Cardiovascular Risk FactorNCT03468894
Breaking up Sitting With a Treadmill Desk in Office Workers
A study testing Treadmill desk walking in people with Cardiovascular Risk Factor and Type2 Diabetes, run by University of Bedfordshire.
Trial summary
Sitting for long uninterrupted periods of time can increase risk of heart disease, diabetes and early death, even if you take part in the United Kingdom government guidelines for physical activity of 21/2 hours per week of exercise. Effective interventions to reduce the risk of these diseases are therefore needed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Type2 Diabetes, Sedentary Lifestyle
- What is being tested?
- Treadmill desk walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2018to 30 Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults aged 18-65 years who work for shifts lasting ≥ 6 h and spend ≥ 75% of this time sitting at their desk
- work a minimum of 3 days per week
Who cannot join
- the presence of any known blood borne disease
- self-reported diagnosed diabetes
- physical activity contraindications
- pregnancy
- any major injury or illness, tobacco use, or any other health issue that my limit the participant in carrying out the required activity bouts.
- any planned absence from their office for more than one week during the 4 week study period.
About this study
Official title: Breaking up Prolonged Sitting Time in Office Workers With Light-intensity Walking: A Pilot Randomized Controlled Trial
Sitting for long uninterrupted periods of time can increase risk of heart disease, diabetes and early death, even if you take part in the United Kingdom government guidelines for physical activity of 21/2 hours per week of exercise. Effective interventions to reduce the risk of these diseases are therefore needed. The aim of this study is to examine the effects of regularly breaking up sitting time with light intensity treadmill desk walking among office workers on health markers, sitting time and physical activity. If using a treadmill desk leads to benefits in these disease risk markers then this could be an effective strategy to improve employee health in the workplace.
Participants will be randomly assigned to the intervention group or the control group. After baseline activity and health measures, they will take part in the study for 4 weeks.
Read more
Intervention group: Participants will have a treadmill desk placed in their office or a nearby location and will be asked to walk while working on the treadmill desk continuously for 20 minutes at a self-selected slow pace each hour for a minimum of 6 hours per shift. There will be one treadmill desk between 2-3 people.
Control group: Participants will be asked to work as usual at their regular workstation with no changes in their physical activity and dietary habits.
Sitting time and physical activity will be measured at baseline and during the last week f the intervention. A range of health and psychological measures will be taken at baseline and post-intervention.
- Being tested
- Treadmill desk walking
- Keywords
- prolonged sitting, sedentary behaviour, physical activity, office workplace
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill desk walkingBehavioural
See intervention arm description
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will continue to work as usual at their regular workstations. |
| Intervention | Experimental | A shared treadmill workstation will be installed in participating offices, or in a nearby location in case there is no space to fit the workstation in the office, enrolled to this group. Within the intervention group there will be a maximum allocation of two participants per treadmill desk. The participants in the intervention group will be asked to interrupt their sitting with 20 minutes of self-selected light-intensity walking at a speed of 1-4 km/h each hour for a minimum of 6 hours per shift to accumulate a total of 2 hours of light-intensity activity per work day. Receives: Behavioral: Treadmill desk walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Workplace sitting time
This will be objectively measured using an activpal thigh worn activity monitor
Measured: Baseline and week 4 of intervention
Secondary outcomes (20)
Change in Workplace stepping
This will be objectively measured using an activpal thigh worn activity monitor
Measured: Baseline and week 4 of intervention
Change in Daily sitting time
This will be objectively measured using an activpal thigh worn activity monitor
Measured: Baseline and week 4 of intervention
Change in Daily physical activity
This will be objectively measured using an activpal thigh worn activity monitor
Measured: Baseline and week 4 of intervention
Change in Sleep quality and quantity
Measured with the Pittsburgh Sleep Quality Index
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in Mental-wellbeing
Measured using the Warwick-Edinburgh Mental Well-being Scale. each of the following items is indicated on the following scale: none of the time=1; rarely=2; some of the time=3; often=4; all of the time=5 (5 indicating a better outcome).The total scores are summed.
Items:
- I've been feeling optimistic about the future
- I've been feeling useful
- I've been feeling relaxed
- I've been feeling interested in other people
- I've had energy to spare
- I've been dealing with problems well
- I've been thinking clearly
- I've been feeling good about myself
- I've been feeling close to other people
- I've been feeling confident
- I've been able to make up my own mind about things
- I've been feeling loved
- I've been interested in new things
- I've been feeling cheerful
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in body mass index (kg/m2)
Calculated with measurement of height and weight
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in waist circumference (cm)
Measured with a tape measure at the level of the umbillicus
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in blood pressure (mmHg)
Measured using an automated blood pressure monitoring device
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in blood glucose (mmol/L)
Measured via finger prick method and analysed using the Cholestech analyser
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in triglycerides (mmol/L)
Measured via finger prick method and analysed using the Cholestech analyser
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in high-density lipoprotein cholesterol (mmol/L)
Measured via finger prick method and analysed using the Cholestech analyser
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in positive and negative affect
Measured using the positive and negative affect scale. Items will be measured on the following scale: very slightly or not at all=1; a little=2; moderately=3; quite a bit=4; extremely=5.
The items are:
- interested
- distressed
- excited
- upset
- strong
- guilty
- scared
- hostile
- enthusiastic
- proud
- irritable
- alert
- ashamed
- inspired
- nervous
- determined
- attentive
- jittery
- active
- afraid
The 10 items for POSITIVE (PA) affect are:
attentive, interested, alert, excited, enthusiastic, inspired, proud, determined, strong and active.
The 10 items for NEGATIVE (NA) affect are:
distressed, upset, hostile, irritable, scared, afraid, ashamed, guilty and nervous, jittery.
The scores generated will vary along the scale of 10 - 50, with lower scores indicating low (positive or negative) affect and higher scores indicating high (positive or negative) affect.
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in self-efficacy
Measured using the Self-Efficacy Scale questionnaire (Schwarzer and Renner, 2009)
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in job performance
Measured using a single-item 7-point likert scale
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in work engagement
Measured using the Utrecht Work Engagement Scale multi-item 7-point likert scale
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in musculoskeletal symptoms
Measured using the Sandardised Nordic Questionnaire
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in presenteeism
Measured using the 8-item Work Limitations Questionnaire
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in quality of life
Measured using the World Health Organization Quality of Life questionnaire
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in perceived stress
Measured using the Cohen Perceived Stress likert scale.
10 items are answered on the following scale that refer to the person's thoughts and feelings over the past month: never=1; almost never=2; sometimes=3; fairly often=4; very often=5
The items are in the past month how often have you:
- been upset because of something that happened unexpectedly
- felt unable to control the important things in your life
- felt nervous or stressed
- felt confident about your ability to handle personal problems
- felt that things were going your way
- found that you could not cope with all the things you had to do
- been able to control irritations in your life
- that you were on top of things
- been angry because of things that happened that were outside of your control
- felt that difficulties were piling up so high that you could not overcome them
Positively worded items are reverse scored and the ratings are summed, with higher scores indicating more perceived stress.
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Change in perceived vigor
Measured using a 12 item likert scale. The scale is: never of almost never=1; very infrequently=2; quite infrequently=3; sometimes=4; quite frequently=5; very frequently=6; always or almost always=7.
The items are based on how often have you felt this way at work? There are three subscales of the Shirom-Melamed Vigor Measure. The three subscales are: Physical Strength; Emotional Energy; and Cognitive Liveliness.
Higher scores indicate better outcomes.
Measured: Baseline and post-intervention (within 1 week after intervention ends)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start22 Mar 2018 (estimated)
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Why it stopped: Insufficient resources to support study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Model description
- Pilot RCT
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bedfordshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bailey, University of Bedfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468894
- Sponsor's protocol ID
- Not yet available
- Status last verified
- Apr 2019
- First submitted
- 28 Feb 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking up Prolonged Sitting Time in Office Workers With Light-intensity Walking: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03468894
- Acronym / sponsor ID
- Not yet available
- Keywords
- prolonged sitting, sedentary behaviour, physical activity, office workplace
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient resources to support study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Study start
- 22 Mar 2018 (estimated)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 19 Mar 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.
Sitting for long uninterrupted periods of time can increase risk of heart disease, diabetes and early death, even if you take part in the United Kingdom government guidelines for physical activity of 21/2 hours per week of exercise. Effective interventions to reduce the risk of these diseases are therefore needed. The aim of this study is to examine the effects of regularly breaking up sitting time with light intensity treadmill desk walking among office workers on health markers, sitting time and physical activity. If using a treadmill desk leads to benefits in these disease risk markers then this could be an effective strategy to improve employee health in the workplace.
Participants will be randomly assigned to the intervention group or the control group. After baseline activity and health measures, they will take part in the study for 4 weeks.
Intervention group: Participants will have a treadmill desk placed in their office or a nearby location and will be asked to walk while working on the treadmill desk continuously for 20 minutes at a self-selected slow pace each hour for a minimum of 6 hours per shift. There will be one treadmill desk between 2-3 people.
Control group: Participants will be asked to work as usual at their regular workstation with no changes in their physical activity and dietary habits.
Sitting time and physical activity will be measured at baseline and during the last week f the intervention. A range of health and psychological measures will be taken at baseline and post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot RCT
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will continue to work as usual at their regular workstations. |
| Intervention | Experimental | Behavioral: Treadmill desk walkingA shared treadmill workstation will be installed in participating offices, or in a nearby location in case there is no space to fit the workstation in the office, enrolled to this group. Within the intervention group there will be a maximum allocation of two participants per treadmill desk. The participants in the intervention group will be asked to interrupt their sitting with 20 minutes of self-selected light-intensity walking at a speed of 1-4 km/h each hour for a minimum of 6 hours per shift to accumulate a total of 2 hours of light-intensity activity per work day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults aged 18-65 years who work for shifts lasting ≥ 6 h and spend ≥ 75% of this time sitting at their desk
- work a minimum of 3 days per week
Key exclusion criteria (6 listed)
- the presence of any known blood borne disease
- self-reported diagnosed diabetes
- physical activity contraindications
- pregnancy
- any major injury or illness, tobacco use, or any other health issue that my limit the participant in carrying out the required activity bouts.
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 |
|---|---|---|
| Treadmill desk walkingSee intervention arm description | Behavioural | Intervention |
Primary outcome
Change in Workplace sitting time
Time frame: Baseline and week 4 of intervention
This will be objectively measured using an activpal thigh worn activity monitor
20 secondary outcomes
Change in Workplace stepping
Time frame: Baseline and week 4 of intervention
Change in Daily sitting time
Time frame: Baseline and week 4 of intervention
Change in Daily physical activity
Time frame: Baseline and week 4 of intervention
Change in Sleep quality and quantity
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in Mental-wellbeing
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in body mass index (kg/m2)
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in waist circumference (cm)
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in blood pressure (mmHg)
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in blood glucose (mmol/L)
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in triglycerides (mmol/L)
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in high-density lipoprotein cholesterol (mmol/L)
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in positive and negative affect
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in self-efficacy
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in job performance
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in work engagement
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in musculoskeletal symptoms
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in presenteeism
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in quality of life
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in perceived stress
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Change in perceived vigor
Time frame: Baseline and post-intervention (within 1 week after intervention ends)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill desk walking in people with Cardiovascular Risk Factor and Type2 Diabetes, run by University of Bedfordshire.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 Workplace sitting time (time frame: Baseline and week 4 of intervention). 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 18 Apr 2019.