Clinical trial NCT05790837: Workplace Intervention to Reduce Sitting Time: a Randomized 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Office Workers
Keywords: Sedentary Behavior
Sitting time
Physical activity
Musculoskeletal symptoms
Cardiometabolic biomarkers
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
Collaborators: name: Superintendencia de Seguridad Social - Gobierno de Chile
First posted: 2023-03-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel-group trial. The groups will be recruited from higher education institutions. The length of this study will be six months. Measurements shall be made for both groups at baseline, 3rd, and 6th months.

The intervention group will receive the computer prompt "Stand up for your Health®" and information about sedentary behaviour. The computer prompt appears when the workers accumulate one hour the work front to screen. The break is two minutes, and one video with exercises starts with instructions for workers during this time.

The control group will receive only information through the leaflet.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sedentary behaviour (occupational sitting time) at baseline
timeFrame: During 1 week at T0 (baseline)
measure: Sedentary behaviour (occupational sitting time) at 3rd month
timeFrame: During 1 week at T1 (3rd month)
measure: Sedentary behaviour (occupational sitting time) at 6th month
timeFrame: During 1 week at T2 (6th month)
Secondary outcomes:
measure: Cardiometabolic biomarkers - Fasting blood glucose
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Cardiometabolic biomarkers - Fasting insulin
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Cardiometabolic biomarkers - Cortisol
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Cardiometabolic biomarkers - Triglycerides
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Cardiometabolic biomarkers - Total cholesterol
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Cardiometabolic biomarkers - Low density lipoprotein cholesterol
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Cardiometabolic biomarkers - High density lipoprotein cholesterol
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Anthropometric measurements - Height
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Anthropometric measurements - Weight
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Anthropometric measurements - Waist Circumference
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Anthropometric measurements - Body Mass Index
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Musculoskeletal symptoms - Pain
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
measure: Musculoskeletal symptoms - Symptoms
timeFrame: At T0 (baseline), T1 (3rd month) and T2 (6th month)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad Autónoma de Chile
Study officials:
affiliation: Universidad del Desarrollo, Santiago, Region Metropolitana, Chile
name: Jaime E Leppe Zamora, PhD©
role: PRINCIPAL_INVESTIGATOR
References:
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