NCT06376864

Brief Summary

The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

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 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

February 28, 2024

Last Update Submit

October 16, 2024

Conditions

Keywords

physical activitysedentary behaviourexecutive fundtionhealth promotionchildren

Outcome Measures

Primary Outcomes (4)

  • Executive function

    The Wisconsin Card Sorting Test (WCST): The computerized version of the WCST will be used to assess flexibility in decision making in this study. The number of total errors and perseverative errors and failure to maintain a set will be used as scores.

    baseline, 8 weeks, and 20 weeks

  • Psychological capacities

    Stroop Task. A computerized modified Stroop task will be used to reflect inhibition skills that help individuals override a prepotent response in favour of an alternative response.

    baseline, 8 weeks, and 20 weeks

  • Working memory

    Digit Span Backward: In this test, a participant will be presented with a series of digits to be repeated backwards.

    baseline, 8 weeks, and 20 weeks

  • Attention

    Measures of child attention levels will be measured using the online version of d2-R test of attention. TN-E is a total performance score which gives a measure of the relationship between performance accuracy and speed. TN-E scores are defined as 50-60% bad, 60-70% medium, 70-85% normal and over 85% is good.

    baseline, 8 weeks, and 20 weeks

Secondary Outcomes (4)

  • Physical activity (min/week)

    baseline, 8 weeks, and 20 weeks

  • Sedentary behavior (hour)

    baseline, 8 weeks, and 20 weeks

  • Body weight (kg)

    baseline, 8 weeks, and 20 weeks

  • Height (cm)

    baseline, 8 weeks, and 20 weeks

Study Arms (2)

Activity Breaks intervention

EXPERIMENTAL

The intervention arm will receive the Activity Breaks intervention.

Behavioral: Activity Breaks

The control group

NO INTERVENTION

The control arm will continue to receive their normal instruction.

Interventions

Activity BreaksBEHAVIORAL

The Activity Breaks intervention is a 5-minute Activity Breaks programme that allows classroom teachers of all ages and ability levels to lead simple movement activities within their classrooms, negating the need for additional personnel or space.

Activity Breaks intervention

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • School children in primary school (exclude private or special education schools), grades 4-6 (8-12 years old)
  • children with parental consent.

You may not qualify if:

  • Children with diagnosed behavioural or learning problems (e.g., attention-deficit hyperactivity disorder, ADHD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sport, Physical Education, and Health, Hong Kong Bapist University

Kowloon Tong, Hong Kong

Location

Related Publications (38)

  • Bartholomew JB, Jowers EM. Physically active academic lessons in elementary children. Prev Med. 2011 Jun;52 Suppl 1(Suppl):S51-4. doi: 10.1016/j.ypmed.2011.01.017. Epub 2011 Jan 31.

    PMID: 21281672BACKGROUND
  • Bates ME, Lemay EP Jr. The d2 Test of attention: construct validity and extensions in scoring techniques. J Int Neuropsychol Soc. 2004 May;10(3):392-400. doi: 10.1017/S135561770410307X.

    PMID: 15147597BACKGROUND
  • Carlson JA, Engelberg JK, Cain KL, Conway TL, Mignano AM, Bonilla EA, Geremia C, Sallis JF. Implementing classroom physical activity breaks: Associations with student physical activity and classroom behavior. Prev Med. 2015 Dec;81:67-72. doi: 10.1016/j.ypmed.2015.08.006. Epub 2015 Aug 19.

    PMID: 26297105BACKGROUND
  • Brooke HL, Atkin AJ, Corder K, Ekelund U, van Sluijs EM. Changes in time-segment specific physical activity between ages 10 and 14 years: A longitudinal observational study. J Sci Med Sport. 2016 Jan;19(1):29-34. doi: 10.1016/j.jsams.2014.10.003. Epub 2014 Oct 16.

    PMID: 25459234BACKGROUND
  • Carson V, Hunter S, Kuzik N, Gray CE, Poitras VJ, Chaput JP, Saunders TJ, Katzmarzyk PT, Okely AD, Connor Gorber S, Kho ME, Sampson M, Lee H, Tremblay MS. Systematic review of sedentary behaviour and health indicators in school-aged children and youth: an update. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S240-65. doi: 10.1139/apnm-2015-0630.

    PMID: 27306432BACKGROUND
  • Carson V, Hunter S, Kuzik N, Wiebe SA, Spence JC, Friedman A, Tremblay MS, Slater L, Hinkley T. Systematic review of physical activity and cognitive development in early childhood. J Sci Med Sport. 2016 Jul;19(7):573-8. doi: 10.1016/j.jsams.2015.07.011. Epub 2015 Jul 10.

    PMID: 26197943BACKGROUND
  • Chesham RA, Booth JN, Sweeney EL, Ryde GC, Gorely T, Brooks NE, Moran CN. The Daily Mile makes primary school children more active, less sedentary and improves their fitness and body composition: a quasi-experimental pilot study. BMC Med. 2018 May 10;16(1):64. doi: 10.1186/s12916-018-1049-z.

    PMID: 29743076BACKGROUND
  • Cliff DP, Hesketh KD, Vella SA, Hinkley T, Tsiros MD, Ridgers ND, Carver A, Veitch J, Parrish AM, Hardy LL, Plotnikoff RC, Okely AD, Salmon J, Lubans DR. Objectively measured sedentary behaviour and health and development in children and adolescents: systematic review and meta-analysis. Obes Rev. 2016 Apr;17(4):330-44. doi: 10.1111/obr.12371. Epub 2016 Feb 24.

    PMID: 26914664BACKGROUND
  • Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.

    PMID: 10797032BACKGROUND
  • Drummy C, Murtagh EM, McKee DP, Breslin G, Davison GW, Murphy MH. The effect of a classroom activity break on physical activity levels and adiposity in primary school children. J Paediatr Child Health. 2016 Jul;52(7):745-9. doi: 10.1111/jpc.13182. Epub 2016 May 11.

    PMID: 27168479BACKGROUND
  • Dumith SC, Gigante DP, Domingues MR, Kohl HW 3rd. Physical activity change during adolescence: a systematic review and a pooled analysis. Int J Epidemiol. 2011 Jun;40(3):685-98. doi: 10.1093/ije/dyq272. Epub 2011 Jan 18.

    PMID: 21245072BACKGROUND
  • Dunn LL, Venturanza JA, Walsh RJ, Nonas CA. An observational evaluation of move-to-improve, a classroom-based physical activity program, New York City schools, 2010. Prev Chronic Dis. 2012;9:E146. doi: 10.5888/pcd9.120072.

    PMID: 22974754BACKGROUND
  • Fairclough SJ, Hackett AF, Davies IG, Gobbi R, Mackintosh KA, Warburton GL, Stratton G, van Sluijs EM, Boddy LM. Promoting healthy weight in primary school children through physical activity and nutrition education: a pragmatic evaluation of the CHANGE! randomised intervention study. BMC Public Health. 2013 Jul 2;13:626. doi: 10.1186/1471-2458-13-626.

    PMID: 23819701BACKGROUND
  • Huang WY, Wong SHS, Sit CHP, Wong MCS, Sum RKW, Wong SWS, Yu JJ. Results from the Hong Kong's 2018 report card on physical activity for children and youth. J Exerc Sci Fit. 2019 Jan;17(1):14-19. doi: 10.1016/j.jesf.2018.10.003. Epub 2018 Oct 8.

    PMID: 30662509BACKGROUND
  • Kobel, S., Kettner, S., Dreyhaupt, J., & Steinacker, J. M. (2017). Objectively Determined Physical Activity Levels in German Primary School Children after a One Year School-based Health Promoting Intervention. Journal of Childhood Obesity, 2 (2).

    BACKGROUND
  • Lavelle HV, Mackay DF, Pell JP. Systematic review and meta-analysis of school-based interventions to reduce body mass index. J Public Health (Oxf). 2012 Aug;34(3):360-9. doi: 10.1093/pubmed/fdr116. Epub 2012 Jan 20.

    PMID: 22267291BACKGROUND
  • Lorentzen C, Ommundsen Y, Jenum AK, Holme I. The "Romsas in Motion" community intervention: program exposure and psychosocial mediated relationships to change in stages of change in physical activity. Int J Behav Nutr Phys Act. 2007 Apr 30;4:15. doi: 10.1186/1479-5868-4-15.

    PMID: 17466077BACKGROUND
  • McMichan L, Gibson AM, Rowe DA. Classroom-Based Physical Activity and Sedentary Behavior Interventions in Adolescents: A Systematic Review and Meta-Analysis. J Phys Act Health. 2018 May 1;15(5):383-393. doi: 10.1123/jpah.2017-0087. Epub 2018 Mar 23.

    PMID: 29570032BACKGROUND
  • Mahar MT, Murphy SK, Rowe DA, Golden J, Shields AT, Raedeke TD. Effects of a classroom-based program on physical activity and on-task behavior. Med Sci Sports Exerc. 2006 Dec;38(12):2086-94. doi: 10.1249/01.mss.0000235359.16685.a3.

    PMID: 17146314BACKGROUND
  • Markland, D., & Tobin, V. (2004). A Modification to the Behavioural Regulation in Exercise Questionnaire to Include an Assessment of Amotivation. Journal of Sport and Exercise Psychology, 26(2), 191-196.

    BACKGROUND
  • Mullins NM, Michaliszyn SF, Kelly-Miller N, Groll L. Elementary school classroom physical activity breaks: student, teacher, and facilitator perspectives. Adv Physiol Educ. 2019 Jun 1;43(2):140-148. doi: 10.1152/advan.00002.2019.

    PMID: 30933539BACKGROUND
  • Murtagh E, Mulvihill M, Markey O. Bizzy Break! The effect of a classroom-based activity break on in-school physical activity levels of primary school children. Pediatr Exerc Sci. 2013 May;25(2):300-7. doi: 10.1123/pes.25.2.300. Epub 2013 Mar 15.

    PMID: 23504941BACKGROUND
  • Norris E, Dunsmuir S, Duke-Williams O, Stamatakis E, Shelton N. Protocol for the 'Virtual Traveller' cluster-randomised controlled trial: a behaviour change intervention to increase physical activity in primary-school Maths and English lessons. BMJ Open. 2016 Jun 27;6(6):e011982. doi: 10.1136/bmjopen-2016-011982.

    PMID: 27354084BACKGROUND
  • Ridgers ND, Timperio A, Cerin E, Salmon J. Within- and between-day associations between children's sitting and physical activity time. BMC Public Health. 2015 Sep 23;15:950. doi: 10.1186/s12889-015-2291-3.

    PMID: 26400793BACKGROUND
  • Routen, A. C., Johnston, J. P., Glazebrook, C., & Sherar, L. B. (2018). Teacher perceptions on the delivery and implementation of movement integration strategies: The CLASS PAL (Physically Active Learning) Programme. International Journal of Educational Research, 88, 48-59.

    BACKGROUND
  • Salmon J, Arundell L, Hume C, Brown H, Hesketh K, Dunstan DW, Daly RM, Pearson N, Cerin E, Moodie M, Sheppard L, Ball K, Bagley S, Paw MC, Crawford D. A cluster-randomized controlled trial to reduce sedentary behavior and promote physical activity and health of 8-9 year olds: the Transform-Us! study. BMC Public Health. 2011 Oct 4;11:759. doi: 10.1186/1471-2458-11-759.

    PMID: 21970511BACKGROUND
  • Skrade, M. A. B. (n.d.). Integrated classroom physical activity: Examining perceived need satisfaction and academic performance in children p.93.

    BACKGROUND
  • Steele RM, van Sluijs EM, Sharp SJ, Landsbaugh JR, Ekelund U, Griffin SJ. An investigation of patterns of children's sedentary and vigorous physical activity throughout the week. Int J Behav Nutr Phys Act. 2010 Dec 9;7:88. doi: 10.1186/1479-5868-7-88.

    PMID: 21143901BACKGROUND
  • Stewart JA, Dennison DA, Kohl HW, Doyle JA. Exercise level and energy expenditure in the TAKE 10! in-class physical activity program. J Sch Health. 2004 Dec;74(10):397-400. doi: 10.1111/j.1746-1561.2004.tb06605.x.

    PMID: 15724566BACKGROUND
  • van Stralen MM, Yildirim M, Wulp A, te Velde SJ, Verloigne M, Doessegger A, Androutsos O, Kovacs E, Brug J, Chinapaw MJ. Measured sedentary time and physical activity during the school day of European 10- to 12-year-old children: the ENERGY project. J Sci Med Sport. 2014 Mar;17(2):201-6. doi: 10.1016/j.jsams.2013.04.019. Epub 2013 May 24.

    PMID: 23707474BACKGROUND
  • Tandon PS, Tovar A, Jayasuriya AT, Welker E, Schober DJ, Copeland K, Dev DA, Murriel AL, Amso D, Ward DS. The relationship between physical activity and diet and young children's cognitive development: A systematic review. Prev Med Rep. 2016 Apr 22;3:379-90. doi: 10.1016/j.pmedr.2016.04.003. eCollection 2016 Jun.

    PMID: 27419040BACKGROUND
  • Taylor SL, Noonan RJ, Knowles ZR, Owen MB, McGrane B, Curry WB, Fairclough SJ. Evaluation of a Pilot School-Based Physical Activity Clustered Randomised Controlled Trial-Active Schools: Skelmersdale. Int J Environ Res Public Health. 2018 May 17;15(5):1011. doi: 10.3390/ijerph15051011.

    PMID: 29772839BACKGROUND
  • Tremblay MS, Barnes JD, Gonzalez SA, Katzmarzyk PT, Onywera VO, Reilly JJ, Tomkinson GR; Global Matrix 2.0 Research Team. Global Matrix 2.0: Report Card Grades on the Physical Activity of Children and Youth Comparing 38 Countries. J Phys Act Health. 2016 Nov;13(11 Suppl 2):S343-S366. doi: 10.1123/jpah.2016-0594.

    PMID: 27848745BACKGROUND
  • Tremblay MS, Carson V, Chaput JP, Connor Gorber S, Dinh T, Duggan M, Faulkner G, Gray CE, Gruber R, Janson K, Janssen I, Katzmarzyk PT, Kho ME, Latimer-Cheung AE, LeBlanc C, Okely AD, Olds T, Pate RR, Phillips A, Poitras VJ, Rodenburg S, Sampson M, Saunders TJ, Stone JA, Stratton G, Weiss SK, Zehr L. Canadian 24-Hour Movement Guidelines for Children and Youth: An Integration of Physical Activity, Sedentary Behaviour, and Sleep. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S311-27. doi: 10.1139/apnm-2016-0151.

    PMID: 27306437BACKGROUND
  • Tremblay MS, Gray CE, Akinroye K, Harrington DM, Katzmarzyk PT, Lambert EV, Liukkonen J, Maddison R, Ocansey RT, Onywera VO, Prista A, Reilly JJ, Rodriguez Martinez MP, Sarmiento Duenas OL, Standage M, Tomkinson G. Physical activity of children: a global matrix of grades comparing 15 countries. J Phys Act Health. 2014 May;11 Suppl 1:S113-25. doi: 10.1123/jpah.2014-0177.

    PMID: 25426906BACKGROUND
  • 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
  • Trost SG, Sallis JF, Pate RR, Freedson PS, Taylor WC, Dowda M. Evaluating a model of parental influence on youth physical activity. Am J Prev Med. 2003 Nov;25(4):277-82. doi: 10.1016/s0749-3797(03)00217-4.

    PMID: 14580627BACKGROUND
  • Watson A, Timperio A, Brown H, Hesketh KD. A primary school active break programme (ACTI-BREAK): study protocol for a pilot cluster randomised controlled trial. Trials. 2017 Sep 19;18(1):433. doi: 10.1186/s13063-017-2163-5.

    PMID: 28927442BACKGROUND

MeSH Terms

Conditions

Child BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Julien S. BAKER, PhD

    HKBU

    STUDY CHAIR
  • Wendy Yajun HUANG, PhD

    Sport, Physical Education and Health/SOSC/HKBU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 28, 2024

First Posted

April 19, 2024

Study Start

January 1, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations