Sedentary LifestyleNCT03560544
The Effect of Breaking up Sitting in the Workplace on Cardiometabolic Risk and Worker Productivity
A study testing Breaking up sitting in people with Sedentary Lifestyle, run by University of Bedfordshire at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Breaking up sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Jun 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-time office employees from any ethnic background, PC/Android phone users, and recruited from two different work sites.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Bedford Borough Council
Bedford, Bedfordshire, MK42 9AP
University of Bedfordshire
Luton, Bedfordshire, LU1 3JU
About this study
Official title: 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- Breaking up sitting
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breaking up sittingBehavioural
A three-part behaviour change intervention, including:
- Supportive organisational culture and knowledge of consequence of prolonged sitting
- Environmental Modification
- Behavioural Changes
| Study group | Role | What they receive |
|---|---|---|
| Breaking up sitting time | Experimental | A behaviour-change intervention to break up prolonged sitting in the workplace Receives: Behavioral: Breaking up sitting |
| Control | No intervention | The participants in the control group will continue their daily activities as normal without any form of information about the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sitting time (objective)
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.
Measured: Change from baseline sitting time at 8 weeks
Change in physical activity level (objective)
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.
Measured: Change from baseline physical activity level at 8 weeks
Change in sitting time (subjective)
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.
Measured: Change from baseline sitting time at 8 weeks
Change in physical activity level (subjective)
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).
Measured: Change from baseline physical activity level at 8 weeks
Secondary outcomes (15)
Absenteeism
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.
Measured: Change from baseline absenteeism at 8 weeks
Presenteeism
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.
Measured: Change from baseline presenteeism at 8 weeks
Ecological momentary assessment (EMA)
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.
Measured: Eight weeks
Height
Measurement of height
Measured: Once at baseline
Change in weight
Measurement of weight
Measured: Change from baseline weight at 8 weeks
Change in waist circumference
Measurement waist circumference
Measured: Change from baseline waist circumference at 8 weeks
Blood pressure
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).
Measured: Change from baseline blood pressure at 8 weeks
Change in fasting total cholesterol
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.
Measured: Change from baseline fasting total cholesterol at 8 weeks
Change in fasting high-density lipoprotein
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.
Measured: Change from baseline fasting high-density lipoprotein at 8 weeks
Change in fasting triglycerides
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.
Measured: Change from baseline fasting triglycerides at 8 weeks
Change in fasting blood glucose levels
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.
Measured: Change from baseline fasting blood glucose levels at 8 weeks
Stress
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.
Measured: Change from baseline stress at 8 weeks
Mood
The positive and negative affect schedule (PANAS) questionnaire is a 20-item self-report measure of both positive and negative affect.
Measured: Change from baseline mood at 8 weeks
Mental Wellbeing
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.
Measured: Change from baseline mental wellbeing at 8 weeks
Self-efficacy
A generalised four-point Likert scale questionnaire will be used to measure the self-efficacy of the participants.
Measured: Change from baseline self-efficacy at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start25 Jun 2018
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bedfordshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof David Hewson, University of Bedfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560544
- Sponsor's protocol ID
- IHREC836
- Status last verified
- Oct 2018
- First submitted
- 11 Apr 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Tailored Intervention to Break up Sitting in the Workplace on Cardiometabolic Risk and Worker Productivity
- ClinicalTrials.gov ID
- NCT03560544
- Acronym / sponsor ID
- IHREC836
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breaking up sitting time | Experimental | Behavioral: Breaking up sittingA behaviour-change intervention to break up prolonged sitting in the workplace |
| Control | No intervention | –The participants in the control group will continue their daily activities as normal without any form of information about the intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Full-time office employees from any ethnic background, PC/Android phone users, and recruited from two different work sites.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breaking up sittingA three-part behaviour change intervention, including: 1. Supportive organisational culture and knowledge of consequence of prolonged sitting 2. Environmental Modification 3. Behavioural Changes | Behavioural | Breaking up sitting time |
Primary outcome
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 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 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.
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).
15 secondary outcomes
Absenteeism
Time frame: Change from baseline absenteeism at 8 weeks
Presenteeism
Time frame: Change from baseline presenteeism at 8 weeks
Ecological momentary assessment (EMA)
Time frame: Eight weeks
Height
Time frame: Once at baseline
Change in weight
Time frame: Change from baseline weight at 8 weeks
Change in waist circumference
Time frame: Change from baseline waist circumference at 8 weeks
Blood pressure
Time frame: Change from baseline blood pressure at 8 weeks
Change in fasting total cholesterol
Time frame: Change from baseline fasting total cholesterol at 8 weeks
Change in fasting high-density lipoprotein
Time frame: Change from baseline fasting high-density lipoprotein at 8 weeks
Change in fasting triglycerides
Time frame: Change from baseline fasting triglycerides at 8 weeks
Change in fasting blood glucose levels
Time frame: Change from baseline fasting blood glucose levels at 8 weeks
Stress
Time frame: Change from baseline stress at 8 weeks
Mood
Time frame: Change from baseline mood at 8 weeks
Mental Wellbeing
Time frame: Change from baseline mental wellbeing at 8 weeks
Self-efficacy
Time frame: Change from baseline self-efficacy at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Sedentary Lifestyle
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breaking up sitting in people with Sedentary Lifestyle, run by University of Bedfordshire at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sitting time (objective) (time frame: Change from baseline sitting time at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.