Classroom Standing Desks for Reducing Sitting Time in Children
28 de abril de 2017 actualizado 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
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
49
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Lisbon, Portugal, 1800-071
- Danilo Rodrigues Pereira da Silva
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
11 años a 13 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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 . |
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Sin intervención: Control
Control classroom will maintain their routine in sitting desks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Sedentary behavior
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Physical activity
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Academic achievement
Periodo de tiempo: 16 weeks
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Participants grades will be obtained in both assessments points.
Individual and sum of disciplines grades changes will be considered to comparisons purposes.
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16 weeks
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Participants self-reported measurements
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Stakeholders perceptions
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Cost-effectiveness
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Cognitive function - Coop Corsi block-tapping test
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Cognitive function - Stroop color test
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Cognitive function - d2 test
Periodo de tiempo: 16 weeks
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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
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Neuropsychological assessment - Raven's matrices test
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Neuropsychological assessment - Rey-Osterrieth complex figure test
Periodo de tiempo: 16 weeks
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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.
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16 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Luís Sardinha, PhD, University of Lisbon
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Choi L, Liu Z, Matthews CE, Buchowski MS. Validation of accelerometer wear and nonwear time classification algorithm. Med Sci Sports Exerc. 2011 Feb;43(2):357-64. doi: 10.1249/MSS.0b013e3181ed61a3.
- Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651. Erratum In: Ann Intern Med. 2015 Sep 1;163(5):400.
- Benden ME, Blake JJ, Wendel ML, Huber JC Jr. The impact of stand-biased desks in classrooms on calorie expenditure in children. Am J Public Health. 2011 Aug;101(8):1433-6. doi: 10.2105/AJPH.2010.300072. Epub 2011 Mar 18.
- Gardner B, Smith L, Lorencatto F, Hamer M, Biddle SJ. How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. Health Psychol Rev. 2016;10(1):89-112. doi: 10.1080/17437199.2015.1082146. Epub 2015 Sep 16.
- Owen N. Sedentary behavior: understanding and influencing adults' prolonged sitting time. Prev Med. 2012 Dec;55(6):535-9. doi: 10.1016/j.ypmed.2012.08.024. Epub 2012 Sep 8.
- Evenson KR, Catellier DJ, Gill K, Ondrak KS, McMurray RG. Calibration of two objective measures of physical activity for children. J Sports Sci. 2008 Dec;26(14):1557-65. doi: 10.1080/02640410802334196.
- Owen N, Sugiyama T, Eakin EE, Gardiner PA, Tremblay MS, Sallis JF. Adults' sedentary behavior determinants and interventions. Am J Prev Med. 2011 Aug;41(2):189-96. doi: 10.1016/j.amepre.2011.05.013.
- Prince SA, Saunders TJ, Gresty K, Reid RD. A comparison of the effectiveness of physical activity and sedentary behaviour interventions in reducing sedentary time in adults: a systematic review and meta-analysis of controlled trials. Obes Rev. 2014 Nov;15(11):905-19. doi: 10.1111/obr.12215. Epub 2014 Aug 11.
- Sedentary Behaviour Research Network. Letter to the editor: standardized use of the terms "sedentary" and "sedentary behaviours". Appl Physiol Nutr Metab. 2012 Jun;37(3):540-2. doi: 10.1139/h2012-024. Epub 2012 Apr 27. No abstract available.
- Tremblay MS, LeBlanc AG, Kho ME, Saunders TJ, Larouche R, Colley RC, Goldfield G, Connor Gorber S. Systematic review of sedentary behaviour and health indicators in school-aged children and youth. Int J Behav Nutr Phys Act. 2011 Sep 21;8:98. doi: 10.1186/1479-5868-8-98.
- Ridgers ND, Salmon J, Ridley K, O'Connell E, Arundell L, Timperio A. Agreement between activPAL and ActiGraph for assessing children's sedentary time. Int J Behav Nutr Phys Act. 2012 Feb 19;9:15. doi: 10.1186/1479-5868-9-15.
- Clemes SA, Barber SE, Bingham DD, Ridgers ND, Fletcher E, Pearson N, Salmon J, Dunstan DW. Reducing children's classroom sitting time using sit-to-stand desks: findings from pilot studies in UK and Australian primary schools. J Public Health (Oxf). 2016 Sep;38(3):526-533. doi: 10.1093/pubmed/fdv084. Epub 2015 Jun 14.
- Hinckson E, Salmon J, Benden M, Clemes SA, Sudholz B, Barber SE, Aminian S, Ridgers ND. Standing Classrooms: Research and Lessons Learned from Around the World. Sports Med. 2016 Jul;46(7):977-87. doi: 10.1007/s40279-015-0436-2. Erratum In: Sports Med. 2016 Feb;46(2):297.
- Minges KE, Chao AM, Irwin ML, Owen N, Park C, Whittemore R, Salmon J. Classroom Standing Desks and Sedentary Behavior: A Systematic Review. Pediatrics. 2016 Feb;137(2):e20153087. doi: 10.1542/peds.2015-3087. Epub 2016 Jan 22.
- Mirwald RL, Baxter-Jones AD, Bailey DA, Beunen GP. An assessment of maturity from anthropometric measurements. Med Sci Sports Exerc. 2002 Apr;34(4):689-94. doi: 10.1097/00005768-200204000-00020.
- Silva DR, Machado DGS, Pinto F, Judice PB, Minderico CS, Collings PJ, Cyrino ES, Sardinha LB. Effect of a 16-week multi-level classroom standing desk intervention on cognitive performance and academic achievement in adolescents. Sci Rep. 2022 Sep 1;12(1):14504. doi: 10.1038/s41598-022-18248-y.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de enero de 2016
Finalización primaria (Actual)
9 de junio de 2016
Finalización del estudio (Actual)
17 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
13 de septiembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2017
Publicado por primera vez (Actual)
3 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- LSardinha
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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