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

Study Overview
=================
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.

Official Title
-----------------
Workplace Intervention to Reduce Sitting Time, Decrease Musculoskeletal Symptoms, and Improve Cardiometabolic Markers in Sedentary Office Workers: a Randomized Clinical Trial.

Conditions
-----------------
Sedentary Behavior, Office Workers

Intervention / Treatment
-----------------
* Behavioral: Computer prompt Stand up for your Health®


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer prompt + Education (CP+E)<br>The intervention group consists of the implementation of the desktop application Stand up for your Health® following the model proposed by the Guide to Physical Activity at Work plus education through an information leaflet | Behavioral: Computer prompt Stand up for your Health®<br>* 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.<br>|
| No Intervention: Only Education (OE)<br>The control group will receive only education through an information leaflet also following the guidelines of the Work Physical Activity Guide on indications to control the time sitting at work. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedentary Behavior, Sitting time, Physical activity, Musculoskeletal symptoms, Cardiometabolic biomarkers