NCT06247228

Brief Summary

The goal of this clinical evaluate the effectiveness of the Ckick2Move Programme, a multicomponent digital-based intervention, to reduce sedentary behaviour among home-office workers, and the impact on employees physcial activity patterns, musculoskeletal risk and work-related outcomes (i.e., absenteeism, presenteeism, occupational fatigue and job satisfaction). The study will take place in four countries along Europe (Spain, Ireland, Netherlands, and Slovenia).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

January 11, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

January 11, 2024

Last Update Submit

July 11, 2024

Conditions

Keywords

Sedentary behaviourHome-officeOffice workTechnology

Outcome Measures

Primary Outcomes (3)

  • Occupational sitting time

    The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions. Participants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.

    Baseline, 3 months, 6 months and 12 months.

  • Leisure sitting time

    The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the leisure sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions.

    Baseline, 3 months, 6 months and 12 months.

  • Total sitting time

    The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the leisure sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions.

    Baseline, 3 months, 6 months and 12 months.

Secondary Outcomes (11)

  • Occupational physical activity (MVPA, LIPA and stepping)

    Baseline, 3 months, 6 months and 12 months.

  • Leisure-time physical activity (MVPA, LIPA and stepping)

    Baseline, 3 months, 6 months and 12 months.

  • Total physical activity (MVPA, LIPA and stepping)

    Baseline, 3 months, 6 months and 12 months.

  • Occupational standing time

    Baseline, 3 months, 6 months and 12 months.

  • Leisure standing time

    Baseline, 3 months, 6 months and 12 months.

  • +6 more secondary outcomes

Other Outcomes (2)

  • Process evaluation

    3 months, 6 months and 12 months

  • Socio demographic

    Baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group will receive the Click2Move intervention for one year, including a wearable (provided by the research group) and mobile phone application downloaded in the participants own mobile phone. Click2Move intervention comprises elements at three levels: environmental (activity tracking and app provision, reminders, cooperative challenges, and social chat), organisational level (organisational support and motivational messages), and at individual level (educational materials, self-monitoring, feedback provision, demonstration videos and a list of strategies).

Behavioral: Click2Move

Control group

NO INTERVENTION

Participants in the control arm will be asked to complete the same study measurements as those in the intervention arms, at the same time points. The control arm participants will not receive any device, nor will they have to download the mobile phone application. After the year of the intervention, they will be able to receive the intervention if they agree.

Interventions

Click2MoveBEHAVIORAL

One year multicomponent intervention including a wearable, and a mobile phone application downloaded in the own mobile phone. Participants will have activity tracking and app provision, sedentary reminders, cooperative challenges, organisational support and motivational messages, educational material, self-monitoring, feedback provision, demonstration videos and strategies.

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthesis Group

Manlleu, Catalonia, 08560, Spain

Location

Related Publications (22)

  • Edwardson CL, Yates T, Biddle SJH, Davies MJ, Dunstan DW, Esliger DW, Gray LJ, Jackson B, O'Connell SE, Waheed G, Munir F. Effectiveness of the Stand More AT (SMArT) Work intervention: cluster randomised controlled trial. BMJ. 2018 Oct 10;363:k3870. doi: 10.1136/bmj.k3870.

    PMID: 30305278BACKGROUND
  • Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.

    PMID: 22530986BACKGROUND
  • Rajkumar E, Rajan AM, Daniel M, Lakshmi R, John R, George AJ, Abraham J, Varghese J. The psychological impact of quarantine due to COVID-19: A systematic review of risk, protective factors and interventions using socio-ecological model framework. Heliyon. 2022 Jun;8(6):e09765. doi: 10.1016/j.heliyon.2022.e09765. Epub 2022 Jun 19.

    PMID: 35756104BACKGROUND
  • Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.

    PMID: 19362699BACKGROUND
  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

    PMID: 21513547BACKGROUND
  • Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.

    PMID: 23512568BACKGROUND
  • Huang Y, Benford S, Blake H. Digital Interventions to Reduce Sedentary Behaviors of Office Workers: Scoping Review. J Med Internet Res. 2019 Feb 7;21(2):e11079. doi: 10.2196/11079.

    PMID: 30730294BACKGROUND
  • Kessler RC, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, Pronk N, Simon G, Stang P, Ustun TB, Wang P. The World Health Organization Health and Work Performance Questionnaire (HPQ). J Occup Environ Med. 2003 Feb;45(2):156-74. doi: 10.1097/01.jom.0000052967.43131.51.

    PMID: 12625231BACKGROUND
  • Kessler RC, Ames M, Hymel PA, Loeppke R, McKenas DK, Richling DE, Stang PE, Ustun TB. Using the World Health Organization Health and Work Performance Questionnaire (HPQ) to evaluate the indirect workplace costs of illness. J Occup Environ Med. 2004 Jun;46(6 Suppl):S23-37. doi: 10.1097/01.jom.0000126683.75201.c5.

    PMID: 15194893BACKGROUND
  • van Veldhoven M, Broersen S. Measurement quality and validity of the "need for recovery scale". Occup Environ Med. 2003 Jun;60 Suppl 1(Suppl 1):i3-9. doi: 10.1136/oem.60.suppl_1.i3.

    PMID: 12782740BACKGROUND
  • de Croon EM, Sluiter JK, Frings-Dresen MH. Psychometric properties of the Need for Recovery after work scale: test-retest reliability and sensitivity to detect change. Occup Environ Med. 2006 Mar;63(3):202-6. doi: 10.1136/oem.2004.018275.

    PMID: 16497863BACKGROUND
  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.

    BACKGROUND
  • Nagy MS. Using a single-item approach to measure facet job satisfaction. Journal of Occupational and Organizational Psychology. 2002;75(1):77-86.

    BACKGROUND
  • Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.

    PMID: 15676628BACKGROUND
  • Powell C, Carson BP, Dowd KP, Donnelly AE. Simultaneous validation of five activity monitors for use in adult populations. Scand J Med Sci Sports. 2017 Dec;27(12):1881-1892. doi: 10.1111/sms.12813. Epub 2016 Dec 1.

    PMID: 27905148BACKGROUND
  • Wu Y, Petterson JL, Bray NW, Kimmerly DS, O'Brien MW. Validity of the activPAL monitor to measure stepping activity and activity intensity: A systematic review. Gait Posture. 2022 Sep;97:165-173. doi: 10.1016/j.gaitpost.2022.08.002. Epub 2022 Aug 6.

    PMID: 35964334BACKGROUND
  • Dowd KP, Harrington DM, Bourke AK, Nelson J, Donnelly AE. The measurement of sedentary patterns and behaviors using the activPAL Professional physical activity monitor. Physiol Meas. 2012 Nov;33(11):1887-99. doi: 10.1088/0967-3334/33/11/1887. Epub 2012 Oct 31.

    PMID: 23111150BACKGROUND
  • O'Brien MW, Wu Y, Petterson JL, Bray NW, Kimmerly DS. Validity of the ActivPAL monitor to distinguish postures: A systematic review. Gait Posture. 2022 May;94:107-113. doi: 10.1016/j.gaitpost.2022.03.002. Epub 2022 Mar 7.

    PMID: 35276456BACKGROUND
  • Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.

    PMID: 25791983BACKGROUND
  • Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.

    PMID: 34593508BACKGROUND
  • Liu JA, Wang Q, Lu ZX. Job satisfaction and its modeling among township health center employees: a quantitative study in poor rural China. BMC Health Serv Res. 2010 May 10;10:115. doi: 10.1186/1472-6963-10-115.

    PMID: 20459725BACKGROUND
  • Bort-Roig J, Pares-Salomon I, Loef B, Vaque-Crusellas C, Coffey A, Gustems-Morral A, Sene-Mir AM, Luznik I, Pajek M, Dowd KP, Puig-Ribera A, Proper KI. A digital intervention to reduce home-office workers' sedentary behaviour: protocol for the evaluation of the Click2Move programme, a cluster randomised controlled trial. BMC Public Health. 2025 Jan 30;25(1):387. doi: 10.1186/s12889-025-21598-7.

Study Officials

  • Judit Bort-Roig, PhD

    UVic-UCC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 11, 2024

First Posted

February 7, 2024

Study Start

April 1, 2024

Primary Completion

September 1, 2024

Study Completion

June 1, 2025

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations