NCT03137836

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2016

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
Last Updated

May 3, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

September 13, 2016

Last Update Submit

April 28, 2017

Conditions

Sedentary LifestyleCognitive Ability, General

Outcome Measures

Primary Outcomes (1)

  • Sedentary behavior

    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

Secondary Outcomes (10)

  • Physical activity

    16 weeks

  • Academic achievement

    16 weeks

  • Participants self-reported measurements

    16 weeks

  • Stakeholders perceptions

    16 weeks

  • Cost-effectiveness

    16 weeks

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Intervention

Control

NO INTERVENTION

Control classroom will maintain their routine in sitting desks.

Interventions

InterventionBEHAVIORAL

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 .

Intervention

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danilo Rodrigues Pereira da Silva

Lisbon, 1800-071, Portugal

Location

Related Publications (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.

    PMID: 22968124BACKGROUND

  • 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.

    PMID: 25112481BACKGROUND

  • 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.

    PMID: 22540258BACKGROUND

  • 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.

    PMID: 25599350BACKGROUND

  • 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.

    PMID: 21767727BACKGROUND

  • 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.

    PMID: 21936895BACKGROUND

  • 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.

    PMID: 22340137BACKGROUND

  • 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.

    PMID: 26076699BACKGROUND

  • 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.

    PMID: 26315814BACKGROUND

  • 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.

    PMID: 21421945BACKGROUND

  • 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.

    PMID: 26626071BACKGROUND

  • 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.

    PMID: 26801914BACKGROUND

  • 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.

    PMID: 11932580BACKGROUND

  • 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.

    PMID: 20581716BACKGROUND

  • 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.

    PMID: 18949660BACKGROUND

  • 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.

    PMID: 36050353DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Luís Sardinha, PhD

    University of Lisbon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

September 13, 2016

First Posted

May 3, 2017

Study Start

January 4, 2016

Primary Completion

June 9, 2016

Study Completion

June 17, 2016

Last Updated

May 3, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)