NCT06149364

Brief Summary

The purpose of this study is to examine the impact and cost effectiveness of a workplace-based intervention aimed at reducing prolonged occupational sitting among office-based workers. The study will be conducted in three phases. Phase I: is an Integrative review on economic evaluations of workplace-based interventions for reducing occupational sitting time. Phase II: is a secondary analysis of register data within the Northern Finland Birth Cohort 1966 (NFBC-1966). This is aimed at evaluating the association between prolonged sitting time with societal and/or organization economic perspective across different occupational categories at midlife. Phase III will be a Randomized Control Trial (RCT) of an office-based intervention designed to reduce prolonged occupational sitting time. The sample for the RCT will be 140 office-based workers - 70 participants will be enrolled in the control group whilst 70 participants will be enrolled within the intervention group. The study will be conducted from 2021 to 2025. An article-based dissertation will be completed at the end of the study, this will be mainly based on four articles that will be published in international peer reviewed journals.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jun 2024

Longer than P75 for not_applicable

Status
not yet recruiting

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 Progress55%
Jun 2024Dec 2027

First Submitted

Initial submission to the registry

November 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

November 15, 2023

Last Update Submit

April 8, 2024

Conditions

Keywords

Cost-effectivenessEconomic evaluationRandomized control trialSitting timeWorkplaceOffice workersProductivityAbsenteeismRCT

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    Physical activity will be objectively measured with the ActivePal accelerometer (PAL technologies LTD, Glasgow, UK). This is a thigh-worn, tri-axial accelerometer. The accelerometer was chosen because it is easy to use, discrete and can differentiate between sitting, standing, and stepping in varying postural transitions. Participants will be asked to wear the monitors for at least 14 days during workdays hours. The participants will then give the accelerometer to the researcher, data recorded on them will be downloaded and analyses.

    Assessments will be done at baseline, 3 months, 6 months, and 12 months. Data from activity monitoring, and a self-administered questionnaires will be used.

Secondary Outcomes (4)

  • Cost

    Assessments will be done at baseline, 3 months, 6 months, and 12 months

  • Absenteeism

    Assessments will be done at baseline, 3 months, 6 months, and 12 months

  • Presenteeism

    Assessments will be done at baseline, 3 months, 6 months, and 12 months

  • Health related quality of life

    Assessments will be done at baseline, 3 months, 6 months, and 12 months

Study Arms (1)

Control

EXPERIMENTAL

Control - usual practice; participants in this arm will be informed that the project is aimed at an economic evaluation of costs associated with usual patterns of office-based routines among desk-based workers. The measurements for both CG and IG will be taken at four times (baseline, 3 months, 6 months, and 12 months).

Behavioral: ISKE

Interventions

ISKEBEHAVIORAL

The intervention will consist of an e-health software Programme that we have named "Istumisen Keskeyttäminen (ISKE)" will be installed on the desktop of participants. Functionality of the software: the primary purpose of the software is to remind users (basically office-based workers) to take a break on a regular basis (recommended time 30 minutes). At the end of the workday, the software provides information on the number of breaks taken and how long each lasted. The user will also have access to such information. What happens during the prompted break: once the software prompts the user to take a break, she/he can click the Continue button to proceed with the break. The software will include activities that are suggested for the user to do during break. After the break, the record of the time (duration of the break, and when the break was taken) can be taken.

Control

Eligibility Criteria

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

You may qualify if:

  • working at least six full time hours
  • Age of 18-65 years
  • Speaking Finnish language
  • Having designated access to internet
  • Telephone, and a desk within their workplace (home and away from home workplaces will be considered).

You may not qualify if:

  • Non-ambulatory
  • Pregnant
  • Those participating in other RCTs
  • Those planning relocation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Kolu P, Kari JT, Raitanen J, Sievanen H, Tokola K, Havas E, Pehkonen J, Tammelin TH, Pahkala K, Hutri-Kahonen N, Raitakari OT, Vasankari T. Economic burden of low physical activity and high sedentary behaviour in Finland. J Epidemiol Community Health. 2022 Jul;76(7):677-684. doi: 10.1136/jech-2021-217998. Epub 2022 Apr 26.

    PMID: 35473717BACKGROUND
  • Akhavan Rad S, Kiwanuka F, Korpelainen R, Torkki P. Evidence base of economic evaluations of workplace-based interventions reducing occupational sitting time: an integrative review. BMJ Open. 2022 Jun 30;12(6):e060139. doi: 10.1136/bmjopen-2021-060139.

    PMID: 35772822BACKGROUND
  • Tcymbal A, Andreasyan D, Whiting S, Mikkelsen B, Rakovac I, Breda J. Prevalence of Physical Inactivity and Sedentary Behavior Among Adults in Armenia. Front Public Health. 2020 May 5;8:157. doi: 10.3389/fpubh.2020.00157. eCollection 2020.

    PMID: 32432072BACKGROUND
  • Deaton A, Cartwright N. Reflections on Randomized Control Trials. Soc Sci Med. 2018 Aug;210:86-90. doi: 10.1016/j.socscimed.2018.04.046. Epub 2018 Apr 28. No abstract available.

    PMID: 29731150BACKGROUND
  • Rollo S, Prapavessis H. A Combined Health Action Process Approach and mHealth Intervention to Increase Non-Sedentary Behaviours in Office-Working Adults-A Randomised Controlled Trial. Appl Psychol Health Well Being. 2020 Nov;12(3):660-686. doi: 10.1111/aphw.12201. Epub 2020 Apr 28.

    PMID: 32342662BACKGROUND
  • Styles, B., & Torgerson, C. (2018). Randomised controlled trials (RCTs) in education research-methodological debates, questions, challenges. Educational Research, 60(3), 255-264

    BACKGROUND
  • Vanni KJ, Neupane S, Siukola AE, Karinen HM, Pursio HK, Uitti J, Nygard CH. The Presenteeism Scale as a measure of productivity loss. Occup Med (Lond). 2018 Nov 16;68(8):512-518. doi: 10.1093/occmed/kqy124.

    PMID: 30219891BACKGROUND

Related Links

MeSH Terms

Conditions

Sedentary BehaviorOccupational DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Raija Korpelainen, Phd

    Oulu Deaconess Institute Foundation sr

    STUDY DIRECTOR

Central Study Contacts

Sanaz Akhavan Rad, MSC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 29, 2023

Study Start

June 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share