Classroom Standing Desks for Reducing Sitting Time in Children
2017年4月28日 更新者：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
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
49
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Lisbon、葡萄牙、1800-071
- Danilo Rodrigues Pereira da Silva
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
11年 至 13年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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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无干预：Control
Control classroom will maintain their routine in sitting desks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Sedentary behavior
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Physical activity
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Luís Sardinha, PhD、University of Lisbon
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年1月4日
初级完成 (实际的)
2016年6月9日
研究完成 (实际的)
2016年6月17日
研究注册日期
首次提交
2016年9月13日
首先提交符合 QC 标准的
2017年4月28日
首次发布 (实际的)
2017年5月3日
研究记录更新
最后更新发布 (实际的)
2017年5月3日
上次提交的符合 QC 标准的更新
2017年4月28日
最后验证
2017年4月1日
更多信息
与本研究相关的术语
其他研究编号
- LSardinha
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Intervention的临床试验
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University完全的