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Classroom Standing Desks for Reducing Sitting Time in Children

28 de abril de 2017 atualizado por: Luís Bettencourt Sardinha, University of Lisbon

Effects of Sit-to-stand Desks on Behavior and Cognitive Function in Children

In this trial the investigators aim to verify the potential impacts of a multi-level intervention with standing desks on behavior and cognitive function in children

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

This is a cluster controlled trial conducted in a school setting. Two classes (intervention and control) of sixth grade will be selected from a large, centrally located school in Lisbon. The intervention will take place over a period of 16 weeks and will be composed of physical environmental (standing desks), social environment, and education/behavior components. Objective measurements of physical activity and sedentary behavior (ActiGraph GT3X+ accelerometer and activPAL inclinometer), school performance (students grades), attention (D2 test), memory (Rey complex figure), fluid intelligence (Raven's Progressive Matrices), visuo-spatial short term working memory (Corsi block-tapping test), processing speed and inhibitory function (Stoop test) will be assessed. Finally, anthropometry and stakeholders' perceptions will also be obtained at baseline and after the intervention.

Tipo de estudo

Intervencional

Inscrição (Real)

49

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Portugal
      • Lisbon, Portugal, 1800-071
        • Danilo Rodrigues Pereira da Silva

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

11 anos a 13 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Aged between 11 and 13 years-old
  • Be able to postural changes

Exclusion Criteria:

  • Do not return the written informed consent properly signed by parents/guardians

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention
Sit-to-stand desks (Ergotron LearnFit®) will replace standard desks. In addition, meeting with parents and teacher's training will be conducted in order to support behavior change.
Comportamental: Intervention

Multi-level intervention focused on school environment (furniture) will be conducted.

Device: Sit-to-stand desks (Ergotron LearnFit®); Device: (Actigraph, Pensacola, FL, USA); Device: ActivPALTM .
Sem intervenção: Control
Control classroom will maintain their routine in sitting desks.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sedentary behavior
Prazo: 16 weeks
Sedentary behavior will be assessed trough the sitting time (min/day) given by ActivPALTM micro device (PAL Technologies Limited, Glasgow, UK). The device will be attached on anterior mid-line of the participants right thigh though 3MTM TegadermTM Transparent Film Roll (4 in x 11yd). Participants will wear the inclinometer continuously for seven days, including shower and sleep time, except in swimming activities. The ActivPAL3TM software v.7.2.32 will be used to data reduction. In addition to the baseline and follow-up measurements, the inclinometer will be used during the intervention just in school time to better clarify the sit-to-stand desks use.
16 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Physical activity
Prazo: 16 weeks
Physical activity will be measured though Actigraph GT3X+ accelerometers (Actigraph, Pensacola, FL, USA). Participants will be instructed to wear the device on the right rip (near the iliac crest) during waking hours for seven days. The device will be attached via an elastic belt and must will removed only in water-based activities. Will be considered a valid evaluations which had four or more days (including one of weekend) of a minimum of 600 minutes of wear. The Choi et al. [16] criteria of wear time and Evenson et al. [17] cuttoffs to PA intensities will be applicable with 15s epochs (collected at 30Hz) by Actilife v.6.10.4. The participants shall register in daily record the time which the device is removed and the reason.
16 weeks
Academic achievement
Prazo: 16 weeks
Participants grades will be obtained in both assessments points. Individual and sum of disciplines grades changes will be considered to comparisons purposes.
16 weeks
Participants self-reported measurements
Prazo: 16 weeks
Information about self-perception of physical and mental health, academic performance, behaviors (exercise and sleep habits) and social relationship will be assessed by a specific questionnaire for the participants. In addition, the intervention group ones will report their expectations (before) and perceptions (after) of the standing desks use.
16 weeks
Stakeholders perceptions
Prazo: 16 weeks
Parents/guardians (individual level) and teachers perceptions (cluster level) about discipline, social interaction, academic performance and health behaviors of the children will be collected by a questionnaire filled before and after the intervention.
16 weeks
Cost-effectiveness
Prazo: 16 weeks
Considering the costs of classroom environmental adaptations and their effects on primary and secondary outcomes, the incremental cost-effectiveness ratio will be calculated comparing with costs of a traditional classroom.
16 weeks
Cognitive function - Coop Corsi block-tapping test
Prazo: 16 weeks
Visual-spatial working memory capacity will be assessed through Coop Corsi block-tapping test. A 3 × 3 grid of 9 blocks indicates a spatial sequence by changing the colour of one block at a time, and participants were then asked to repeat that sequence by clicking on the blocks in the same order. During the 12 trials, sequence length increased by 1 block location each time the participant correctly repeated the sequence. Any error in repeating a sequence led to the next sequence being shortened by one location. The variable of interest was mean memory span, calculated as the average length of the three longest correctly repeated sequences.
16 weeks
Cognitive function - Stroop color test
Prazo: 16 weeks
Sensitivity to interference and the ability to suppress an automated response will be assessed using the Stroop color test. The Stroop test consists in two levels. Both levels involve the test word being placed in the center of the screen, with the target and distractor presented randomly on the right or left of the test word. The target position was counterbalanced for the left and right side within each test level. The participant is asked to respond as quickly as possible, using the left and right arrow keys, to identify the position of the target word. The variable of interest is the proportion of correct responses made.
16 weeks
Cognitive function - d2 test
Prazo: 16 weeks

Sustained attention and visual scanning ability will be assessed using the d2 test. This paper-and-pencil task requires participants to detect "d" symbols with two dashes (that may be located either both above, both below, or one above and one below the "d") among distractors ("d's" with one, three, or four marks or "p's" with one or two marks).

The concentration performance score was determined on the number of correct responses minus errors. Higher scores indicate a better and more stable performance.
16 weeks
Neuropsychological assessment - Raven's matrices test
Prazo: 16 weeks
Neuropsychological assessment will be assessed using the Raven's Progressive Matrices. The test provides a simplified 36-item paper format. Each item contains a pattern problem with one part removed and six pictured inserts of which one contains the correct pattern. Participants point to the pattern piece they select or to its number. The total score is the total number of matrices completed correctly, and the test is thus scored out of 36.
16 weeks
Neuropsychological assessment - Rey-Osterrieth complex figure test
Prazo: 16 weeks
Neuropsychological assessment will be assessed using the Rey-Osterrieth complex figure test. The Rey-Osterrieth complex figure test (ROCF) is a neuropsychological assessment in which participants are asked to reproduce a complicated line drawing, first by copying it freehand (direct), and then drawing from memory (delayed copying). ROCF includes 18 units and the maximum score for each of the two tasks (direct and delayed copying) is 36. Two points are given when the element is correctly reproduced, 1 point when the reproduction is distorted, incomplete but placed properly, or complete but placed poorly; 0.5 point is credited when the element is distorted or incomplete and placed poorly. A zero score is given when the unit is absent or not recognizable.
16 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Lisbon

Investigadores

  • Cadeira de estudo: Luís Sardinha, PhD, University of Lisbon

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de janeiro de 2016

Conclusão Primária (Real)

9 de junho de 2016

Conclusão do estudo (Real)

17 de junho de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

13 de setembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de abril de 2017

Primeira postagem (Real)

3 de maio de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de maio de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de abril de 2017

Última verificação

1 de abril de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • LSardinha

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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