Workplace Intervention to Reduce Sitting Time: a Randomized Clinical Trial.

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790837
• Other study ID #: 280-2022
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Universidad del Desarrollo
• Contact: Jaime E Leppe Zamora, PhD©
• Phone: +59 2 23279416/+56 985020166
• Email: jleppe[@]udd.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Sedentary behaviour and physical inactivity are risk factors for noncommunicable diseases related to the work environment. The accumulation of sitting time during the workday is related to musculoskeletal symptoms and worse cardiometabolic indicators.

The purpose of this study is to determine the effect of the "Stand up for your Health®" computer app on sitting time, musculoskeletal symptoms, cardiometabolic markers, and physical activity in office workers. Also, to determine the adherence to the intervention program by identifying barriers and facilitators referred by the participants.

In this 2-arm randomized controlled trial, both groups will be recruited from educational establishments and will be measured at baseline, 3rd, and 6th months. The experimental group will be implementing the "Stand Up for Your Health®" computer app plus educational information, while the control group will only receive educational information.

The same measurements will be completed in both groups during a 6 months follow-up period:

sedentary behaviour using the Actigraph accelerometers and the Occupational Sitting and Physical Activity Questionnaire (OSPAQ); musculoskeletal symptoms will be assessed by a pressure pain algometer and the Standardized Nordic Questionnaire of Perception of musculoskeletal Symptoms; and cardiometabolic markers and anthropometric measurements will also be assessed according to protocol.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Office Workers
• Sedentary Behavior

Intervention

Behavioral:
• Computer prompt "Stand up for your Health®"
The intervention group consists on the implementation of a desktop application "Stand up for your Health®" computer prompt following the model proposed by the Guide to Physical Activity at Work (34). This app works by showing reminders and asking users to pause their work activity and take an active break. Pauses can be customized and programmed according to the user's preference, allowing control of the time of each pause, between pauses, and the possibility of delaying or interrupting the pause. In this study, the "Stand up for your Health®" app will be scheduled to appear every 60 minutes on the workers' computers and each break will last for 2 minutes. During this resting period, the worker will see a notice or reminder on their screen with a countdown clock. The application allows you to postpone or interrupt directions.

Locations

Country	Name	City	State
Chile	Universidad Autónoma de Chile	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
Universidad del Desarrollo	Superintendencia de Seguridad Social, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (8)

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

Outcome

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)