Physical Activity Clinical Trial
— ISKEOfficial title:
Cost-effectiveness and Impact of a Workplace-based Intervention to Reduce Occupational Sitting Time Among Office-based Workers: a Randomized Controlled Trial
NCT number | NCT06149364 |
Other study ID # | S1371 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | December 2027 |
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.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | December 2027 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - Non-ambulatory - Pregnant - Those participating in other RCTs - Those planning relocation |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Helsinki | University of Oulu |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Styles, B., & Torgerson, C. (2018). Randomised controlled trials (RCTs) in education research-methodological debates, questions, challenges. Educational Research, 60(3), 255-264
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Cost | Costs will be measured using the full cohort data for the control and intervention group including intervention costs, visits to the occupational health care, participant time spent on intervention and estimated work loss costs due to absenteeism/ sickness absence. | Assessments will be done at baseline, 3 months, 6 months, and 12 months | |
Secondary | Absenteeism | Work time missed,will be objectively measured through employer-recorded absence data for the intervention and control participants. Costs according to the reason of absence e.g., sickness leave will be obtained from the occupational health records and the employer. | Assessments will be done at baseline, 3 months, 6 months, and 12 months | |
Secondary | Presenteeism | Impairment at work/ reduced on-the-job effectiveness will be measured with Presenteeism Scale. | Assessments will be done at baseline, 3 months, 6 months, and 12 months | |
Secondary | Health related quality of life | will be measure with the Finnish version of the European Quality of Life with Five Domains (EQ-5D-5L), this questioner has three levels of quality in each domain. | Assessments will be done at baseline, 3 months, 6 months, and 12 months |
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