in standing posture (items 8-10); or seated (items 11-13); or lying (items 23 and 24); habits in carrying heavy objects in a backpack (items 14-18); and how to move heavy loads (items 19-22). Additionally, the questionnaire validated with Spanish schoolchildren and used in Méndez et al. will be used to assess back posture knowledge related to general principles of good body mechanics and fear-avoiding beliefs.

  16 weeks

Secondary Outcomes (5)

• Daily postural habits

  16 weeks

• Backpack use

  16 weeks

• LBP prevalence

  16 weeks

• Back care knowledge

  16 weeks

• LBP prevalence and daily postural habits

  16 weeks

Study Arms (2)

Back care intervention program

EXPERIMENTAL

Behavioral: Back care intervention program

Control condition

NO INTERVENTION

Interventions

Back care intervention program 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.

Back care intervention program

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Balearic Islands: lead
• State Research Agency, Spain: collaborator
• European Regional Development Fund: collaborator
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (1)

University of the Balearic Islands

Palma, Balearic Islands, 07122, Spain

Location

MeSH Terms

Conditions

Motor Activity; Low Back Pain

Condition Hierarchy (Ancestors)

Behavior; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 31, 2024
• Study Start: February 1, 2021
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

ES (1)