- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03560544
The Effect of Breaking up Sitting in the Workplace on Cardiometabolic Risk and Worker Productivity
October 9, 2018 updated by: Prof David Hewson, University of Bedfordshire
Pilot Study of a Tailored Intervention to Break up Sitting in the Workplace on Cardiometabolic Risk and Worker Productivity
This pilot randomized controlled trial (RCT) will examine the effect of a tailored workplace intervention based on interrupting sitting on work productivity, well-being and cardio-metabolic risk in office workers.
The experimental group in the 8-week intervention will be prompted to alternate between sitting and standing while working.
The ratio between sitting and standing will begin at 3:1 (two hours per day in an eight-hour day) and increase to 1:1 (four hours per day in an eight-hour day) by the end of the second week of the eight-week intervention.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bedfordshire
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Bedford, Bedfordshire, United Kingdom, MK42 9AP
- Bedford Borough Council
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Luton, Bedfordshire, United Kingdom, LU1 3JU
- University of Bedfordshire
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Full-time office employees from any ethnic background, PC/Android phone users, and recruited from two different work sites.
Exclusion Criteria:
- Pregnancy
- History of musculoskeletal complaint
- Non-ambulatory
- Having a planned holiday that would mean they would not be at work for more than two weeks during the 8-week intervention period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breaking up sitting time
A behaviour-change intervention to break up prolonged sitting in the workplace
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A three-part behaviour change intervention, including:
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No Intervention: Control
The participants in the control group will continue their daily activities as normal without any form of information about the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sitting time (objective)
Time Frame: Change from baseline sitting time at 8 weeks
|
Evaluation of change in sitting time in the workplace using wearable accelerometers (ActivPAL3; PAL Technologies Ltd., Glasgow, UK).
The ActivPAL will be worn on the right thigh.
|
Change from baseline sitting time at 8 weeks
|
Change in physical activity level (objective)
Time Frame: Change from baseline physical activity level at 8 weeks
|
Evaluation of physical activity time in the workplace using wearable accelerometers (ActivPAL3; PAL Technologies Ltd., Glasgow, UK).
The ActivPAL will be worn on the right thigh.
|
Change from baseline physical activity level at 8 weeks
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Change in sitting time (subjective)
Time Frame: Change from baseline sitting time at 8 weeks
|
The International Physical Activity Questionnaire (IPAQ) will be used to provide a subjective measure of sitting.
The scale provides a measure of reported sitting time in minutes.
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Change from baseline sitting time at 8 weeks
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Change in physical activity level (subjective)
Time Frame: Change from baseline physical activity level at 8 weeks
|
The International Physical Activity Questionnaire (IPAQ) will be used to provide a subjective measure of physical activity level.
The scale provides a measure of reported sitting time in minutes for each of three types of physical activity (vigorous, moderate, and walking).
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Change from baseline physical activity level at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absenteeism
Time Frame: Change from baseline absenteeism at 8 weeks
|
Participants will be asked to respond to questions on the Gaudine and Gregory questionnaire on unsanctioned absence.
Self-reported absenteeism will be calculated by adding the number of days reported for all the three questions.
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Change from baseline absenteeism at 8 weeks
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Presenteeism
Time Frame: Change from baseline presenteeism at 8 weeks
|
Presenteeism will be measured using Work Limitations Questionnaire (WLQ).
The WLQ requires employees to self-report their level of difficulty (or ability) to perform 25 specific job demands in the last 2 weeks.
Answers generated for the 25 items will be grouped into four work limitation scales including Time Management; Physical Demands; Mental/Interpersonal and Output Demands.
The scores for each subscale range from 0-100%, with 0 equivalent to no limitation and 100 equivalent to complete limitation.
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Change from baseline presenteeism at 8 weeks
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Ecological momentary assessment (EMA)
Time Frame: Eight weeks
|
Participants will be prompted at random four times between 9am to 5pm from Monday to Friday to complete a short questionnaire which will only take them 60 seconds to complete whilst in sitting position, standing and /or in walking position to enter their level of productivity.
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Eight weeks
|
Height
Time Frame: Once at baseline
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Measurement of height
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Once at baseline
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Change in weight
Time Frame: Change from baseline weight at 8 weeks
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Measurement of weight
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Change from baseline weight at 8 weeks
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Change in waist circumference
Time Frame: Change from baseline waist circumference at 8 weeks
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Measurement waist circumference
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Change from baseline waist circumference at 8 weeks
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Blood pressure
Time Frame: Change from baseline blood pressure at 8 weeks
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Systolic and diastolic blood pressure on the right arm after resting for at least 10 min in a seated position using an automated blood pressure monitor (Omron HEM705 CP, Omron Healthcare UK Limited, Milton Keynes, UK).
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Change from baseline blood pressure at 8 weeks
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Change in fasting total cholesterol
Time Frame: Change from baseline fasting total cholesterol at 8 weeks
|
Blood samples will be collected in capillary tubes after an overnight fast using a finger prick method with lancet.
Measures of total cholesterol will be made.
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Change from baseline fasting total cholesterol at 8 weeks
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Change in fasting high-density lipoprotein
Time Frame: Change from baseline fasting high-density lipoprotein at 8 weeks
|
Blood samples will be collected in capillary tubes after an overnight fast using a finger prick method with lancet.
Measures of high-density lipoprotein will be made.
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Change from baseline fasting high-density lipoprotein at 8 weeks
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Change in fasting triglycerides
Time Frame: Change from baseline fasting triglycerides at 8 weeks
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Blood samples will be collected in capillary tubes after an overnight fast using a finger prick method with lancet.
Measures of triglycerides will be made.
|
Change from baseline fasting triglycerides at 8 weeks
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Change in fasting blood glucose levels
Time Frame: Change from baseline fasting blood glucose levels at 8 weeks
|
Blood samples will be collected in capillary tubes after an overnight fast using a finger prick method with lancet.
Measures of blood glucose levels will be made.
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Change from baseline fasting blood glucose levels at 8 weeks
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Stress
Time Frame: Change from baseline stress at 8 weeks
|
Cohen Perceived Stress questionnaire will be used to assess perception of stress.
It primarily evaluates the unpredictability, uncontrollability and overload of an individual's life.
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Change from baseline stress at 8 weeks
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Mood
Time Frame: Change from baseline mood at 8 weeks
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The positive and negative affect schedule (PANAS) questionnaire is a 20-item self-report measure of both positive and negative affect.
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Change from baseline mood at 8 weeks
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Mental Wellbeing
Time Frame: Change from baseline mental wellbeing at 8 weeks
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The Warwick-Edinburgh Mental well-being Scale will be used to determine whether mental wellbeing changes.
This scale has 14 questions, with each question scored from 1-5, giving a total score from 14-70.
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Change from baseline mental wellbeing at 8 weeks
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Self-efficacy
Time Frame: Change from baseline self-efficacy at 8 weeks
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A generalised four-point Likert scale questionnaire will be used to measure the self-efficacy of the participants.
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Change from baseline self-efficacy at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2018
Primary Completion (Anticipated)
September 30, 2018
Study Completion (Anticipated)
December 31, 2018
Study Registration Dates
First Submitted
April 11, 2018
First Submitted That Met QC Criteria
June 6, 2018
First Posted (Actual)
June 18, 2018
Study Record Updates
Last Update Posted (Actual)
October 10, 2018
Last Update Submitted That Met QC Criteria
October 9, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- IHREC836
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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