Sedentary Behavior Clinical Trial
Official title:
Workplace Intervention to Reduce Sitting Time, Decrease Musculoskeletal Symptoms, and Improve Cardiometabolic Markers in Sedentary Office Workers: a Randomized Clinical Trial.
NCT number | NCT05790837 |
Other study ID # | 280-2022 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 16, 2023 |
Est. completion date | June 2024 |
The goal of this randomized clinical trial is to determine the effect of the computer prompt to break sitting time in office workers. The main question is: What is the effect of the computer prompt "Stand Up for Your Health®" plus education on sitting time, musculoskeletal symptoms, cardiometabolic markers, and physical activity in office workers compared with only education? In addition, to determine the level of adherence to the intervention program by identifying barriers and facilitators referred by the participants. The participants will be divided into two groups, the experimental and the control group. The participants in the experimental group will use the computer prompt on their desktop and receive information about sedentary behaviour, and the control group will receive only information. All participants will wear accelerometers for one week. The musculoskeletal symptoms and cardiometabolic markers will be measured at baseline, 3rd and 6th month.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - office workers over 18 years of age, - Full-time employees (=35 hours per week); - Spend most of their workday sitting (> 60%). This will be initially self-reported and used as selection criteria prior to the initial consent and measurement visit. This will be later confirmed using accelerometers; - Work in the same office place during the week; and - Able to walk without using an assistive device or requiring the assistance of another person. Exclusion Criteria: - Pregnant women; - Desktop workers using a height-adjustable workstation; and - Office workers sufficiently active according to WHO criteria. |
Country | Name | City | State |
---|---|---|---|
Chile | Universidad Autónoma de Chile | Santiago |
Lead Sponsor | Collaborator |
---|---|
Universidad del Desarrollo | Superintendencia de Seguridad Social, Chile |
Chile,
Ekelund U, Brown WJ, Steene-Johannessen J, Fagerland MW, Owen N, Powell KE, Bauman AE, Lee IM. Do the associations of sedentary behaviour with cardiovascular disease mortality and cancer mortality differ by physical activity level? A systematic review and harmonised meta-analysis of data from 850 060 participants. Br J Sports Med. 2019 Jul;53(14):886-894. doi: 10.1136/bjsports-2017-098963. Epub 2018 Jul 10. — View Citation
Ekelund U, Tarp J, Steene-Johannessen J, Hansen BH, Jefferis B, Fagerland MW, Whincup P, Diaz KM, Hooker SP, Chernofsky A, Larson MG, Spartano N, Vasan RS, Dohrn IM, Hagstromer M, Edwardson C, Yates T, Shiroma E, Anderssen SA, Lee IM. Dose-response associations between accelerometry measured physical activity and sedentary time and all cause mortality: systematic review and harmonised meta-analysis. BMJ. 2019 Aug 21;366:l4570. doi: 10.1136/bmj.l4570. — View Citation
Fernandez-Verdejo R, Suarez-Reyes M. [Physical inactivity versus sedentariness: analysis of the chilean national health survey 2016-2017]. Rev Med Chil. 2021 Jan;149(1):103-109. doi: 10.4067/S0034-98872021000100103. Spanish. — View Citation
Hadgraft NT, Winkler E, Climie RE, Grace MS, Romero L, Owen N, Dunstan D, Healy G, Dempsey PC. Effects of sedentary behaviour interventions on biomarkers of cardiometabolic risk in adults: systematic review with meta-analyses. Br J Sports Med. 2021 Feb;55(3):144-154. doi: 10.1136/bjsports-2019-101154. Epub 2020 Apr 8. — View Citation
Nunes AMP, Moita JPAM, Espanha MMMR, Petersen KK, Arendt-Nielsen L. Pressure pain thresholds in office workers with chronic neck pain: A systematic review and meta-analysis. Pain Pract. 2021 Sep;21(7):799-814. doi: 10.1111/papr.13014. Epub 2021 May 6. — View Citation
Parry SP, Coenen P, Shrestha N, O'Sullivan PB, Maher CG, Straker LM. Workplace interventions for increasing standing or walking for decreasing musculoskeletal symptoms in sedentary workers. Cochrane Database Syst Rev. 2019 Nov 17;2019(11):CD012487. doi: 10.1002/14651858.CD012487.pub2. — View Citation
Taylor WC, Williams JR, Harris LE, Shegog R. Computer Prompt Software to Reduce Sedentary Behavior and Promote Physical Activity Among Desk-Based Workers: A Systematic Review. Hum Factors. 2023 Aug;65(5):891-908. doi: 10.1177/00187208211034271. Epub 2021 Aug 15. — View Citation
Waongenngarm P, Areerak K, Janwantanakul P. The effects of breaks on low back pain, discomfort, and work productivity in office workers: A systematic review of randomized and non-randomized controlled trials. Appl Ergon. 2018 Apr;68:230-239. doi: 10.1016/j.apergo.2017.12.003. Epub 2017 Dec 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sedentary behaviour (occupational sitting time) at baseline | Sedentary behaviour will be objectively assessed using accelerometers Actigraph GT3X per a period of one week. Data will be downloaded and analyzed with ActiLife software.
Occupational sitting time shall be measured subjectively using the Occupational Sitting and Physical Activity Questionnaire (OSPAQ). |
During 1 week at T0 (baseline) | |
Primary | Sedentary behaviour (occupational sitting time) at 3rd month | Sedentary behaviour will be objectively assessed using accelerometers Actigraph GT3X per a period of one week. Data will be downloaded and analyzed with ActiLife software.
Occupational sitting time shall be measured subjectively using the Occupational Sitting and Physical Activity Questionnaire (OSPAQ). |
During 1 week at T1 (3rd month) | |
Primary | Sedentary behaviour (occupational sitting time) at 6th month | Sedentary behaviour will be objectively assessed using accelerometers Actigraph GT3X per a period of one week. Data will be downloaded and analyzed with ActiLife software.
Occupational sitting time shall be measured subjectively using the Occupational Sitting and Physical Activity Questionnaire (OSPAQ). |
During 1 week at T2 (6th month) | |
Secondary | Cardiometabolic biomarkers - Fasting blood glucose | Cardiometabolic health outcomes will be carried out following the standardized protocol in this study population. Measurements of fasting blood glucose in milligrams per deciliter (mg/dL) will be collected in blood samples on an empty stomach in the workplace by a trained and certified health professional. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Cardiometabolic biomarkers - Fasting insulin | Cardiometabolic health outcomes will be carried out following the standardized protocol in this study population. Measurements of fasting insulin in milligrams per deciliter (mg/dL) will be collected in blood samples on an empty stomach in the workplace by a trained and certified health professional. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Cardiometabolic biomarkers - Cortisol | Cardiometabolic health outcomes will be carried out following the standardized protocol in this study population. Measurements of cortisol in micrograms per deciliter (mcg/dL)will be collected in blood samples on an empty stomach in the workplace by a trained and certified health professional. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Cardiometabolic biomarkers - Triglycerides | Cardiometabolic health outcomes will be carried out following the standardized protocol in this study population. Measurements of triglycerides in milligrams per deciliter (mg/dL) will be collected in blood samples on an empty stomach in the workplace by a trained and certified health professional. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Cardiometabolic biomarkers - Total cholesterol | Cardiometabolic health outcomes will be carried out following the standardized protocol in this study population. Measurements of total cholesterol in milligrams per deciliter (mg/dL) will be collected in blood sample on an empty stomach in the workplace by a trained and certified health professional. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Cardiometabolic biomarkers - Low density lipoprotein cholesterol | Cardiometabolic health outcomes will be carried out following the standardized protocol in this study population. Measurements of low-density lipoprotein (LDL) cholesterol will be collected in a blood sample on an empty stomach in the workplace by a trained and certified health professional. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Cardiometabolic biomarkers - High density lipoprotein cholesterol | Cardiometabolic health outcomes will be carried out following the standardized protocol in this study population. Measurements of high-density lipoprotein (HDL) cholesterol will be collected in a blood sample on an empty stomach in the workplace by a trained and certified health professional.
Anthropometric measurements and blood pressure will be assessed in all participants. |
At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Anthropometric measurements - Height | Anthropometric measurements outcomes will be carried out following the standardized protocol in this study population. Height in meters (m) will be measured using an altimeter. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Anthropometric measurements - Weight | Anthropometric measurements outcomes will be carried out following the standardized protocol in this study population. Weight in kilograms (kg) will be measured using a digital scale. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Anthropometric measurements - Waist Circumference | Anthropometric measurements outcomes will be carried out following the standardized protocol in this study population. Waist Circumference in centimeters (cm) will be measured using a tape measure. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Anthropometric measurements - Body Mass Index | Anthropometric measurements outcomes will be carried out following the standardized protocol in this study population. Body Mass Index (BMI) in kilograms per square meters (kg/m2) will be calculated using the weight and height outcome measures. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Musculoskeletal symptoms - Pain | A pressure pain threshold algometer shall be used as an objective measurement and will provide a quantitative measurement of sensory perception of mechanical stimuli in kilopascal (kPa) units. | At T0 (baseline), T1 (3rd month) and T2 (6th month) | |
Secondary | Musculoskeletal symptoms - Symptoms | The standardized Nordic Questionnaire of perception of musculoskeletal symptoms will be used as a subjective measurement, providing a numerical pain scale.
All measurements will be performed by a physiotherapist and following a standardized measurement procedure for office workers |
At T0 (baseline), T1 (3rd month) and T2 (6th month) |
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